GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing [see Contraindications (4)].

GENOTROPIN is indicated for the treatment of growth failure in pediatric patients born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.

GENOTROPIN is indicated for the treatment of growth failure associated with Turner syndrome.

GENOTROPIN is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) ≤-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.

GENOTROPIN is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

General Pediatric Dosing Information

The GENOTROPIN dosage and administration schedule should be individualized based on the growth response of each patient.

Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).

Treatment with GENOTROPIN for short stature should be discontinued when the epiphyses are fused.

Pediatric Growth Hormone Deficiency (GHD)

Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended.

Prader-Willi Syndrome

Generally, a dose of 0.24 mg/kg body weight/week is recommended.

Turner Syndrome

Generally, a dose of 0.33 mg/kg body weight/week is recommended.

Idiopathic Short Stature

Generally, a dose up to 0.47 mg/kg body weight/week is recommended.

Small for Gestational Age1

Generally, a dose of up to 0.48 mg/kg body weight/week is recommended.

Adult Growth Hormone Deficiency (GHD)

Either of two approaches to GENOTROPIN dosing may be followed: a non-weight based regimen or a weight based regimen.

Non-weight based — based on published consensus guidelines, a starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1–2 months by increments of approximately 0.1–0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor I (IGF-I) concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients.

Weight based — based on the dosing regimen used in the original adult GHD registration trials, the recommended dosage at the start of treatment is not more than 0.04 mg/kg/week. The dose may be increased according to individual patient requirements to not more than 0.08 mg/kg/week at 4–8 week intervals. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I concentrations should be used as guidance in dose titration.

A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.

The GENOTROPIN 5 and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN PEN delivery device. The 5 mg cartridge has a green tip to match the green pen window on the Pen 5, while the 12 mg cartridge has a purple tip to match the purple pen window on the Pen 12.

Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. GENOTROPIN MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

GENOTROPIN may be given in the thigh, buttocks, or abdomen; the site of SC injections should be rotated daily to help prevent lipoatrophy.

GENOTROPIN is a white, lyophilized powder available as:

{ "type": "p", "children": [], "text": "GENOTROPIN is a white, lyophilized powder available as:" }

{ "type": "", "children": [], "text": "" }

GENOTROPIN is contraindicated in patients with:

• Acute Critical Illness

Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure [see Warnings and Precautions (5.1)].

• Prader-Willi Syndrome in Children

Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients [see Warnings and Precautions (5.2)].

• Active Malignancy

In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.

• Hypersensitivity

GENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6)].

• Diabetic Retinopathy

Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

• Closed Epiphyses

Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses.

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin [see Contraindications (4)]. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3–8 mg/day) compared to those receiving placebo. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients having acute critical illnesses should be weighed against the potential risk.

There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If during treatment with somatropin, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications (4)].

In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence [see Contraindications (4)].

Monitor all patients with a history of GHD secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor.

Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, practitioners should thoroughly consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms.

Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi.

Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in susceptible patients. As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. New-onset Type 2 diabetes mellitus has been reported. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin therapy. The doses of antihyperglycemic drugs (i.e., insulin or oral/injectable agents) may require adjustment when somatropin therapy is instituted in these patients.

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with somatropins. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Fundoscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by fundoscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner syndrome and Prader-Willi syndrome may be at increased risk for the development of IH.

Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications (4)].

Fluid retention during somatropin replacement therapy in adults may occur. Clinical manifestations of fluid retention (e.g., edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent.

Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment [see Drug Interactions (7.1)].

Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, the growth response in children. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. In patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients treated with somatropin should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.

Slipped capital femoral epiphyses may occur more frequently in patients with endocrine disorders (including GHD and Turner syndrome) or in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.

Progression of scoliosis can occur in patients who experience rapid growth. Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. However, somatropin has not been shown to increase the occurrence of scoliosis. Skeletal abnormalities including scoliosis are commonly seen in untreated Turner syndrome patients. Scoliosis is also commonly seen in untreated patients with Prader-Willi syndrome. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy.

Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions.

When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site [see Dosage and Administration (2.3)].

Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-I may increase during somatropin therapy.

Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin–treated patient, especially a child, who develops persistent severe abdominal pain.

Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation, and may not reflect the adverse reaction rates observed in practice.

Clinical Trials in children with GHD

In clinical studies with GENOTROPIN in pediatric GHD patients, the following events were reported infrequently: injection site reactions, including pain or burning associated with the injection, fibrosis, nodules, rash, inflammation, pigmentation, or bleeding; lipoatrophy; headache; hematuria; hypothyroidism; and mild hyperglycemia.

Clinical Trials in PWS

In two clinical studies with GENOTROPIN in pediatric patients with Prader-Willi syndrome, the following drug-related events were reported: edema, aggressiveness, arthralgia, benign intracranial hypertension, hair loss, headache, and myalgia.

Clinical Trials in children with SGA

In clinical studies of 273 pediatric patients born small for gestational age treated with GENOTROPIN, the following clinically significant events were reported: mild transient hyperglycemia, one patient with benign intracranial hypertension, two patients with central precocious puberty, two patients with jaw prominence, and several patients with aggravation of preexisting scoliosis, injection site reactions, and self-limited progression of pigmented nevi. Anti-hGH antibodies were not detected in any of the patients treated with GENOTROPIN.

Clinical Trials in children with Turner Syndrome

In two clinical studies with GENOTROPIN in pediatric patients with Turner syndrome, the most frequently reported adverse events were respiratory illnesses (influenza, tonsillitis, otitis, sinusitis), joint pain, and urinary tract infection. The only treatment-related adverse event that occurred in more than 1 patient was joint pain.

Clinical Trials in children with Idiopathic Short Stature

In two open-label clinical studies with GENOTROPIN in pediatric patients with ISS, the most commonly encountered adverse events include upper respiratory tract infections, influenza, tonsillitis, nasopharyngitis, gastroenteritis, headaches, increased appetite, pyrexia, fracture, altered mood, and arthralgia. In one of the two studies, during GENOTROPIN treatment, the mean IGF-1 standard deviation (SD) scores were maintained in the normal range. IGF-1 SD scores above +2 SD were observed as follows: 1 subject (3%), 10 subjects (30%) and 16 subjects (38%) in the untreated control, 0. 23 and the 0.47 mg/kg/week groups, respectively, had at least one measurement; while 0 subjects (0%), 2 subjects (7%) and 6 subjects (14%) had two or more consecutive IGF-1 measurements above +2 SD.

Clinical Trials in adults with GHD

In clinical trials with GENOTROPIN in 1,145 GHD adults, the majority of the adverse events consisted of mild to moderate symptoms of fluid retention, including peripheral swelling, arthralgia, pain and stiffness of the extremities, peripheral edema, myalgia, paresthesia, and hypoesthesia. These events were reported early during therapy and tended to be transient and/or responsive to dosage reduction.

Table 1 displays the adverse events reported by 5% or more of adult GHD patients in clinical trials after various durations of treatment with GENOTROPIN. Also presented are the corresponding incidence rates of these adverse events in placebo patients during the 6-month double-blind portion of the clinical trials.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 1. Adverse Events Reported by ≥ 5% of 1,145 Adult GHD Patients During Clinical Trials of GENOTROPIN and Placebo, Grouped by Duration of Treatment</span> </caption> <col width="19%"/> <col width="12%"/> <col width="17%"/> <col width="12%"/> <col width="12%"/> <col width="12%"/> <thead> <tr class="First"> <th align="left" class="Rrule Toprule" valign="top"></th><th align="center" class="Rrule Toprule" colspan="2" valign="top">Double Blind Phase</th><th align="center" class="Toprule" colspan="3" valign="top">Open Label Phase<br/>GENOTROPIN</th> </tr> <tr class="Last"> <th align="left" class="Botrule Rrule" valign="top">Adverse Event</th><th align="center" class="Botrule Rrule" valign="bottom">Placebo<br/>0–6 mo.<br/>n = 572<br/>% Patients</th><th align="center" class="Botrule Rrule" valign="bottom">GENOTROPIN<br/>0–6 mo.<br/>n = 573<br/>% Patients</th><th align="center" class="Botrule Rrule" valign="bottom">6–12 mo.<br/>n = 504<br/>% Patients</th><th align="center" class="Botrule Rrule" valign="bottom">12–18 mo.<br/>n = 63<br/>% Patients</th><th align="center" class="Botrule" valign="bottom">18–24 mo.<br/>n = 60<br/>% Patients</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="6" valign="top">n = number of patients receiving treatment during the indicated period.<br/> %= percentage of patients who reported the event during the indicated period. </td> </tr> <tr> <td align="left" colspan="6"> <dl class="Footnote"> <dt> <a href="#footnote-reference-2" name="footnote-2">*</a> </dt> <dd>Increased significantly when compared to placebo, <span class="Italics">P</span>≤.025: Fisher´s Exact Test (one-sided)</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Rrule Toprule" valign="top"> <p class="First">Swelling, peripheral</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">5.1</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">17.5<a class="Sup" href="#footnote-2" name="footnote-reference-2">*</a> </p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">5.6</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">0</p> </td><td align="center" class="Toprule" valign="top"> <p class="First">1.7</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Arthralgia</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4.2</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">17.3<a class="Sup" href="#footnote-2">*</a> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">6.9</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">6.3</p> </td><td align="center" valign="top"> <p class="First">3.3</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Upper respiratory infection</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">14.5</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">15.5</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">13.1</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">15.9</p> </td><td align="center" valign="top"> <p class="First">13.3</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Pain, extremities</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">5.9</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">14.7<a class="Sup" href="#footnote-2">*</a> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">6.7</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">1.6</p> </td><td align="center" valign="top"> <p class="First">3.3</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Edema, peripheral</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">2.6</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">10.8<a class="Sup" href="#footnote-2">*</a> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">3.0</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">0</p> </td><td align="center" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Paresthesia</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">1.9</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">9.6<a class="Sup" href="#footnote-2">*</a> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">2.2</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">3.2</p> </td><td align="center" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Headache</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">7.7</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">9.9</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">6.2</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">0</p> </td><td align="center" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Stiffness of extremities</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">1.6</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">7.9<a class="Sup" href="#footnote-2">*</a> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">2.4</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">1.6</p> </td><td align="center" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Fatigue</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">3.8</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">5.8</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4.6</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">6.3</p> </td><td align="center" valign="top"> <p class="First">1.7</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Myalgia</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">1.6</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4.9<a class="Sup" href="#footnote-2">*</a> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">2.0</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4.8</p> </td><td align="center" valign="top"> <p class="First">6.7</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule" valign="top"> <p class="First">Back pain</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4.4</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2.8</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3.4</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4.8</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">5.0</p> </td> </tr> </tbody> </table></div>

Post-Trial Extension Studies in Adults

In expanded post-trial extension studies, diabetes mellitus developed in 12 of 3,031 patients (0.4%) during treatment with GENOTROPIN. All 12 patients had predisposing factors, e.g., elevated glycated hemoglobin levels and/or marked obesity, prior to receiving GENOTROPIN. Of the 3,031 patients receiving GENOTROPIN, 61 (2%) developed symptoms of carpal tunnel syndrome, which lessened after dosage reduction or treatment interruption (52) or surgery (9). Other adverse events that have been reported include generalized edema and hypoesthesia.

Periplasmic Escherichia coli Peptides

Preparations of GENOTROPIN contain a small amount of periplasmic Escherichia coli peptides (PECP). Anti-PECP antibodies are found in a small number of patients treated with GENOTROPIN, but these appear to be of no clinical significance.

Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6)].

Leukemia has been reported in a small number of GHD children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin. It is uncertain whether these cases of leukemia are related to GH therapy, the pathology of GHD itself, or other associated treatments such as radiation therapy. On the basis of current evidence, experts have not been able to conclude that GH therapy per se was responsible for these cases of leukemia. The risk for children with GHD, if any, remains to be established [see Contraindications (4) and Warnings and Precautions (5.3)].

The following serious adverse reactions have been observed with use of somatropin (including events observed in patients who received brands of somatropin other than GENOTROPIN): acute critical illness [see Warnings and Precautions (5.1)], sudden death [see Warnings and Precautions (5.2)], intracranial tumors [see Warnings and Precautions (5.3)], central hypothyroidism [see Warnings and Precautions (5.9)], cardiovascular disorders, and pancreatitis [see Warnings and Precautions (5.15)].

Slipped capital femoral epiphysis and Legg-Calve-Perthes disease (osteonecrosis/avascular necrosis; occasionally associated with slipped capital femoral epiphysis) have been reported in children treated with growth hormone [see Warnings and Precautions (5.10)]. Cases have been reported with GENOTROPIN.

The following additional adverse reactions have been observed during the appropriate use of somatropin: headaches (children and adults), gynecomastia (children), and significant diabetic retinopathy.

New-onset type 2 diabetes mellitus has been reported.

The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH and somatropin inhibit 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. As a consequence, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required in patients treated with somatropin. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1 [see Warnings and Precautions (5.8)].

Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth‑promoting effects of somatropin in children. Therefore, glucocorticoid replacement dosing should be carefully adjusted in children receiving concomitant somatropin and glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.

Limited published data indicate that somatropin treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance in man. These data suggest that somatropin administration may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CYP450 liver enzymes. However, formal drug interaction studies have not been conducted.

In patients on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal [see Dosage and Administration (2.2)].

In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral/injectable agent may require adjustment when somatropin therapy is initiated [see Warnings and Precautions (5.4)].

Risk Summary

Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal studies (rats and rabbits), there was no evidence of embryo‑fetal or neonatal harm following somatropin administration during organogenesis at doses approximately 24 times and 19 times the recommended human therapeutic levels, respectively, based on body surface area (see Data).

The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Animal reproduction studies with somatropin during the period of organogenesis at doses of 0.3, 1, and 3.3 mg/kg/day administered subcutaneously (SC) in pregnant rats and 0.08, 0.3, and 1.3 mg/kg/day administered intramuscularly in pregnant rabbits were not teratogenic (highest doses approximately 24 times and 19 times the recommended human therapeutic levels, respectively, based on body surface area).

In perinatal and postnatal studies in rats, somatropin doses of 0.3, 1, and 3.3 mg/kg/day produced growth‑promoting effects in the dams but not in the fetuses. Young rats at the highest dose showed increased weight gain during suckling but the effect was not apparent by 10 weeks of age. No adverse effects were observed on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring due to somatropin.

Risk Summary

There is no information regarding the presence of somatropin in human milk. Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone. No adverse effects related to somatropin in the breastfeed infant have been reported. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GENOTROPIN and any potential adverse effects on the breastfed infant from GENOTROPIN or from the underlying maternal condition.

Safety and effectiveness of GENOTROPIN in pediatric patients have been established in growth failure due to Prader-Willi syndrome (PWS), growth failure in children born small for gestational age (SGA) with no catch-up growth by age 2 years, growth failure associated with Turner syndrome, idiopathic short stature (ISS) and growth failure due to inadequate secretion of endogenous growth hormone.

Growth Failure Due to Prader-Willi Syndrome (PWS)

Safety and effectiveness of GENOTROPIN have been established in pediatric patients with growth failure due to Prader-Willi syndrome based on data from two randomized, open-label, controlled clinical trials with GENOTROPIN in 43 pediatric patients. There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin [see Contraindications (4), Warnings and Precautions (5.2), Clinical Studies (14.2)].

Short Stature in Pediatric Patients Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2

Safety and effectiveness of GENOTROPIN have been established in pediatric patients with short stature born SGA with no catch-up growth based on data from 4 randomized, open-label, controlled clinical trials with GENOTROPIN in 209 pediatric patients [see Clinical Studies (14.3)].

Short Stature associated with Turner Syndrome

Safety and effectiveness of GENOTROPIN have been established in pediatric patients with short stature associated with Turner syndrome based on data from two randomized, open-label, clinical trials with GENOTROPIN in 38 pediatric patients [see Clinical Studies (14.4)].

Idiopathic Short Stature (ISS)

Safety and effectiveness of GENOTROPIN have been established in pediatric patients with ISS based on data from one randomized, open-label, clinical trial with GENOTROPIN in 102 pediatric patients [see Clinical Studies (14.5)].

The safety and effectiveness of GENOTROPIN in patients aged 65 and over have not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of GENOTROPIN, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.2)].

Short-Term

{ "type": "p", "children": [], "text": "\nShort-Term\n" }

Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Furthermore, overdose with somatropin is likely to cause fluid retention.

{ "type": "p", "children": [], "text": "Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Furthermore, overdose with somatropin is likely to cause fluid retention." }

Long-Term

{ "type": "p", "children": [], "text": "\nLong-Term\n" }

Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone [see Dosage and Administration (2)].

{ "type": "p", "children": [], "text": "Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone [see Dosage and Administration (2)].\n" }

Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin.

{ "type": "p", "children": [], "text": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin." }

GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent.

{ "type": "p", "children": [], "text": "GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent." }

GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL.

{ "type": "p", "children": [], "text": "GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL." }

GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL.

{ "type": "p", "children": [], "text": "GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL." }

GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL.

{ "type": "p", "children": [], "text": "GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL." }

The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.

{ "type": "p", "children": [], "text": "The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7." }

In vitro, preclinical, and clinical tests have demonstrated that GENOTROPIN lyophilized powder is therapeutically equivalent to human growth hormone of pituitary origin and achieves similar pharmacokinetic profiles in normal adults. In pediatric patients who have growth hormone deficiency (GHD), have Prader-Willi syndrome (PWS), were born small for gestational age (SGA), have Turner syndrome (TS), or have Idiopathic short stature (ISS), treatment with GENOTROPIN stimulates linear growth. In patients with GHD or PWS, treatment with GENOTROPIN also normalizes concentrations of IGF-I (Insulin-like Growth Factor-I/Somatomedin C). In adults with GHD, treatment with GENOTROPIN results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations.

In addition, the following actions have been demonstrated for GENOTROPIN and/or somatropin.

Tissue Growth

Protein Metabolism

Linear growth is facilitated in part by increased cellular protein synthesis. Nitrogen retention, as demonstrated by decreased urinary nitrogen excretion and serum urea nitrogen, follows the initiation of therapy with GENOTROPIN.

Carbohydrate Metabolism

Pediatric patients with hypopituitarism sometimes experience fasting hypoglycemia that is improved by treatment with GENOTROPIN. Large doses of growth hormone may impair glucose tolerance.

Lipid Metabolism

In GHD patients, administration of somatropin has resulted in lipid mobilization, reduction in body fat stores, and increased plasma fatty acids.

Mineral Metabolism

Somatropin induces retention of sodium, potassium, and phosphorus. Serum concentrations of inorganic phosphate are increased in patients with GHD after therapy with GENOTROPIN. Serum calcium is not significantly altered by GENOTROPIN. Growth hormone could increase calciuria.

Body Composition

Adult GHD patients treated with GENOTROPIN at the recommended adult dose [see Dosage and Administration (2)] demonstrate a decrease in fat mass and an increase in lean body mass. When these alterations are coupled with the increase in total body water, the overall effect of GENOTROPIN is to modify body composition, an effect that is maintained with continued treatment.

Absorption

Following a 0.03 mg/kg subcutaneous (SC) injection in the thigh of 1.3 mg/mL GENOTROPIN to adult GHD patients, approximately 80% of the dose was systemically available as compared with that available following intravenous dosing. Results were comparable in both male and female patients. Similar bioavailability has been observed in healthy adult male subjects.

In healthy adult males, following an SC injection in the thigh of 0.03 mg/kg, the extent of absorption (AUC) of a concentration of 5.3 mg/mL GENOTROPIN was 35% greater than that for 1.3 mg/mL GENOTROPIN. The mean (± standard deviation) peak (Cmax) serum levels were 23.0 (± 9.4) ng/mL and 17.4 (± 9.2) ng/mL, respectively.

In a similar study involving pediatric GHD patients, 5.3 mg/mL GENOTROPIN yielded a mean AUC that was 17% greater than that for 1.3 mg/mL GENOTROPIN. The mean Cmax levels were 21.0 ng/mL and 16.3 ng/mL, respectively.

Adult GHD patients received two single SC doses of 0.03 mg/kg of GENOTROPIN at a concentration of 1.3 mg/mL, with a one- to four-week washout period between injections. Mean Cmax levels were 12.4 ng/mL (first injection) and 12.2 ng/mL (second injection), achieved at approximately six hours after dosing.

There are no data on the bioequivalence between the 12 mg/mL formulation and either the 1.3 mg/mL or the 5.3 mg/mL formulations.

Distribution

The mean volume of distribution of GENOTROPIN following administration to GHD adults was estimated to be 1.3 (± 0.8) L/kg.

Metabolism

The metabolic fate of GENOTROPIN involves classical protein catabolism in both the liver and kidneys. In renal cells, at least a portion of the breakdown products are returned to the systemic circulation. The mean terminal half-life of intravenous GENOTROPIN in normal adults is 0.4 hours, whereas subcutaneously administered GENOTROPIN has a half-life of 3.0 hours in GHD adults. The observed difference is due to slow absorption from the subcutaneous injection site.

Excretion

The mean clearance of subcutaneously administered GENOTROPIN in 16 GHD adult patients was 0.3 (± 0.11) L/hrs/kg.

Special Populations

Pediatric: The pharmacokinetics of GENOTROPIN are similar in GHD pediatric and adult patients.

Gender: No gender studies have been performed in pediatric patients; however, in GHD adults, the absolute bioavailability of GENOTROPIN was similar in males and females.

Race: No studies have been conducted with GENOTROPIN to assess pharmacokinetic differences among races.

Renal or hepatic insufficiency: No studies have been conducted with GENOTROPIN in these patient populations.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2. Mean SC Pharmacokinetic Parameters in Adult GHD Patients</span> </caption> <col width="16%"/> <col width="17%"/> <col width="17%"/> <col width="17%"/> <col width="17%"/> <col width="16%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Rrule Toprule" valign="top"></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Bioavailability</span> <br/> <span class="Bold">(%)</span> <br/> <span class="Bold">(N=15)</span></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">T<span class="Sub">max</span></span> <br/> <span class="Bold">(hours)</span> <br/> <span class="Bold">(N=16)</span></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">CL/F</span> <br/> <span class="Bold">(L/hr × kg)</span> <br/> <span class="Bold">(N=16)</span></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Vss/F</span> <br/> <span class="Bold">(L/kg)</span> <br/> <span class="Bold">(N=16)</span></th><th align="center" class="Botrule Toprule" valign="top"><span class="Bold">T<span class="Sub">1/2</span></span> <br/> <span class="Bold">(hours)</span> <br/> <span class="Bold">(N=16)</span></th> </tr> </thead> <tfoot> <tr class="First"> <td align="left" colspan="6" valign="top">T<span class="Sub">max</span> = time of maximum plasma concentration<br/>CL/F = plasma clearance<br/>Vss/F = volume of distribution</td> </tr> <tr class="Last"> <td align="left" colspan="6" valign="top">T <span class="Sub">1/2</span> = terminal half-life<br/>SD = standard deviation<br/>CI = confidence interval</td> </tr> <tr> <td align="left" colspan="6"> <dl class="Footnote"> <dt> <a href="#footnote-reference-3" name="footnote-3">*</a> </dt> <dd>The absolute bioavailability was estimated under the assumption that the log-transformed data follow a normal distribution. The mean and standard deviation of the log-transformed data were mean = 0.22 (± 0.241).</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td align="center" class="Rrule Toprule" valign="top"> <p class="First">Mean</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">80.5</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">5.9</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">0.3</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">1.3</p> </td><td align="center" class="Toprule" valign="top"> <p class="First">3.0</p> </td> </tr> <tr> <td align="center" class="Rrule" valign="top"> <p class="First">(± SD)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First"> <a class="Sup" href="#footnote-3" name="footnote-reference-3">*</a> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">(± 1.65)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">(± 0.11)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">(± 0.80)</p> </td><td align="center" valign="top"> <p class="First">(± 1.44)</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">95% CI</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">70.5 – 92.1</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">5.0 – 6.7</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">0.2 – 0.4</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">0.9 – 1.8</p> </td><td align="center" class="Botrule Toprule" valign="top"> <p class="First">2.2 – 3.7</p> </td> </tr> </tbody> </table></div>

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of GENOTROPIN or other somatropins.

In the case of growth hormone, antibodies with binding capacities lower than 2 mg/mL have not been associated with growth attenuation. In a very small number of patients treated with somatropin, when binding capacity was greater than 2 mg/mL, interference with the growth response was observed.

In 419 pediatric patients evaluated in clinical studies with GENOTROPIN lyophilized powder, 244 had been treated previously with GENOTROPIN or other growth hormone preparations and 175 had received no previous growth hormone therapy. Antibodies to growth hormone (anti-hGH antibodies) were present in six previously treated patients at baseline. Three of the six became negative for anti-hGH antibodies during 6 to 12 months of treatment with GENOTROPIN. Of the remaining 413 patients, eight (1.9%) developed detectable anti-hGH antibodies during treatment with GENOTROPIN; none had an antibody binding capacity >2 mg/L. There was no evidence that the growth response to GENOTROPIN was affected in these antibody-positive patients.

Carcinogenicity studies have not been conducted with GENOTROPIN. No potential mutagenicity of GENOTROPIN was revealed in a battery of tests including induction of gene mutations in bacteria (the Ames test), gene mutations in mammalian cells grown in vitro (mouse L5178Y cells), and chromosomal damage in intact animals (bone marrow cells in rats).

In a fertility study in male and female rats receiving SC doses during gametogenesis (2 weeks prior to mating for females and 9 weeks prior to mating for males) and continuing up to 7 days of pregnancy, 3.3 mg/kg/day (approximately 24 times human dose by body surface area) produced anestrus or extended estrus cycles in females and fewer and less motile sperm in males. Lower copulation and pregnancy rates were also observed at 3.3 mg/kg/day. At 1 mg/kg/day (approximately 7 times human dose by body surface area), rats showed slightly extended estrus cycles, whereas at 0.3 mg/kg/day no effects were noted (approximately 2 times human dose by body surface).

GENOTROPIN lyophilized powder was compared with placebo in six randomized clinical trials involving a total of 172 adult GHD patients. These trials included a 6-month double-blind treatment period, during which 85 patients received GENOTROPIN and 87 patients received placebo, followed by an open-label treatment period in which participating patients received GENOTROPIN for up to a total of 24 months. GENOTROPIN was administered as a daily SC injection at a dose of 0.04 mg/kg/week for the first month of treatment and 0.08 mg/kg/week for subsequent months.

Beneficial changes in body composition were observed at the end of the 6-month treatment period for the patients receiving GENOTROPIN as compared with the placebo patients. Lean body mass, total body water, and lean/fat ratio increased while total body fat mass and waist circumference decreased. These effects on body composition were maintained when treatment was continued beyond 6 months. Bone mineral density declined after 6 months of treatment but returned to baseline values after 12 months of treatment.

The safety and efficacy of GENOTROPIN in the treatment of pediatric patients with Prader-Willi syndrome (PWS) were evaluated in two randomized, open-label, controlled clinical trials. Patients received either GENOTROPIN or no treatment for the first year of the studies, while all patients received GENOTROPIN during the second year. GENOTROPIN was administered as a daily SC injection, and the dose was calculated for each patient every 3 months. In Study 1, the treatment group received GENOTROPIN at a dose of 0.24 mg/kg/week during the entire study. During the second year, the control group received GENOTROPIN at a dose of 0.48 mg/kg/week. In Study 2, the treatment group received GENOTROPIN at a dose of 0.36 mg/kg/week during the entire study. During the second year, the control group received GENOTROPIN at a dose of 0.36 mg/kg/week.

Patients who received GENOTROPIN showed significant increases in linear growth during the first year of study, compared with patients who received no treatment (see Table 3). Linear growth continued to increase in the second year, when both groups received treatment with GENOTROPIN.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 3. Efficacy of GENOTROPIN in Pediatric Patients with Prader-Willi Syndrome (Mean ± SD)</span> </caption> <col width="23%"/> <col width="23%"/> <col width="18%"/> <col width="18%"/> <col width="18%"/> <thead> <tr class="First"> <th align="left" class="Botrule Toprule" rowspan="3" valign="top"></th><th align="left" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Study 1</span></th><th align="left" class="Botrule Toprule" colspan="2" valign="top"><span class="Bold">Study 2</span></th> </tr> <tr> <th align="left" class="Lrule Rrule" valign="top"><span class="Bold"><span class="Underline">GENOTROPIN</span></span></th><th align="center" class="Rrule" rowspan="2" valign="top"><span class="Bold">Untreated Control</span> <br/> <span class="Bold">n=12</span></th><th align="left" class="Rrule" valign="top"><span class="Bold"><span class="Underline">GENOTROPIN</span></span></th><th align="center" rowspan="2" valign="top"><span class="Bold">Untreated Control</span> <br/> <span class="Bold">n=9</span></th> </tr> <tr class="Last"> <th align="center" class="Botrule Lrule Rrule" valign="top"><span class="Bold">(0.24 mg/kg/week)</span> <br/> <span class="Bold">n=15</span></th><th align="center" class="Botrule Rrule" valign="top"><span class="Bold">(0.36 mg/kg/week)</span> <br/> <span class="Bold">n=7</span></th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-4" name="footnote-4">*</a> </dt> <dd>p ≤ 0.001</dd> <dt> <a href="#footnote-reference-5" name="footnote-5">†</a> </dt> <dd>p ≤ 0.002 (when comparing SDS change at 12 months)</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Linear growth (cm)</span> <br/>  Baseline height</p> </td><td align="center" class="Botrule Rrule Toprule" valign="bottom"> <p class="First">112.7 ± 14.9</p> </td><td align="center" class="Botrule Rrule Toprule" valign="bottom"> <p class="First">109.5 ± 12.0</p> </td><td align="center" class="Botrule Rrule Toprule" valign="bottom"> <p class="First">120.3 ± 17.5</p> </td><td align="center" class="Botrule Toprule" valign="bottom"> <p class="First">120.5 ± 11.2</p> </td> </tr> <tr> <td class="Botrule Rrule" valign="top"> <p class="First">  Growth from months 0 to 12</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11.6<a class="Sup" href="#footnote-4" name="footnote-reference-4">*</a> ± 2.3</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5.0 ± 1.2</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">10.7<a class="Sup" href="#footnote-4">*</a> ± 2.3</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">4.3 ± 1.5</p> </td> </tr> <tr> <td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">Height Standard Deviation Score (SDS) for age</span> <br/>  Baseline SDS</p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First">-1.6 ± 1.3</p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First">-1.8 ± 1.5</p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First">-2.6 ± 1.7</p> </td><td align="center" class="Botrule" valign="bottom"> <p class="First">-2.1 ± 1.4</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule" valign="top"> <p class="First">  SDS at 12 months</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">-0.5<a class="Sup" href="#footnote-5" name="footnote-reference-5">†</a> ± 1.3</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">-1.9 ± 1.4</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">-1.4<a class="Sup" href="#footnote-5">†</a> ± 1.5</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">-2.2 ± 1.4</p> </td> </tr> </tbody> </table></div>

Changes in body composition were also observed in the patients receiving GENOTROPIN (see Table 4). These changes included a decrease in the amount of fat mass, and increases in the amount of lean body mass and the ratio of lean-to-fat tissue, while changes in body weight were similar to those seen in patients who received no treatment. Treatment with GENOTROPIN did not accelerate bone age, compared with patients who received no treatment.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 4. Effect of GENOTROPIN on Body Composition in Pediatric Patients with Prader-Willi Syndrome (Mean ± SD)</span> </caption> <col width="33%"/> <col width="33%"/> <col width="34%"/> <thead> <tr class="First"> <th align="left" class="Rrule Toprule" rowspan="2" valign="top"></th><th align="center" class="Rrule Toprule" valign="top"><span class="Bold"><span class="Underline">GENOTROPIN</span></span></th><th align="center" class="Toprule" rowspan="2" valign="top"><span class="Bold">Untreated Control</span> <br/> <span class="Bold">n=10</span></th> </tr> <tr class="Last"> <th align="center" class="Botrule Rrule" valign="top"><span class="Bold">n=14</span></th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-6" name="footnote-6">*</a> </dt> <dd>p &lt; 0.005</dd> <dt> <a href="#footnote-reference-7" name="footnote-7">†</a> </dt> <dd>n=15 for the group receiving GENOTROPIN; n=12 for the Control group</dd> <dt> <a href="#footnote-reference-8" name="footnote-8">‡</a> </dt> <dd>n.s.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Fat mass (kg)</span> </p> </td><td class="Rrule Toprule" valign="top"></td><td class="Toprule" valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">12.3 ± 6.8</p> </td><td align="center" valign="top"> <p class="First">9.4 ± 4.9</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule" valign="top"> <p class="First">  Change from months 0 to 12</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">-0.9<a class="Sup" href="#footnote-6" name="footnote-reference-6">*</a> ± 2.2</p> </td><td align="center" class="Botrule Toprule" valign="top"> <p class="First">2.3 ± 2.4</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First"> <span class="Bold">Lean body mass (kg)</span> </p> </td><td class="Rrule" valign="top"></td><td valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">15.6 ± 5.7</p> </td><td align="center" valign="top"> <p class="First">14.3 ± 4.0</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule" valign="top"> <p class="First">  Change from months 0 to 12</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">4.7<a class="Sup" href="#footnote-6">*</a> ± 1.9</p> </td><td align="center" class="Botrule Toprule" valign="top"> <p class="First">0.7 ± 2.4</p> </td> </tr> <tr> <td class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Lean body mass/Fat mass</span> </p> </td><td class="Rrule Toprule" valign="top"></td><td class="Toprule" valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">1.4 ± 0.4</p> </td><td align="center" valign="top"> <p class="First">1.8 ± 0.8</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule" valign="top"> <p class="First">  Change from months 0 to 12</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">1.0<a class="Sup" href="#footnote-6">*</a> ± 1.4</p> </td><td align="center" class="Botrule Toprule" valign="top"> <p class="First">-0.1 ± 0.6</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First"> <span class="Bold">Body weight (kg) </span><a class="Sup" href="#footnote-7" name="footnote-reference-7">†</a> </p> </td><td class="Rrule" valign="top"></td><td valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">27.2 ± 12.0</p> </td><td align="center" valign="top"> <p class="First">23.2 ± 7.0</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule Toprule" valign="top"> <p class="First">  Change from months 0 to 12</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">3.7<a class="Sup" href="#footnote-8" name="footnote-reference-8">‡</a> ± 2.0</p> </td><td align="center" class="Botrule Toprule" valign="top"> <p class="First">3.5 ± 1.9</p> </td> </tr> </tbody> </table></div>

Pediatric Patients Born Small for Gestational Age (SGA) Who Fail to Manifest Catch-up Growth by Age 2

The safety and efficacy of GENOTROPIN in the treatment of pediatric patients born small for gestational age (SGA) were evaluated in 4 randomized, open-label, controlled clinical trials. Patients (age range of 2 to 8 years) were observed for 12 months before being randomized to receive either GENOTROPIN (two doses per study, most often 0.24 and 0.48 mg/kg/week) as a daily SC injection or no treatment for the first 24 months of the studies. After 24 months in the studies, all patients received GENOTROPIN.

Patients who received any dose of GENOTROPIN showed significant increases in growth during the first 24 months of study, compared with patients who received no treatment (see Table 5). Children receiving 0.48 mg/kg/week demonstrated a significant improvement in height standard deviation score (SDS) compared with children treated with 0.24 mg/kg/week. Both of these doses resulted in a slower but constant increase in growth between months 24 to 72 (data not shown).

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 5. Efficacy of GENOTROPIN in Pediatric Patients Born Small for Gestational Age (Mean ± SD)</span> </caption> <col width="27%"/> <col width="27%"/> <col width="23%"/> <col width="23%"/> <thead> <tr class="First"> <th align="left" class="Rrule Toprule" rowspan="2" valign="top"></th><th align="center" class="Rrule Toprule" valign="top"><span class="Bold"><span class="Underline">GENOTROPIN</span></span></th><th align="center" class="Rrule Toprule" valign="top"><span class="Bold"><span class="Underline">GENOTROPIN</span></span></th><th align="center" class="Toprule" rowspan="2" valign="top"><span class="Bold">Untreated Control</span> <br/> <span class="Bold">n=40</span></th> </tr> <tr class="Last"> <th align="center" class="Botrule Rrule" valign="top"><span class="Bold">(0.24 mg/kg/week)</span> <br/> <span class="Bold">n=76</span></th><th align="center" class="Botrule Rrule" valign="top"><span class="Bold">(0.48 mg/kg/week)</span> <br/> <span class="Bold">n=93</span></th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-9" name="footnote-9">*</a> </dt> <dd>p = 0.0001 vs Untreated Control group</dd> <dt> <a href="#footnote-reference-10" name="footnote-10">†</a> </dt> <dd>p = 0.0001 vs group treated with GENOTROPIN 0.24 mg/kg/week</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Height Standard Deviation Score (SDS)</span> </p> </td><td class="Rrule Toprule" valign="top"></td><td class="Rrule Toprule" valign="top"></td><td class="Toprule" valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">Baseline SDS</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">-3.2 ± 0.8</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">-3.4 ± 1.0</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">-3.1 ± 0.9</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule" valign="top"> <p class="First">SDS at 24 months</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">-2.0 ± 0.8</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">-1.7 ± 1.0</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">-2.9 ± 0.9</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule" valign="top"> <p class="First">Change in SDS from baseline to month 24</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1.2<a class="Sup" href="#footnote-9" name="footnote-reference-9">*</a> ± 0.5</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1.7<a class="Sup" href="#footnote-9">*</a><a class="Sup" href="#footnote-10" name="footnote-reference-10">†</a> ± 0.6</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">0.1 ± 0.3</p> </td> </tr> </tbody> </table></div>

Two randomized, open-label, clinical trials were conducted that evaluated the efficacy and safety of GENOTROPIN in Turner syndrome patients with short stature. Turner syndrome patients were treated with GENOTROPIN alone or GENOTROPIN plus adjunctive hormonal therapy (ethinylestradiol or oxandrolone). A total of 38 patients were treated with GENOTROPIN alone in the two studies. In Study 055, 22 patients were treated for 12 months, and in Study 092, 16 patients were treated for 12 months. Patients received GENOTROPIN at a dose between 0.13 to 0.33 mg/kg/week.

SDS for height velocity and height are expressed using either the Tanner (Study 055) or Sempé (Study 092) standards for age-matched normal children as well as the Ranke standard (both studies) for age-matched, untreated Turner syndrome patients. As seen in Table 6, height velocity SDS and height SDS values were smaller at baseline and after treatment with GENOTROPIN when the normative standards were utilized as opposed to the Turner syndrome standard.

Both studies demonstrated statistically significant increases from baseline in all of the linear growth variables (i.e., mean height velocity, height velocity SDS, and height SDS) after treatment with GENOTROPIN (see Table 6). The linear growth response was greater in Study 055 wherein patients were treated with a larger dose of GENOTROPIN.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 6. Growth Parameters (mean ± SD) after 12 Months of Treatment with GENOTROPIN in Pediatric Patients with Turner Syndrome in Two Open Label Studies</span> </caption> <col width="36%"/> <col width="32%"/> <col width="32%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Rrule Toprule" valign="top"></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold"><span class="Underline">GENOTROPIN</span></span> <br/> <span class="Bold">0.33 mg/kg/week</span> <br/> <span class="Bold">Study 055^ n=22</span></th><th align="center" class="Botrule Toprule" valign="top"><span class="Bold"><span class="Underline">GENOTROPIN </span></span> <br/> <span class="Bold">0.13–0.23 mg/kg/week</span> <br/> <span class="Bold">Study 092# n=16</span></th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top">SDS = Standard Deviation Score<br/> Ranke standard based on age-matched, untreated Turner syndrome patients<br/> Tanner^/Sempé# standards based on age-matched normal children<br/> p&lt;0.05, for all changes from baseline</td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Height Velocity (cm/yr)</span> </p> </td><td class="Rrule Toprule" valign="top"></td><td class="Toprule" valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4.1 ± 1.5</p> </td><td align="center" valign="top"> <p class="First">3.9 ± 1.0</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Month 12</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">7.8 ± 1.6</p> </td><td align="center" valign="top"> <p class="First">6.1 ± 0.9</p> </td> </tr> <tr> <td class="Botrule Rrule" valign="top"> <p class="First">  Change from baseline (95% CI)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3.7 (3.0, 4.3)</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">2.2 (1.5, 2.9)</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First"> <span class="Bold">Height Velocity SDS (Tanner^/Sempé# Standards)</span> </p> </td><td align="center" class="Rrule" valign="top"> <p class="First">(n=20)</p> </td><td valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">-2.3 ± 1.4</p> </td><td align="center" valign="top"> <p class="First">-1.6 ± 0.6</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Month 12</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">2.2 ± 2.3</p> </td><td align="center" valign="top"> <p class="First">0.7 ± 1.3</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Change from baseline (95% CI)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4.6 (3.5, 5.6)</p> </td><td align="center" valign="top"> <p class="First">2.2 (1.4, 3.0)</p> </td> </tr> <tr> <td class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Height Velocity SDS (Ranke Standard)</span> </p> </td><td class="Rrule Toprule" valign="top"></td><td class="Toprule" valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">-0.1 ± 1.2</p> </td><td align="center" valign="top"> <p class="First">-0.4 ± 0.6</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Month 12</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4.2 ± 1.2</p> </td><td align="center" valign="top"> <p class="First">2.3 ± 1.2</p> </td> </tr> <tr> <td class="Botrule Rrule" valign="top"> <p class="First">  Change from baseline (95% CI)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4.3 (3.5, 5.0)</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">2.7 (1.8, 3.5)</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First"> <span class="Bold">Height SDS (Tanner^/Sempé# Standards)</span> </p> </td><td class="Rrule" valign="top"></td><td valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">-3.1 ± 1.0</p> </td><td align="center" valign="top"> <p class="First">-3.2 ± 1.0</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Month 12</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">-2.7 ± 1.1</p> </td><td align="center" valign="top"> <p class="First">-2.9 ± 1.0</p> </td> </tr> <tr> <td class="Botrule Rrule" valign="top"> <p class="First">  Change from baseline (95% CI)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0.4 (0.3, 0.6)</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">0.3 (0.1, 0.4)</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First"> <span class="Bold">Height SDS (Ranke Standard)</span> </p> </td><td class="Rrule" valign="top"></td><td valign="top"></td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Baseline</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">-0.2 ± 0.8</p> </td><td align="center" valign="top"> <p class="First">-0.3 ± 0.8</p> </td> </tr> <tr> <td class="Rrule" valign="top"> <p class="First">  Month 12</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">0.6 ± 0.9</p> </td><td align="center" valign="top"> <p class="First">0.1 ± 0.8</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule" valign="top"> <p class="First">  Change from baseline (95% CI)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0.8 (0.7, 0.9)</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">0.5 (0.4, 0.5)</p> </td> </tr> </tbody> </table></div>

The long-term efficacy and safety of GENOTROPIN in patients with idiopathic short stature (ISS) were evaluated in one randomized, open-label, clinical trial that enrolled 177 children. Patients were enrolled on the basis of short stature, stimulated GH secretion >10 ng/mL, and prepubertal status (criteria for idiopathic short stature were retrospectively applied and included 126 patients). All patients were observed for height progression for 12 months and were subsequently randomized to GENOTROPIN or observation only and followed to final height. Two GENOTROPIN doses were evaluated in this trial: 0.23 mg/kg/week (0.033 mg/kg/day) and 0.47 mg/kg/week (0.067 mg/kg/day). Baseline patient characteristics for the ISS patients who remained prepubertal at randomization (n= 105) were: mean (± SD): chronological age 11.4 (1.3) years, height SDS -2.4 (0.4), height velocity SDS -1.1 (0.8), and height velocity 4.4 (0.9) cm/yr, IGF-1 SDS -0.8 (1.4). Patients were treated for a median duration of 5.7 years. Results for final height SDS are displayed by treatment arm in Table 7. GENOTROPIN therapy improved final height in ISS children relative to untreated controls. The observed mean gain in final height was 9.8 cm for females and 5.0 cm for males for both doses combined compared to untreated control subjects. A height gain of 1 SDS was observed in 10% of untreated subjects, 50% of subjects receiving 0.23 mg/kg/week and 69% of subjects receiving 0.47 mg/kg/week.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 7. Final height SDS results for pre-pubertal patients with ISS<a class="Sup" href="#footnote-11" name="footnote-reference-11">*</a></span> </caption> <col width="23%"/> <col width="15%"/> <col width="14%"/> <col width="14%"/> <col width="15%"/> <col width="15%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule Toprule" valign="top"></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Untreated</span> <br/> <span class="Bold">(n=30)</span></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">GEN 0.033</span> <br/> <span class="Bold">(n=30)</span></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">GEN 0.067</span> <br/> <span class="Bold">(n=42)</span></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">GEN 0.033 vs. Untreated</span> <br/> <span class="Bold">(95% CI)</span></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">GEN 0.067 vs. Untreated</span> <br/> <span class="Bold">(95% CI)</span></th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="6" valign="top">**Least square means based on ANCOVA (final height SDS and final height SDS minus baseline predicted height SDS were adjusted for baseline height SDS)</td> </tr> <tr> <td align="left" colspan="6"> <dl class="Footnote"> <dt> <a href="#footnote-reference-11" name="footnote-11">*</a> </dt> <dd>Mean (SD) are observed values.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Lrule Toprule" valign="top"> <p class="First">Baseline height SDS</p> </td><td class="Lrule Toprule" valign="top"></td><td class="Lrule Toprule" valign="top"></td><td class="Lrule Toprule" valign="top"></td><td class="Lrule Toprule" valign="top"></td><td class="Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Final height SDS minus baseline</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">0.41 (0.58)</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">0.95 (0.75)</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">1.36 (0.64)</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">+0.53 (0.20, 0.87)<br/>p=0.0022</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">+0.94 (0.63, 1.26)<br/>p&lt;0.0001</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Baseline predicted ht</p> </td><td class="Lrule" valign="top"></td><td class="Lrule" valign="top"></td><td class="Lrule" valign="top"></td><td class="Lrule" valign="top"></td><td class="Lrule Rrule" valign="top"></td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="top"> <p class="First">Final height SDS minus baseline predicted final height SDS</p> </td><td align="center" class="Botrule Lrule" valign="top"> <p class="First">0.23 (0.66)</p> </td><td align="center" class="Botrule Lrule" valign="top"> <p class="First">0.73 (0.63)</p> </td><td align="center" class="Botrule Lrule" valign="top"> <p class="First">1.05 (0.83)</p> </td><td align="center" class="Botrule Lrule" valign="top"> <p class="First">+0.60 (0.09, 1.11)<br/>p=0.0217</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">+0.90 (0.42, 1.39)<br/>p=0.0004</p> </td> </tr> </tbody> </table></div>

GENOTROPIN (somatropin) for injection is a white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains the diluent.

GENOTROPIN lyophilized powder is available in the following packages:

5 mg single‑patient‑use two-chamber cartridge (with preservative)

12 mg single‑patient‑use two-chamber cartridge (with preservative)

GENOTROPIN MINIQUICK, a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (without preservative)

GENOTROPIN MINIQUICK is available in the following strengths, each in a package of 7:

<div class="scrollingtable"><table width="100%"> <col width="24%"/> <col width="34%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Strength</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">NDC Number</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.2 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2649-02</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.4 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2650-02</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.6 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2651-02</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.8 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2652-02</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2653-02</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1.2 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2654-02</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1.4 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2655-02</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1.6 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2656-02</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1.8 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2657-02</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0013-2658-02</p> </td> </tr> </tbody> </table></div>

The 5 mg and 12 mg GENOTROPIN single-patient-use cartridges:

The 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg single-dose Growth Hormone Delivery Devices containing a two-chamber cartridge (GENOTROPIN MINIQUICK):

Patients being treated with GENOTROPIN (and/or their parents) should be informed about the potential benefits and risks associated with GENOTROPIN treatment. This information is intended to better educate patients (and caregivers); it is not a disclosure of all possible adverse or intended effects.

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Patients and caregivers who will administer GENOTROPIN should receive appropriate training and instruction on the proper use of GENOTROPIN from the physician or other suitably qualified health care professional. A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended. Patients and/or parents should be thoroughly instructed in the importance of proper disposal, and cautioned against any reuse of needles and syringes. This information is intended to aid in the safe and effective administration of the medication.

{ "type": "p", "children": [], "text": "Patients and caregivers who will administer GENOTROPIN should receive appropriate training and instruction on the proper use of GENOTROPIN from the physician or other suitably qualified health care professional. A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended. Patients and/or parents should be thoroughly instructed in the importance of proper disposal, and cautioned against any reuse of needles and syringes. This information is intended to aid in the safe and effective administration of the medication." }

GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. A reconstitution device is used to mix the diluent and powder.

{ "type": "p", "children": [], "text": "GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. A reconstitution device is used to mix the diluent and powder." }

The GENOTROPIN 5 mg and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN PEN delivery device. The 5 mg cartridge has a green tip to match the green pen window on the Pen 5, while the 12 mg cartridge has a purple tip to match the purple pen window on the Pen 12.

{ "type": "p", "children": [], "text": "The GENOTROPIN 5 mg and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN PEN delivery device. The 5 mg cartridge has a green tip to match the green pen window on the Pen 5, while the 12 mg cartridge has a purple tip to match the purple pen window on the Pen 12." }

Follow the directions for reconstitution provided with each device. Do not shake; shaking may cause denaturation of the active ingredient.

{ "type": "p", "children": [], "text": "Follow the directions for reconstitution provided with each device. Do not shake; shaking may cause denaturation of the active ingredient." }

Please see accompanying directions for use of the reconstitution and/or delivery device.

{ "type": "p", "children": [], "text": "Please see accompanying directions for use of the reconstitution and/or delivery device." }

Rx only

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Manufactured by:Pharmacia & Upjohn Company LLCA subsidiary of Pfizer Inc.New York, NY 10001 U.S. License No. 1216

{ "type": "p", "children": [], "text": "Manufactured by:Pharmacia & Upjohn Company LLCA subsidiary of Pfizer Inc.New York, NY 10001\nU.S. License No. 1216\n" }

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

{ "type": "p", "children": [], "text": "This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com." }

LAB-0222-25.0

{ "type": "p", "children": [], "text": "LAB-0222-25.0" }

INSTRUCTIONS FOR USE GENOTROPIN 5 (JEEN-o-tro-pin 5) GENOTROPIN PEN 5 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. Use this device only for administration of GENOTROPIN.

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USE\n\nGENOTROPIN 5 (JEEN-o-tro-pin 5)\n\nGENOTROPIN PEN 5 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. Use this device only for administration of GENOTROPIN.\n" }

<div class="scrollingtable"><table width="100%"> <col width="100%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Important Note</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Please read these instructions completely before using the GENOTROPIN PEN 5. These instructions need to be followed step by step. Please do not use the GENOTROPIN PEN 5 unless your healthcare provider has trained you.<br/>If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280. If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Your pen should not be used near electrical or electronic equipment, including mobile phones. If your pen has been damaged, it should not be used and should be disposed of as instructed by your healthcare provider.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important Note</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Please read these instructions completely before using the GENOTROPIN PEN 5. These instructions need to be followed step by step. Please do not use the GENOTROPIN PEN 5 unless your healthcare provider has trained you.<br/>If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280. If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Your pen should not be used near electrical or electronic equipment, including mobile phones. If your pen has been damaged, it should not be used and should be disposed of as instructed by your healthcare provider.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

GENOTROPIN PEN 5 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

{ "type": "p", "children": [], "text": "GENOTROPIN PEN 5 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period." }

For your injection you will need:

{ "type": "p", "children": [], "text": "\nFor your injection you will need:\n" }

{ "type": "", "children": [], "text": "" }

Parts of the GENOTROPIN PEN 5 (See Figure A)

{ "type": "p", "children": [], "text": "\nParts of the GENOTROPIN PEN 5 (See Figure A)" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="100%"/> <tbody class="Headless"> <tr> <td valign="middle"> <p class="First"> <a name="IFU1_FigA"></a><span class="Bold">Figure A</span> <br/> <a name="id-809322744"></a><img alt="Figure A" src="/dailymed/image.cfm?name=genotropin-03.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td valign=\"middle\">\n<p class=\"First\">\n<a name=\"IFU1_FigA\"></a><span class=\"Bold\">Figure A</span>\n<br/>\n<a name=\"id-809322744\"></a><img alt=\"Figure A\" src=\"/dailymed/image.cfm?name=genotropin-03.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Storage instructions for your GENOTROPIN PEN 5

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{ "type": "", "children": [], "text": "" }

Using your GENOTROPIN PEN 5

{ "type": "p", "children": [], "text": "\nUsing your GENOTROPIN PEN 5\n" }

Step 1.

{ "type": "p", "children": [], "text": "\nStep 1.\n" }

Wash your hands well with soap and water before using the GENOTROPIN PEN 5.

{ "type": "p", "children": [], "text": "Wash your hands well with soap and water before using the GENOTROPIN PEN 5." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="75%"/> <col width="25%"/> <tbody class="Headless"> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 2. Attach the Needle</span> </p> <dl> <dt>•</dt> <dd>Pull off the front cap (<span class="Bold">See <a href="#IFU1_FigB">Figure B</a></span>).</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigB"></a><span class="Bold">Figure B</span><a name="id719555010"></a><img alt="Figure B" src="/dailymed/image.cfm?name=genotropin-04.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (<span class="Bold">See <a href="#IFU1_FigC">Figure C</a></span>).</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigC"></a><span class="Bold">Figure C</span><a name="id-1600486570"></a><img alt="Figure C" src="/dailymed/image.cfm?name=genotropin-05.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Peel off the foil from the needle.</dd> <dt>•</dt> <dd>Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (<span class="Bold">See <a href="#IFU1_FigD">Figure D</a></span>).</dd> <dt>•</dt> <dd>Do not remove the outer needle cover and inner needle cap until you are ready to inject.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigD"></a><span class="Bold">Figure D</span><a name="id652257201"></a><img alt="Figure D" src="/dailymed/image.cfm?name=genotropin-06.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN</span> <br/>Use only the 5 mg cartridge.</p> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Open the cartridge pack and take out 1 cartridge.</dd> <dt>•</dt> <dd>Check that the color on the cartridge matches the color around the window of the plastic body (<span class="Bold">See <a href="#IFU1_FigE">Figure E</a></span>).</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigE"></a><span class="Bold">Figure E</span><a name="id-595942003"></a><img alt="Figure E" src="/dailymed/image.cfm?name=genotropin-07.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (<span class="Bold">See <a href="#IFU1_FigF">Figure F</a></span>).</dd> <dt>•</dt> <dd>Push the cartridge firmly into place.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigF"></a><span class="Bold">Figure F</span><a name="id1433403511"></a><img alt="Figure F" src="/dailymed/image.cfm?name=genotropin-08.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 4. Prepare your Pen</span> </p> <dl> <dt>•</dt> <dd>Press the red release button. The injection button will pop up (<span class="Bold">See <a href="#IFU1_FigG">Figure G</a></span>).</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigG"></a><span class="Bold">Figure G</span><a name="id-1367441766"></a><img alt="Figure G" src="/dailymed/image.cfm?name=genotropin-09.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="middle"> <dl> <dt>•</dt> <dd>Turn the injection button in a counter clockwise direction (to the left) as far as it will go (<span class="Bold">See <a href="#IFU1_FigH">Figure H</a></span>). This will draw back the plunger rod.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigH"></a><span class="Bold">Figure H</span><a name="id924005506"></a><img alt="Figure H" src="/dailymed/image.cfm?name=genotropin-10.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="middle"> <dl> <dt>•</dt> <dd> <span class="Bold">Check that the plunger rod is not visible</span> through the plunger rod window (<span class="Bold">See <a href="#IFU1_FigI">Figure I</a></span>). <span class="Bold">Do not</span> proceed if the plunger rod is visible, as the medicine will not be properly mixed.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigI"></a><span class="Bold">Figure I</span><a name="id625051926"></a><img alt="Figure I" src="/dailymed/image.cfm?name=genotropin-11.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 5. Mix your GENOTROPIN</span> </p> <dl> <dt>•</dt> <dd>Make sure that a needle is attached to the metal front part.</dd> <dt>•</dt> <dd>While holding your pen <span class="Bold">upright</span>, gently screw the metal front part and the plastic body back together as shown (<span class="Bold">See <a href="#IFU1_FigJ">Figure J</a></span>). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigJ"></a><span class="Bold">Figure J</span><a name="id1739130136"></a><img alt="Figure J" src="/dailymed/image.cfm?name=genotropin-12.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 6. Examine the Solution</span> </p> <dl> <dt>•</dt> <dd>Gently tip your pen from side to side to help dissolve the powder completely (<span class="Bold">See <a href="#IFU1_figK">Figure K</a></span>).</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_figK"></a><span class="Bold">Figure K</span><a name="id788320512"></a><img alt="Figure K" src="/dailymed/image.cfm?name=genotropin-13.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Do not shake</span> your pen, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (<span class="Bold">See <a href="#IFU1_FigL">Figure L</a></span>).</dd> <dt>•</dt> <dd>If you see particles, or if the solution is not clear, <span class="Bold">do not inject</span>. Remove the cartridge and use a new one.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigL"></a><span class="Bold">Figure L</span><a name="id-987171003"></a><img alt="Figure L" src="/dailymed/image.cfm?name=genotropin-14.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 7. Release Trapped Air</span> </p> <dl> <dt>•</dt> <dd>Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. <span class="Bold">Do not to touch</span> the exposed needle.</dd> </dl> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Remove any trapped air from the solution as follows:</dd> </dl> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt> </dt> <dd> <dl> <dt>a)</dt> <dd>Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (<span class="Bold">See <a href="#IFU1_FigM">Figure M</a></span>).</dd> </dl> </dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigM"></a><span class="Bold">Figure M</span><a name="id-992016869"></a><img alt="Figure M" src="/dailymed/image.cfm?name=genotropin-15.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt> </dt> <dd> <dl> <dt>b)</dt> <dd>Hold your pen with the needle pointing <span class="Bold">upwards</span>. Gently tap the metal front part with your finger to move any air bubbles to the top.</dd> </dl> </dd> </dl> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt> </dt> <dd> <dl> <dt>c)</dt> <dd>Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (<span class="Bold">See <a href="#IFU1_FigN">Figure N</a>).</span> </dd> </dl> </dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigN"></a><span class="Bold">Figure N</span><a name="id2114934408"></a><img alt="Figure N" src="/dailymed/image.cfm?name=genotropin-16.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt> </dt> <dd> <dl> <dt>d)</dt> <dd>If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.1'. Repeat steps b) and c) to remove any trapped air from the solution (<span class="Bold">see <a href="#IFU1_FigO">Figure O</a></span>).</dd> </dl> </dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigO"></a><span class="Bold">Figure O</span><a name="id-1394353352"></a><img alt="Figure O" src="/dailymed/image.cfm?name=genotropin-17.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 8. Attach the Needle Guard (Optional)</span> <br/>The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.</p> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Grip the sides of the needle guard. Push it over the needle until it snaps in place (<span class="Bold">See <a href="#IFU1_FigP">Figure P</a></span>). <span class="Bold">Do not</span> push the needle guard on the end.<br/>Be careful not to touch the exposed needle.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigP"></a><span class="Bold">Figure P</span><a name="id-1557474968"></a><img alt="Figure P" src="/dailymed/image.cfm?name=genotropin-18.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">My daily dose is </span><a name="id1702428157"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-18a.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/><span class="Bold">mg</span><span class="Italics"> (write in your daily dose)</span> </p> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 9. Dial Your Prescribed Dose</span> </p> <dl> <dt>•</dt> <dd>Press the red release button to reset your pen.</dd> <dt>•</dt> <dd>The button will pop up and the dose display window will read '0.0'.</dd> <dt>•</dt> <dd>Turn the injection button in a clockwise direction (to the right) as shown, until your prescribed dose is displayed (<span class="Bold">See <a href="#IFU1_FigQ">Figure Q</a></span>).</dd> <dt>•</dt> <dd>If you turn the button too far, turn it back the other way until your correct dose is displayed.</dd> </dl> </td><td valign="middle"> <p class="First"> <a name="IFU1_FigQ"></a><span class="Bold">Figure Q</span><a name="id589199655"></a><img alt="Figure Q" src="/dailymed/image.cfm?name=genotropin-19.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 10. Inject your GENOTROPIN</span> </p> <dl> <dt>•</dt> <dd>Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (<span class="Bold">see <a href="#IFU1_FigR">Figure R</a></span>).</dd> <dt>•</dt> <dd>Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas of the skin that have scars or skin problems.</dd> <dt>•</dt> <dd>Clean the injection site with the alcohol swab.</dd> <dt>•</dt> <dd>Allow the injection site to dry.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigR"></a><span class="Bold">Figure R</span><a name="id-1594780316"></a><img alt="Figure R" src="/dailymed/image.cfm?name=genotropin-20.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (<span class="Bold">See <a href="#IFU1_FigS">Figure S</a></span>).</dd> <dt>•</dt> <dd>Push the injection button until it clicks. Wait while counting <span class="Bold">slowly</span> for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (<span class="Bold">See <a href="#IFU1_FigS">Figure S</a></span>).</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigS"></a><span class="Bold">Figure S</span><a name="id-1670255967"></a><img alt="Figure S" src="/dailymed/image.cfm?name=genotropin-21.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 11. Throw away the Needle and Store your GENOTROPIN PEN 5</span> </p> <dl> <dt>•</dt> <dd>Pull off the needle guard, gripping the sides. Be careful not to push on the end. (<span class="Bold">See <a href="#IFU1_FigT">Figure T</a></span>).</dd> <dt>•</dt> <dd>Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (<span class="Bold">See <a href="#IFU1_step14">Step 14</a></span>). <span class="Bold">Do not reuse the needle</span>.</dd> <dt>•</dt> <dd>Push on the front cap, and put your pen back in its protective case.</dd> <dt>•</dt> <dd>Store your pen (with the cartridge) in the <span class="Bold">refrigerator</span> between 36ºF to 46ºF (2ºC to 8ºC) until your next injection.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigT"></a><span class="Bold">Figure T</span><a name="id1691951560"></a><img alt="Figure T" src="/dailymed/image.cfm?name=genotropin-22.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 12. Your Next Injection</span> <br/>If you already have a cartridge in your pen, prepare the pen and give the injection as follows:</p> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Remove the front cap (<span class="Bold">See <a href="#IFU1_FigU">Figure U</a></span>).</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigU"></a><span class="Bold">Figure U</span><a name="id-1661914681"></a><img alt="Figure U" src="/dailymed/image.cfm?name=genotropin-23.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (<span class="Bold">See <a href="#IFU1_FigV">Figure V</a></span>).</dd> <dt>•</dt> <dd>Peel off the foil from a needle.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigV"></a><span class="Bold">Figure V</span><a name="id2128116629"></a><img alt="Figure V" src="/dailymed/image.cfm?name=genotropin-24.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Push and screw the needle onto the metal front part of the pen as shown (<span class="Bold">See <a href="#IFU1_FigW">Figure W</a></span>). Remove the outer needle cover and inner needle cap.</dd> <dt>•</dt> <dd>Follow the instructions above, starting with <span class="Bold">Step 8: Attach the Needle Guard</span>.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigW"></a><span class="Bold">Figure W</span><a name="id1907255465"></a><img alt="Figure W" src="/dailymed/image.cfm?name=genotropin-25.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 13. To Replace the Cartridge</span> </p> <dl> <dt>•</dt> <dd>Press the red release button to reset your pen (<span class="Bold">See <a href="#IFU1_FigX">Figure X</a></span>).</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigX"></a><span class="Bold">Figure X</span><a name="id-263380984"></a><img alt="Figure X" src="/dailymed/image.cfm?name=genotropin-26.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (<span class="Bold">See <a href="#IFU1_FigY">Figure Y</a></span>).This will draw back the plunger rod.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigY"></a><span class="Bold">Figure Y</span><a name="id-2011371227"></a><img alt="Figure Y" src="/dailymed/image.cfm?name=genotropin-27.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Unscrew the metal front part and remove the empty cartridge (<span class="Bold">See <a href="#IFU1_FigZ">Figure Z</a></span>).</dd> <dt>•</dt> <dd>Throw away the empty cartridge as instructed by your healthcare provider.</dd> <dt>•</dt> <dd>To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with <span class="Bold"><a href="#IFU1_step1">Step 1</a></span>.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU1_FigZ"></a><span class="Bold">Figure Z</span><a name="id36866137"></a><img alt="Figure Z" src="/dailymed/image.cfm?name=genotropin-28.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"75%\"/>\n<col width=\"25%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2. Attach the Needle</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Pull off the front cap (<span class=\"Bold\">See <a href=\"#IFU1_FigB\">Figure B</a></span>).</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigB\"></a><span class=\"Bold\">Figure B</span><a name=\"id719555010\"></a><img alt=\"Figure B\" src=\"/dailymed/image.cfm?name=genotropin-04.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (<span class=\"Bold\">See <a href=\"#IFU1_FigC\">Figure C</a></span>).</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigC\"></a><span class=\"Bold\">Figure C</span><a name=\"id-1600486570\"></a><img alt=\"Figure C\" src=\"/dailymed/image.cfm?name=genotropin-05.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Peel off the foil from the needle.</dd>\n<dt>•</dt>\n<dd>Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (<span class=\"Bold\">See <a href=\"#IFU1_FigD\">Figure D</a></span>).</dd>\n<dt>•</dt>\n<dd>Do not remove the outer needle cover and inner needle cap until you are ready to inject.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigD\"></a><span class=\"Bold\">Figure D</span><a name=\"id652257201\"></a><img alt=\"Figure D\" src=\"/dailymed/image.cfm?name=genotropin-06.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN</span>\n<br/>Use only the 5 mg cartridge.</p>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Open the cartridge pack and take out 1 cartridge.</dd>\n<dt>•</dt>\n<dd>Check that the color on the cartridge matches the color around the window of the plastic body (<span class=\"Bold\">See <a href=\"#IFU1_FigE\">Figure E</a></span>).</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigE\"></a><span class=\"Bold\">Figure E</span><a name=\"id-595942003\"></a><img alt=\"Figure E\" src=\"/dailymed/image.cfm?name=genotropin-07.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (<span class=\"Bold\">See <a href=\"#IFU1_FigF\">Figure F</a></span>).</dd>\n<dt>•</dt>\n<dd>Push the cartridge firmly into place.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigF\"></a><span class=\"Bold\">Figure F</span><a name=\"id1433403511\"></a><img alt=\"Figure F\" src=\"/dailymed/image.cfm?name=genotropin-08.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4. Prepare your Pen</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Press the red release button. The injection button will pop up (<span class=\"Bold\">See <a href=\"#IFU1_FigG\">Figure G</a></span>).</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigG\"></a><span class=\"Bold\">Figure G</span><a name=\"id-1367441766\"></a><img alt=\"Figure G\" src=\"/dailymed/image.cfm?name=genotropin-09.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"middle\">\n<dl>\n<dt>•</dt>\n<dd>Turn the injection button in a counter clockwise direction (to the left) as far as it will go (<span class=\"Bold\">See <a href=\"#IFU1_FigH\">Figure H</a></span>). This will draw back the plunger rod.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigH\"></a><span class=\"Bold\">Figure H</span><a name=\"id924005506\"></a><img alt=\"Figure H\" src=\"/dailymed/image.cfm?name=genotropin-10.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"middle\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check that the plunger rod is not visible</span> through the plunger rod window (<span class=\"Bold\">See <a href=\"#IFU1_FigI\">Figure I</a></span>). <span class=\"Bold\">Do not</span> proceed if the plunger rod is visible, as the medicine will not be properly mixed.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigI\"></a><span class=\"Bold\">Figure I</span><a name=\"id625051926\"></a><img alt=\"Figure I\" src=\"/dailymed/image.cfm?name=genotropin-11.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5. Mix your GENOTROPIN</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Make sure that a needle is attached to the metal front part.</dd>\n<dt>•</dt>\n<dd>While holding your pen <span class=\"Bold\">upright</span>, gently screw the metal front part and the plastic body back together as shown (<span class=\"Bold\">See <a href=\"#IFU1_FigJ\">Figure J</a></span>). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigJ\"></a><span class=\"Bold\">Figure J</span><a name=\"id1739130136\"></a><img alt=\"Figure J\" src=\"/dailymed/image.cfm?name=genotropin-12.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 6. Examine the Solution</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Gently tip your pen from side to side to help dissolve the powder completely (<span class=\"Bold\">See <a href=\"#IFU1_figK\">Figure K</a></span>).</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_figK\"></a><span class=\"Bold\">Figure K</span><a name=\"id788320512\"></a><img alt=\"Figure K\" src=\"/dailymed/image.cfm?name=genotropin-13.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not shake</span> your pen, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (<span class=\"Bold\">See <a href=\"#IFU1_FigL\">Figure L</a></span>).</dd>\n<dt>•</dt>\n<dd>If you see particles, or if the solution is not clear, <span class=\"Bold\">do not inject</span>. Remove the cartridge and use a new one.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigL\"></a><span class=\"Bold\">Figure L</span><a name=\"id-987171003\"></a><img alt=\"Figure L\" src=\"/dailymed/image.cfm?name=genotropin-14.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 7. Release Trapped Air</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. <span class=\"Bold\">Do not to touch</span> the exposed needle.</dd>\n</dl>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Remove any trapped air from the solution as follows:</dd>\n</dl>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>a)</dt>\n<dd>Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (<span class=\"Bold\">See <a href=\"#IFU1_FigM\">Figure M</a></span>).</dd>\n</dl>\n</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigM\"></a><span class=\"Bold\">Figure M</span><a name=\"id-992016869\"></a><img alt=\"Figure M\" src=\"/dailymed/image.cfm?name=genotropin-15.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>b)</dt>\n<dd>Hold your pen with the needle pointing <span class=\"Bold\">upwards</span>. Gently tap the metal front part with your finger to move any air bubbles to the top.</dd>\n</dl>\n</dd>\n</dl>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>c)</dt>\n<dd>Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (<span class=\"Bold\">See <a href=\"#IFU1_FigN\">Figure N</a>).</span>\n</dd>\n</dl>\n</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigN\"></a><span class=\"Bold\">Figure N</span><a name=\"id2114934408\"></a><img alt=\"Figure N\" src=\"/dailymed/image.cfm?name=genotropin-16.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>d)</dt>\n<dd>If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.1'. Repeat steps b) and c) to remove any trapped air from the solution (<span class=\"Bold\">see <a href=\"#IFU1_FigO\">Figure O</a></span>).</dd>\n</dl>\n</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigO\"></a><span class=\"Bold\">Figure O</span><a name=\"id-1394353352\"></a><img alt=\"Figure O\" src=\"/dailymed/image.cfm?name=genotropin-17.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 8. Attach the Needle Guard (Optional)</span>\n<br/>The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.</p>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Grip the sides of the needle guard. Push it over the needle until it snaps in place (<span class=\"Bold\">See <a href=\"#IFU1_FigP\">Figure P</a></span>). <span class=\"Bold\">Do not</span> push the needle guard on the end.<br/>Be careful not to touch the exposed needle.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigP\"></a><span class=\"Bold\">Figure P</span><a name=\"id-1557474968\"></a><img alt=\"Figure P\" src=\"/dailymed/image.cfm?name=genotropin-18.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">My daily dose is </span><a name=\"id1702428157\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-18a.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/><span class=\"Bold\">mg</span><span class=\"Italics\"> (write in your daily dose)</span>\n</p>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 9. Dial Your Prescribed Dose</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Press the red release button to reset your pen.</dd>\n<dt>•</dt>\n<dd>The button will pop up and the dose display window will read '0.0'.</dd>\n<dt>•</dt>\n<dd>Turn the injection button in a clockwise direction (to the right) as shown, until your prescribed dose is displayed (<span class=\"Bold\">See <a href=\"#IFU1_FigQ\">Figure Q</a></span>).</dd>\n<dt>•</dt>\n<dd>If you turn the button too far, turn it back the other way until your correct dose is displayed.</dd>\n</dl>\n</td><td valign=\"middle\">\n<p class=\"First\">\n<a name=\"IFU1_FigQ\"></a><span class=\"Bold\">Figure Q</span><a name=\"id589199655\"></a><img alt=\"Figure Q\" src=\"/dailymed/image.cfm?name=genotropin-19.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 10. Inject your GENOTROPIN</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (<span class=\"Bold\">see <a href=\"#IFU1_FigR\">Figure R</a></span>).</dd>\n<dt>•</dt>\n<dd>Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas of the skin that have scars or skin problems.</dd>\n<dt>•</dt>\n<dd>Clean the injection site with the alcohol swab.</dd>\n<dt>•</dt>\n<dd>Allow the injection site to dry.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigR\"></a><span class=\"Bold\">Figure R</span><a name=\"id-1594780316\"></a><img alt=\"Figure R\" src=\"/dailymed/image.cfm?name=genotropin-20.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (<span class=\"Bold\">See <a href=\"#IFU1_FigS\">Figure S</a></span>).</dd>\n<dt>•</dt>\n<dd>Push the injection button until it clicks. Wait while counting <span class=\"Bold\">slowly</span> for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (<span class=\"Bold\">See <a href=\"#IFU1_FigS\">Figure S</a></span>).</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigS\"></a><span class=\"Bold\">Figure S</span><a name=\"id-1670255967\"></a><img alt=\"Figure S\" src=\"/dailymed/image.cfm?name=genotropin-21.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 11. Throw away the Needle and Store your GENOTROPIN PEN 5</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Pull off the needle guard, gripping the sides. Be careful not to push on the end. (<span class=\"Bold\">See <a href=\"#IFU1_FigT\">Figure T</a></span>).</dd>\n<dt>•</dt>\n<dd>Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (<span class=\"Bold\">See <a href=\"#IFU1_step14\">Step 14</a></span>). <span class=\"Bold\">Do not reuse the needle</span>.</dd>\n<dt>•</dt>\n<dd>Push on the front cap, and put your pen back in its protective case.</dd>\n<dt>•</dt>\n<dd>Store your pen (with the cartridge) in the <span class=\"Bold\">refrigerator</span> between 36ºF to 46ºF (2ºC to 8ºC) until your next injection.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigT\"></a><span class=\"Bold\">Figure T</span><a name=\"id1691951560\"></a><img alt=\"Figure T\" src=\"/dailymed/image.cfm?name=genotropin-22.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 12. Your Next Injection</span>\n<br/>If you already have a cartridge in your pen, prepare the pen and give the injection as follows:</p>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Remove the front cap (<span class=\"Bold\">See <a href=\"#IFU1_FigU\">Figure U</a></span>).</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigU\"></a><span class=\"Bold\">Figure U</span><a name=\"id-1661914681\"></a><img alt=\"Figure U\" src=\"/dailymed/image.cfm?name=genotropin-23.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (<span class=\"Bold\">See <a href=\"#IFU1_FigV\">Figure V</a></span>).</dd>\n<dt>•</dt>\n<dd>Peel off the foil from a needle.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigV\"></a><span class=\"Bold\">Figure V</span><a name=\"id2128116629\"></a><img alt=\"Figure V\" src=\"/dailymed/image.cfm?name=genotropin-24.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Push and screw the needle onto the metal front part of the pen as shown (<span class=\"Bold\">See <a href=\"#IFU1_FigW\">Figure W</a></span>). Remove the outer needle cover and inner needle cap.</dd>\n<dt>•</dt>\n<dd>Follow the instructions above, starting with <span class=\"Bold\">Step 8: Attach the Needle Guard</span>.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigW\"></a><span class=\"Bold\">Figure W</span><a name=\"id1907255465\"></a><img alt=\"Figure W\" src=\"/dailymed/image.cfm?name=genotropin-25.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 13. To Replace the Cartridge</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Press the red release button to reset your pen (<span class=\"Bold\">See <a href=\"#IFU1_FigX\">Figure X</a></span>).</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigX\"></a><span class=\"Bold\">Figure X</span><a name=\"id-263380984\"></a><img alt=\"Figure X\" src=\"/dailymed/image.cfm?name=genotropin-26.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (<span class=\"Bold\">See <a href=\"#IFU1_FigY\">Figure Y</a></span>).This will draw back the plunger rod.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigY\"></a><span class=\"Bold\">Figure Y</span><a name=\"id-2011371227\"></a><img alt=\"Figure Y\" src=\"/dailymed/image.cfm?name=genotropin-27.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Unscrew the metal front part and remove the empty cartridge (<span class=\"Bold\">See <a href=\"#IFU1_FigZ\">Figure Z</a></span>).</dd>\n<dt>•</dt>\n<dd>Throw away the empty cartridge as instructed by your healthcare provider.</dd>\n<dt>•</dt>\n<dd>To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with <span class=\"Bold\"><a href=\"#IFU1_step1\">Step 1</a></span>.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigZ\"></a><span class=\"Bold\">Figure Z</span><a name=\"id36866137\"></a><img alt=\"Figure Z\" src=\"/dailymed/image.cfm?name=genotropin-28.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Step 14. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 5 Put the used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and cartridges in the household trash.

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If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

{ "type": "p", "children": [], "text": "If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:" }

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When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

{ "type": "p", "children": [], "text": "When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal." }

{ "type": "", "children": [], "text": "" }

Important: Always keep the sharps disposal container out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Always keep the sharps disposal container out of the reach of children." }

Dispose of the entire GENOTROPIN PEN 5 as electronic waste per state and local regulations.

{ "type": "p", "children": [], "text": "Dispose of the entire GENOTROPIN PEN 5 as electronic waste per state and local regulations." }

Customizing your Pen

{ "type": "p", "children": [], "text": "\nCustomizing your Pen\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="75%"/> <col width="25%"/> <tbody class="Headless"> <tr> <td valign="top"> <p class="First">Your pen is supplied with 2 colored clip-on panels, so that you can customize the look of your pen. To remove the clip-on panel from the pen, insert the lip of the front cap into the groove under the front end of the panel, and pry the panel off. The new panel simply clicks into place (<span class="Bold">See <a href="#IFU1_FigAA">Figure AA</a></span>).</p> </td><td valign="top"> <p class="First"> <a name="IFU1_FigAA"></a><span class="Bold">Figure AA</span><a name="id1553043654"></a><img alt="Figure AA" src="/dailymed/image.cfm?name=genotropin-29.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"75%\"/>\n<col width=\"25%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Your pen is supplied with 2 colored clip-on panels, so that you can customize the look of your pen. To remove the clip-on panel from the pen, insert the lip of the front cap into the groove under the front end of the panel, and pry the panel off. The new panel simply clicks into place (<span class=\"Bold\">See <a href=\"#IFU1_FigAA\">Figure AA</a></span>).</p>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU1_FigAA\"></a><span class=\"Bold\">Figure AA</span><a name=\"id1553043654\"></a><img alt=\"Figure AA\" src=\"/dailymed/image.cfm?name=genotropin-29.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Caring for your Pen To clean your pen, wipe the outside surface with a damp cloth. Do not put the pen in water or this may damage your pen. Do not use alcohol or any other cleaning agents to clean the pen, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol pad.

{ "type": "p", "children": [], "text": "\nCaring for your Pen\nTo clean your pen, wipe the outside surface with a damp cloth. Do not put the pen in water or this may damage your pen. Do not use alcohol or any other cleaning agents to clean the pen, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol pad." }

<div class="scrollingtable"><table width="90%"> <col width="45%"/> <col width="55%"/> <thead> <tr class="First"> <th align="left" class="Botrule Lrule Toprule" valign="top"><span class="Bold">Questions and Answers</span></th><th align="left" class="Botrule Rrule Toprule" valign="top"></th> </tr> <tr class="Last"> <th align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Question</span></th><th align="left" class="Botrule Rrule" valign="top"><span class="Bold">Answer</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">How long is the use period of my pen?</p> </td><td class="Botrule Rrule Toprule" valign="top"> <p class="First">The pen has a use period of 2 years starting from the first use by the patient.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">How can I tell how much GENOTROPIN is left in my pen?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further. The dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">If the display does not work, can my pen still be used?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">Contact your healthcare provider as soon as possible to get a new pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">What happens if I dial the injection button beyond the maximum dose ('2.0' mg)?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Why is it difficult to turn or push the injection button?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"90%\">\n<col width=\"45%\"/>\n<col width=\"55%\"/>\n<thead>\n<tr class=\"First\">\n<th align=\"left\" class=\"Botrule Lrule Toprule\" valign=\"top\"><span class=\"Bold\">Questions and Answers</span></th><th align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"top\"></th>\n</tr>\n<tr class=\"Last\">\n<th align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Question</span></th><th align=\"left\" class=\"Botrule Rrule\" valign=\"top\"><span class=\"Bold\">Answer</span></th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">How long is the use period of my pen?</p>\n</td><td class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">The pen has a use period of 2 years starting from the first use by the patient.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">How can I tell how much GENOTROPIN is left in my pen?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further. The dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">If the display does not work, can my pen still be used?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">Contact your healthcare provider as soon as possible to get a new pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">What happens if I dial the injection button beyond the maximum dose ('2.0' mg)?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Why is it difficult to turn or push the injection button?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Display Information:

{ "type": "p", "children": [], "text": "\nDisplay Information:\n" }

<div class="scrollingtable"><table width="90%"> <col width="5%"/> <col width="15%"/> <col width="25%"/> <col width="55%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Toprule" valign="middle"></td><td class="Botrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Botrule Rrule Toprule" valign="top"><a name="id165984458"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-30.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">The selected dose size.</span> <br/>The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id-82295831"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-31.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">A dose is not set.</span> <br/>The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Flashing</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id327950852"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-32.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">The injection button is rotated too fast or too slow.</span> <br/>Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Flashing</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id-348264515"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-33.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">The injection button is rotated too fast or too slow.</span> <br/>Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.</p> </td> </tr> <tr> <td class="Lrule" valign="middle"></td><td valign="middle"> <p class="First"> <span class="Bold">Flashing</span> </p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"> <p class="First"> <span class="Bold">1 month before the end of the 2 year use period.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="bottom"> <p class="First"> <span class="Bold">(5 seconds)</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id-1088695728"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-34.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First">This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.</p> </td> </tr> <tr> <td class="Lrule" valign="middle"></td><td valign="bottom"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Rrule" valign="top"><a name="id-1290277696"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-35.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Rrule" valign="top"> <p class="First"> <span class="Bold">Pen has reached the end of its use period of 2 years.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="middle"></td><td class="Botrule Rrule" valign="middle"> <p class="First">The display will continue to show <a name="id-217135775"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-35a.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/> until the battery is completely empty. <br/>This does not indicate a problem with the pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.</p> </td> </tr> <tr> <td class="Lrule" valign="middle"></td><td valign="middle"> <p class="First"> <span class="Bold">Flashing</span> </p> </td><td class="Rrule" valign="top"></td><td class="Botrule Rrule" rowspan="2" valign="top"> <p class="First"> <span class="Bold">Battery charge is low and will be empty in 1 month.<br/> </span>Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">(5 seconds)</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id-1077824250"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-36.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id-1254353930"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-37.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">Battery power low.</span> <br/>The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id487603602"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-38.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">Blank screen</span> <br/>To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"90%\">\n<col width=\"5%\"/>\n<col width=\"15%\"/>\n<col width=\"25%\"/>\n<col width=\"55%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Toprule\" valign=\"middle\"></td><td class=\"Botrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Botrule Rrule Toprule\" valign=\"top\"><a name=\"id165984458\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-30.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">The selected dose size.</span>\n<br/>The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id-82295831\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-31.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">A dose is not set.</span>\n<br/>The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Flashing</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id327950852\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-32.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">The injection button is rotated too fast or too slow.</span>\n<br/>Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Flashing</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id-348264515\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-33.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">The injection button is rotated too fast or too slow.</span>\n<br/>Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"middle\"></td><td valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Flashing</span>\n</p>\n</td><td class=\"Rrule\" valign=\"top\"></td><td class=\"Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">1 month before the end of the 2 year use period.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">(5 seconds)</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id-1088695728\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-34.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"middle\"></td><td valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Rrule\" valign=\"top\"><a name=\"id-1290277696\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-35.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Pen has reached the end of its use period of 2 years.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"middle\"></td><td class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">The display will continue to show <a name=\"id-217135775\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-35a.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/> until the battery is completely empty. <br/>This does not indicate a problem with the pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"middle\"></td><td valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Flashing</span>\n</p>\n</td><td class=\"Rrule\" valign=\"top\"></td><td class=\"Botrule Rrule\" rowspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Battery charge is low and will be empty in 1 month.<br/>\n</span>Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">(5 seconds)</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id-1077824250\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-36.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id-1254353930\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-37.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Battery power low.</span>\n<br/>The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id487603602\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-38.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Blank screen</span>\n<br/>To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

{ "type": "p", "children": [], "text": "If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away." }

Use this device only for the person for whom it was prescribed.

{ "type": "p", "children": [], "text": "Use this device only for the person for whom it was prescribed." }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "\nThis Instructions for Use has been approved by the U.S. Food and Drug Administration.\n" }

Caution: Federal law restricts this device to sale by or on the order of a physician.

{ "type": "p", "children": [], "text": "\nCaution: Federal law restricts this device to sale by or on the order of a physician." }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Pharmacia & Upjohn Company LLC

{ "type": "p", "children": [], "text": "Pharmacia & Upjohn Company LLC" }

A subsidiary of Pfizer Inc.

{ "type": "p", "children": [], "text": "A subsidiary of Pfizer Inc." }

New York, NY 10001

{ "type": "p", "children": [], "text": "New York, NY 10001" }

U.S. License No. 1216

{ "type": "p", "children": [], "text": "U.S. License No. 1216" }

LAB-0225-10.0

{ "type": "p", "children": [], "text": "LAB-0225-10.0" }

Revised August 2024

{ "type": "p", "children": [], "text": "Revised August 2024" }

INSTRUCTIONS FOR USE GENOTROPIN 12 (JEEN-o-tro-pin 12) GENOTROPIN PEN 12 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. Use this device only for administration of GENOTROPIN.

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USE\n\nGENOTROPIN 12 (JEEN-o-tro-pin 12)\n\nGENOTROPIN PEN 12 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. Use this device only for administration of GENOTROPIN.\n" }

<div class="scrollingtable"><table width="100%"> <col width="100%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Important Note</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Please read these instructions completely before using the GENOTROPIN PEN 12. These instructions need to be followed step by step. Please do not use the GENOTROPIN PEN 12 unless your healthcare provider has trained you. If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280. If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Your pen should not be used near electrical or electronic equipment, including mobile phones. If your pen has been damaged, it should not be used and should be disposed of as instructed by your healthcare provider.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important Note</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Please read these instructions completely before using the GENOTROPIN PEN 12. These instructions need to be followed step by step. Please do not use the GENOTROPIN PEN 12 unless your healthcare provider has trained you. If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280. If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Your pen should not be used near electrical or electronic equipment, including mobile phones. If your pen has been damaged, it should not be used and should be disposed of as instructed by your healthcare provider.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

{ "type": "p", "children": [], "text": "GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period." }

For your injection you will need:

{ "type": "p", "children": [], "text": "\nFor your injection you will need:\n" }

{ "type": "", "children": [], "text": "" }

Parts of the GENOTROPIN PEN 12 (See Figure A)

{ "type": "p", "children": [], "text": "\nParts of the GENOTROPIN PEN 12 (See Figure A)" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="100%"/> <tbody class="Headless"> <tr> <td align="center" valign="middle"> <p class="First"> <a name="IFU2_FigA"></a><span class="Bold">Figure A</span> </p> </td> </tr> <tr> <td valign="middle"><a name="id4228"></a><img alt="Figure A" src="/dailymed/image.cfm?name=genotropin-41.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" valign=\"middle\">\n<p class=\"First\">\n<a name=\"IFU2_FigA\"></a><span class=\"Bold\">Figure A</span>\n</p>\n</td>\n</tr>\n<tr>\n<td valign=\"middle\"><a name=\"id4228\"></a><img alt=\"Figure A\" src=\"/dailymed/image.cfm?name=genotropin-41.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td>\n</tr>\n</tbody>\n</table></div>" }

Storage instructions for your GENOTROPIN PEN 12

{ "type": "p", "children": [], "text": "\nStorage instructions for your GENOTROPIN PEN 12\n" }

{ "type": "", "children": [], "text": "" }

Using your GENOTROPIN PEN 12

{ "type": "p", "children": [], "text": "\nUsing your GENOTROPIN PEN 12\n" }

Step 1. Wash your hands well with soap and water before using the GENOTROPIN PEN 12.

{ "type": "p", "children": [], "text": "\nStep 1.\nWash your hands well with soap and water before using the GENOTROPIN PEN 12." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="75%"/> <col width="25%"/> <tbody class="Headless"> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 2. Attach the Needle</span> </p> <dl> <dt>•</dt> <dd>Pull off the front cap (<span class="Bold">See <a href="#IFU2_FigB">Figure B</a></span>).</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigB"></a><span class="Bold">Figure B</span><a name="figb2"></a><img alt="Figure B" src="/dailymed/image.cfm?name=genotropin-42.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (<span class="Bold">See <a href="#IFU2_FigC">Figure C</a></span>).</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigC"></a><span class="Bold">Figure C</span><a name="figc2"></a><img alt="Figure C" src="/dailymed/image.cfm?name=genotropin-43.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Peel off the foil from the needle.</dd> <dt>•</dt> <dd>Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (<span class="Bold">See <a href="#IFU2_FigD">Figure D</a></span>).</dd> <dt>•</dt> <dd>Do not remove the outer needle cover and inner needle cap until you are ready to inject.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigD"></a><span class="Bold">Figure D</span><a name="figd2"></a><img alt="Figure D" src="/dailymed/image.cfm?name=genotropin-44.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN</span> <br/>Use only the 12 mg cartridge.</p> <dl> <dt>•</dt> <dd>Open the cartridge pack and take out 1 cartridge.</dd> <dt>•</dt> <dd>Check that the color on the cartridge matches the color around the window of the plastic body (<span class="Bold">See <a href="#IFU2_FigE">Figure E</a></span>).</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigE"></a><span class="Bold">Figure E</span><a name="fige2"></a><img alt="Figure E" src="/dailymed/image.cfm?name=genotropin-45.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (<span class="Bold">See <a href="#IFU2_FigF">Figure F</a></span>).</dd> <dt>•</dt> <dd>Push the cartridge firmly into place.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigF"></a><span class="Bold">Figure F</span><a name="figf2"></a><img alt="Figure F" src="/dailymed/image.cfm?name=genotropin-46.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="middle"> <p class="First"> <span class="Bold">Step 4. Prepare the Pen</span> </p> <dl> <dt>•</dt> <dd>Press the red release button. The injection button will pop up (<span class="Bold">See <a href="#IFU2_FigG">Figure G</a></span>).</dd> </dl> </td><td align="center" valign="middle"> <p class="First"> <a name="IFU2_FigG"></a><span class="Bold">Figure G</span><a name="figg2"></a><img alt="Figure G" src="/dailymed/image.cfm?name=genotropin-47.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="middle"> <dl> <dt>•</dt> <dd>Turn the injection button in a counter clockwise direction (to the left) as far as it will go (<span class="Bold">See <a href="#IFU2_FigH">Figure H</a></span>). This will draw back the plunger rod.</dd> </dl> </td><td align="center" valign="middle"> <p class="First"> <a name="IFU2_FigH"></a><span class="Bold">Figure H</span><a name="figh2"></a><img alt="Figure H" src="/dailymed/image.cfm?name=genotropin-48.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="middle"> <dl> <dt>•</dt> <dd> <span class="Bold">Check that the plunger rod is not visible</span> through the plunger rod window (<span class="Bold">See <a href="#IFU2_FigI">Figure I</a></span>). <span class="Bold">Do not</span> proceed if the plunger rod is visible, as the medicine will not be properly mixed.</dd> </dl> </td><td align="center" valign="middle"> <p class="First"> <a name="IFU2_FigI"></a><span class="Bold">Figure I</span><a name="figi2"></a><img alt="Figure I" src="/dailymed/image.cfm?name=genotropin-49.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 5. Mix your GENOTROPIN</span> </p> <dl> <dt>•</dt> <dd>Make sure that a needle is attached to the metal front part.</dd> <dt>•</dt> <dd>While holding your pen <span class="Bold">upright</span>, gently screw the metal front part and the plastic body back together as shown (<span class="Bold">See <a href="#IFU2_FigJ">Figure J</a></span>). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigJ"></a><span class="Bold">Figure J</span><a name="figj2"></a><img alt="Figure J" src="/dailymed/image.cfm?name=genotropin-50.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 6. Examine the Solution</span> </p> <dl> <dt>•</dt> <dd>Gently tip the pen from side to side to help dissolve the powder completely (<span class="Bold">See <a href="#IFU2_FigK">Figure K</a></span>).</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigK"></a><span class="Bold">Figure K</span><a name="figk2"></a><img alt="Figure K" src="/dailymed/image.cfm?name=genotropin-51.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Do not shake your pen</span>, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (<span class="Bold">See <a href="#IFU2_FigL">Figure L</a></span>).</dd> </dl> <p class="First">If you see particles, or if the solution is not clear, <span class="Bold">do not inject</span>. Remove the cartridge and use a new one.</p> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigL"></a><span class="Bold">Figure L</span><a name="figl2"></a><img alt="Figure L" src="/dailymed/image.cfm?name=genotropin-52.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 7. Release Trapped Air</span> </p> <dl> <dt>•</dt> <dd>Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. <span class="Bold">Do not touch</span> the exposed needle.</dd> </dl> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Remove any trapped air from the solution as follows:</dd> </dl> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt> </dt> <dd> <dl> <dt>a)</dt> <dd>Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (<span class="Bold">See <a href="#IFU2_FigM">Figure M</a></span>).</dd> </dl> </dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigM"></a><span class="Bold">Figure M</span><a name="figm2"></a><img alt="Figure M" src="/dailymed/image.cfm?name=genotropin-53.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt> </dt> <dd> <dl> <dt>b)</dt> <dd>Hold your pen with the needle pointing <span class="Bold">upwards</span> (<span class="Bold">See <a href="#IFU2_FigN">Figure N</a></span>). Gently tap the metal front part with your finger to move any air bubbles to the top.</dd> </dl> </dd> </dl> </td><td align="center" rowspan="2" valign="top"> <p class="First"> <a name="IFU2_FigN"></a><span class="Bold">Figure N</span><a name="fign2"></a><img alt="Figure N" src="/dailymed/image.cfm?name=genotropin-54.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt> </dt> <dd> <dl> <dt>c)</dt> <dd>Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (<span class="Bold">See <a href="#IFU2_FigN">Figure N</a></span>).</dd> </dl> </dd> </dl> </td> </tr> <tr> <td valign="top"> <dl> <dt> </dt> <dd> <dl> <dt>d)</dt> <dd>If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.2'. Repeat steps b) and c) to remove any trapped air from the solution (<span class="Bold">See <a href="#IFU2_FigO">Figure O</a></span>).</dd> </dl> </dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigO"></a><span class="Bold">Figure O</span><a name="figo2"></a><img alt="Figure O" src="/dailymed/image.cfm?name=genotropin-55.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 8. Attach the Needle Guard (Optional)</span> <br/>The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.</p> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Grip the sides of the needle guard. Push it over the needle until it snaps in place (<span class="Bold">See <a href="#IFU2_FigP">Figure P</a></span>). <span class="Bold">Do not</span> push the needle guard on the end.</dd> </dl> <p class="First">Be careful not to touch the exposed needle.</p> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigP"></a><span class="Bold">Figure P</span><a name="figp2"></a><img alt="Figure P" src="/dailymed/image.cfm?name=genotropin-56.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">My daily dose is </span><a name="id4413"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-56a.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/><span class="Bold">mg</span><span class="Italics"> (write in your daily dose)</span> </p> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 9. Dial Your Prescribed Dose</span> </p> <dl> <dt>•</dt> <dd>Press the red release button to reset your pen.</dd> <dt>•</dt> <dd>The button will pop up and the dose display window will read '0.0'.</dd> <dt>•</dt> <dd>Turn the injection button in a clockwise direction (to the right) as shown until your prescribed dose is displayed (<span class="Bold">See <a href="#IFU2_FigQ">Figure Q</a></span>).</dd> <dt>•</dt> <dd>If you turn the button too far, turn it back the other way until your correct dose is displayed.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigQ"></a><span class="Bold">Figure Q</span><a name="figq2"></a><img alt="Figure Q" src="/dailymed/image.cfm?name=genotropin-57.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 10. Inject your GENOTROPIN</span> </p> <dl> <dt>•</dt> <dd>Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (<span class="Bold">See <a href="#IFU2_FigR">Figure R</a></span>).</dd> <dt>•</dt> <dd>Avoid areas that are bony, bruised, red, sore or hard, and areas of the skin that have scars or skin conditions.</dd> <dt>•</dt> <dd>Clean the injection site with the alcohol swab.</dd> <dt>•</dt> <dd>Allow the injection site to dry.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigR"></a><span class="Bold">Figure R</span><a name="figr2"></a><img alt="Figure R" src="/dailymed/image.cfm?name=genotropin-58.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (<span class="Bold">See <a href="#IFU2_FigS">Figure S</a></span>).</dd> <dt>•</dt> <dd>Push the injection button until it clicks. Wait while counting <span class="Bold">slowly</span> for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (<span class="Bold">See <a href="#IFU2_FigS">Figure S</a></span>).</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigS"></a><span class="Bold">Figure S</span><a name="figs2"></a><img alt="Figure S" src="/dailymed/image.cfm?name=genotropin-59.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 11. Throw away the Needle and Store the GENOTROPIN PEN 12</span> </p> <dl> <dt>•</dt> <dd>Pull off the needle guard, gripping the sides. Be careful not to push on the end (<span class="Bold">See <a href="#IFU2_FigT">Figure T</a></span>).</dd> <dt>•</dt> <dd>Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (<span class="Bold">See <a href="#IFU2_Step14">Step 14</a></span>). <span class="Bold">Do not reuse the needle</span>.</dd> <dt>•</dt> <dd>Push on the front cap, and put your pen back in its protective case.</dd> <dt>•</dt> <dd>Store your pen (with the cartridge) in the <span class="Bold">refrigerator</span> between 36°F to 46°F (2°C to 8°C) until your next injection.</dd> </dl> </td><td align="center" valign="middle"> <p class="First"> <a name="IFU2_FigT"></a><span class="Bold">Figure T</span><a name="figt2"></a><img alt="Figure T" src="/dailymed/image.cfm?name=genotropin-60.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 12. Your Next Injection</span> <br/>If you already have a cartridge in your pen, prepare the pen and give the injection as follows:</p> <dl> <dt>•</dt> <dd>Remove the front cap (<span class="Bold">See <a href="#IFU2_FigU">Figure U</a></span>).</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigU"></a><span class="Bold">Figure U</span><a name="figu2"></a><img alt="Figure U" src="/dailymed/image.cfm?name=genotropin-61.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (<span class="Bold">See <a href="#IFU2_FigV">Figure V</a></span>).</dd> <dt>•</dt> <dd>Peel off the foil from a needle.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigV"></a><span class="Bold">Figure V</span><a name="figv2"></a><img alt="Figure V" src="/dailymed/image.cfm?name=genotropin-62.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Push and screw the needle onto the metal front part of your pen as shown (<span class="Bold">See <a href="#IFU2_FigW">Figure W</a></span>). Remove the outer needle cover and inner needle cap.</dd> <dt>•</dt> <dd>Follow the instructions above, starting with <span class="Bold">Step 8: Attach the Needle Guard</span>.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigW"></a><span class="Bold">Figure W</span><a name="figw2"></a><img alt="Figure W" src="/dailymed/image.cfm?name=genotropin-63.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 13. To Replace the Cartridge</span> </p> <dl> <dt>•</dt> <dd>Press the red release button to reset your pen (<span class="Bold">See <a href="#IFU2_FigX">Figure X</a></span>).</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigX"></a><span class="Bold">Figure X</span><a name="figx2"></a><img alt="Figure X" src="/dailymed/image.cfm?name=genotropin-64.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (<span class="Bold">See <a href="#IFU2_FigY">Figure Y</a></span>). This will draw back the plunger rod.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigY"></a><span class="Bold">Figure Y</span><a name="figy2"></a><img alt="Figure Y" src="/dailymed/image.cfm?name=genotropin-65.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <dl> <dt>•</dt> <dd>Unscrew the metal front part and remove the empty cartridge (<span class="Bold">See <a href="#IFU2_FigZ">Figure Z</a></span>).</dd> <dt>•</dt> <dd>Throw away the empty cartridge as instructed by your healthcare provider.</dd> <dt>•</dt> <dd>To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with <span class="Bold"><a href="#IFU2_Step1">Step 1</a></span>.</dd> </dl> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigZ"></a><span class="Bold">Figure Z</span><a name="figz2"></a><img alt="Figure Z" src="/dailymed/image.cfm?name=genotropin-66.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"75%\"/>\n<col width=\"25%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2. Attach the Needle</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Pull off the front cap (<span class=\"Bold\">See <a href=\"#IFU2_FigB\">Figure B</a></span>).</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigB\"></a><span class=\"Bold\">Figure B</span><a name=\"figb2\"></a><img alt=\"Figure B\" src=\"/dailymed/image.cfm?name=genotropin-42.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (<span class=\"Bold\">See <a href=\"#IFU2_FigC\">Figure C</a></span>).</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigC\"></a><span class=\"Bold\">Figure C</span><a name=\"figc2\"></a><img alt=\"Figure C\" src=\"/dailymed/image.cfm?name=genotropin-43.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Peel off the foil from the needle.</dd>\n<dt>•</dt>\n<dd>Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (<span class=\"Bold\">See <a href=\"#IFU2_FigD\">Figure D</a></span>).</dd>\n<dt>•</dt>\n<dd>Do not remove the outer needle cover and inner needle cap until you are ready to inject.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigD\"></a><span class=\"Bold\">Figure D</span><a name=\"figd2\"></a><img alt=\"Figure D\" src=\"/dailymed/image.cfm?name=genotropin-44.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN</span>\n<br/>Use only the 12 mg cartridge.</p>\n<dl>\n<dt>•</dt>\n<dd>Open the cartridge pack and take out 1 cartridge.</dd>\n<dt>•</dt>\n<dd>Check that the color on the cartridge matches the color around the window of the plastic body (<span class=\"Bold\">See <a href=\"#IFU2_FigE\">Figure E</a></span>).</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigE\"></a><span class=\"Bold\">Figure E</span><a name=\"fige2\"></a><img alt=\"Figure E\" src=\"/dailymed/image.cfm?name=genotropin-45.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (<span class=\"Bold\">See <a href=\"#IFU2_FigF\">Figure F</a></span>).</dd>\n<dt>•</dt>\n<dd>Push the cartridge firmly into place.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigF\"></a><span class=\"Bold\">Figure F</span><a name=\"figf2\"></a><img alt=\"Figure F\" src=\"/dailymed/image.cfm?name=genotropin-46.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4. Prepare the Pen</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Press the red release button. The injection button will pop up (<span class=\"Bold\">See <a href=\"#IFU2_FigG\">Figure G</a></span>).</dd>\n</dl>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">\n<a name=\"IFU2_FigG\"></a><span class=\"Bold\">Figure G</span><a name=\"figg2\"></a><img alt=\"Figure G\" src=\"/dailymed/image.cfm?name=genotropin-47.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"middle\">\n<dl>\n<dt>•</dt>\n<dd>Turn the injection button in a counter clockwise direction (to the left) as far as it will go (<span class=\"Bold\">See <a href=\"#IFU2_FigH\">Figure H</a></span>). This will draw back the plunger rod.</dd>\n</dl>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">\n<a name=\"IFU2_FigH\"></a><span class=\"Bold\">Figure H</span><a name=\"figh2\"></a><img alt=\"Figure H\" src=\"/dailymed/image.cfm?name=genotropin-48.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"middle\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check that the plunger rod is not visible</span> through the plunger rod window (<span class=\"Bold\">See <a href=\"#IFU2_FigI\">Figure I</a></span>). <span class=\"Bold\">Do not</span> proceed if the plunger rod is visible, as the medicine will not be properly mixed.</dd>\n</dl>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">\n<a name=\"IFU2_FigI\"></a><span class=\"Bold\">Figure I</span><a name=\"figi2\"></a><img alt=\"Figure I\" src=\"/dailymed/image.cfm?name=genotropin-49.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5. Mix your GENOTROPIN</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Make sure that a needle is attached to the metal front part.</dd>\n<dt>•</dt>\n<dd>While holding your pen <span class=\"Bold\">upright</span>, gently screw the metal front part and the plastic body back together as shown (<span class=\"Bold\">See <a href=\"#IFU2_FigJ\">Figure J</a></span>). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigJ\"></a><span class=\"Bold\">Figure J</span><a name=\"figj2\"></a><img alt=\"Figure J\" src=\"/dailymed/image.cfm?name=genotropin-50.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 6. Examine the Solution</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Gently tip the pen from side to side to help dissolve the powder completely (<span class=\"Bold\">See <a href=\"#IFU2_FigK\">Figure K</a></span>).</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigK\"></a><span class=\"Bold\">Figure K</span><a name=\"figk2\"></a><img alt=\"Figure K\" src=\"/dailymed/image.cfm?name=genotropin-51.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not shake your pen</span>, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (<span class=\"Bold\">See <a href=\"#IFU2_FigL\">Figure L</a></span>).</dd>\n</dl>\n<p class=\"First\">If you see particles, or if the solution is not clear, <span class=\"Bold\">do not inject</span>. Remove the cartridge and use a new one.</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigL\"></a><span class=\"Bold\">Figure L</span><a name=\"figl2\"></a><img alt=\"Figure L\" src=\"/dailymed/image.cfm?name=genotropin-52.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 7. Release Trapped Air</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. <span class=\"Bold\">Do not touch</span> the exposed needle.</dd>\n</dl>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Remove any trapped air from the solution as follows:</dd>\n</dl>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>a)</dt>\n<dd>Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (<span class=\"Bold\">See <a href=\"#IFU2_FigM\">Figure M</a></span>).</dd>\n</dl>\n</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigM\"></a><span class=\"Bold\">Figure M</span><a name=\"figm2\"></a><img alt=\"Figure M\" src=\"/dailymed/image.cfm?name=genotropin-53.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>b)</dt>\n<dd>Hold your pen with the needle pointing <span class=\"Bold\">upwards</span> (<span class=\"Bold\">See <a href=\"#IFU2_FigN\">Figure N</a></span>). Gently tap the metal front part with your finger to move any air bubbles to the top.</dd>\n</dl>\n</dd>\n</dl>\n</td><td align=\"center\" rowspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigN\"></a><span class=\"Bold\">Figure N</span><a name=\"fign2\"></a><img alt=\"Figure N\" src=\"/dailymed/image.cfm?name=genotropin-54.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>c)</dt>\n<dd>Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (<span class=\"Bold\">See <a href=\"#IFU2_FigN\">Figure N</a></span>).</dd>\n</dl>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>d)</dt>\n<dd>If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.2'. Repeat steps b) and c) to remove any trapped air from the solution (<span class=\"Bold\">See <a href=\"#IFU2_FigO\">Figure O</a></span>).</dd>\n</dl>\n</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigO\"></a><span class=\"Bold\">Figure O</span><a name=\"figo2\"></a><img alt=\"Figure O\" src=\"/dailymed/image.cfm?name=genotropin-55.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 8. Attach the Needle Guard (Optional)</span>\n<br/>The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.</p>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Grip the sides of the needle guard. Push it over the needle until it snaps in place (<span class=\"Bold\">See <a href=\"#IFU2_FigP\">Figure P</a></span>). <span class=\"Bold\">Do not</span> push the needle guard on the end.</dd>\n</dl>\n<p class=\"First\">Be careful not to touch the exposed needle.</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigP\"></a><span class=\"Bold\">Figure P</span><a name=\"figp2\"></a><img alt=\"Figure P\" src=\"/dailymed/image.cfm?name=genotropin-56.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">My daily dose is </span><a name=\"id4413\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-56a.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/><span class=\"Bold\">mg</span><span class=\"Italics\"> (write in your daily dose)</span>\n</p>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 9. Dial Your Prescribed Dose</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Press the red release button to reset your pen.</dd>\n<dt>•</dt>\n<dd>The button will pop up and the dose display window will read '0.0'.</dd>\n<dt>•</dt>\n<dd>Turn the injection button in a clockwise direction (to the right) as shown until your prescribed dose is displayed (<span class=\"Bold\">See <a href=\"#IFU2_FigQ\">Figure Q</a></span>).</dd>\n<dt>•</dt>\n<dd>If you turn the button too far, turn it back the other way until your correct dose is displayed.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigQ\"></a><span class=\"Bold\">Figure Q</span><a name=\"figq2\"></a><img alt=\"Figure Q\" src=\"/dailymed/image.cfm?name=genotropin-57.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 10. Inject your GENOTROPIN</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (<span class=\"Bold\">See <a href=\"#IFU2_FigR\">Figure R</a></span>).</dd>\n<dt>•</dt>\n<dd>Avoid areas that are bony, bruised, red, sore or hard, and areas of the skin that have scars or skin conditions.</dd>\n<dt>•</dt>\n<dd>Clean the injection site with the alcohol swab.</dd>\n<dt>•</dt>\n<dd>Allow the injection site to dry.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigR\"></a><span class=\"Bold\">Figure R</span><a name=\"figr2\"></a><img alt=\"Figure R\" src=\"/dailymed/image.cfm?name=genotropin-58.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (<span class=\"Bold\">See <a href=\"#IFU2_FigS\">Figure S</a></span>).</dd>\n<dt>•</dt>\n<dd>Push the injection button until it clicks. Wait while counting <span class=\"Bold\">slowly</span> for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (<span class=\"Bold\">See <a href=\"#IFU2_FigS\">Figure S</a></span>).</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigS\"></a><span class=\"Bold\">Figure S</span><a name=\"figs2\"></a><img alt=\"Figure S\" src=\"/dailymed/image.cfm?name=genotropin-59.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 11. Throw away the Needle and Store the GENOTROPIN PEN 12</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Pull off the needle guard, gripping the sides. Be careful not to push on the end (<span class=\"Bold\">See <a href=\"#IFU2_FigT\">Figure T</a></span>).</dd>\n<dt>•</dt>\n<dd>Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (<span class=\"Bold\">See <a href=\"#IFU2_Step14\">Step 14</a></span>). <span class=\"Bold\">Do not reuse the needle</span>.</dd>\n<dt>•</dt>\n<dd>Push on the front cap, and put your pen back in its protective case.</dd>\n<dt>•</dt>\n<dd>Store your pen (with the cartridge) in the <span class=\"Bold\">refrigerator</span> between 36°F to 46°F (2°C to 8°C) until your next injection.</dd>\n</dl>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">\n<a name=\"IFU2_FigT\"></a><span class=\"Bold\">Figure T</span><a name=\"figt2\"></a><img alt=\"Figure T\" src=\"/dailymed/image.cfm?name=genotropin-60.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 12. Your Next Injection</span>\n<br/>If you already have a cartridge in your pen, prepare the pen and give the injection as follows:</p>\n<dl>\n<dt>•</dt>\n<dd>Remove the front cap (<span class=\"Bold\">See <a href=\"#IFU2_FigU\">Figure U</a></span>).</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigU\"></a><span class=\"Bold\">Figure U</span><a name=\"figu2\"></a><img alt=\"Figure U\" src=\"/dailymed/image.cfm?name=genotropin-61.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (<span class=\"Bold\">See <a href=\"#IFU2_FigV\">Figure V</a></span>).</dd>\n<dt>•</dt>\n<dd>Peel off the foil from a needle.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigV\"></a><span class=\"Bold\">Figure V</span><a name=\"figv2\"></a><img alt=\"Figure V\" src=\"/dailymed/image.cfm?name=genotropin-62.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Push and screw the needle onto the metal front part of your pen as shown (<span class=\"Bold\">See <a href=\"#IFU2_FigW\">Figure W</a></span>). Remove the outer needle cover and inner needle cap.</dd>\n<dt>•</dt>\n<dd>Follow the instructions above, starting with <span class=\"Bold\">Step 8: Attach the Needle Guard</span>.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigW\"></a><span class=\"Bold\">Figure W</span><a name=\"figw2\"></a><img alt=\"Figure W\" src=\"/dailymed/image.cfm?name=genotropin-63.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 13. To Replace the Cartridge</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Press the red release button to reset your pen (<span class=\"Bold\">See <a href=\"#IFU2_FigX\">Figure X</a></span>).</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigX\"></a><span class=\"Bold\">Figure X</span><a name=\"figx2\"></a><img alt=\"Figure X\" src=\"/dailymed/image.cfm?name=genotropin-64.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (<span class=\"Bold\">See <a href=\"#IFU2_FigY\">Figure Y</a></span>). This will draw back the plunger rod.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigY\"></a><span class=\"Bold\">Figure Y</span><a name=\"figy2\"></a><img alt=\"Figure Y\" src=\"/dailymed/image.cfm?name=genotropin-65.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Unscrew the metal front part and remove the empty cartridge (<span class=\"Bold\">See <a href=\"#IFU2_FigZ\">Figure Z</a></span>).</dd>\n<dt>•</dt>\n<dd>Throw away the empty cartridge as instructed by your healthcare provider.</dd>\n<dt>•</dt>\n<dd>To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with <span class=\"Bold\"><a href=\"#IFU2_Step1\">Step 1</a></span>.</dd>\n</dl>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigZ\"></a><span class=\"Bold\">Figure Z</span><a name=\"figz2\"></a><img alt=\"Figure Z\" src=\"/dailymed/image.cfm?name=genotropin-66.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Step 14. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12 Put the used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and cartridges in the household trash.

{ "type": "p", "children": [], "text": "\nStep 14. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12\nPut the used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and cartridges in the household trash." }

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

{ "type": "p", "children": [], "text": "If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:" }

{ "type": "", "children": [], "text": "" }

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

{ "type": "p", "children": [], "text": "When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal." }

{ "type": "", "children": [], "text": "" }

Important: Always keep the sharps disposal container out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Always keep the sharps disposal container out of the reach of children." }

Dispose of the entire GENOTROPIN PEN 12 as electronic waste per state and local regulations.

{ "type": "p", "children": [], "text": "Dispose of the entire GENOTROPIN PEN 12 as electronic waste per state and local regulations." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="75%"/> <col width="25%"/> <tbody class="Headless"> <tr> <td valign="top"> <p class="First"> <span class="Bold">Customizing your Pen</span> <br/>Your pen is supplied with 2 colored clip-on panels, so that you can customize the look of your pen. To remove the clip-on panel from your pen, insert the lip of the front cap into the groove under the front end of the panel, and pry the panel off. The new panel simply clicks into place (<span class="Bold">See <a href="#IFU2_FigAA">Figure AA</a></span>).</p> </td><td align="center" valign="top"> <p class="First"> <a name="IFU2_FigAA"></a><span class="Bold">Figure AA</span><a name="figaa2"></a><img alt="Figure AA" src="/dailymed/image.cfm?name=genotropin-67.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"75%\"/>\n<col width=\"25%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Customizing your Pen</span>\n<br/>Your pen is supplied with 2 colored clip-on panels, so that you can customize the look of your pen. To remove the clip-on panel from your pen, insert the lip of the front cap into the groove under the front end of the panel, and pry the panel off. The new panel simply clicks into place (<span class=\"Bold\">See <a href=\"#IFU2_FigAA\">Figure AA</a></span>).</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU2_FigAA\"></a><span class=\"Bold\">Figure AA</span><a name=\"figaa2\"></a><img alt=\"Figure AA\" src=\"/dailymed/image.cfm?name=genotropin-67.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Caring for your Pen

{ "type": "p", "children": [], "text": "\nCaring for your Pen\n" }

To clean your pen, wipe the outside surface with a damp cloth. Do not put the pen in water as this may damage your pen. Do not use alcohol or any other cleaning agents to clean the pen, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol pad.

{ "type": "p", "children": [], "text": "To clean your pen, wipe the outside surface with a damp cloth. Do not put the pen in water as this may damage your pen. Do not use alcohol or any other cleaning agents to clean the pen, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol pad." }

<div class="scrollingtable"><table width="90%"> <col width="45%"/> <col width="55%"/> <thead> <tr class="First"> <th align="left" class="Botrule Lrule Toprule" valign="top"><span class="Bold">Questions and Answers</span></th><th align="left" class="Botrule Rrule Toprule" valign="top"></th> </tr> <tr class="Last"> <th align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Question</span></th><th align="left" class="Botrule Rrule" valign="top"><span class="Bold">Answer</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">How long is the use period of my pen?</p> </td><td class="Botrule Rrule Toprule" valign="top"> <p class="First">The pen has a use period of 2 years starting from the first use by the patient.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">How can I tell how much GENOTROPIN is left in my pen?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further, the dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">If the display does not work, can my pen still be used?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">Contact your healthcare provider as soon as possible to get a new pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">What happens if I dial the injection button beyond the maximum dose ('4.0' mg)?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Why is it difficult to turn or push the injection button?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"90%\">\n<col width=\"45%\"/>\n<col width=\"55%\"/>\n<thead>\n<tr class=\"First\">\n<th align=\"left\" class=\"Botrule Lrule Toprule\" valign=\"top\"><span class=\"Bold\">Questions and Answers</span></th><th align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"top\"></th>\n</tr>\n<tr class=\"Last\">\n<th align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Question</span></th><th align=\"left\" class=\"Botrule Rrule\" valign=\"top\"><span class=\"Bold\">Answer</span></th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">How long is the use period of my pen?</p>\n</td><td class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">The pen has a use period of 2 years starting from the first use by the patient.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">How can I tell how much GENOTROPIN is left in my pen?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further, the dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">If the display does not work, can my pen still be used?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">Contact your healthcare provider as soon as possible to get a new pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">What happens if I dial the injection button beyond the maximum dose ('4.0' mg)?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Why is it difficult to turn or push the injection button?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Display Information

{ "type": "p", "children": [], "text": "\nDisplay Information\n" }

<div class="scrollingtable"><table width="90%"> <col width="5%"/> <col width="15%"/> <col width="25%"/> <col width="55%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Toprule" valign="middle"></td><td class="Botrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Botrule Rrule Toprule" valign="top"><a name="id4614"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-68.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">The selected dose size.</span> <br/>The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id4623"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-69.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">A dose is not set.</span> <br/>The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Flashing</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id4632"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-70.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">The injection button is rotated too fast or too slow.</span> <br/>Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Flashing</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id4641"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-71.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">The injection button is rotated too fast or too slow.</span> <br/>Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.</p> </td> </tr> <tr> <td class="Lrule" valign="middle"></td><td valign="middle"> <p class="First"> <span class="Bold">Flashing</span> </p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"> <p class="First"> <span class="Bold">1 month before the end of the 2 year use period.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="bottom"> <p class="First"> <span class="Bold">(5 seconds)</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id4657"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-72.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First">This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.</p> </td> </tr> <tr> <td class="Lrule" valign="middle"></td><td valign="bottom"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Rrule" valign="top"><a name="id4664"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-73.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Rrule" valign="top"> <p class="First"> <span class="Bold">Pen has reached the end of its use period of 2 years.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="middle"></td><td class="Botrule Rrule" valign="middle"> <p class="First">The display will continue to show <a name="id4670"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-73a.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/> until the battery is completely empty. This does not indicate a problem with your pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.</p> </td> </tr> <tr> <td class="Lrule" valign="middle"></td><td valign="middle"> <p class="First"> <span class="Bold">Flashing</span> </p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"> <p class="First"> <span class="Bold">Battery charge is low and will be empty in 1 month.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">(5 seconds)</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id4684"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-74.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First">Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id4691"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-75.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">Battery power low.</span> <br/>The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Steady</span> </p> </td><td class="Botrule Rrule" valign="top"><a name="id4700"></a><img alt="Image" src="/dailymed/image.cfm?name=genotropin-76.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">Blank screen</span> <br/>To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"90%\">\n<col width=\"5%\"/>\n<col width=\"15%\"/>\n<col width=\"25%\"/>\n<col width=\"55%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Toprule\" valign=\"middle\"></td><td class=\"Botrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Botrule Rrule Toprule\" valign=\"top\"><a name=\"id4614\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-68.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">The selected dose size.</span>\n<br/>The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id4623\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-69.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">A dose is not set.</span>\n<br/>The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Flashing</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id4632\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-70.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">The injection button is rotated too fast or too slow.</span>\n<br/>Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Flashing</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id4641\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-71.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">The injection button is rotated too fast or too slow.</span>\n<br/>Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"middle\"></td><td valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Flashing</span>\n</p>\n</td><td class=\"Rrule\" valign=\"top\"></td><td class=\"Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">1 month before the end of the 2 year use period.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">(5 seconds)</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id4657\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-72.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"middle\"></td><td valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Rrule\" valign=\"top\"><a name=\"id4664\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-73.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Pen has reached the end of its use period of 2 years.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"middle\"></td><td class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">The display will continue to show <a name=\"id4670\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-73a.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/> until the battery is completely empty. This does not indicate a problem with your pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"middle\"></td><td valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Flashing</span>\n</p>\n</td><td class=\"Rrule\" valign=\"top\"></td><td class=\"Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Battery charge is low and will be empty in 1 month.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">(5 seconds)</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id4684\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-74.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id4691\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-75.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Battery power low.</span>\n<br/>The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule\" valign=\"middle\"></td><td class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Steady</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"><a name=\"id4700\"></a><img alt=\"Image\" src=\"/dailymed/image.cfm?name=genotropin-76.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Blank screen</span>\n<br/>To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

{ "type": "p", "children": [], "text": "If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away." }

Use this device only for the person for whom it was prescribed.

{ "type": "p", "children": [], "text": "Use this device only for the person for whom it was prescribed." }

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Caution: Federal law restricts this device to sale by or on the order of a physician.

{ "type": "p", "children": [], "text": "\nThis Instructions for Use has been approved by the U.S. Food and Drug Administration.\n\nCaution: Federal law restricts this device to sale by or on the order of a physician." }

Manufactured by:Pharmacia & Upjohn Company LLCA subsidiary of Pfizer Inc.New York, NY 10001U.S. License No. 1216

{ "type": "p", "children": [], "text": "Manufactured by:Pharmacia & Upjohn Company LLCA subsidiary of Pfizer Inc.New York, NY 10001U.S. License No. 1216\n" }

LAB-0224-10.0

{ "type": "p", "children": [], "text": "LAB-0224-10.0" }

Revised August 2024

{ "type": "p", "children": [], "text": "Revised August 2024" }

INSTRUCTIONS FOR USEGENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)Growth Hormone Delivery Device containing GENOTROPIN® (somatropin) for injection

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USEGENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)Growth Hormone Delivery Device containing GENOTROPIN® (somatropin) for injection\n" }

<div class="scrollingtable"><table width="100%"> <col width="100%"/> <tbody class="Headless"> <tr class="First"> <td class="Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Important Note</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Please read these instructions completely before using GENOTROPIN MINIQUICK. If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">GENOTROPIN MINIQUICK is available in 10 dose strengths. <span class="Bold">Check your GENOTROPIN MINIQUICK to be sure you have the dose your healthcare provider prescribed.</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important Note</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Please read these instructions completely before using GENOTROPIN MINIQUICK. If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">GENOTROPIN MINIQUICK is available in 10 dose strengths. <span class=\"Bold\">Check your GENOTROPIN MINIQUICK to be sure you have the dose your healthcare provider prescribed.</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN.

{ "type": "p", "children": [], "text": "GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN." }

For each injection you will need:

{ "type": "p", "children": [], "text": "\nFor each injection you will need:\n" }

{ "type": "", "children": [], "text": "" }

Parts of the GENOTROPIN MINIQUICK (See Figure A)

{ "type": "p", "children": [], "text": "\nParts of the GENOTROPIN MINIQUICK (See Figure A)" }

Storage instructions for your GENOTROPIN MINIQUICK

{ "type": "p", "children": [], "text": "\nStorage instructions for your GENOTROPIN MINIQUICK\n" }

{ "type": "", "children": [], "text": "" }

Using your GENOTROPIN MINIQUICK

{ "type": "p", "children": [], "text": "\nUsing your GENOTROPIN MINIQUICK\n" }

Step 1. Wash your hands well with soap and water before using the GENOTROPIN MINIQUICK.

{ "type": "p", "children": [], "text": "\nStep 1.\nWash your hands well with soap and water before using the GENOTROPIN MINIQUICK." }

Step 2. Open the plastic bag that contains your GENOTROPIN MINIQUICK by tearing the bag along the dotted lines on the plastic.

{ "type": "p", "children": [], "text": "\nStep 2.\nOpen the plastic bag that contains your GENOTROPIN MINIQUICK by tearing the bag along the dotted lines on the plastic." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="70%"/> <col width="30%"/> <tbody class="Headless"> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 3.</span> <br/>Wipe the rubber stopper on the GENOTROPIN MINIQUICK with an alcohol pad. (<span class="Bold">See <a href="#IFU3_FigB">Figure B</a></span>)</p> </td><td valign="top"> <p class="First"> <a name="IFU3_FigB"></a><span class="Bold">Figure B</span><a name="id-1104417710"></a><img alt="Figure B" src="/dailymed/image.cfm?name=genotropin-79.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 4.</span> <br/>Peel the seal from the back of the injection needle. Leave both the inner needle cover and the outer needle cover on the needle. (<span class="Bold">See <a href="#IFU3_FigC">Figure C</a></span>)</p> </td><td valign="top"> <p class="First"> <a name="IFU3_FigC"></a><span class="Bold">Figure C</span><a name="id1885757587"></a><img alt="Figure C" src="/dailymed/image.cfm?name=genotropin-80.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 5.</span> </p> <dl> <dt>•</dt> <dd>Attach the needle onto the GENOTROPIN MINIQUICK by pushing it down and turning it clockwise (to the right) until it will no longer turn.</dd> <dt>•</dt> <dd>Make sure the needle is placed directly over the rubber stopper (not at an angle), before screwing the needle onto the rubber stopper of the GENOTROPIN MINIQUICK. (<span class="Bold">See <a href="#IFU3_FigD">Figure D</a></span>)</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU3_FigD"></a><span class="Bold">Figure D</span><a name="id1089197656"></a><img alt="Figure D" src="/dailymed/image.cfm?name=genotropin-81.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 6.</span> </p> <dl> <dt>•</dt> <dd>Hold the GENOTROPIN MINIQUICK with the needle pointing up. Turn the plunger rod clockwise (to the right) until it will not go any further. (<span class="Bold">See <a href="#IFU3_FigE">Figure E</a></span>) This will automatically mix the growth hormone powder and the liquid.</dd> <dt>•</dt> <dd> <span class="Bold">Do not shake</span> the GENOTROPIN MINIQUICK. Shaking may cause the growth hormone to not work as well.</dd> <dt>•</dt> <dd>Make sure the solution (combined growth hormone powder and liquid) is clear, and that the growth hormone powder is completely dissolved. If you see particles in the solution, or if the solution is discolored, <span class="Bold">do not inject it</span>. Call the Pfizer Bridge Program at 1-800-645-1280.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU3_FigE"></a><span class="Bold">Figure E</span><a name="id1739970464"></a><img alt="Figure E" src="/dailymed/image.cfm?name=genotropin-82.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 7.</span> </p> <dl> <dt>•</dt> <dd>Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be at least 1 inch from the site you used before (<span class="Bold">See <a href="#IFU3_FigF">Figure F</a></span>).<br/>Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas that have scars or skin problems.</dd> <dt>•</dt> <dd>Clean the injection site with the alcohol swab. Allow the injection site to dry.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU3_FigF"></a><span class="Bold">Figure F</span><a name="id2125959706"></a><img alt="Figure F" src="/dailymed/image.cfm?name=genotropin-83.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 8.</span> </p> <dl> <dt>•</dt> <dd>Remove the outer needle cover and the inner needle cover from the needle. <span class="Bold">Save the outer needle cover.</span> (<span class="Bold">See <a href="#IFU3_FigG">Figure G</a></span>)</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU3_FigG"></a><span class="Bold">Figure G</span><a name="id1443798535"></a><img alt="Figure G" src="/dailymed/image.cfm?name=genotropin-84.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 9.</span> </p> <dl> <dt>•</dt> <dd>Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle. (<span class="Bold">See <a href="#IFU3_FigH">Figure H</a></span>)</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU3_FigH"></a><span class="Bold">Figure H</span><a name="id-623763023"></a><img alt="Figure H" src="/dailymed/image.cfm?name=genotropin-85.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 10.</span> </p> <dl> <dt>•</dt> <dd>Push the plunger rod in as far as it will go, to inject all of the medicine in the GENOTROPIN MINIQUICK into the fold of skin. (<span class="Bold">See <a href="#IFU3_FigI">Figure I</a></span>)</dd> <dt>•</dt> <dd>Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU3_FigI"></a><span class="Bold">Figure I</span><a name="id-780339059"></a><img alt="Figure I" src="/dailymed/image.cfm?name=genotropin-86.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Step 11</span> </p> <dl> <dt>•</dt> <dd>Replace the outer needle cover on the needle. (<span class="Bold">See <a href="#IFU3_FigJ">Figure J</a></span>)</dd> </dl> </td><td valign="top"> <p class="First"> <a name="IFU3_FigJ"></a><span class="Bold">Figure J</span><a name="id-1418853781"></a><img alt="Figure J" src="/dailymed/image.cfm?name=genotropin-87.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"70%\"/>\n<col width=\"30%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3.</span>\n<br/>Wipe the rubber stopper on the GENOTROPIN MINIQUICK with an alcohol pad. (<span class=\"Bold\">See <a href=\"#IFU3_FigB\">Figure B</a></span>)</p>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigB\"></a><span class=\"Bold\">Figure B</span><a name=\"id-1104417710\"></a><img alt=\"Figure B\" src=\"/dailymed/image.cfm?name=genotropin-79.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4.</span>\n<br/>Peel the seal from the back of the injection needle. Leave both the inner needle cover and the outer needle cover on the needle. (<span class=\"Bold\">See <a href=\"#IFU3_FigC\">Figure C</a></span>)</p>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigC\"></a><span class=\"Bold\">Figure C</span><a name=\"id1885757587\"></a><img alt=\"Figure C\" src=\"/dailymed/image.cfm?name=genotropin-80.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5.</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Attach the needle onto the GENOTROPIN MINIQUICK by pushing it down and turning it clockwise (to the right) until it will no longer turn.</dd>\n<dt>•</dt>\n<dd>Make sure the needle is placed directly over the rubber stopper (not at an angle), before screwing the needle onto the rubber stopper of the GENOTROPIN MINIQUICK. (<span class=\"Bold\">See <a href=\"#IFU3_FigD\">Figure D</a></span>)</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigD\"></a><span class=\"Bold\">Figure D</span><a name=\"id1089197656\"></a><img alt=\"Figure D\" src=\"/dailymed/image.cfm?name=genotropin-81.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 6.</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Hold the GENOTROPIN MINIQUICK with the needle pointing up. Turn the plunger rod clockwise (to the right) until it will not go any further. (<span class=\"Bold\">See <a href=\"#IFU3_FigE\">Figure E</a></span>) This will automatically mix the growth hormone powder and the liquid.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not shake</span> the GENOTROPIN MINIQUICK. Shaking may cause the growth hormone to not work as well.</dd>\n<dt>•</dt>\n<dd>Make sure the solution (combined growth hormone powder and liquid) is clear, and that the growth hormone powder is completely dissolved. If you see particles in the solution, or if the solution is discolored, <span class=\"Bold\">do not inject it</span>. Call the Pfizer Bridge Program at 1-800-645-1280.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigE\"></a><span class=\"Bold\">Figure E</span><a name=\"id1739970464\"></a><img alt=\"Figure E\" src=\"/dailymed/image.cfm?name=genotropin-82.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 7.</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be at least 1 inch from the site you used before (<span class=\"Bold\">See <a href=\"#IFU3_FigF\">Figure F</a></span>).<br/>Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas that have scars or skin problems.</dd>\n<dt>•</dt>\n<dd>Clean the injection site with the alcohol swab. Allow the injection site to dry.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigF\"></a><span class=\"Bold\">Figure F</span><a name=\"id2125959706\"></a><img alt=\"Figure F\" src=\"/dailymed/image.cfm?name=genotropin-83.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 8.</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Remove the outer needle cover and the inner needle cover from the needle. <span class=\"Bold\">Save the outer needle cover.</span> (<span class=\"Bold\">See <a href=\"#IFU3_FigG\">Figure G</a></span>)</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigG\"></a><span class=\"Bold\">Figure G</span><a name=\"id1443798535\"></a><img alt=\"Figure G\" src=\"/dailymed/image.cfm?name=genotropin-84.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 9.</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle. (<span class=\"Bold\">See <a href=\"#IFU3_FigH\">Figure H</a></span>)</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigH\"></a><span class=\"Bold\">Figure H</span><a name=\"id-623763023\"></a><img alt=\"Figure H\" src=\"/dailymed/image.cfm?name=genotropin-85.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 10.</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Push the plunger rod in as far as it will go, to inject all of the medicine in the GENOTROPIN MINIQUICK into the fold of skin. (<span class=\"Bold\">See <a href=\"#IFU3_FigI\">Figure I</a></span>)</dd>\n<dt>•</dt>\n<dd>Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigI\"></a><span class=\"Bold\">Figure I</span><a name=\"id-780339059\"></a><img alt=\"Figure I\" src=\"/dailymed/image.cfm?name=genotropin-86.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 11</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Replace the outer needle cover on the needle. (<span class=\"Bold\">See <a href=\"#IFU3_FigJ\">Figure J</a></span>)</dd>\n</dl>\n</td><td valign=\"top\">\n<p class=\"First\">\n<a name=\"IFU3_FigJ\"></a><span class=\"Bold\">Figure J</span><a name=\"id-1418853781\"></a><img alt=\"Figure J\" src=\"/dailymed/image.cfm?name=genotropin-87.jpg&amp;setid=ffebf88b-d257-4542-9808-74d9b7167765\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Step 12. Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles

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Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and syringes in the household trash.

{ "type": "p", "children": [], "text": "Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and syringes in the household trash." }

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

{ "type": "p", "children": [], "text": "If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:" }

{ "type": "", "children": [], "text": "" }

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

{ "type": "p", "children": [], "text": "When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal." }

{ "type": "", "children": [], "text": "" }

Important: Always keep the sharps disposal container out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Always keep the sharps disposal container out of the reach of children." }

<div class="scrollingtable"><table width="90%"> <col width="50%"/> <col width="50%"/> <thead> <tr class="First"> <th align="left" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Questions and Answers</span></th> </tr> <tr class="Last"> <th align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Question</span></th><th align="left" class="Botrule Rrule" valign="top"><span class="Bold">Answer</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Is it a problem if I see air bubbles in the syringe?</p> </td><td class="Botrule Rrule Toprule" valign="top"> <p class="First">No. There is no need to remove the air bubbles from the GENOTROPIN MINIQUICK. The small amount of air in the syringe does not affect your injection.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">What should I do if I have problems turning the plunger rod (Step 6)?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">The problem could be because the needle has been inserted at an angle onto the rubber stopper.<br/>Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">What should I do if I have problems pushing the plunger when making the injection (Step 10)?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">The problem could be because the needle has been inserted at an angle onto the rubber stopper.<br/>Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">What should I do if the needle is damaged or bent?</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">Throw away the needle and use a new needle with the GENOTROPIN MINIQUICK.<br/> <span class="Bold">See "<a href="#_Refthrowingaway">Disposing of (throwing away) your GENOTROPIN MINIQUICK and needles</a>".</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"90%\">\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<thead>\n<tr class=\"First\">\n<th align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Questions and Answers</span></th>\n</tr>\n<tr class=\"Last\">\n<th align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Question</span></th><th align=\"left\" class=\"Botrule Rrule\" valign=\"top\"><span class=\"Bold\">Answer</span></th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Is it a problem if I see air bubbles in the syringe?</p>\n</td><td class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">No. There is no need to remove the air bubbles from the GENOTROPIN MINIQUICK. The small amount of air in the syringe does not affect your injection.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">What should I do if I have problems turning the plunger rod (Step 6)?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">The problem could be because the needle has been inserted at an angle onto the rubber stopper.<br/>Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">What should I do if I have problems pushing the plunger when making the injection (Step 10)?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">The problem could be because the needle has been inserted at an angle onto the rubber stopper.<br/>Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">What should I do if the needle is damaged or bent?</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">Throw away the needle and use a new needle with the GENOTROPIN MINIQUICK.<br/>\n<span class=\"Bold\">See \"<a href=\"#_Refthrowingaway\">Disposing of (throwing away) your GENOTROPIN MINIQUICK and needles</a>\".</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

{ "type": "p", "children": [], "text": "If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away." }

Use this device only for the person for whom it was prescribed.

{ "type": "p", "children": [], "text": "Use this device only for the person for whom it was prescribed." }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "\nThis Instructions for Use has been approved by the U.S. Food and Drug Administration.\n" }

Manufactured by:Pharmacia & Upjohn Company LLCA subsidiary of Pfizer Inc.New York, NY 10001 U.S. License No. 1216

{ "type": "p", "children": [], "text": "Manufactured by:Pharmacia & Upjohn Company LLCA subsidiary of Pfizer Inc.New York, NY 10001\nU.S. License No. 1216\n" }

LAB-0227-9.0Revised: August 2024

{ "type": "p", "children": [], "text": "LAB-0227-9.0Revised: August 2024" }

Genotropin® (somatropin) for injectionTwo-chamber cartridgeFor s.c. injection. 5 mg/mLRefrigerate. Protect from light.Pharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionTwo-chamber cartridgeFor s.c. injection. 5 mg/mLRefrigerate. Protect from light.Pharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

5 mg

{ "type": "p", "children": [], "text": "5 mg" }

NDC 0013-2626-81

{ "type": "p", "children": [], "text": "NDC 0013-2626-81" }

LOT/EXPPAA185891

{ "type": "p", "children": [], "text": "LOT/EXPPAA185891" }

PfizerGenotropin® 5 mg

{ "type": "p", "children": [], "text": "PfizerGenotropin®\n5 mg" }

(somatropin) for injectionNDC 0013-2626-81

{ "type": "p", "children": [], "text": "(somatropin) for injectionNDC 0013-2626-81" }

For subcutaneous injectionRx only1 Two-Chamber Cartridge

{ "type": "p", "children": [], "text": "For subcutaneous injectionRx only1 Two-Chamber Cartridge" }

PAA185820

{ "type": "p", "children": [], "text": "PAA185820" }

OPEN HERE

{ "type": "p", "children": [], "text": "OPEN HERE" }

Genotropin® (somatropin) for injectionTwo-chamber cartridgeFor s.c. injection. 12 mg/mLRefrigerate. Protect from light.Pharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionTwo-chamber cartridgeFor s.c. injection. 12 mg/mLRefrigerate. Protect from light.Pharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

12 mg

{ "type": "p", "children": [], "text": "12 mg" }

NDC 0013-2646-81

{ "type": "p", "children": [], "text": "NDC 0013-2646-81" }

LOT/EXPPAA185895

{ "type": "p", "children": [], "text": "LOT/EXPPAA185895" }

PfizerGenotropin® 12 mg

{ "type": "p", "children": [], "text": "PfizerGenotropin®\n12 mg" }

(somatropin) for injectionNDC 0013-2646-81

{ "type": "p", "children": [], "text": "(somatropin) for injectionNDC 0013-2646-81" }

For subcutaneous injectionRx only1 Two-Chamber Cartridge

{ "type": "p", "children": [], "text": "For subcutaneous injectionRx only1 Two-Chamber Cartridge" }

PAA185893

{ "type": "p", "children": [], "text": "PAA185893" }

OPEN HERE

{ "type": "p", "children": [], "text": "OPEN HERE" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionGenotropin MiniQuick®\nGrowth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

0.2 mg

{ "type": "p", "children": [], "text": "0.2 mg" }

NDC 0013-2649-01

{ "type": "p", "children": [], "text": "NDC 0013-2649-01" }

PAA142719

{ "type": "p", "children": [], "text": "PAA142719" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2649-02

{ "type": "p", "children": [], "text": "NDC 0013-2649-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

0.2 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "0.2 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionGenotropin MiniQuick®\nGrowth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

0.4 mg

{ "type": "p", "children": [], "text": "0.4 mg" }

NDC 0013-2650-01

{ "type": "p", "children": [], "text": "NDC 0013-2650-01" }

PAA142720

{ "type": "p", "children": [], "text": "PAA142720" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2650-02

{ "type": "p", "children": [], "text": "NDC 0013-2650-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

0.4 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "0.4 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

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0.6 mg

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NDC 0013-2651-01

{ "type": "p", "children": [], "text": "NDC 0013-2651-01" }

PAA142731

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LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2651-02

{ "type": "p", "children": [], "text": "NDC 0013-2651-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

0.6 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "0.6 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

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0.8 mg

{ "type": "p", "children": [], "text": "0.8 mg" }

NDC 0013-2652-01

{ "type": "p", "children": [], "text": "NDC 0013-2652-01" }

PAA142732

{ "type": "p", "children": [], "text": "PAA142732" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2652-02

{ "type": "p", "children": [], "text": "NDC 0013-2652-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

0.8 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "0.8 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionGenotropin MiniQuick®\nGrowth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

1 mg

{ "type": "p", "children": [], "text": "1 mg" }

NDC 0013-2653-01

{ "type": "p", "children": [], "text": "NDC 0013-2653-01" }

PAA142733

{ "type": "p", "children": [], "text": "PAA142733" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2653-02

{ "type": "p", "children": [], "text": "NDC 0013-2653-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

1 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "1 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

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1.2 mg

{ "type": "p", "children": [], "text": "1.2 mg" }

NDC 0013-2654-01

{ "type": "p", "children": [], "text": "NDC 0013-2654-01" }

PAA142734

{ "type": "p", "children": [], "text": "PAA142734" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2654-02

{ "type": "p", "children": [], "text": "NDC 0013-2654-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

1.2 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "1.2 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionGenotropin MiniQuick®\nGrowth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

1.4 mg

{ "type": "p", "children": [], "text": "1.4 mg" }

NDC 0013-2655-01

{ "type": "p", "children": [], "text": "NDC 0013-2655-01" }

PAA142735

{ "type": "p", "children": [], "text": "PAA142735" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2655-02

{ "type": "p", "children": [], "text": "NDC 0013-2655-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

1.4 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "1.4 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionGenotropin MiniQuick®\nGrowth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

1.6 mg

{ "type": "p", "children": [], "text": "1.6 mg" }

NDC 0013-2656-01

{ "type": "p", "children": [], "text": "NDC 0013-2656-01" }

PAA142736

{ "type": "p", "children": [], "text": "PAA142736" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2656-02

{ "type": "p", "children": [], "text": "NDC 0013-2656-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

1.6 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "1.6 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionGenotropin MiniQuick®\nGrowth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

1.8 mg

{ "type": "p", "children": [], "text": "1.8 mg" }

NDC 0013-2657-01

{ "type": "p", "children": [], "text": "NDC 0013-2657-01" }

PAA142737

{ "type": "p", "children": [], "text": "PAA142737" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2657-02

{ "type": "p", "children": [], "text": "NDC 0013-2657-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

1.8 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "1.8 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

Genotropin® (somatropin) for injectionGenotropin MiniQuick® Growth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injectionGenotropin MiniQuick®\nGrowth Hormone Delivery DevicePharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017" }

2 mg

{ "type": "p", "children": [], "text": "2 mg" }

NDC 0013-2658-01

{ "type": "p", "children": [], "text": "NDC 0013-2658-01" }

PAA142738

{ "type": "p", "children": [], "text": "PAA142738" }

LOTEXP

{ "type": "p", "children": [], "text": "LOTEXP" }

NDC 0013-2658-02

{ "type": "p", "children": [], "text": "NDC 0013-2658-02" }

Pfizer

{ "type": "p", "children": [], "text": "Pfizer" }

Genotropin® (somatropin) for injection

{ "type": "p", "children": [], "text": "Genotropin®\n(somatropin) for injection" }

2 mg Genotropin MiniQuick®

{ "type": "p", "children": [], "text": "2 mg Genotropin MiniQuick®\n" }

For single subcutaneous injection onlyGrowth Hormone Delivery Device

{ "type": "p", "children": [], "text": "For single subcutaneous injection onlyGrowth Hormone Delivery Device" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

7 Pack

{ "type": "p", "children": [], "text": "7 Pack" }

NORDITROPIN is indicated for the treatment of pediatric patients with:

NORDITROPIN is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)

Injection: NORDITROPIN is available as a clear and colorless solution in a

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NORDITROPIN is contraindicated in patients with:

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Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin [see Contraindications (4)]. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo. The safety of continuing NORDITROPIN treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. NORDITROPIN is not indicated for the treatment of non-GH deficient adults.

There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If, during treatment with NORDITROPIN, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with NORDITROPIN should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications (4)].

Active Malignancy

There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy [See Contraindications (4)]. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with NORDITROPIN. Discontinue NORDITROPIN if there is evidence of recurrent activity.

Risk of Second Neoplasm in Pediatric Patients

There is an increased risk of a second neoplasm in pediatric cancer survivors who were treated with radiation to the brain/head and who developed subsequent GH deficiency and were treated with somatropin. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence. Monitor all patients receiving NORDITROPIN who have a history of GH deficiency secondary to an intracranial neoplasm for progression or recurrence of the tumor.

New Malignancy During Treatment

Because pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting NORDITROPIN in these patients. If NORDITROPIN is initiated, carefully monitor patients for development of neoplasms.

Monitor all patients receiving NORDITROPIN carefully for increased growth, or potential malignant changes, of preexisting nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi.

Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients taking somatropin. Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked. Monitor glucose levels periodically in all patients receiving NORDITROPIN, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely. The doses of antidiabetic agents may require adjustment when NORDITROPIN is initiated.

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropins. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Funduscopic examination should be performed routinely before initiating treatment with NORDITROPIN to exclude preexisting papilledema, and periodically thereafter. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with NORDITROPIN can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner syndrome may be at increased risk for the development of IH.

Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications (4)].

Fluid retention during somatropin replacement therapy in adults may frequently occur. Clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) are usually transient and dose dependent.

Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NORDITROPIN treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism [see Drug Interactions (7)].

Undiagnosed/untreated hypothyroidism may prevent an optimal response to NORDITROPIN, in particular, the growth response in pediatric patients. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.

Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders (including GH deficiency and Turner syndrome) or in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of hip or knee pain.

Somatropin increases the growth rate, and progression of existing scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for progression of scoliosis.

Cases of pancreatitis have been reported in pediatric patients and adults receiving somatropin products. There may be a greater risk in pediatric patients compared with adults. Published literature indicates that females who have Turner syndrome may be at greater risk than other pediatric patients receiving somatropin products. Pancreatitis should be considered in patients who develop persistent severe abdominal pain.

When somatropin products are administered subcutaneously at the same site over a long period of time, tissue atrophy may result. Rotate injection sites when administering NORDITROPIN to reduce this risk [see Administration and Use Instructions (2.1)].

Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-I may increase after NORDITROPIN treatment.

Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin product cannot always be directly compared to the rates observed during the clinical trials performed with another somatropin product, and may not reflect the adverse reaction rates observed in practice.

Pediatric Patients

Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone

In one randomized, open label, clinical study the most frequent adverse reactions were headache, pharyngitis, otitis media and fever. There were no clinically significant differences between the three doses assessed in the study (0.025, 0.05 and 0.1 mg/kg/day).

Short Stature Associated with Noonan Syndrome

NORDITROPIN was studied in 21 pediatric patients, 3 years to 14 years of age at doses of 0.033 mg/kg/day and 0.066 mg/kg/day. After the two-year study, patients continued NORDITROPIN treatment until final height was achieved; randomized dose groups were not maintained. Adverse reactions were later collected retrospectively from 18 pediatric patients; total follow-up was 11 years. An additional 6 pediatric patients were not randomized, but followed the protocol and are included in this assessment of adverse reactions.

The most frequent adverse reactions were upper respiratory infection, gastroenteritis, ear infection, and influenza. Cardiac disorders was the system organ class with the second most adverse reactions reported. Scoliosis was reported in 1 and 4 pediatric patients receiving doses of 0.033 mg/kg/day and 0.066 mg/kg/day respectively. The following additional adverse reactions also occurred once: insulin resistance and panic reaction for the 0.033 mg/kg/day dose group; injection site pruritus, bone development abnormal, depression, and self-injurious ideation in the 0.066 mg/kg/day dose group. Headache occurred in 2 cases in the 0.066 mg/kg/day dose group.

Short Stature Associated with Turner Syndrome

In two clinical studies in pediatric patients that were treated until final height with various doses of NORDITROPIN, the most frequently reported adverse reactions were influenza-like illness, otitis media, upper respiratory tract infection, otitis externa, gastroenteritis, eczema and, impaired fasting glucose. Adverse reactions in study 1 were most frequent in the highest dose groups. Three patients in study 1 had excessive growth of hands and/or feet in the high dose groups. Two patients in study 1 had a serious adverse reaction of exacerbation of preexisting scoliosis in the 0.045 mg/kg/day group.

Small for Gestational Age (SGA) with No Catch-up Growth by Age 2-4 Years

In a study, 53 pediatric patients were treated with 2 doses of NORDITROPIN (0.033 or 0.067 mg/kg/day) to final height for up to 13 years (mean duration of treatment 7.9 and 9.5 years for girls and boys, respectively). The most frequently reported adverse reactions were influenza-like illness, upper respiratory tract infection, bronchitis, gastroenteritis, abdominal pain, otitis media, pharyngitis, arthralgia, headache, gynecomastia, and increased sweating. One pediatric patient treated with 0.067 mg/kg/day for 4 years was reported with disproportionate growth of the lower jaw, and another patient treated with 0.067 mg/kg/day developed a melanocytic nevus. 4 pediatric patients treated with 0.067 mg/kg/day and 2 pediatric patients treated with 0.033 mg/kg/day of NORDITROPIN had increased fasting blood glucose levels after 1 year of treatment. In addition, small increases in mean fasting blood glucose and insulin levels after 1 and 2 years of NORDITROPIN treatment appeared to be dose-dependent.

In a second study, 98 Japanese pediatric patients were treated with 2 doses of NORDITROPIN (0.033 or 0.067 mg/kg/day) for 2 years or were untreated for 1 year. Adverse reactions were otitis media, arthralgia and impaired glucose tolerance. Arthralgia and transiently impaired glucose tolerance were reported in the 0.067 mg/kg/day treatment group.

Idiopathic Short Stature

In two open-label clinical studies with another somatropin product in pediatric patients, the most common adverse reactions were upper respiratory tract infections, influenza, tonsillitis, nasopharyngitis, gastroenteritis, headaches, increased appetite, pyrexia, fracture, altered mood, and arthralgia.

Growth Failure Due to Prader-Willi Syndrome

In two clinical studies in pediatric patients with PWS carried out with another somatropin product, the following adverse reactions were reported: edema, aggressiveness, arthralgia, benign intracranial hypertension, hair loss, headache, and myalgia.

Adult Patients

Adults with Growth Hormone Deficiency

Adverse reactions with an incidence of ≥5% occurring in patients with AO GHD during the 6 month placebo-controlled portion of a clinical trial for NORDITROPIN are presented in Table 1.

Table 1 – Adverse Reactions with ≥5% Overall Incidence in Adult Onset Growth Hormone

Deficient Patients Treated with NORDITROPIN During a Six Month Placebo-Controlled Clinical Trial

<div class="scrollingtable"><table width="100%"> <col width="37%"/> <col width="23%"/> <col width="23%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Placebo</p> <p>(N=52)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NORDITROPIN</p> <p>(N=53)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Adverse Reactions</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">%</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Peripheral Edema</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">42</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Edema</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">25</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Arthralgia</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">19</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Leg Edema</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Myalgia</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Infection (non-viral) </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">13</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Paraesthesia</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">11</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Skeletal Pain</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">11</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Headache</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Bronchitis</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Flu-like symptoms</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hypertension</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Gastroenteritis</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Other Non-Classifiable Disorders (excludes accidental injury)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Increased sweating</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Glucose tolerance abnormal</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Laryngitis</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Type 2 diabetes mellitus </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5</p> </td> </tr> </tbody> </table></div>

Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune system disorders — Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema

Skin — Increase in size or number of cutaneous nevi

Endocrine disorders — Hypothyroidism - Gynecomastia

Metabolism and nutrition disorders — Hyperglycemia

Musculoskeletal and connective tissue disorders —Slipped capital femoral epiphysis— Legg-Calvé-Perthes disease

Investigations — Increase in blood alkaline phosphatase level — Decrease in serum thyroxin (T4) levels

Gastrointestinal — Pancreatitis

Neoplasm — Leukemia has been reported in a small number of GH deficient children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin

Table 2 includes a list of drugs with clinically important drug interactions when administered concomitantly with NORDITROPIN and instructions for preventing or managing them.

{ "type": "p", "children": [], "text": "\nTable 2 includes a list of drugs with clinically important drug interactions when administered concomitantly with NORDITROPIN and instructions for preventing or managing them." }

Table 2: Clinically Important Drug Interactions with NORDITROPIN

{ "type": "p", "children": [], "text": "\nTable 2: Clinically Important Drug Interactions with NORDITROPIN\n" }

<div class="scrollingtable"><table width="513pt"> <col width="21%"/> <col width="79%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Glucocorticoids </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. NORDITROPIN inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NORDITROPIN may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NORDITROPIN <span class="Italics">[see <a href="#ID_baf68c53-f344-4419-88b4-019dd203c5b8">Warnings and Precautions (5.8)</a>].</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Cortisone acetate and prednisone may be effected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of NORDITROPIN in pediatric patients.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Cytochrome P450-Metabolized Drugs</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. NORDITROPIN may alter the clearance of compounds known to be metabolized by CP450 liver enzymes.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Careful monitoring is advisable when NORDITROPIN is administered in combination with drugs metabolized by CP450 liver enzymes.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Oral Estrogen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Oral estrogens may reduce the serum IGF-1 response to NORDITROPIN. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Patients receiving oral estrogen replacement may require greater NORDITROPIN dosages <span class="Italics">[see <a href="#i4i_section_id_c0a91673-bf31-4219-beb5-d42d3641bc31">Dosage and Administration (2.3)</a>]</span>.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Insulin and/or Other Hypoglycemic Agents</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Treatment with NORDITROPIN may decrease insulin sensitivity, particularly at higher doses. </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents <span class="Italics">[see <a href="#i4i_section_id_160d3380-8e15-4125-8147-387e730c3351">Warnings and Precautions (5.4)</a>].</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"513pt\">\n<col width=\"21%\"/>\n<col width=\"79%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Glucocorticoids </span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. NORDITROPIN inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NORDITROPIN may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NORDITROPIN <span class=\"Italics\">[see <a href=\"#ID_baf68c53-f344-4419-88b4-019dd203c5b8\">Warnings and Precautions (5.8)</a>].</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Cortisone acetate and prednisone may be effected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of NORDITROPIN in pediatric patients.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Cytochrome P450-Metabolized Drugs</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. NORDITROPIN may alter the clearance of compounds known to be metabolized by CP450 liver enzymes.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Careful monitoring is advisable when NORDITROPIN is administered in combination with drugs metabolized by CP450 liver enzymes.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Oral Estrogen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Oral estrogens may reduce the serum IGF-1 response to NORDITROPIN. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Patients receiving oral estrogen replacement may require greater NORDITROPIN dosages <span class=\"Italics\">[see <a href=\"#i4i_section_id_c0a91673-bf31-4219-beb5-d42d3641bc31\">Dosage and Administration (2.3)</a>]</span>.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Insulin and/or Other Hypoglycemic Agents</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Treatment with NORDITROPIN may decrease insulin sensitivity, particularly at higher doses. </p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents <span class=\"Italics\">[see <a href=\"#i4i_section_id_160d3380-8e15-4125-8147-387e730c3351\">Warnings and Precautions (5.4)</a>].</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary

Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous NORDITROPIN during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area (see Data).

The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

In an embryo-fetal development study, NORDITROPIN was administered via subcutaneous injection to pregnant rats from gestation Day 6 to 17, corresponding with the period of organogenesis. NORDITROPIN did not adversely affect fetal viability or developmental outcomes at maternal doses that were approximately 10-times the clinical dose of 0.016 mg/kg, based on body surface area.

In a pre- and post-natal development study in pregnant rats, NORDITROPIN was administered from gestation Day 17 through lactation Day 21 (weaning). No adverse developmental effects were observed in the offspring at doses up to 1.1 mg/kg (approximately 10 times the clinical dose of 0.016 mg/kg, based on body surface area).

Risk Summary

There is no information regarding the presence of somatropin in human milk. Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone. No adverse effects on the breastfed infant have been reported with somatropin. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NORDITROPIN and any potential adverse effects on the breastfed infant from NORDITROPIN or from the underlying maternal condition.

Safety and effectiveness of NORDITROPIN in pediatric patients have been established in growth failure due to inadequate secretion of endogenous growth hormone, short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature in children born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, idiopathic short stature (ISS), and growth failure due to Prader-Willi syndrome (PWS).

Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone

Safety and effectiveness of NORDITROPIN have been established in pediatric patients with growth failure due to growth hormone deficiency in a multi-center, prospective, randomized, open-label, dose-response study in 111 pediatric patients conducted for a two-year period [see Clinical Studies (14.1)].

Short Stature Associated with Noonan Syndrome

Safety and effectiveness of NORDITROPIN have been established in pediatric patients with Noonan syndrome in a prospective, open-label, randomized, parallel group study in 21 pediatric patients conducted for 2 years [see Clinical Studies (14.2)].

Short Stature Associated with Turner Syndrome

Safety and effectiveness of NORDITROPIN have been established in pediatric patients with short stature associated with Turner syndrome in two randomized, parallel group, open-label, multicenter studies in 87 pediatric patients [see Clinical Studies (14.3)].

Short Stature in Pediatric Patients Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 Years to 4 Years of Age

Safety and effectiveness of NORDITROPIN have been established in pediatric patients with short stature born SGA with no catch-up growth in a multi-center, randomized, double-blind, two-arm study to final height in 53 pediatric patients and in a randomized study of 84 prepubertal, non-GHD, Japanese pediatric patients [see Clinical Studies (14.4)].

Idiopathic Short Stature (ISS)

Safety and effectiveness of NORDITROPIN have been established in pediatric patients with ISS based on data from a randomized, open-label clinical study with another somatropin product in 105 pediatric patients [see Clinical Studies (14.5)].

Growth Failure Due to Prader-Willi Syndrome (PWS)

Safety and effectiveness of NORDITROPIN have been established in pediatric patients with growth failure due to Prader-Willi Syndrome based on data from two randomized, open label, controlled clinical trials with another somatropin product in pediatric patients. There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. [see Contraindications (4), Warnings and Precautions (5.2), Clinical Studies (14.6)].

The safety and effectiveness of NORDITROPIN in patients aged 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.3)].

Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone.

{ "type": "p", "children": [], "text": "Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone.\n" }

Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia Coli. The protein is comprised of 191 amino acids and has a molecular weight of about 22,000 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin.

{ "type": "p", "children": [], "text": "Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia Coli. The protein is comprised of 191 amino acids and has a molecular weight of about 22,000 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin." }

NORDITROPIN (somatropin) injection is a sterile, clear and colorless solution for subcutaneous use in ready-to-administer prefilled single-patient-use pens with a volume of 1.5 mL or 3 mL with a pH of 6.13–6.20.

{ "type": "p", "children": [], "text": "NORDITROPIN (somatropin) injection is a sterile, clear and colorless solution for subcutaneous use in ready-to-administer prefilled single-patient-use pens with a volume of 1.5 mL or 3 mL with a pH of 6.13–6.20." }

Each NORDITROPIN contains the following (see Table 3):

{ "type": "p", "children": [], "text": "Each NORDITROPIN contains the following (see Table 3):" }

Table 3. Contents of NORDITROPIN Pen

{ "type": "p", "children": [], "text": "\nTable 3. Contents of NORDITROPIN Pen\n" }

<div class="scrollingtable"><table width="491.4pt"> <col width="21%"/> <col width="18%"/> <col width="20%"/> <col width="20%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Component</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">5 mg/1.5 mL</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">10 mg/1.5 mL</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">15 mg/1.5 mL</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">30 mg/3 mL</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Somatropin</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">30 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Histidine</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.7 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3.3 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Mannitol</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">60 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">60 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">58 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">117 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Phenol</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Poloxamer 188</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hydrochloric acid/sodium hydroxide </p> <p>to adjust pH</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">as needed</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">as needed</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">as needed</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">as needed</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Water for Injection, USP</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">up to 1.5 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">up to 1.5 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">up to 1.5 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">up to 3 mL</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"491.4pt\">\n<col width=\"21%\"/>\n<col width=\"18%\"/>\n<col width=\"20%\"/>\n<col width=\"20%\"/>\n<col width=\"20%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Component</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">5 mg/1.5 mL</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">10 mg/1.5 mL</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">15 mg/1.5 mL</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">30 mg/3 mL</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Somatropin</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">10 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">15 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">30 mg</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Histidine</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">1 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">1 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">1.7 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">3.3 mg</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Mannitol</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">60 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">60 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">58 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">117 mg</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Phenol</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">4.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">4.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">4.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">9 mg</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Poloxamer 188</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">4.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">4.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">4.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">9 mg</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Hydrochloric acid/sodium hydroxide </p>\n<p>to adjust pH</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">as needed</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">as needed</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">as needed</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">as needed</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Water for Injection, USP</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">up to 1.5 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">up to 1.5 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">up to 1.5 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">up to 3 mL</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation hepatic glucose output, protein synthesis and lipolysis.

Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis.

Subcutaneous administration of a single dose of 4 mg NORDITROPIN in healthy subjects (n=26) with suppressed endogenous growth hormone results in an increased mean (SD) IGF-1 level from 190 (46) ng/mL predose to maximal level of 276 (49) ng/mL after approx. 24 hours. After 96 hours, the subjects displayed a mean (SD) IGF-1 concentration of 196 (41) ng/mL, comparable to the predose value.

Absorption - Somatropin has been studied following subcutaneous and intravenous administration in adult healthy subjects and GHD patients. A single dose administration of 4 mg NORDITROPIN in healthy subjects (n=26) with suppressed endogenous growth hormone resulted in a mean (SD) Cmax of 34.9 (10.4) ng/mL after approximately 3.0 hours. After a 180-min IV infusion of NORDITROPIN (33 ng/kg/min) administered to GHD patients (n=9), a mean (SD) hGH steady state serum level of approximately 23.1 (15.0) ng/mL was reached at 150 min.

After a SC dose of 0.024 mg/kg or 3 IU/m2 given in the thigh to adult GHD patients (n=18), mean (SD) Cmax values of 13.8 (5.8) and 17.1 (10.0) ng/mL were observed for the 4 and 8 mg NORDITROPIN vials, respectively, at approximately 4 to 5 hr. post dose. The absolute bioavailability for NORDITROPIN after the SC route of administration is currently not known.

Distribution — The mean (SD) apparent volume of distribution of somatropin after single dose subcutaneous administration of 4 mg NORDITROPIN in healthy subjects is 43.9 (14.9) L.

Elimination

Metabolism — Extensive metabolism studies have not been conducted. The metabolic fate of somatropin involves classical protein catabolism in both the liver and kidneys.

Excretion – The mean apparent terminal T1/2 values in healthy adult subjects (n=26) was 2.0 (0.5) hours. In GHD patients receiving 180-min IV infusion of NORDITROPIN (33 ng/kg/min), a mean clearance rate of approximately 2.3 (1.8) mL/min/kg or 139 (105) mL/min for hGH was observed. Following infusion, serum hGH levels had a biexponential decay with a terminal elimination half-life (T1/2) of approximately 21.1 (5.1) min. The mean apparent terminal T1/2 values in GHD patients receiving a SC dose of 0.024 mg/kg or 3 IU/m2 was estimated to be approximately 7 to 10 hr. The longer half-life observed after subcutaneous administration is due to slow absorption from the injection site. Urinary excretion of intact somatropin has not been measured.

Geriatric patients — The pharmacokinetics of somatropin have not been studied in patients greater than 65 years of age.

Pediatric patients — The pharmacokinetics of somatropin in pediatric patients are similar to those of adults.

Male and Female Patients — No gender-specific pharmacokinetic studies have been performed with somatropin. The available literature indicates that the pharmacokinetics of somatropin are similar in men and women.

Patients with Renal or Hepatic Impairment — No studies have been performed with somatropin.

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of NORDITROPIN or other somatropins. In the case of growth hormone, antibodies with binding capacities lower than 2 mg/mL have not been associated with growth attenuation. In a very small number of patients treated with somatropin, when binding capacity was greater than 2 mg/mL, interference with the growth response was observed.

In clinical trials, GH deficient pediatric patients receiving NORDITROPIN for up to 12 months were tested for induction of antibodies, and 0 of 358 patients developed antibodies with binding capacities above 2 mg/L. Amongst these patients, 165 had previously been treated with other somatropin formulations, and 193 were previously untreated naive patients. Eighteen of 76 children (~24%) treated with NORDITROPIN for short stature born SGA developed anti-rhGH antibodies.

Carcinogenicity and mutagenicity studies have not been conducted with NORDITROPIN.

Impairment of Fertility

In a rat study evaluating female fertility, animals were administered once daily subcutaneous doses of 0.1, 0.3, and 1.1 mg/kg NORDITROPIN beginning two weeks prior to mating, throughout mating and during the first 7 days of pregnancy. Delays in the time to mating were observed at doses greater than or equal to 0.3 mg/kg (approximately 3 times the maximum adult clinical dose of 0.016 mg/kg, based on body surface area), but these doses were also associated with increases in the number of corpora lutea and implantations. A decrease in the pregnancy rate was observed at the dose of 1.1 mg/kg (approximately 10 times the clinical dose of 0.016 mg/kg, based on body surface area). Male fertility parameters have not been evaluated with administration of NORDITROPIN.

The efficacy and safety of NORDITROPIN was assessed in a multicenter, prospective randomized, open label, dose response study with three doses (0.025, 0.05 and 0.1 mg/kg/day). A total of 111 pediatric patients with GH deficiency were randomized to each dose; 37(0.025 mg/kg/day):38(0.05 mg/kg/day):36(0.1 mg/kg/day). Patients met the following entry criteria: chronological age ≥ 3 years with a skeletal age < 10 years if male and < 8 years if female; pubertal stage = stage 1; previously untreated GH deficiency; peak plasma hormone concentration < 7 ng/ml or < 10 ng/ml (depending on assay used) in two tests.

The results are displayed in Table 4. The adjusted mean increases in HSDS over the 2-year period were 0.81, 1.57 and 1.73 in the 0.025, 0.05 and 0.1 mg/kg/day dose groups, respectively. There was no significant difference in ΔHSDS between the 0.05 and 0.1 mg/kg/day treatment groups. Height velocity (HV, cm/year) and HVSDS increased considerably after initiation of treatment, with the greatest response observed during the first year of treatment.

Table 4 – Efficacy of NORDITROPIN in Pediatric GH Deficiency

<div class="scrollingtable"><table width="540.9pt"> <col width="28%"/> <col width="8%"/> <col width="8%"/> <col width="8%"/> <col width="8%"/> <col width="8%"/> <col width="8%"/> <col width="8%"/> <col width="8%"/> <col width="8%"/> <tbody class="Headless"> <tr class="First"> <td class="Lrule Rrule Toprule" valign="top"></td><td align="center" class="Lrule Rrule Toprule" colspan="9" valign="top"> <p class="First"> <span class="Bold">NORDITROPIN</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">0.025 mg/kg/day</span> </p> </td><td class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">0.05 mg/kg/day</span> </p> </td><td class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">0.1 mg/kg/day</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Mean</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">SD</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Mean</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">SD</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Mean</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">SD</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Change in Standing Height (cm)</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> Baseline to Month 12</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">37</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9.5</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">37</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">13.2*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">34</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">13.7*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.7</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> Baseline to Month 24</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">34</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">17.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">37</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">22.2*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.7</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">33</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">23.7*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Change in Sitting Height (cm)</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> Baseline to Month 12</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">32</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">36</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6.5*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">32</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7.4**</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.5</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> Baseline to Month 24</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">29</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.5</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">35</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10.8**</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">31</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">12.2**</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Change in Bone Age (yr)</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> Baseline to Month 12</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">37</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">38</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.7</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.8</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">34</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.8</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> Month 12 to Month 24</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">37</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.5</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">38</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.7</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">34</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.6*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.8</p> </td> </tr> </tbody> </table></div>

**Significant (p <0.05) change from baseline compared to both other groups

A prospective, open label, randomized, parallel group study with 21 pediatric patients was conducted for 2 years to evaluate the efficacy and safety of NORDITROPIN. Additional 6 children were not randomized, but did follow the protocol. Inclusion criteria included bone age determination showing no significant acceleration, prepubertal status, height SDS <-2, and HV SDS <1 during the 12 months pre-treatment. Exclusion criteria were previous or ongoing treatment with growth hormone, anabolic steroids or corticosteroids, congenital heart disease or other serious disease perceived to possibly have major impact on growth, FPG >6.7 mmol/L (>120 mg/dL), or growth hormone deficiency (peak GH levels <10 ng/mL). The twenty-four, 12 female and 12 male, patients 3 – 14 years of age received either 0.033 mg/kg/day or 0.066 mg/kg/day of NORDITROPIN subcutaneously which was adjusted based on growth response after the first 2 years.

After the initial two-year study, NORDITROPIN treatment continued until final height. Retrospective final height was collected from 18 patients in the study and the 6 who had followed the protocol without randomization. Historical reference materials of height velocity and adult height analyses of Noonan patients served as the controls.

Patients obtained a final height (FH) gain from baseline of 1.5 and 1.6 SDS estimated according to the national and the Noonan reference, respectively. A height gain of 1.5 SDS (national) corresponds to a mean height gain of 9.9 cm in boys and 9.1 cm in girls at 18 years of age, while a height gain of 1.6 SDS (Noonan) corresponds to a mean height gain of 11.5 cm in boys and 11.0 cm in girls at 18 years of age.

A comparison of HV between the two treatment groups during the first two years of treatment for the randomized subjects was 10.1 and 7.6 cm/year with 0.066 mg/kg/day versus 8.55 and 6.7 cm/year with 0.033 mg/kg/day, for Year 1 and Year 2, respectively.

Two randomized, parallel group, open label, multicenter studies were conducted in the Netherlands to evaluate the efficacy and safety of NORDITROPIN. Patients were treated to final height in both studies [height velocity (HV) < 2 cm/year]. Changes in height were expressed as standard deviation scores (SDS) utilizing reference data for untreated Turner syndrome patients as well as the national Dutch population.

In Study 1, 68 euthyroid Caucasian patients stratified based on age and baseline height SDS were randomized in a 1:1:1 ratio to three different NORDITROPIN treatment regimens: 0.045 mg/kg/day (Dose A) for the entire study; 0.045 mg/kg/day for the first year and 0.067 mg/kg/day thereafter (Dose B); or 0.045 mg/kg/day for the first year, 0.067 for the second year, and 0.089 mg/kg/day thereafter (Dose C). At baseline, mean age was 6.5 years, mean height SDS (National standard) was -2.7, and mean HV during the previous year was 6.5 cm/year. Patients also received estrogen therapy after age 12 and following four years of NORDITROPIN treatment if they did not have spontaneous puberty.

Patients were treated for a mean of 8.4 years. As seen in Table 5, overall mean final height was 161 cm in the 46 children who attained final height. Seventy percent of these children reached a final height within the normal range (height SDS > -2 using the National standard). A greater percentage of children in the two escalated dose groups reached normal final height. The mean changes from baseline to final height in height SDS after treatment with Dose B and Dose C were significantly greater than the mean changes observed after treatment with Dose A (utilizing both the National and Turner standards). The mean changes from baseline to final height in height SDS (Turner standard) in Table 5 correspond to mean height gains of 9.4, 14.1 and 14.4 cm after treatment with Doses A, B and C, respectively. The mean changes from baseline to final height in height SDS (National standard) in Table 5 correspond to mean height gains of 4.5, 9.1 and 9.4 cm after treatment with Doses A, B and C, respectively. In each treatment group, peak HV was observed during treatment Year 1, and then gradually decreased each year; during Year 4, HV was less than the pre-treatment HV. However, between Year 2 and Year 6, a greater HV was observed in the two dose escalation groups compared to the 0.045 mg/kg/day group.

Table 5 – Final Height-Related Results After Treatment of Patients with Turner Syndrome with NORDITROPIN in a Randomized, Dose Escalating Study

<div class="scrollingtable"><table width="100%"> <col width="33%"/> <col width="17%"/> <col width="17%"/> <col width="17%"/> <col width="17%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Dose A</span> </p> <p> <span class="Bold">0.045 mg/kg/day</span> </p> <p> <span class="Bold">(n = 19)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Dose B</span> </p> <p> <span class="Bold">up to 0.067 mg/kg/day</span> </p> <p> <span class="Bold">(n = 15)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Dose C</span> </p> <p> <span class="Bold">up to 0.089 mg/kg/day</span> </p> <p> <span class="Bold">(n = 12)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Total</span> </p> <p> <span class="Bold">(n = 46)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Baseline height (cm)<span class="Sup">1</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">105 (12)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">108 (12.7)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">107 (11.7)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">106 (11.9)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Final height (cm)<span class="Sup">1</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">157 (6.7)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">163 (6.0)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">163 (4.9)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">161 (6.5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Number (%) of patients reaching normal height (height SDS &gt;-2 using National standard)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10 (53%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">12 (80%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10 (83%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">32 (70%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Height SDS (Turner standard)<span class="Sup">2</span> </p> </td><td class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Final [95% CI]</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.7 [1.4, 2.0]</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.5 [2.1, 2.8]<span class="Sup">3</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.5 [2.1, 2.9]<span class="Sup">4</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NA</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Change from baseline [95% CI]</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.5 [1.2, 1.8]</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.2 [1.9, 2.5]<span class="Sup">3</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.2 [1.9, 2.6]<span class="Sup">4</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NA</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Height SDS (National standard)<span class="Sup">2</span> </p> </td><td class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Final [95% CI]</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.9 [-2.2, -1.6]</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.2 [-1.5, -0.9]<span class="Sup">4</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.2 [-1.6, -0.8]<span class="Sup">5</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NA</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Change from baseline [95% CI]</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.7 [0.4, 1.0]</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.4 [1.1, 1.7]<span class="Sup">4</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.4 [1.1, 1.8]<span class="Sup">5</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NA</p> </td> </tr> </tbody> </table></div>

Values are expressed as mean (SD) unless otherwise indicated. SDS: Standard deviation score.

1Unadjusted (raw) means; 2Adjusted (least squares) means based on an ANCOVA model including terms for treatment,

duration of treatment, age at baseline, bone age at baseline, height SDS at baseline, age at onset of puberty and mid-parental target height SDS;

3p=0.005 vs. Dose A; 4p=0.006 vs. Dose A; 5p=0.008 vs. Dose A

In Study 2, 19 euthyroid Caucasian patients (with bone age ≤13.9 years) were randomized to treatment with 0.067 mg/kg/day of NORDITROPIN as a single subcutaneous dose in the evening, or divided into two doses (1/3 morning and 2/3 evening). All subjects were treated with concomitant ethinyl estradiol. Overall, at baseline, mean age was 13.6 years, mean height SDS (National standard) was -3.5 and mean HV during the previous year was 4.3 cm/year. Patients were treated for a mean of 3.6 years. In that there were no significant differences between the two treatment groups for any linear growth variables, the data from all patients were pooled. Overall mean final height was 155 cm in the 17 children who attained final height. Height SDS changed significantly from -3.5 at baseline to -2.4 at final height (National standard), and from 0.7 to 1.3 at final height (Turner standard).

A multi-center, randomized, double-blind, two-arm study to final height (Study 1) and a 2-year, multi-center, randomized, double-blind, parallel-group study (Study 2) were conducted to assess the efficacy and safety of NORDITROPIN. Changes in height and height velocity were compared to a national reference population in both studies.

Study 1 included 53, 38 male, 15 female, non-GHD, Dutch prepubertal pediatric patients 3-11 years of age with short stature born SGA with no catch-up growth. Catch-up growth was defined as obtaining a height of ≥ 3rd percentile within the first 2 years of life or at a later stage. Inclusion criteria included: birth length < 3rd percentile for gestational age, and height velocity (cm/year) for chronological age < 50th percentile. Exclusion criteria included chromosomal abnormalities, signs of a syndrome (except for Silver-Russell syndrome), serious/chronic co-morbid disease, malignancy, and previous rhGH therapy. NORDITROPIN was administered subcutaneously daily at bedtime at a dose of approximately 0.033 (Dose A) or 0.067 mg/kg/day (Dose B) for the entire treatment period. Final height was defined as a height velocity below 2 cm/year. Treatment with NORDITROPIN was continued to final height for up to 13 years. Mean duration of treatment was 9.5 years (boys) and 7.9 years (girls).

38 out of 53 children (72%) reached final height. Sixty-three percent (24 out of 38) of the children who reached final height were within the normal range of their healthy peers (Dutch national reference). For both doses combined, actual mean final height was 171 (SD 6.1) cm in boys and 159 (SD 4.3) cm in girls.

As seen in Table 6, for boys and girls combined, both mean final height SDS, and increase in height SDS from baseline to final height, were significantly greater after treatment with Dose B (0.067 mg/kg/day). A similar dose response was observed for the increase in height SDS from baseline to Year 2 (Table 6).

Overall mean height velocity at baseline was 5.4 cm/y (SD 1.2; n=29). Height velocity was greatest during the first year of NORDITROPIN treatment and was significantly greater after treatment with Dose B (mean 11.1 cm/y [SD 1.9; n=19]) compared with Dose A (mean 9.7 cm/y [SD 1.3; n=10]).

Table 6 – Study 1: Results for Final Height SDS and Change from Baseline to Final Height in Height SDS Using National Standard After Long-Term Treatment of SGA Children with NORDITROPIN

<div class="scrollingtable"><table width="508.5pt"> <col width="34%"/> <col width="22%"/> <col width="22%"/> <col width="22%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"> <p class="First"> <span class="Bold">Raw Mean ± SD (N)</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Dose A</p> <p>0.033 mg/kg/day</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Dose B</p> <p>0.067 mg/kg/day</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Total</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Baseline Height SDS </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-3.2 ± 0.7 (26)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-3.2 ± 0.7 (27)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-3.2 ± 0.7 (53)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Adjusted least-squares mean ± standard error (N), Treatment Difference [95% confidence intervals]</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Height SDS: Change from Baseline at Year 2<span class="Sup">2</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.4 ± 0.1 (26)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.8 ± 0.1 (26)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Treatment Diff = 0.4</p> <p>[0.2, 0.7]<span class="Sup">3</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Height SDS: Change from Baseline at Final Height<span class="Sup">1</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.4 ± 0.2 (19)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.8 ± 0.2 (19)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="middle"> <p class="First">Treatment Diff = 0.5</p> <p>[0.0, 0.9]<span class="Sup">3</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Final Height SDS<span class="Sup">1</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-1.8 ± 0.2 (19)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-1.3 ± 0.2 (19)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Final Height SDS &gt; -2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">13/19 (68%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">11/19 (58%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">24/38 (63%)</p> </td> </tr> </tbody> </table></div>

SDS: Standard deviation score.

1Adjusted (least-squares) means based on an ANCOVA model including terms for treatment, gender, age at baseline, bone age at baseline, height SDS at baseline, duration of treatment, peak GH after stimulation and baseline IGF-1.

2 Adjusted (least-squares) means based on an ANCOVA model including terms for treatment, gender, age at baseline, height SDS at baseline, and pubertal status.

3 p<0.05

In study 2, 84 randomized, prepubertal, non-GHD, Japanese children (age 3-8) were treated for 2 years with 0.033 or 0.067 mg/kg/day of NORDITROPIN subcutaneously daily at bedtime or received no treatment for 1 year. Additional inclusion criteria included birth length or weight SDS ≤ -2 or < 10th percentile for gestational age, height SDS for chronological age ≤ -2, and height velocity SDS for chronological age < 0 within one year prior to Visit 1. Exclusion criteria included diabetes mellitus, history or presence of active malignancy, and serious co-morbid conditions.

As seen in Table 7, for boys and girls combined, there was a dose-dependent increase in height SDS at Year 1 and Year 2. The increase in height SDS from baseline to Year 2 (0.033 mg/kg/day, 0.8 vs. 0.067 mg/kg/day, 1.4) was significantly greater after treatment with 0.067 mg/kg/day. In addition, the increase in height SDS at Year 1 was significantly greater in both active treatment groups compared to the untreated control group.

Table 7 – Study 2: Results for Change from Baseline in Height SDS At Year 1 and Year 2 Using National Standard After Short-Term Treatment of SGA Children with NORDITROPIN

<div class="scrollingtable"><table width="100%"> <col width="25%"/> <col width="21%"/> <col width="21%"/> <col width="21%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"> <p class="First"> <span class="Bold">Raw Mean ± SD (N)</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">No Treatment</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.033 mg/kg/day</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.067 mg/kg/day</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Height SDS: Baseline</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.9 ± 0.5 (15)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-3.0 ± 0.6 (35)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.9 ± 0.7 (34)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Height SDS: Year 1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.8 ± 0.5 (15)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.4 ± 0.6 (33)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.0 ± 0.8 (34)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Height SDS: Year 2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">NA</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.2 ± 0.7 (33)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-1.4 ± 0.7 (32)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="4" valign="middle"> <p class="First"> <span class="Bold">Adjusted least-squares mean ± standard error (N), Treatment Diff</span> </p> <p> <span class="Bold">[95% confidence intervals]</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" rowspan="2" valign="middle"> <p class="First">Height SDS: Change from Baseline at Year 1<span class="Sup">1</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.1 ± 0.1 (15)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.6 ± 0.1 (33)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.9 ± 0.1 (34)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"> <p class="First">0.033 vs. No Treatment: Treatment Diff = 0.5, [0.3, 0.7]<span class="Sup">2</span> </p> <p>0.067 vs. No Treatment: Treatment Diff = 0.8, [0.6, 1.0]<span class="Sup">2</span> </p> <p>0.067 vs. 0.033: Treatment Diff = 0.3, [0.2, 0.5]<span class="Sup">2</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" rowspan="2" valign="middle"> <p class="First">Height SDS: Change from Baseline at Year 2<span class="Sup">1</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">NA</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.8 ± 0.1 (33)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.4 ± 0.1 (32)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"> <p class="First">0.067 vs. 0.033: Treatment Diff = 0.6, [0.5, 0.8], p-value &lt; 0.0001</p> </td> </tr> </tbody> </table></div>

SDS: Standard deviation score.

1Adjusted (least-squares) means based on an ANCOVA model including terms for treatment, gender, age at baseline, and height SDS at baseline. All children remained prepubertal during the study.

2 p< 0.0001

The efficacy and safety of another somatropin product was evaluated in 105 patients who were retrospectively identified as having ISS in a randomized, open-label, clinical study. Patients were enrolled on the basis of short stature, stimulated GH secretion > 10 ng/mL, and prepubertal status. All patients were observed for height progression for 12 months and were subsequently randomized to this other somatropin product or observation only and followed to final height. Two doses of this other somatropin product were evaluated in this trial: 0.23 mg/kg/week (0.033 mg/kg/day) and 0.47 mg/kg/week (0.067 mg/kg/day). Baseline patient characteristics for the ISS patients who remained prepubertal at randomization (n= 105) were: mean (± SD): chronological age 11.4 (1.3) years, height SDS -2.4 (0.4), height velocity SDS -1.1 (0.8), and height velocity 4.4 (0.9) cm/yr, IGF-1 SDS -0.8 (1.4). Patients were treated for a median duration of 5.7 years. Results for final height SDS are displayed by treatment arm in Table 8. The observed mean gain in final height was 9.8 cm for females and 5.0 cm for males for both doses combined compared to untreated control subjects. A height gain of 1 SDS was observed in 10% of untreated subjects, 50% of subjects receiving 0.23 mg/kg/week and 69% of subjects receiving 0.47 mg/kg/week.

Table 8 – Final height SDS results for pre-pubertal patients with ISS*

<div class="scrollingtable"><table width="100%"> <col width="20%"/> <col width="16%"/> <col width="16%"/> <col width="16%"/> <col width="16%"/> <col width="16%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"></span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="4" valign="middle"> <p class="First"> <span class="Bold">Another Somatropin Product</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Untreated</span> </p> <p> <span class="Bold">(n=30)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">0.033 mg/kg/day</span> </p> <p> <span class="Bold">(n=30)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">0.067 mg/kg/day</span> </p> <p> <span class="Bold">(n=42)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">0.033 vs Untreated</span> </p> <p> <span class="Bold">(95% CI)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">0.067 vs Untreated</span> </p> <p> <span class="Bold">(95% CI)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Baseline height SDS </p> <p>Final height SDS minus baseline </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.41 (0.58)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.95 (0.75)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.36 (0.64)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">+0.53 (0.20, 0.87)**</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">+0.94 (0.63, 1.26)**</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Baseline predicted ht</p> <p>Final height SDS minus baseline predicted final height SDS</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.23 (0.66)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0.73 (0.63)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.05 (0.83)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">+0.60 (0.09, 1.11)**</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">+0.90 (0.42, 1.39)**</p> </td> </tr> </tbody> </table></div>

Least square means based on ANCOVA (final height SDS and final height SDS minus baseline predicted height SDS were adjusted for baseline height SDS)

* Mean (SD) are observed values

**p<0.05

The safety and efficacy of another somatropin product were evaluated in two randomized, open-label, controlled clinical studies. Patients received either this other somatropin product or no treatment for the first year of the studies, while all patients received this other somatropin product during the second year. This other somatropin product was administered as a daily SC injection, and the dose was calculated for each patient every 3 months. In Study 1, the treatment group received this other somatropin product at a dose of 0.24 mg/kg/week during the entire study. During the second year, the control group received this other somatropin product at a dose of 0.48 mg/kg/week. In Study 2, the treatment group received this other somatropin product at a dose of 0.36 mg/kg/week during the entire study. During the second year, the control group received this other somatropin product at a dose of 0.36 mg/kg/week.

The results are presented in Table 9. Linear growth continued to increase in the second year, when both groups received treatment with this other somatropin product.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 9 – Efficacy of Another Somatropin Product in Pediatric Patients with Prader-Willi Syndrome (Mean ± SD)</span> </caption> <col width="28%"/> <col width="17%"/> <col width="18%"/> <col width="18%"/> <col width="18%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Study 1</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Study 2</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Another Somatropin Product (0.24 mg/kg/week)</span> </p> <p> <span class="Bold">(n=15)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Untreated Control (n=12)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Another Somatropin Product (0.36 mg/kg/week)</span> </p> <p> <span class="Bold">(n=7)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Untreated Control </span> </p> <p> <span class="Bold">(n=9)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">Linear growth (cm)</span> </p> <p>Baseline height</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">112.7 ± 14.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">109.5 ± 12.0</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">120.3 ± 17.5</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">120.5 ± 11.2</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Growth from 0 to 12 months</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">11.6* ± 2.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">5.0 ± 1.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">10.7* ± 2.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">4.3 ± 1.5</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Baseline SDS</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-1.6 ± 1.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-1.8 ± 1.5</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.6 ± 1.7</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.1 ± 1.4</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">SDS at 12 months</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-0.5* ± 1.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-1.9 ± 1.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-1.4* ± 1.5</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-2.2 ± 1.4</p> </td> </tr> </tbody> </table></div>

* p <0.05

A total of six randomized, double-blind, placebo-controlled studies were performed. Two representative studies, one in adult onset (AO) GHD patients and a second in childhood onset (CO) GHD patients, are described below.

Study 1

A single center, randomized, double-blind, placebo-controlled, parallel-group, six month clinical trial was conducted in 31 adults with AO GHD comparing the effects of NORDITROPIN (somatropin) injection and placebo on body composition. Patients in the active treatment arm were treated with NORDITROPIN 0.017 mg/kg/day (not to exceed 1.33 mg/day). The changes from baseline in lean body mass (LBM) and percent total body fat (TBF) were measured by total body potassium (TBP) after 6 months.

Treatment with NORDITROPIN produced a significant increase from baseline in LBM compared to placebo (Table 10).

Table 10 – Lean Body Mass (kg) by TBP

<div class="scrollingtable"><table width="100%"> <col width="47%"/> <col width="23%"/> <col width="23%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">NORDITROPIN</p> <p>(n=15)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Placebo</p> <p>(n=16)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Baseline (mean)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">50.27</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">51.72</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Change from baseline at 6 months (mean)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.12</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">-0.63</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Treatment difference (mean) </p> <p>95% confidence interval</p> <p>p-value </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First">1.74</p> <p>(0.65, 2.83)</p> <p>p=0.0028*</p> </td> </tr> </tbody> </table></div>

*Least square mean based on an ANOVA model including treatment and sex as factors

Analysis of the treatment difference on the change from baseline in percent TBF revealed a significant decrease in the NORDITROPIN-treated group compared to the placebo group (Table 11).

Table 11 – Total Body Fat (%) by TBP

<div class="scrollingtable"><table width="100%"> <col width="47%"/> <col width="26%"/> <col width="23%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NORDITROPIN</p> <p>(n=15)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Placebo</p> <p>(n=16)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Baseline (mean)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">44.74</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">42.26</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Change from baseline at 6 months (mean)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-2.83</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.92</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Treatment difference (mean) </p> <p>95% confidence interval</p> <p>p-value </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">-4.74</p> <p>(-7.18, -2.30)</p> <p>p=0.0004*</p> </td> </tr> </tbody> </table></div>

*Least square mean based on an ANOVA model including treatment and sex as factors

NORDITROPIN also significantly increased serum osteocalcin (a marker of osteoblastic activity).

Study 2

A single center, randomized, double-blind, placebo-controlled, parallel-group, dose-finding, six month clinical trial was conducted in 49 men with CO GHD comparing the effects of NORDITROPIN and placebo on body composition. Patients were randomized to placebo or one of three active treatment groups (0.008, 0.016, and 0.024 mg/kg/day). Thirty three percent of the total dose to which each patient was randomized was administered during weeks 1-4, 67% during weeks 5-8, and 100% for the remainder of the study. The changes from baseline in LBM and percent TBF were measured by TBP after 6 months.

Treatment with NORDITROPIN produced a significant increase from baseline in LBM compared to placebo (pooled data) (Table 12).

Table 12 – Lean Body Mass (kg) by TBP

<div class="scrollingtable"><table width="100%"> <col width="47%"/> <col width="23%"/> <col width="23%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NORDITROPIN</p> <p>(n=36)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Placebo</p> <p>(n=13)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Baseline (mean)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">48.18</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">48.90</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Change from baseline at 6 months (mean)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.06</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.70</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Treatment difference (mean) </p> <p>95% confidence interval</p> <p>p-value </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">1.40</p> <p>(0.39, 2.41)</p> <p>p=0.0079*</p> </td> </tr> </tbody> </table></div>

*Least square mean based on an ANOVA model including treatment as a factor

Analysis of the treatment difference on the change from baseline in percent TBF revealed a significant decrease in the NORDITROPIN-treated groups (pooled data) compared to the placebo group (Table 13).

Table 13 – Total Body Fat (%) by TBP

<div class="scrollingtable"><table width="100%"> <col width="47%"/> <col width="26%"/> <col width="23%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NORDITROPIN</p> <p>(n=36)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Placebo</p> <p>(n=13)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Baseline (mean)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">34.55</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">34.07</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Change from baseline at 6 months (mean)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-6.00</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.78</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Treatment difference (mean) </p> <p>95% confidence interval</p> <p>p-value </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">-4.24</p> <p>(-7.11, -1.37)</p> <p>p=0.0048*</p> </td> </tr> </tbody> </table></div>

*Least square mean based on an ANOVA model including treatment as a factor

NORDITROPIN (somatropin) injection is a clear and colorless solution available as FlexPro single-patient-use prefilled pens:

{ "type": "p", "children": [], "text": "NORDITROPIN (somatropin) injection is a clear and colorless solution available as FlexPro single-patient-use prefilled pens:" }

{ "type": "", "children": [], "text": "" }

NORDITROPIN 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL FlexPro pens are compatible with FlexPro PenMate. The FlexPro PenMate is an accessory device that is dispensed separately with its enclosed Instructions for Use.

{ "type": "p", "children": [], "text": "NORDITROPIN 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL FlexPro pens are compatible with FlexPro PenMate. The FlexPro PenMate is an accessory device that is dispensed separately with its enclosed Instructions for Use. " }

NORDITROPIN 30 mg/3 mL FlexPro pen is not compatible with FlexPro PenMate.

{ "type": "p", "children": [], "text": "NORDITROPIN 30 mg/3 mL FlexPro pen is not compatible with FlexPro PenMate." }

Each NORDITROPIN FlexPro pen is for use by a single patient. A NORDITROPIN FlexPro pen must never be shared between patients, even if the needle is changed.

{ "type": "p", "children": [], "text": "Each NORDITROPIN FlexPro pen is for use by a single patient. A NORDITROPIN FlexPro pen must never be shared between patients, even if the needle is changed. " }

Unused NORDITROPIN FlexPro prefilled pens must be stored refrigerated at 2°C to 8°C (36°F to 46°F). Do not store directly adjacent to the refrigerator cooling element. Do not freeze. Avoid direct light.

{ "type": "p", "children": [], "text": "Unused NORDITROPIN FlexPro prefilled pens must be stored refrigerated at 2°C to 8°C (36°F to 46°F). Do not store directly adjacent to the refrigerator cooling element. Do not freeze. Avoid direct light." }

Table 14 – Storage Conditions and Expiration

{ "type": "p", "children": [], "text": "\nTable 14 – Storage Conditions and Expiration\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="25%"/> <col width="32%"/> <col width="32%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Before Use</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">In-use (After 1<span class="Sup">st</span> injection)</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">Storage</span> </p> <p> <span class="Bold">requirement</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Storage Option 1</span> </p> <p> <span class="Bold">(Refrigeration)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Storage Option 2</span> </p> <p> <span class="Bold">(Room temperature)</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">2ºC to 8ºC </p> <p>(36ºF to 46ºF)</p> <p>Until exp. date</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">2ºC to 8ºC </p> <p>(36ºF to 46ºF)</p> <p>4 weeks</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Up to 25ºC (77ºF)</p> <p>3 weeks</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"25%\"/>\n<col width=\"32%\"/>\n<col width=\"32%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Before Use</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">In-use (After 1<span class=\"Sup\">st</span> injection)</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Storage</span>\n</p>\n<p>\n<span class=\"Bold\">requirement</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Storage Option 1</span>\n</p>\n<p>\n<span class=\"Bold\">(Refrigeration)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Storage Option 2</span>\n</p>\n<p>\n<span class=\"Bold\">(Room temperature)</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">2ºC to 8ºC </p>\n<p>(36ºF to 46ºF)</p>\n<p>Until exp. date</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">2ºC to 8ºC </p>\n<p>(36ºF to 46ºF)</p>\n<p>4 weeks</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Up to 25ºC (77ºF)</p>\n<p>3 weeks</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

See FDA-approved patient labeling.

{ "type": "p", "children": [], "text": "\nSee FDA-approved patient labeling.\n" }

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)." }

{ "type": "", "children": [], "text": "" }

NORDITROPIN® and FlexPro® are registered trademarks of Novo Nordisk Health Care AG.

{ "type": "p", "children": [], "text": "\nNORDITROPIN® and FlexPro® are registered trademarks of Novo Nordisk Health Care AG.\n" }

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

{ "type": "p", "children": [], "text": "\nNovo Nordisk is a registered trademark of Novo Nordisk A/S.\n" }

PATENT Information: http://novonordisk-us.com/products/product-patents.html

{ "type": "p", "children": [], "text": "PATENT Information: http://novonordisk-us.com/products/product-patents.html\n" }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Novo Nordisk Inc.

{ "type": "p", "children": [], "text": "Novo Nordisk Inc." }

800 Scudders Mill Road

{ "type": "p", "children": [], "text": "800 Scudders Mill Road" }

Plainsboro, NJ 08536 USA

{ "type": "p", "children": [], "text": "Plainsboro, NJ 08536 USA" }

U.S. License No. 1261

{ "type": "p", "children": [], "text": "U.S. License No. 1261" }

For information aboutNORDITROPIN call:1 (888) 668-6444

{ "type": "p", "children": [], "text": "For information aboutNORDITROPIN call:1 (888) 668-6444" }

© 2025 Novo Nordisk A/S

{ "type": "p", "children": [], "text": "© 2025 Novo Nordisk A/S" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="100%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">PATIENT INFORMATION </span> </p> <p>NORDITROPIN<span class="Sup">®</span> (nor-dee-tro-pin)</p> <p>(somatropin) injection for subcutaneous use</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">What is NORDITROPIN?</span> </p> <p>NORDITROPIN is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.</p> <dl> <dt>•</dt> <dd>NORDITROPIN is given by injection under the skin (subcutaneous) and is used to treat:<br/>children who are not growing because of low or no growth hormone.</dd> <dt>•</dt> <dd>children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years.</dd> <dt>•</dt> <dd>children who have Idiopathic Short Stature (ISS).</dd> <dt>•</dt> <dd>children who are not growing who have Prader-Willi syndrome (PWS).</dd> <dt>•</dt> <dd>adults who do not make enough growth hormone.</dd> <dt> </dt> <dd>.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Do not use NORDITROPIN if:</span> </p> <dl> <dt>•</dt> <dd>you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.</dd> <dt>•</dt> <dd>you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stop breathing during sleep). <span class="Bold"><span class="Italics"></span></span> </dd> <dt>•</dt> <dd>you have cancer or other tumors.</dd> <dt>•</dt> <dd>you are allergic to somatropin or any of the ingredients in NORDITROPIN. See the end of this leaflet for a complete list of ingredients in NORDITROPIN.</dd> <dt>•</dt> <dd>your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).</dd> <dt>•</dt> <dd>you are a child with closed bone growth plates (epiphyses).</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Before taking NORDITROPIN, tell your healthcare provider about all of your medical conditions, including if you:</span> </p> <dl> <dt>•</dt> <dd>have had heart or stomach surgery, trauma or serious breathing (respiratory) problems. </dd> <dt>•</dt> <dd>have had a history of problems breathing while you sleep (sleep apnea). </dd> <dt>•</dt> <dd>have or have had cancer or any tumor.</dd> <dt>•</dt> <dd>have diabetes.</dd> <dt>•</dt> <dd>are pregnant or plan to become pregnant. It is not known if NORDITROPIN will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.</dd> <dt>•</dt> <dd>are breastfeeding or plan to breastfeed. It is not known if NORDITROPIN passes into your breast milk. You and your healthcare provider should decide if you will take NORDITROPIN while you breastfeed. </dd> </dl> <p> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. NORDITROPIN may affect how other medicines work, and other medicines may affect how NORDITROPIN works.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">How should I use NORDITROPIN?</span> </p> <dl> <dt>•</dt> <dd>Read the detailed <span class="Bold">Instructions for Use </span>that come with NORDITROPIN.</dd> <dt>•</dt> <dd>NORDITROPIN comes in 4 different dosage strengths. Your healthcare provider will prescribe the dose that is right for you.</dd> <dt>•</dt> <dd>Your healthcare provider will show you how to inject NORDITROPIN.</dd> <dt>•</dt> <dd>Use NORDITROPIN exactly as your healthcare provider tells you to.<dl> <dt>•</dt> <dd>NORDITROPIN FlexPro pens are for use by 1 person only.</dd> <dt>•</dt> <dd> <span class="Bold">Do not share your NORDITROPIN pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them.</span> </dd> </dl> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of NORDITROPIN?</span> </p> <p> <span class="Bold">NORDITROPIN may cause serious side effects, including: </span> </p> <dl> <dt>•</dt> <dd>high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems.</dd> <dt>•</dt> <dd>high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.</dd> <dt>•</dt> <dd>increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child starts to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin. </dd> <dt>•</dt> <dd>new or worsening high blood sugar (hyperglycemia) or diabetes. Your or your child’s blood sugar may need to be monitored during treatment with NORDITROPIN.</dd> <dt>•</dt> <dd>increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider.</dd> <dt>•</dt> <dd>serious allergic reactions. Get medical help right away if you or your child has the following symptoms:</dd> <dt>o</dt> <dd>swelling of your face, lips, mouth, or tongue </dd> <dt>o</dt> <dd>trouble breathing</dd> <dt>o</dt> <dd>wheezing</dd> <dt>o</dt> <dd>severe itching</dd> <dt>o</dt> <dd>skin rashes, redness, or swelling</dd> <dt>o</dt> <dd>dizziness or fainting</dd> <dt>o</dt> <dd>fast heartbeat or pounding in your chest </dd> <dt>o</dt> <dd>sweating</dd> <dt>•</dt> <dd>your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in adults during treatment with NORDITROPIN. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention.</dd> <dt>•</dt> <dd>decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss. </dd> <dt>•</dt> <dd>decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NORDITROPIN works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels.</dd> <dt>•</dt> <dd>hip and knee pain or a limp in children (slipped capital femoral epiphysis)</dd> <dt>•</dt> <dd>worsening of curvature of the spine (scoliosis)</dd> <dt>•</dt> <dd>severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain. </dd> <dt>•</dt> <dd>loss of fat and tissue weakness in the area of skin you inject. Talk to your healthcare provider about rotating the areas where you inject NORDITROPIN.</dd> <dt>•</dt> <dd>increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your or your child’s healthcare provider will do blood tests to check this.</dd> </dl> <p> <span class="Bold">The most common side effects of NORDITROPIN include:</span> </p> <dl> <dt>•</dt> <dd>injection site reactions and rashes</dd> <dt>•</dt> <dd>headaches</dd> </dl> <p>These are not all the possible side effects of NORDITROPIN.</p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Novo Nordisk at 1-888-668-6444.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">How should I store NORDITROPIN?</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Before you use NORDITROPIN FlexPro pens for the first time: </span> </dd> <dt>o</dt> <dd>Store your new, unused NORDITROPIN pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). </dd> <dt>o</dt> <dd>Do not freeze NORDITROPIN. </dd> <dt>o</dt> <dd>When stored in the refrigerator, do not store NORDITROPIN directly next to the cooling element.</dd> <dt>o</dt> <dd>Keep NORDITROPIN away from direct light.</dd> <dt>o</dt> <dd>Do not use NORDITROPIN that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd> <dt>o</dt> <dd>Do not use NORDITROPIN after the expiration date printed on the carton and the pen.</dd> <dt>•</dt> <dd> <span class="Bold">After you use NORDITROPIN FlexPro pens and there is still medicine left: </span> </dd> <dt>o</dt> <dd>Store remaining NORDITROPIN in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd> <dt>o</dt> <dd>Store remaining NORDITROPIN at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. </dd> </dl> <p> <span class="Bold">Keep NORDITROPIN and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of NORDITROPIN.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NORDITROPIN for a condition for which it was not prescribed. Do not give NORDITROPIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NORDITROPIN that is written for health professionals.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in NORDITROPIN?</span> </p> <p> <span class="Bold">Active ingredient:</span> somatropin </p> <p> <span class="Bold">Inactive ingredients</span>: Histidine, Mannitol, Phenol, Poloxamer 188, Hydrochloric Acid/Sodium Hydroxide (as needed) and Water for Injection</p> <p>Manufactured by: Novo Nordisk Inc.<br/>Plainsboro, NJ 08536 </p> <p>U.S. License No. 1261</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">PATIENT INFORMATION </span>\n</p>\n<p>NORDITROPIN<span class=\"Sup\">®</span> (nor-dee-tro-pin)</p>\n<p>(somatropin) injection for subcutaneous use</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is NORDITROPIN?</span>\n</p>\n<p>NORDITROPIN is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.</p>\n<dl>\n<dt>•</dt>\n<dd>NORDITROPIN is given by injection under the skin (subcutaneous) and is used to treat:<br/>children who are not growing because of low or no growth hormone.</dd>\n<dt>•</dt>\n<dd>children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years.</dd>\n<dt>•</dt>\n<dd>children who have Idiopathic Short Stature (ISS).</dd>\n<dt>•</dt>\n<dd>children who are not growing who have Prader-Willi syndrome (PWS).</dd>\n<dt>•</dt>\n<dd>adults who do not make enough growth hormone.</dd>\n<dt> </dt>\n<dd>.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not use NORDITROPIN if:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.</dd>\n<dt>•</dt>\n<dd>you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stop breathing during sleep). <span class=\"Bold\"><span class=\"Italics\"></span></span>\n</dd>\n<dt>•</dt>\n<dd>you have cancer or other tumors.</dd>\n<dt>•</dt>\n<dd>you are allergic to somatropin or any of the ingredients in NORDITROPIN. See the end of this leaflet for a complete list of ingredients in NORDITROPIN.</dd>\n<dt>•</dt>\n<dd>your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).</dd>\n<dt>•</dt>\n<dd>you are a child with closed bone growth plates (epiphyses).</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Before taking NORDITROPIN, tell your healthcare provider about all of your medical conditions, including if you:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>have had heart or stomach surgery, trauma or serious breathing (respiratory) problems. </dd>\n<dt>•</dt>\n<dd>have had a history of problems breathing while you sleep (sleep apnea). </dd>\n<dt>•</dt>\n<dd>have or have had cancer or any tumor.</dd>\n<dt>•</dt>\n<dd>have diabetes.</dd>\n<dt>•</dt>\n<dd>are pregnant or plan to become pregnant. It is not known if NORDITROPIN will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.</dd>\n<dt>•</dt>\n<dd>are breastfeeding or plan to breastfeed. It is not known if NORDITROPIN passes into your breast milk. You and your healthcare provider should decide if you will take NORDITROPIN while you breastfeed. </dd>\n</dl>\n<p>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. NORDITROPIN may affect how other medicines work, and other medicines may affect how NORDITROPIN works.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I use NORDITROPIN?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Read the detailed <span class=\"Bold\">Instructions for Use </span>that come with NORDITROPIN.</dd>\n<dt>•</dt>\n<dd>NORDITROPIN comes in 4 different dosage strengths. Your healthcare provider will prescribe the dose that is right for you.</dd>\n<dt>•</dt>\n<dd>Your healthcare provider will show you how to inject NORDITROPIN.</dd>\n<dt>•</dt>\n<dd>Use NORDITROPIN exactly as your healthcare provider tells you to.<dl>\n<dt>•</dt>\n<dd>NORDITROPIN FlexPro pens are for use by 1 person only.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not share your NORDITROPIN pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them.</span>\n</dd>\n</dl>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of NORDITROPIN?</span>\n</p>\n<p>\n<span class=\"Bold\">NORDITROPIN may cause serious side effects, including: </span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems.</dd>\n<dt>•</dt>\n<dd>high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.</dd>\n<dt>•</dt>\n<dd>increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child starts to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin. </dd>\n<dt>•</dt>\n<dd>new or worsening high blood sugar (hyperglycemia) or diabetes. Your or your child’s blood sugar may need to be monitored during treatment with NORDITROPIN.</dd>\n<dt>•</dt>\n<dd>increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider.</dd>\n<dt>•</dt>\n<dd>serious allergic reactions. Get medical help right away if you or your child has the following symptoms:</dd>\n<dt>o</dt>\n<dd>swelling of your face, lips, mouth, or tongue </dd>\n<dt>o</dt>\n<dd>trouble breathing</dd>\n<dt>o</dt>\n<dd>wheezing</dd>\n<dt>o</dt>\n<dd>severe itching</dd>\n<dt>o</dt>\n<dd>skin rashes, redness, or swelling</dd>\n<dt>o</dt>\n<dd>dizziness or fainting</dd>\n<dt>o</dt>\n<dd>fast heartbeat or pounding in your chest </dd>\n<dt>o</dt>\n<dd>sweating</dd>\n<dt>•</dt>\n<dd>your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in adults during treatment with NORDITROPIN. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention.</dd>\n<dt>•</dt>\n<dd>decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss. </dd>\n<dt>•</dt>\n<dd>decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NORDITROPIN works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels.</dd>\n<dt>•</dt>\n<dd>hip and knee pain or a limp in children (slipped capital femoral epiphysis)</dd>\n<dt>•</dt>\n<dd>worsening of curvature of the spine (scoliosis)</dd>\n<dt>•</dt>\n<dd>severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain. </dd>\n<dt>•</dt>\n<dd>loss of fat and tissue weakness in the area of skin you inject. Talk to your healthcare provider about rotating the areas where you inject NORDITROPIN.</dd>\n<dt>•</dt>\n<dd>increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your or your child’s healthcare provider will do blood tests to check this.</dd>\n</dl>\n<p>\n<span class=\"Bold\">The most common side effects of NORDITROPIN include:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>injection site reactions and rashes</dd>\n<dt>•</dt>\n<dd>headaches</dd>\n</dl>\n<p>These are not all the possible side effects of NORDITROPIN.</p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Novo Nordisk at 1-888-668-6444.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store NORDITROPIN?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Before you use NORDITROPIN FlexPro pens for the first time: </span>\n</dd>\n<dt>o</dt>\n<dd>Store your new, unused NORDITROPIN pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). </dd>\n<dt>o</dt>\n<dd>Do not freeze NORDITROPIN. </dd>\n<dt>o</dt>\n<dd>When stored in the refrigerator, do not store NORDITROPIN directly next to the cooling element.</dd>\n<dt>o</dt>\n<dd>Keep NORDITROPIN away from direct light.</dd>\n<dt>o</dt>\n<dd>Do not use NORDITROPIN that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd>\n<dt>o</dt>\n<dd>Do not use NORDITROPIN after the expiration date printed on the carton and the pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">After you use NORDITROPIN FlexPro pens and there is still medicine left: </span>\n</dd>\n<dt>o</dt>\n<dd>Store remaining NORDITROPIN in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd>\n<dt>o</dt>\n<dd>Store remaining NORDITROPIN at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. </dd>\n</dl>\n<p>\n<span class=\"Bold\">Keep NORDITROPIN and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of NORDITROPIN.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NORDITROPIN for a condition for which it was not prescribed. Do not give NORDITROPIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NORDITROPIN that is written for health professionals.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in NORDITROPIN?</span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span> somatropin </p>\n<p>\n<span class=\"Bold\">Inactive ingredients</span>: Histidine, Mannitol, Phenol, Poloxamer 188, Hydrochloric Acid/Sodium Hydroxide (as needed) and Water for Injection</p>\n<p>Manufactured by: Novo Nordisk Inc.<br/>Plainsboro, NJ 08536 </p>\n<p>U.S. License No. 1261</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 01/2025

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration\tRevised: 01/2025" }

NORDITROPIN® [nor-dee-tro-pin] (somatropin)injection, for subcutaneous use5mg

{ "type": "p", "children": [], "text": "\nNORDITROPIN® [nor-dee-tro-pin]\n(somatropin)injection, for subcutaneous use5mg" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><a name="id-155538904"></a><img alt="5mg-overview" src="/dailymed/image.cfm?name=image-05.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id746619391"></a><img alt="5mg-needle-ex" src="/dailymed/image.cfm?name=image-06.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">Norditropin FlexPro Pen is for single-patient-use only.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Supplies you will need:</span> </p> <dl> <dt>•</dt> <dd>Norditropin FlexPro prefilled Pen <br/>new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm</dd> <dt>•</dt> <dd>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</dd> <dt>•</dt> <dd>alcohol pad</dd> <dt>•</dt> <dd>gauze pad</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2040159561"></a><img alt="5mg-supplies" src="/dailymed/image.cfm?name=image-07.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How to use your Norditropin FlexPro Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">5 steps you should follow for a Norditropin injection:</span> </p> <dl> <dt> </dt> <dd>Step 1: Prepare your Norditropin FlexPro Pen </dd> <dt> </dt> <dd>Step 2: Check the Norditropin flow with each new Pen </dd> <dt> </dt> <dd>Step 3: Select your dose</dd> <dt> </dt> <dd>Step 4: Inject your dose</dd> <dt> </dt> <dd>Step 5: After your injection</dd> </dl> <p> <span class="Bold">For further information about your Pen see:</span> </p> <dl> <dt> </dt> <dd>Frequently Asked Questions</dd> <dt> </dt> <dd>Important information</dd> <dt> </dt> <dd>Patient Information</dd> <dt> </dt> <dd> <a name="id1618562781"></a><img alt="alert" src="/dailymed/image.cfm?name=alert.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Important information</span> </dd> <dt> </dt> <dd>Make sure that you read this information carefully</dd> <dt> </dt> <dd> <a name="id-984998540"></a><img alt="info" src="/dailymed/image.cfm?name=info.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Additional information</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Norditropin is for use under the skin only (subcutaneous).</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Do not</span> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </p> <p> <span class="Bold">Do not use your Pen without proper training from your healthcare provider</span>. </p> <p>Make sure that you are confident in giving an injection with the Pen before you start your treatment.</p> <p></p> <p>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1. Prepare your Norditropin FlexPro Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Wash your hands with soap and water. </dd> <dt> </dt> <dd> <dl> <dt>•</dt> <dd> <span class="Bold">Check the name, strength, and colored label </span>on your Pen to make sure that it contains Norditropin in the right strength. </dd> </dl> </dd> <dt> </dt> <dd> <dl> <dt>•</dt> <dd>Pull off the Pen cap. </dd> </dl> </dd> <dt> </dt> <dd> <dl> <dt>•</dt> <dd>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</dd> </dl> </dd> <dt> </dt> <dd>See figure A. <span class="Bold">If the Norditropin looks cloudy, do not use the Pen.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id204454492"></a><img alt="5mg-a" src="/dailymed/image.cfm?name=image-08.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </dd> <dt>•</dt> <dd>Push the needle straight onto the Pen. Turn the needle clockwise <span class="Bold">until it is on tight</span>. See figure B.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-930046935"></a><img alt="5mg-b" src="/dailymed/image.cfm?name=image-09.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-281335180"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-01.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the outer needle cap and <span class="Bold">dispose of it</span>. See figure C</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1129979604"></a><img alt="5mg-c" src="/dailymed/image.cfm?name=image-10.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the inner needle cap and dispose of it. See figure D.</dd> <dt> </dt> <dd> <a name="id1341044713"></a><img alt="info" src="/dailymed/image.cfm?name=info-01.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id77788548"></a><img alt="5mg-d" src="/dailymed/image.cfm?name=image-11.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id130371350"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-02.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Never use a bent or damaged needle.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2. Check the Norditropin flow with each new Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id-99497513"></a><img alt="info" src="/dailymed/image.cfm?name=info-02.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If your Pen is already in use</span>, go to step 3.</dd> <dt> </dt> <dd> <span class="Bold">Before using a new Pen</span>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</dd> <dt>•</dt> <dd>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.025 mg. You will hear a faint “click” when you turn the dose selector. See figure E.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1123817563"></a><img alt="5mg-e" src="/dailymed/image.cfm?name=image-12.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">1 marking on the dose counter equals 0.025 mg</span>. See figure F.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1412074451"></a><img alt="5mg-f" src="/dailymed/image.cfm?name=image-13.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. <span class="Bold">The “0” must line up with the dose pointer</span>. See figure G.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id766659825"></a><img alt="5mg-g" src="/dailymed/image.cfm?name=image-14.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check that a drop of Norditropin appears at the needle tip. See figure H.</dd> <dt> </dt> <dd> <a name="id-979146292"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-03.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If no Norditropin appears</span>, repeat step 2 up to 6 times.</dd> <dt> </dt> <dd>If you still do not see a drop of Norditropin, <span class="Bold">change the needle:</span> </dd> <dt>•</dt> <dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</dd> <dt>•</dt> <dd>and repeat step 2 again.<p class="First"> <span class="Bold">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </span> </p> <p> <span class="Bold">1-888-668-6444 for help.</span> </p> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id378594839"></a><img alt="5mg-h" src="/dailymed/image.cfm?name=image-15.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 3. Select your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>To start, check that the dose pointer is set at <span class="Bold">“0”.</span> </dd> <dt> </dt> <dd>• Turn the dose selector clockwise to select the dose you need. See figure I.<p class="First">When you have selected your dose, you can go to step 4.</p> </dd> </dl> <p class="First"> <a name="id413586244"></a><img alt="info" src="/dailymed/image.cfm?name=info-03.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If there is not enough Norditropin left </span>to select a full dose, see <span class="Bold">Frequently Asked Questions</span><span class="Italics">.</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1557972136"></a><img alt="5mg-i" src="/dailymed/image.cfm?name=image-16.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id714160666"></a><img alt="info" src="/dailymed/image.cfm?name=info-04.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>The dose counter shows the dose in “mg“. See figures J and K. Always use the dose counter to select the exact dose<span class="Bold">. Do not use the “click“ sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected. </span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-923565870"></a><img alt="5mg-j" src="/dailymed/image.cfm?name=image-17.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1078438641"></a><img alt="5mg-k" src="/dailymed/image.cfm?name=image-18.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id1341200488"></a><img alt="info" src="/dailymed/image.cfm?name=info-05.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</p> <dl> <dt> </dt> <dd>The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1816074406"></a><img alt="5mg-l" src="/dailymed/image.cfm?name=image-19.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 4. Inject your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Select the injection site.</dd> <dt>•</dt> <dd>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day. </dd> <dt>•</dt> <dd>Wipe the injection site with an alcohol swab and let the area dry.</dd> <dt>•</dt> <dd>Insert the needle into your skin as your healthcare provider has shown you. See figure M. <p class="First">Make sure you can see the dose counter. <span class="Bold">Do not cover it with your fingers</span>. This could block the injection.</p> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-746179374"></a><img alt="5mg-m" src="/dailymed/image.cfm?name=image-20.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Press and hold down the dose button until the dose counter shows “0”. See figure N. <span class="Bold">The “0” must line up with the dose pointer</span>. You may then hear or feel a “click”. </dd> <dt>•</dt> <dd> <span class="Bold">Continue to hold the needle in your skin. </span> </dd> <dt> </dt> <dd> <a name="id-1661455075"></a><img alt="info" src="/dailymed/image.cfm?name=info-06.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <span class="Bold">Frequently Asked Questions</span>.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1095175329"></a><img alt="5mg-n" src="/dailymed/image.cfm?name=image-21.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Keep the needle in your skin</span> after the dose counter has returned to “0”. <span class="Bold">Count slowly to 6</span> to ensure that the full dose has been delivered. See figure O.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-220753526"></a><img alt="5mg-o" src="/dailymed/image.cfm?name=image-22.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd> <dt> </dt> <dd> <a name="id309441939"></a><img alt="info" src="/dailymed/image.cfm?name=info-07.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1333527336"></a><img alt="image-p" src="/dailymed/image.cfm?name=image-23.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 5. After your injection</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1698271051"></a><img alt="5mg-q" src="/dailymed/image.cfm?name=image-24.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</dd> <dt> </dt> <dd> <a name="id1956896393"></a><img alt="info" src="/dailymed/image.cfm?name=info-08.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>Always dispose of the needle after each injection.</dd> <dt> </dt> <dd>For further information about safe sharps disposal, see <span class="Bold">Frequently Asked Questions</span>.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1913689255"></a><img alt="5mg-r" src="/dailymed/image.cfm?name=image-25.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id724561781"></a><img alt="info" src="/dailymed/image.cfm?name=info-09.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Do not try to put the needle cap back on</span>. You may stick yourself with the needle.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S. <p class="First"> <span class="Bold">See “How should I store Norditropin?”</span> </p> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1986932516"></a><img alt="5mg-s" src="/dailymed/image.cfm?name=image-26.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd> </dl> <p class="First"> <span class="Bold">How should I store Norditropin?</span> </p> <dl> <dt>o</dt> <dd> <span class="Bold">Before you use Norditropin FlexPro pens for the first time:</span> </dd> <dt>o</dt> <dd>Store your new, unused <span class="Bold">Norditropin</span> pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). </dd> <dt>o</dt> <dd>Do not freeze <span class="Bold">Norditropin</span>. </dd> <dt>o</dt> <dd>When stored in the refrigerator, do not store <span class="Bold">Norditropin</span> directly next to the cooling element.</dd> <dt>o</dt> <dd>Keep <span class="Bold">Norditropin</span> away from direct light.</dd> <dt>o</dt> <dd>Do not use <span class="Bold">Norditropin</span> that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd> <dt>o</dt> <dd>Do not use <span class="Bold">Norditropin</span> after the expiration date printed on the carton and the pen.</dd> <dt>•</dt> <dd> <span class="Bold">After you use Norditropin FlexPro pens and there is still medicine left:</span> </dd> <dt>o</dt> <dd>Store remaining <span class="Bold">Norditropin</span> in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd> <dt>o</dt> <dd>Store remaining <span class="Bold">Norditropin</span> at room temperature no warmer than 77ºF (25ºC) and use within 3 </dd> <dt> </dt> <dd>weeks.</dd> <dt> </dt> <dd> <span class="Bold">Keep Norditropin and all medicines out of the reach of children.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Frequently Asked Questions</span> </p> <p> <span class="Bold">How do I see how </span> </p> <p> <span class="Bold">much Norditropin is </span> </p> <p> <span class="Bold">left in my Pen?</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-508831711"></a><img alt="5mg-t" src="/dailymed/image.cfm?name=image-27.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 2.0 mg. If the dose counter stops with the dose pointer lined up with “2.0”, at least 2.0 mg are left in your Pen. </p> <p>If the dose counter stops with the dose pointer lined up with “1.25”, only 1.25 mg are left in your Pen. See figure U.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-857339633"></a><img alt="5mg-u" src="/dailymed/image.cfm?name=image-28.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if I need a larger dose than what is left in my Pen? </span> </p> <p>It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen.</p> <p>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <span class="Bold">Only split your dose if you have been trained or advised by your healthcare provider on how to do this. </span>You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</p> <p> <span class="Bold">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</span>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if no Norditropin appears when I check the flow?</span> </p> <p> <span class="Bold">A. Your needle may be blocked or damaged</span>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</p> <p> <span class="Bold">B. Your Pen may be defective</span>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if “0” does not appear after completing my injection?</span> </p> <p>The needle may be blocked or damaged, and <span class="Bold">you have not received any Norditropin</span> – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</p> <p>If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I take care of my Pen?</span> </p> <p>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</p> <p>See <span class="Bold">“How should I store Norditropin?”. </span> </p> <p>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “<span class="Bold">How do I dispose of used needles and Pens?</span>”.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Frequently Asked Questions</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if I drop my Pen?</span> </p> <p>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I clean my Pen?</span> </p> <p>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I dispose of used needles and Pens?</span> </p> <p>Put your used needles in an FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not throw away (dispose of) loose needles in your household trash</span>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </p> <dl> <dt>•</dt> <dd>made of a heavy-duty plastic, </dd> <dt>•</dt> <dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </dd> <dt>•</dt> <dd>upright and stable during use, </dd> <dt>•</dt> <dd>leak-resistant, and </dd> <dt>•</dt> <dd>properly labeled to warn of hazardous waste inside the container.</dd> </dl> <p>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: <a href="http://www.fda.gov/safesharpsdisposal">http://www.fda.gov/safesharpsdisposal</a>.</p> <p>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</p> <p>Do not recycle your used sharps disposal container.</p> <p>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id699591925"></a><img alt="info" src="/dailymed/image.cfm?name=info-10.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Important information</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Caregivers must <span class="Bold">be very careful when handling needles</span> to reduce the risk of needle sticks and infection.</dd> <dt>•</dt> <dd>Norditropin<span class="Sup">®</span> FlexPro<span class="Sup">®</span> 5 mg/1.5 mL Pen <span class="Bold">is compatible with FlexPro<span class="Sup">®</span> PenMate<span class="Sup">®</span>.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id-855339967"></a><img alt="phone-qrcode" src="/dailymed/image.cfm?name=image-29.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><p class="First"> <a href="http://www.norditropin.com">www.norditropin.com</a> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p> <span class="Italics">Norditropin</span><span class="Bold"><span class="Sup">®</span></span> and <span class="Italics">FlexPro</span><span class="Bold"><span class="Sup">®</span></span> are registered trademarks of Novo Nordisk Health Care AG.</p> <p> <span class="Italics">Novo Nordisk</span><span class="Bold"><span class="Sup">®</span></span> and <span class="Italics">PenMate</span><span class="Bold"><span class="Sup">® </span></span>are registered trademarks of Novo Nordisk A/S.</p> <p>PATENT Information: http://novonordisk-us.com/products/product-patents.html</p> <p>Manufactured by:</p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road</p> <p>Plainsboro, NJ 08536 </p> <p>U.S. License No. 1261</p> <p>For information about NORDITROPIN<span class="Sup">®</span> </p> <p>Visit: norditropin.com</p> <p>Or call: 1 (888) 668-6444</p> <p>Revised: 01/2025</p> <p>© 2025 Novo Nordisk A/S</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><a name=\"id-155538904\"></a><img alt=\"5mg-overview\" src=\"/dailymed/image.cfm?name=image-05.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id746619391\"></a><img alt=\"5mg-needle-ex\" src=\"/dailymed/image.cfm?name=image-06.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Norditropin FlexPro Pen is for single-patient-use only.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Supplies you will need:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Norditropin FlexPro prefilled Pen <br/>new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm</dd>\n<dt>•</dt>\n<dd>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</dd>\n<dt>•</dt>\n<dd>alcohol pad</dd>\n<dt>•</dt>\n<dd>gauze pad</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2040159561\"></a><img alt=\"5mg-supplies\" src=\"/dailymed/image.cfm?name=image-07.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How to use your Norditropin FlexPro Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">5 steps you should follow for a Norditropin injection:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>Step 1: Prepare your Norditropin FlexPro Pen </dd>\n<dt> </dt>\n<dd>Step 2: Check the Norditropin flow with each new Pen </dd>\n<dt> </dt>\n<dd>Step 3: Select your dose</dd>\n<dt> </dt>\n<dd>Step 4: Inject your dose</dd>\n<dt> </dt>\n<dd>Step 5: After your injection</dd>\n</dl>\n<p>\n<span class=\"Bold\">For further information about your Pen see:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>Frequently Asked Questions</dd>\n<dt> </dt>\n<dd>Important information</dd>\n<dt> </dt>\n<dd>Patient Information</dd>\n<dt> </dt>\n<dd>\n<a name=\"id1618562781\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Important information</span>\n</dd>\n<dt> </dt>\n<dd>Make sure that you read this information carefully</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-984998540\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Additional information</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Norditropin is for use under the skin only (subcutaneous).</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not</span> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </p>\n<p>\n<span class=\"Bold\">Do not use your Pen without proper training from your healthcare provider</span>. </p>\n<p>Make sure that you are confident in giving an injection with the Pen before you start your treatment.</p>\n<p></p>\n<p>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 1. Prepare your Norditropin FlexPro Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Wash your hands with soap and water. </dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check the name, strength, and colored label </span>on your Pen to make sure that it contains Norditropin in the right strength. </dd>\n</dl>\n</dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt>•</dt>\n<dd>Pull off the Pen cap. </dd>\n</dl>\n</dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt>•</dt>\n<dd>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</dd>\n</dl>\n</dd>\n<dt> </dt>\n<dd>See figure A. <span class=\"Bold\">If the Norditropin looks cloudy, do not use the Pen.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id204454492\"></a><img alt=\"5mg-a\" src=\"/dailymed/image.cfm?name=image-08.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd> When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </dd>\n<dt>•</dt>\n<dd>Push the needle straight onto the Pen. Turn the needle clockwise <span class=\"Bold\">until it is on tight</span>. See figure B.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-930046935\"></a><img alt=\"5mg-b\" src=\"/dailymed/image.cfm?name=image-09.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-281335180\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-01.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Pull off the outer needle cap and <span class=\"Bold\">dispose of it</span>. See figure C</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1129979604\"></a><img alt=\"5mg-c\" src=\"/dailymed/image.cfm?name=image-10.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Pull off the inner needle cap and dispose of it. See figure D.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id1341044713\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-01.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id77788548\"></a><img alt=\"5mg-d\" src=\"/dailymed/image.cfm?name=image-11.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id130371350\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-02.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Never use a bent or damaged needle.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2. Check the Norditropin flow with each new Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-99497513\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-02.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If your Pen is already in use</span>, go to step 3.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Before using a new Pen</span>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</dd>\n<dt>•</dt>\n<dd>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.025 mg. You will hear a faint “click” when you turn the dose selector. See figure E.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1123817563\"></a><img alt=\"5mg-e\" src=\"/dailymed/image.cfm?name=image-12.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">1 marking on the dose counter equals 0.025 mg</span>. See figure F.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1412074451\"></a><img alt=\"5mg-f\" src=\"/dailymed/image.cfm?name=image-13.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. <span class=\"Bold\">The “0” must line up with the dose pointer</span>. See figure G.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id766659825\"></a><img alt=\"5mg-g\" src=\"/dailymed/image.cfm?name=image-14.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Check that a drop of Norditropin appears at the needle tip. See figure H.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-979146292\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-03.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If no Norditropin appears</span>, repeat step 2 up to 6 times.</dd>\n<dt> </dt>\n<dd>If you still do not see a drop of Norditropin, <span class=\"Bold\">change the needle:</span>\n</dd>\n<dt>•</dt>\n<dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</dd>\n<dt>•</dt>\n<dd>and repeat step 2 again.<p class=\"First\">\n<span class=\"Bold\">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </span>\n</p>\n<p>\n<span class=\"Bold\">1-888-668-6444 for help.</span>\n</p>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id378594839\"></a><img alt=\"5mg-h\" src=\"/dailymed/image.cfm?name=image-15.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. Select your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>To start, check that the dose pointer is set at <span class=\"Bold\">“0”.</span>\n</dd>\n<dt> </dt>\n<dd>•\tTurn the dose selector clockwise to select the dose you need. See figure I.<p class=\"First\">When you have selected your dose, you can go to step 4.</p>\n</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id413586244\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-03.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If there is not enough Norditropin left </span>to select a full dose, see <span class=\"Bold\">Frequently Asked Questions</span><span class=\"Italics\">.</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1557972136\"></a><img alt=\"5mg-i\" src=\"/dailymed/image.cfm?name=image-16.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id714160666\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-04.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>The dose counter shows the dose in “mg“. See figures J and K. Always use the dose counter to select the exact dose<span class=\"Bold\">. Do not use the “click“ sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected. </span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-923565870\"></a><img alt=\"5mg-j\" src=\"/dailymed/image.cfm?name=image-17.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1078438641\"></a><img alt=\"5mg-k\" src=\"/dailymed/image.cfm?name=image-18.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id1341200488\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-05.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</p>\n<dl>\n<dt> </dt>\n<dd>The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1816074406\"></a><img alt=\"5mg-l\" src=\"/dailymed/image.cfm?name=image-19.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4. Inject your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Select the injection site.</dd>\n<dt>•</dt>\n<dd>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day. </dd>\n<dt>•</dt>\n<dd>Wipe the injection site with an alcohol swab and let the area dry.</dd>\n<dt>•</dt>\n<dd>Insert the needle into your skin as your healthcare provider has shown you. See figure M. <p class=\"First\">Make sure you can see the dose counter. <span class=\"Bold\">Do not cover it with your fingers</span>. This could block the injection.</p>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-746179374\"></a><img alt=\"5mg-m\" src=\"/dailymed/image.cfm?name=image-20.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Press and hold down the dose button until the dose counter shows “0”. See figure N. <span class=\"Bold\">The “0” must line up with the dose pointer</span>. You may then hear or feel a “click”. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Continue to hold the needle in your skin. </span>\n</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-1661455075\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-06.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <span class=\"Bold\">Frequently Asked Questions</span>.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1095175329\"></a><img alt=\"5mg-n\" src=\"/dailymed/image.cfm?name=image-21.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep the needle in your skin</span> after the dose counter has returned to “0”. <span class=\"Bold\">Count slowly to 6</span> to ensure that the full dose has been delivered. See figure O.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-220753526\"></a><img alt=\"5mg-o\" src=\"/dailymed/image.cfm?name=image-22.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id309441939\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-07.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1333527336\"></a><img alt=\"image-p\" src=\"/dailymed/image.cfm?name=image-23.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5. After your injection</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1698271051\"></a><img alt=\"5mg-q\" src=\"/dailymed/image.cfm?name=image-24.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id1956896393\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-08.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>Always dispose of the needle after each injection.</dd>\n<dt> </dt>\n<dd>For further information about safe sharps disposal, see <span class=\"Bold\">Frequently Asked Questions</span>.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1913689255\"></a><img alt=\"5mg-r\" src=\"/dailymed/image.cfm?name=image-25.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id724561781\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-09.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Do not try to put the needle cap back on</span>. You may stick yourself with the needle.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S. <p class=\"First\">\n<span class=\"Bold\">See “How should I store Norditropin?”</span>\n</p>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1986932516\"></a><img alt=\"5mg-s\" src=\"/dailymed/image.cfm?name=image-26.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">How should I store Norditropin?</span>\n</p>\n<dl>\n<dt>o</dt>\n<dd>\n<span class=\"Bold\">Before you use Norditropin FlexPro pens for the first time:</span>\n</dd>\n<dt>o</dt>\n<dd>Store your new, unused <span class=\"Bold\">Norditropin</span> pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). </dd>\n<dt>o</dt>\n<dd>Do not freeze <span class=\"Bold\">Norditropin</span>. </dd>\n<dt>o</dt>\n<dd>When stored in the refrigerator, do not store <span class=\"Bold\">Norditropin</span> directly next to the cooling element.</dd>\n<dt>o</dt>\n<dd>Keep <span class=\"Bold\">Norditropin</span> away from direct light.</dd>\n<dt>o</dt>\n<dd>Do not use <span class=\"Bold\">Norditropin</span> that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd>\n<dt>o</dt>\n<dd>Do not use <span class=\"Bold\">Norditropin</span> after the expiration date printed on the carton and the pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">After you use Norditropin FlexPro pens and there is still medicine left:</span>\n</dd>\n<dt>o</dt>\n<dd>Store remaining <span class=\"Bold\">Norditropin</span> in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd>\n<dt>o</dt>\n<dd>Store remaining <span class=\"Bold\">Norditropin</span> at room temperature no warmer than 77ºF (25ºC) and use within 3 </dd>\n<dt> </dt>\n<dd>weeks.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Keep Norditropin and all medicines out of the reach of children.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Frequently Asked Questions</span>\n</p>\n<p>\n<span class=\"Bold\">How do I see how </span>\n</p>\n<p>\n<span class=\"Bold\">much Norditropin is </span>\n</p>\n<p>\n<span class=\"Bold\">left in my Pen?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-508831711\"></a><img alt=\"5mg-t\" src=\"/dailymed/image.cfm?name=image-27.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 2.0 mg. If the dose counter stops with the dose pointer lined up with “2.0”, at least 2.0 mg are left in your Pen. </p>\n<p>If the dose counter stops with the dose pointer lined up with “1.25”, only 1.25 mg are left in your Pen. See figure U.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-857339633\"></a><img alt=\"5mg-u\" src=\"/dailymed/image.cfm?name=image-28.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if I need a larger dose than what is left in my Pen? </span>\n</p>\n<p>It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen.</p>\n<p>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <span class=\"Bold\">Only split your dose if you have been trained or advised by your healthcare provider on how to do this. </span>You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</p>\n<p>\n<span class=\"Bold\">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</span>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if no Norditropin appears when I check the flow?</span>\n</p>\n<p>\n<span class=\"Bold\">A. Your needle may be blocked or damaged</span>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</p>\n<p>\n<span class=\"Bold\">B. Your Pen may be defective</span>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if “0” does not appear after completing my injection?</span>\n</p>\n<p>The needle may be blocked or damaged, and <span class=\"Bold\">you have not received any Norditropin</span> – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</p>\n<p>If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take care of my Pen?</span>\n</p>\n<p>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</p>\n<p>See <span class=\"Bold\">“How should I store Norditropin?”. </span>\n</p>\n<p>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “<span class=\"Bold\">How do I dispose of used needles and Pens?</span>”.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Frequently Asked Questions</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if I drop my Pen?</span>\n</p>\n<p>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I clean my Pen?</span>\n</p>\n<p>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I dispose of used needles and Pens?</span>\n</p>\n<p>Put your used needles in an FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not throw away (dispose of) loose needles in your household trash</span>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </p>\n<dl>\n<dt>•</dt>\n<dd>made of a heavy-duty plastic, </dd>\n<dt>•</dt>\n<dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </dd>\n<dt>•</dt>\n<dd>upright and stable during use, </dd>\n<dt>•</dt>\n<dd>leak-resistant, and </dd>\n<dt>•</dt>\n<dd>properly labeled to warn of hazardous waste inside the container.</dd>\n</dl>\n<p>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: <a href=\"http://www.fda.gov/safesharpsdisposal\">http://www.fda.gov/safesharpsdisposal</a>.</p>\n<p>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</p>\n<p>Do not recycle your used sharps disposal container.</p>\n<p>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id699591925\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-10.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Important information</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Caregivers must <span class=\"Bold\">be very careful when handling needles</span> to reduce the risk of needle sticks and infection.</dd>\n<dt>•</dt>\n<dd>Norditropin<span class=\"Sup\">®</span> FlexPro<span class=\"Sup\">®</span> 5 mg/1.5 mL Pen <span class=\"Bold\">is compatible with FlexPro<span class=\"Sup\">®</span> PenMate<span class=\"Sup\">®</span>.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id-855339967\"></a><img alt=\"phone-qrcode\" src=\"/dailymed/image.cfm?name=image-29.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><p class=\"First\">\n<a href=\"http://www.norditropin.com\">www.norditropin.com</a>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>\n<span class=\"Italics\">Norditropin</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> and <span class=\"Italics\">FlexPro</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> are registered trademarks of Novo Nordisk Health Care AG.</p>\n<p>\n<span class=\"Italics\">Novo Nordisk</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> and <span class=\"Italics\">PenMate</span><span class=\"Bold\"><span class=\"Sup\">® </span></span>are registered trademarks of Novo Nordisk A/S.</p>\n<p>PATENT Information: http://novonordisk-us.com/products/product-patents.html</p>\n<p>Manufactured by:</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road</p>\n<p>Plainsboro, NJ 08536 </p>\n<p>U.S. License No. 1261</p>\n<p>For information about NORDITROPIN<span class=\"Sup\">®</span>\n</p>\n<p>Visit: norditropin.com</p>\n<p>Or call: 1 (888) 668-6444</p>\n<p>Revised: 01/2025</p>\n<p>© 2025 Novo Nordisk A/S</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

INSTRUCTIONS FOR USENORDITROPIN ® [nor-dee-tro-pin](somatropin)injection, for subcutancous use10mg

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USENORDITROPIN ® [nor-dee-tro-pin](somatropin)injection, for subcutancous use10mg" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><a name="id-870445576"></a><img alt="10mg-overview" src="/dailymed/image.cfm?name=10mg-overview.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id-1286350008"></a><img alt="10mg-example" src="/dailymed/image.cfm?name=10mg-example.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">Norditropin FlexPro Pen is for single-patient-use only.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Supplies you will need:</span> </p> <dl> <dt>•</dt> <dd>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm.</dd> <dt>•</dt> <dd>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</dd> <dt>•</dt> <dd>alcohol pad</dd> <dt>•</dt> <dd>gauze pad</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2094846594"></a><img alt="10mg-supplies" src="/dailymed/image.cfm?name=10mg-supplies.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How to use your Norditropin FlexPro Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">5 steps you should follow for a Norditropin injection:</span> </p> <dl> <dt> </dt> <dd>Step 1: Prepare your Norditropin FlexPro Pen </dd> <dt> </dt> <dd>Step 2: Check the Norditropin flow with each new Pen </dd> <dt> </dt> <dd>Step 3: Select your dose</dd> <dt> </dt> <dd>Step 4: Inject your dose</dd> <dt> </dt> <dd>Step 5: After your injection</dd> </dl> <p> <span class="Bold">For further information about your Pen see:</span> </p> <dl> <dt> </dt> <dd>Frequently Asked Questions</dd> <dt> </dt> <dd>Important information</dd> <dt> </dt> <dd>Patient Information </dd> </dl> <p> <a name="id-267542804"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-04.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Important information</span> </p> <p>Make sure that you read this information carefully.</p> <p> <a name="id1664354209"></a><img alt="info" src="/dailymed/image.cfm?name=info-11.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Additional information</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">Norditropin is for use under the skin only (subcutaneous).</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Do not</span> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </p> <p> <span class="Bold">Do not use your Pen without proper training from your healthcare provider</span>. </p> <p>Make sure that you are confident in giving an injection with the Pen before you start your treatment.</p> <p>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1. Prepare your Norditropin FlexPro Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Wash your hands with soap and water. </dd> <dt> </dt> <dd> <dl> <dt>•</dt> <dd> <span class="Bold">Check the name, strength, and colored label </span>on your Pen to make sure that it contains Norditropin in the right strength. </dd> </dl> </dd> <dt> </dt> <dd> <dl> <dt>•</dt> <dd>Pull off the Pen cap. </dd> </dl> </dd> <dt> </dt> <dd> <dl> <dt>•</dt> <dd>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</dd> </dl> </dd> <dt>•</dt> <dd>See figure A. <span class="Bold">If the Norditropin looks cloudy, do not use the Pen.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-596243184"></a><img alt="10mg-a" src="/dailymed/image.cfm?name=10mg-a.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </dd> <dt>•</dt> <dd>Push the needle straight onto the Pen. Turn the needle clockwise <span class="Bold">until it is on tight</span>. See figure B.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1359044005"></a><img alt="10mg-b" src="/dailymed/image.cfm?name=10mg-b.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-1149519023"></a><img alt="info" src="/dailymed/image.cfm?name=info-12.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the outer needle cap and <span class="Bold">dispose of it</span>. See figure C.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-154377509"></a><img alt="10mg-c" src="/dailymed/image.cfm?name=10mg-c.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the inner needle cap and dispose of it. See figure D.</dd> <dt> </dt> <dd> <a name="id-799063491"></a><img alt="info" src="/dailymed/image.cfm?name=info-13.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-932516676"></a><img alt="10mg-d" src="/dailymed/image.cfm?name=10mg-d.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-831990638"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-05.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Never use a bent or damaged needle</span>.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2. Check the Norditropin flow with each new Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id658882537"></a><img alt="info" src="/dailymed/image.cfm?name=info-14.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If your Pen is already in use</span>, go to step 3.</dd> <dt> </dt> <dd> <span class="Bold">Before using a new Pen</span>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</dd> <dt>•</dt> <dd>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.05 mg. You will hear a faint “click” when you turn the dose selector. See figure E.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1776445664"></a><img alt="10mg-e" src="/dailymed/image.cfm?name=10mg-e.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">1 marking on the dose counter equals 0.05 mg</span>. See figure F.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id688639174"></a><img alt="10mg-f" src="/dailymed/image.cfm?name=10mg-f.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. <span class="Bold">The “0” must line up with the dose pointer</span>. See figure G.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-306708811"></a><img alt="10mg-g" src="/dailymed/image.cfm?name=10mg-g.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check that a drop of Norditropin appears at the needle tip. See figure H.</dd> <dt> </dt> <dd> <a name="id1215858884"></a><img alt="info" src="/dailymed/image.cfm?name=info-15.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If no Norditropin appears</span>, repeat step 2 up to 6 times.</dd> </dl> <p class="First">If you still do not see a drop of Norditropin, <span class="Bold">change the needle:</span> </p> <dl> <dt>•</dt> <dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</dd> <dt>•</dt> <dd>and repeat step 2 again.</dd> <dt> </dt> <dd> <span class="Bold">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </span> </dd> <dt> </dt> <dd> <span class="Bold">1-888-668-6444 for help.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1369756190"></a><img alt="10mg-h" src="/dailymed/image.cfm?name=10mg-h.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 3. Select your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>To start, check that the dose pointer is set at <span class="Bold">“0”.</span> </dd> <dt>•</dt> <dd>Turn the dose selector clockwise to select the dose you need. See figure I.</dd> <dt> </dt> <dd>When you have selected your dose, you can go to step 4.</dd> <dt> </dt> <dd> <a name="id-2024775011"></a><img alt="info" src="/dailymed/image.cfm?name=info-16.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If there is not enough Norditropin left </span>to select a full dose, see <span class="Bold">Frequently Asked Questions</span><span class="Italics">.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id655804076"></a><img alt="10mg-i" src="/dailymed/image.cfm?name=10mg-i.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id-1265917291"></a><img alt="info" src="/dailymed/image.cfm?name=info-17.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>The dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose<span class="Bold">. Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1208871398"></a><img alt="10mg-j" src="/dailymed/image.cfm?name=10mg-j.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id627593348"></a><img alt="10mg-k" src="/dailymed/image.cfm?name=10mg-k.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id-416483286"></a><img alt="info" src="/dailymed/image.cfm?name=info-18.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</dd> <dt> </dt> <dd>The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-868525148"></a><img alt="10mg-l" src="/dailymed/image.cfm?name=10mg-l.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 4. Inject your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Select the injection site.</dd> <dt> </dt> <dd> <dl> <dt>•</dt> <dd>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. <span class="Bold">Change the injection site every day</span>. </dd> </dl> </dd> <dt>•</dt> <dd>Wipe the injection site with an alcohol swab and let the area dry.</dd> <dt>•</dt> <dd>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</dd> <dt> </dt> <dd>Make sure you can see the dose counter. <span class="Bold">Do not cover it with your fingers</span>. This could block the injection.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1182316676"></a><img alt="10mg-m" src="/dailymed/image.cfm?name=10mg-m.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Press and hold down the dose button until the dose counter shows “0”. See figure N. <span class="Bold">The “0” must line up with the dose pointer</span>. You may then hear or feel a “click”. </dd> <dt>•</dt> <dd> <span class="Bold">Continue to hold the needle in your skin.</span> </dd> <dt> </dt> <dd> <a name="id1621109889"></a><img alt="info" src="/dailymed/image.cfm?name=info-19.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <span class="Bold">Frequently Asked Questions</span>. <span class="Bold"></span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id531392548"></a><img alt="10mg-n" src="/dailymed/image.cfm?name=10mg-n.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Keep the needle in your skin</span> after the dose counter has returned to “0”. <span class="Bold">Count slowly to 6</span> to ensure that the full dose has been delivered. See figure O.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1520589604"></a><img alt="10mg-o" src="/dailymed/image.cfm?name=10mg-o.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd> <dt> </dt> <dd> <a name="id-1003506043"></a><img alt="info" src="/dailymed/image.cfm?name=info-20.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1899506582"></a><img alt="10mg-p" src="/dailymed/image.cfm?name=10mg-p.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 5. After your injection</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-647820017"></a><img alt="10mg-q" src="/dailymed/image.cfm?name=10mg-q.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</dd> <dt> </dt> <dd> <a name="id1390147966"></a><img alt="info" src="/dailymed/image.cfm?name=info-21.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>Always dispose of the needle after each injection.</dd> <dt> </dt> <dd>For further information about safe sharps disposal, see <span class="Bold">Frequently Asked Questions</span>.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id835350278"></a><img alt="10mg-r" src="/dailymed/image.cfm?name=10mg-r.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-666162644"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-06.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Do not try to put the needle cap back on</span>. You may stick yourself with the needle.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</dd> <dt> </dt> <dd>See <span class="Bold">“How should I store Norditropin?”.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1765373586"></a><img alt="10mg-s" src="/dailymed/image.cfm?name=10mg-s.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-217133488"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-07.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd> <dt> </dt> <dd> <span class="Bold">How should I store Norditropin?</span> </dd> </dl> <p class="First">•<span class="Bold">Before you use Norditropin FlexPro pens for the first time: </span> </p> <dl> <dt>o</dt> <dd>Store your new, unused <span class="Bold">Norditropin</span> pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). </dd> <dt>o</dt> <dd>Do not freeze <span class="Bold">Norditropin</span>. </dd> <dt>o</dt> <dd>When stored in the refrigerator, do not store <span class="Bold">Norditropin</span> directly next to the cooling element.</dd> <dt>o</dt> <dd>Keep <span class="Bold">Norditropin</span> away from direct light.</dd> <dt>o</dt> <dd>Do not use <span class="Bold">Norditropin</span> that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd> <dt>o</dt> <dd>Do not use <span class="Bold">Norditropin</span> after the expiration date printed on the carton and the pen.</dd> </dl> <p>•<span class="Bold">After you use Norditropin FlexPro pens and there is still medicine left: </span> </p> <dl> <dt>o</dt> <dd>Store remaining <span class="Bold">Norditropin</span> in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd> <dt>o</dt> <dd>Store remaining <span class="Bold">Norditropin </span>at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.</dd> </dl> <p> <span class="Bold">Keep Norditropin and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Frequently Asked Questions</span> </p> <p> <span class="Bold">How do I see how </span> </p> <p> <span class="Bold">much Norditropin is </span> </p> <p> <span class="Bold">left in my Pen?</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-796533184"></a><img alt="10mg-t" src="/dailymed/image.cfm?name=10mg-t.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 4.0 mg. If the dose counter stops with the dose pointer lined up with “4.0”, at least 4.0 mg are left in your Pen. </p> <p>If the dose counter stops with the dose pointer lined up with “2.4”, only 2.4 mg are left in your Pen. See figure U.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2070918056"></a><img alt="10mg-u" src="/dailymed/image.cfm?name=10mg-u.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if I need a larger dose than what is left in my Pen? </span> </p> <p>It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen.</p> <p>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <span class="Bold">Only split your dose if you have been trained or advised by your healthcare provider on how to do this.</span> You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</p> <p> <span class="Bold">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</span>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if no Norditropin appears when I check the flow?</span> </p> <p> <span class="Bold">A. Your needle may be blocked or damaged</span>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</p> <p> <span class="Bold">B. Your Pen may be defective</span>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if “0” does not appear after completing my injection?</span> </p> <p>The needle may be blocked or damaged, and <span class="Bold">you have not received any Norditropin</span> – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</p> <p>If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I take care of my Pen?</span> </p> <p>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</p> <p>See <span class="Bold">“How should I store Norditropin?”. </span> </p> <p>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “<span class="Bold">How do I dispose of used needles and Pens?</span>”.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Frequently Asked Questions</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if I drop my Pen?</span> </p> <p>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I clean my Pen?</span> </p> <p>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I dispose of used needles and Pens?</span> </p> <p>Put your used needles in an FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not throw away (dispose of) loose needles in your household trash</span>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </p> <p>• made of a heavy-duty plastic, </p> <dl> <dt> </dt> <dd>• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </dd> </dl> <p>• upright and stable during use, </p> <p>• leak-resistant, and </p> <p>• properly labeled to warn of hazardous waste inside the container.</p> <p>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. <br/> </p> <p>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</p> <p>Do not recycle your used sharps disposal container.</p> <p>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id-1174715696"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-08.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Important information</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Caregivers must <span class="Bold">be very careful when handling needles</span> to reduce the risk of needle sticks and infection.</dd> <dt>•</dt> <dd>Norditropin<span class="Sup">®</span> FlexPro<span class="Sup">®</span> 10 mg/1.5 mL Pen <span class="Bold">is compatible with FlexPro<span class="Sup">®</span> PenMate<span class="Sup">®</span>.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id-1504582640"></a><img alt="10mg images-phone-qrcode." src="/dailymed/image.cfm?name=phone-qrcode.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p> <span class="Italics">Norditropin</span><span class="Sup">®</span> and <span class="Italics">FlexPro</span><span class="Bold"><span class="Sup">®</span></span> are registered trademarks of Novo Nordisk Health Care AG.</p> <p> <span class="Italics">Novo Nordisk</span><span class="Bold"><span class="Sup">®</span></span> and <span class="Italics">PenMate</span><span class="Bold"><span class="Sup">® </span></span>are registered trademarks of Novo Nordisk A/S.</p> <p>PATENT Information: <a href="http://novonordisk-us.com/products/product-patents.html">http://novonordisk-us.com/products/product-patents.html</a> </p> <p>Manufactured by:</p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road</p> <p>Plainsboro, NJ 08536 USA</p> <p>U.S. License No. 1261</p> <p>For information about NORDITROPIN<span class="Sup">®</span> </p> <p>Visit: norditropin.com</p> <p>Or call: 1 (888) 668-6444</p> <p>Revised: 01/2025</p> <p>© 2025 Novo Nordisk A/S</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><a name=\"id-870445576\"></a><img alt=\"10mg-overview\" src=\"/dailymed/image.cfm?name=10mg-overview.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id-1286350008\"></a><img alt=\"10mg-example\" src=\"/dailymed/image.cfm?name=10mg-example.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Norditropin FlexPro Pen is for single-patient-use only.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Supplies you will need:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm.</dd>\n<dt>•</dt>\n<dd>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</dd>\n<dt>•</dt>\n<dd>alcohol pad</dd>\n<dt>•</dt>\n<dd>gauze pad</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2094846594\"></a><img alt=\"10mg-supplies\" src=\"/dailymed/image.cfm?name=10mg-supplies.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How to use your Norditropin FlexPro Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">5 steps you should follow for a Norditropin injection:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>Step 1: Prepare your Norditropin FlexPro Pen </dd>\n<dt> </dt>\n<dd>Step 2: Check the Norditropin flow with each new Pen </dd>\n<dt> </dt>\n<dd>Step 3: Select your dose</dd>\n<dt> </dt>\n<dd>Step 4: Inject your dose</dd>\n<dt> </dt>\n<dd>Step 5: After your injection</dd>\n</dl>\n<p>\n<span class=\"Bold\">For further information about your Pen see:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>Frequently Asked Questions</dd>\n<dt> </dt>\n<dd>Important information</dd>\n<dt> </dt>\n<dd>Patient Information </dd>\n</dl>\n<p>\n<a name=\"id-267542804\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-04.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Important information</span>\n</p>\n<p>Make sure that you read this information carefully.</p>\n<p>\n<a name=\"id1664354209\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-11.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Additional information</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Norditropin is for use under the skin only (subcutaneous).</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not</span> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </p>\n<p>\n<span class=\"Bold\">Do not use your Pen without proper training from your healthcare provider</span>. </p>\n<p>Make sure that you are confident in giving an injection with the Pen before you start your treatment.</p>\n<p>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 1. Prepare your Norditropin FlexPro Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Wash your hands with soap and water. </dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check the name, strength, and colored label </span>on your Pen to make sure that it contains Norditropin in the right strength. </dd>\n</dl>\n</dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt>•</dt>\n<dd>Pull off the Pen cap. </dd>\n</dl>\n</dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt>•</dt>\n<dd>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>See figure A. <span class=\"Bold\">If the Norditropin looks cloudy, do not use the Pen.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-596243184\"></a><img alt=\"10mg-a\" src=\"/dailymed/image.cfm?name=10mg-a.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </dd>\n<dt>•</dt>\n<dd>Push the needle straight onto the Pen. Turn the needle clockwise <span class=\"Bold\">until it is on tight</span>. See figure B.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1359044005\"></a><img alt=\"10mg-b\" src=\"/dailymed/image.cfm?name=10mg-b.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-1149519023\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-12.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Pull off the outer needle cap and <span class=\"Bold\">dispose of it</span>. See figure C.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-154377509\"></a><img alt=\"10mg-c\" src=\"/dailymed/image.cfm?name=10mg-c.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Pull off the inner needle cap and dispose of it. See figure D.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-799063491\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-13.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-932516676\"></a><img alt=\"10mg-d\" src=\"/dailymed/image.cfm?name=10mg-d.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-831990638\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-05.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Never use a bent or damaged needle</span>.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2. Check the Norditropin flow with each new Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id658882537\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-14.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If your Pen is already in use</span>, go to step 3.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Before using a new Pen</span>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</dd>\n<dt>•</dt>\n<dd>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.05 mg. You will hear a faint “click” when you turn the dose selector. See figure E.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1776445664\"></a><img alt=\"10mg-e\" src=\"/dailymed/image.cfm?name=10mg-e.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">1 marking on the dose counter equals 0.05 mg</span>. See figure F.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id688639174\"></a><img alt=\"10mg-f\" src=\"/dailymed/image.cfm?name=10mg-f.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. <span class=\"Bold\">The “0” must line up with the dose pointer</span>. See figure G.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-306708811\"></a><img alt=\"10mg-g\" src=\"/dailymed/image.cfm?name=10mg-g.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Check that a drop of Norditropin appears at the needle tip. See figure H.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id1215858884\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-15.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If no Norditropin appears</span>, repeat step 2 up to 6 times.</dd>\n</dl>\n<p class=\"First\">If you still do not see a drop of Norditropin, <span class=\"Bold\">change the needle:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</dd>\n<dt>•</dt>\n<dd>and repeat step 2 again.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </span>\n</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">1-888-668-6444 for help.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1369756190\"></a><img alt=\"10mg-h\" src=\"/dailymed/image.cfm?name=10mg-h.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. Select your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>To start, check that the dose pointer is set at <span class=\"Bold\">“0”.</span>\n</dd>\n<dt>•</dt>\n<dd>Turn the dose selector clockwise to select the dose you need. See figure I.</dd>\n<dt> </dt>\n<dd>When you have selected your dose, you can go to step 4.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-2024775011\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-16.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If there is not enough Norditropin left </span>to select a full dose, see <span class=\"Bold\">Frequently Asked Questions</span><span class=\"Italics\">.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id655804076\"></a><img alt=\"10mg-i\" src=\"/dailymed/image.cfm?name=10mg-i.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-1265917291\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-17.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>The dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose<span class=\"Bold\">. Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1208871398\"></a><img alt=\"10mg-j\" src=\"/dailymed/image.cfm?name=10mg-j.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id627593348\"></a><img alt=\"10mg-k\" src=\"/dailymed/image.cfm?name=10mg-k.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-416483286\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-18.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</dd>\n<dt> </dt>\n<dd>The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-868525148\"></a><img alt=\"10mg-l\" src=\"/dailymed/image.cfm?name=10mg-l.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4. Inject your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Select the injection site.</dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt>•</dt>\n<dd>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. <span class=\"Bold\">Change the injection site every day</span>. </dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>Wipe the injection site with an alcohol swab and let the area dry.</dd>\n<dt>•</dt>\n<dd>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</dd>\n<dt> </dt>\n<dd>Make sure you can see the dose counter. <span class=\"Bold\">Do not cover it with your fingers</span>. This could block the injection.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1182316676\"></a><img alt=\"10mg-m\" src=\"/dailymed/image.cfm?name=10mg-m.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Press and hold down the dose button until the dose counter shows “0”. See figure N. <span class=\"Bold\">The “0” must line up with the dose pointer</span>. You may then hear or feel a “click”. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Continue to hold the needle in your skin.</span>\n</dd>\n<dt> </dt>\n<dd>\n<a name=\"id1621109889\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-19.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <span class=\"Bold\">Frequently Asked Questions</span>. <span class=\"Bold\"></span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id531392548\"></a><img alt=\"10mg-n\" src=\"/dailymed/image.cfm?name=10mg-n.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep the needle in your skin</span> after the dose counter has returned to “0”. <span class=\"Bold\">Count slowly to 6</span> to ensure that the full dose has been delivered. See figure O.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1520589604\"></a><img alt=\"10mg-o\" src=\"/dailymed/image.cfm?name=10mg-o.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-1003506043\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-20.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1899506582\"></a><img alt=\"10mg-p\" src=\"/dailymed/image.cfm?name=10mg-p.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5. After your injection</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-647820017\"></a><img alt=\"10mg-q\" src=\"/dailymed/image.cfm?name=10mg-q.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id1390147966\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-21.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>Always dispose of the needle after each injection.</dd>\n<dt> </dt>\n<dd>For further information about safe sharps disposal, see <span class=\"Bold\">Frequently Asked Questions</span>.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id835350278\"></a><img alt=\"10mg-r\" src=\"/dailymed/image.cfm?name=10mg-r.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-666162644\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-06.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Do not try to put the needle cap back on</span>. You may stick yourself with the needle.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</dd>\n<dt> </dt>\n<dd>See <span class=\"Bold\">“How should I store Norditropin?”.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1765373586\"></a><img alt=\"10mg-s\" src=\"/dailymed/image.cfm?name=10mg-s.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-217133488\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-07.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">How should I store Norditropin?</span>\n</dd>\n</dl>\n<p class=\"First\">•<span class=\"Bold\">Before you use Norditropin FlexPro pens for the first time: </span>\n</p>\n<dl>\n<dt>o</dt>\n<dd>Store your new, unused <span class=\"Bold\">Norditropin</span> pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). </dd>\n<dt>o</dt>\n<dd>Do not freeze <span class=\"Bold\">Norditropin</span>. </dd>\n<dt>o</dt>\n<dd>When stored in the refrigerator, do not store <span class=\"Bold\">Norditropin</span> directly next to the cooling element.</dd>\n<dt>o</dt>\n<dd>Keep <span class=\"Bold\">Norditropin</span> away from direct light.</dd>\n<dt>o</dt>\n<dd>Do not use <span class=\"Bold\">Norditropin</span> that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd>\n<dt>o</dt>\n<dd>Do not use <span class=\"Bold\">Norditropin</span> after the expiration date printed on the carton and the pen.</dd>\n</dl>\n<p>•<span class=\"Bold\">After you use Norditropin FlexPro pens and there is still medicine left: </span>\n</p>\n<dl>\n<dt>o</dt>\n<dd>Store remaining <span class=\"Bold\">Norditropin</span> in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd>\n<dt>o</dt>\n<dd>Store remaining <span class=\"Bold\">Norditropin </span>at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Keep Norditropin and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Frequently Asked Questions</span>\n</p>\n<p>\n<span class=\"Bold\">How do I see how </span>\n</p>\n<p>\n<span class=\"Bold\">much Norditropin is </span>\n</p>\n<p>\n<span class=\"Bold\">left in my Pen?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-796533184\"></a><img alt=\"10mg-t\" src=\"/dailymed/image.cfm?name=10mg-t.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 4.0 mg. If the dose counter stops with the dose pointer lined up with “4.0”, at least 4.0 mg are left in your Pen. </p>\n<p>If the dose counter stops with the dose pointer lined up with “2.4”, only 2.4 mg are left in your Pen. See figure U.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2070918056\"></a><img alt=\"10mg-u\" src=\"/dailymed/image.cfm?name=10mg-u.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if I need a larger dose than what is left in my Pen? </span>\n</p>\n<p>It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen.</p>\n<p>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <span class=\"Bold\">Only split your dose if you have been trained or advised by your healthcare provider on how to do this.</span> You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</p>\n<p>\n<span class=\"Bold\">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</span>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if no Norditropin appears when I check the flow?</span>\n</p>\n<p>\n<span class=\"Bold\">A. Your needle may be blocked or damaged</span>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</p>\n<p>\n<span class=\"Bold\">B. Your Pen may be defective</span>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if “0” does not appear after completing my injection?</span>\n</p>\n<p>The needle may be blocked or damaged, and <span class=\"Bold\">you have not received any Norditropin</span> – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</p>\n<p>If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take care of my Pen?</span>\n</p>\n<p>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</p>\n<p>See <span class=\"Bold\">“How should I store Norditropin?”. </span>\n</p>\n<p>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “<span class=\"Bold\">How do I dispose of used needles and Pens?</span>”.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Frequently Asked Questions</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if I drop my Pen?</span>\n</p>\n<p>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I clean my Pen?</span>\n</p>\n<p>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I dispose of used needles and Pens?</span>\n</p>\n<p>Put your used needles in an FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not throw away (dispose of) loose needles in your household trash</span>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </p>\n<p>•\tmade of a heavy-duty plastic, </p>\n<dl>\n<dt> </dt>\n<dd>•\tcan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </dd>\n</dl>\n<p>•\tupright and stable during use, </p>\n<p>•\tleak-resistant, and </p>\n<p>•\tproperly labeled to warn of hazardous waste inside the container.</p>\n<p>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. <br/>\n</p>\n<p>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</p>\n<p>Do not recycle your used sharps disposal container.</p>\n<p>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-1174715696\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-08.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Important information</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Caregivers must <span class=\"Bold\">be very careful when handling needles</span> to reduce the risk of needle sticks and infection.</dd>\n<dt>•</dt>\n<dd>Norditropin<span class=\"Sup\">®</span> FlexPro<span class=\"Sup\">®</span> 10 mg/1.5 mL Pen <span class=\"Bold\">is compatible with FlexPro<span class=\"Sup\">®</span> PenMate<span class=\"Sup\">®</span>.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id-1504582640\"></a><img alt=\"10mg images-phone-qrcode.\" src=\"/dailymed/image.cfm?name=phone-qrcode.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>\n<span class=\"Italics\">Norditropin</span><span class=\"Sup\">®</span> and <span class=\"Italics\">FlexPro</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> are registered trademarks of Novo Nordisk Health Care AG.</p>\n<p>\n<span class=\"Italics\">Novo Nordisk</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> and <span class=\"Italics\">PenMate</span><span class=\"Bold\"><span class=\"Sup\">® </span></span>are registered trademarks of Novo Nordisk A/S.</p>\n<p>PATENT Information: <a href=\"http://novonordisk-us.com/products/product-patents.html\">http://novonordisk-us.com/products/product-patents.html</a>\n</p>\n<p>Manufactured by:</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road</p>\n<p>Plainsboro, NJ 08536 USA</p>\n<p>U.S. License No. 1261</p>\n<p>For information about NORDITROPIN<span class=\"Sup\">®</span>\n</p>\n<p>Visit: norditropin.com</p>\n<p>Or call: 1 (888) 668-6444</p>\n<p>Revised: 01/2025</p>\n<p>© 2025 Novo Nordisk A/S</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

INSTRUCTIONS FOR USENORDITROPIN® [nor-dee-tro-pin](somatropin)injection, for subcutaneous use15mg

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USENORDITROPIN® [nor-dee-tro-pin](somatropin)injection, for subcutaneous use15mg" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><a name="id260115962"></a><img alt="15mg-overview" src="/dailymed/image.cfm?name=15mg-overview.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id-238943898"></a><img alt="15mg-example" src="/dailymed/image.cfm?name=15mg-example.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">Norditropin FlexPro Pen is for single-patient-use only.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Supplies you will need:</span> </p> <dl> <dt>•</dt> <dd>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm </dd> <dt>•</dt> <dd>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</dd> <dt>•</dt> <dd>alcohol pad</dd> <dt>•</dt> <dd>gauze pad</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1279335656"></a><img alt="15mg-supplies" src="/dailymed/image.cfm?name=15mg-supplies.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How to use your Norditropin FlexPro Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">5 steps you should follow for a Norditropin injection:</span> </p> <dl> <dt> </dt> <dd>Step 1: Prepare your Norditropin FlexPro Pen </dd> <dt> </dt> <dd>Step 2: Check the Norditropin flow with each new Pen </dd> <dt> </dt> <dd>Step 3: Select your dose</dd> <dt> </dt> <dd>Step 4: Inject your dose</dd> <dt> </dt> <dd>Step 5: After your injection</dd> </dl> <p> <span class="Bold">For further information about your Pen see:</span> </p> <dl> <dt> </dt> <dd>Frequently Asked Questions</dd> <dt> </dt> <dd>Important information</dd> <dt> </dt> <dd>Patient Information </dd> </dl> <p> <a name="id-1909449222"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-09.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Important information</span> </p> <p>Make sure that you read this information carefully.</p> <p> <a name="id1083576438"></a><img alt="info" src="/dailymed/image.cfm?name=info-22.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Additional information</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">Norditropin is for use under the skin only (subcutaneous).</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Do not</span> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </p> <p> <span class="Bold">Do not use your Pen without proper training from your healthcare provider</span>. </p> <p>Make sure that you are confident in giving an injection with the Pen before you start your treatment. </p> <p>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1. Prepare your Norditropin FlexPro Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Wash your hands with soap and water. </dd> <dt>•</dt> <dd> <span class="Bold">Check the name, strength, and colored label </span>on your Pen to make sure that it contains Norditropin in the right strength. </dd> <dt>•</dt> <dd>Pull off the Pen cap. </dd> <dt>•</dt> <dd>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</dd> <dt>•</dt> <dd>See figure A. <span class="Bold">If the Norditropin looks cloudy, do not use the Pen.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-617599951"></a><img alt="15mg-a" src="/dailymed/image.cfm?name=15mg-a.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </dd> <dt>•</dt> <dd>Push the needle straight onto the Pen. Turn the needle clockwise <span class="Bold">until it is on tight</span>. See figure B.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id203768889"></a><img alt="15mg-b" src="/dailymed/image.cfm?name=15mg-b.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-1667928245"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-10.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the outer needle cap and <span class="Bold">dispose of it</span>. See figure C.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2008433805"></a><img alt="15mg-c" src="/dailymed/image.cfm?name=15mg-c.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the inner needle cap and dispose of it. See figure D.</dd> <dt> </dt> <dd> <a name="id-294919016"></a><img alt="info" src="/dailymed/image.cfm?name=info-23.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-611982190"></a><img alt="15mg-d" src="/dailymed/image.cfm?name=15mg-d.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id1345820290"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-11.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Never use a bent or damaged needle</span>.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2. Check the Norditropin flow with each new Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id-162862457"></a><img alt="info" src="/dailymed/image.cfm?name=info-24.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If your Pen is already in use</span>, go to step 3.</dd> <dt> </dt> <dd> <span class="Bold">Before using a new Pen</span>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</dd> <dt>•</dt> <dd>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint “click” when you turn the dose selector. See figure E.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id200983904"></a><img alt="15mg-e" src="/dailymed/image.cfm?name=15mg-e.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">1 marking on the dose counter equals 0.1 mg</span>. See figure F.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id85427497"></a><img alt="15mg-f" src="/dailymed/image.cfm?name=15mg-f.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. <span class="Bold">The “0” must line up with the dose pointer</span>. See figure G.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1080332586"></a><img alt="15mg-g" src="/dailymed/image.cfm?name=15mg-g.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check that a drop of Norditropin appears at the needle tip. See figure H.</dd> <dt> </dt> <dd> <a name="id825247375"></a><img alt="info" src="/dailymed/image.cfm?name=info-25.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If no Norditropin appears</span>, repeat step 2 up to 6 times.</dd> </dl> <p class="First">If you still do not see a drop of Norditropin, <span class="Bold">change the needle:</span> </p> <dl> <dt>•</dt> <dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</dd> <dt>•</dt> <dd>And repeat step 2 again.</dd> <dt> </dt> <dd> <span class="Bold">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </span> </dd> <dt> </dt> <dd> <span class="Bold">1-888-668-6444 for help.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2113012975"></a><img alt="15mg-h" src="/dailymed/image.cfm?name=15mg-h.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 3. Select your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>To start, check that the dose pointer is set at <span class="Bold">“0”.</span> </dd> <dt>•</dt> <dd>When you have selected your dose, you can go to step 4. </dd> <dt> </dt> <dd> <a name="id-1885632805"></a><img alt="info" src="/dailymed/image.cfm?name=info-26.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If there is not enough Norditropin left </span>to select a full dose, see <span class="Bold">Frequently Asked Questions</span><span class="Italics">.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id185570163"></a><img alt="15mg-i" src="/dailymed/image.cfm?name=15mg-i.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id401184343"></a><img alt="info" src="/dailymed/image.cfm?name=info-27.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>The dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose<span class="Bold">. Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose.</span><span class="Bold">Only the dose pointer on the dose counter will show the exact dose selected.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-314567994"></a><img alt="15mg-j" src="/dailymed/image.cfm?name=15mg-j.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2091002338"></a><img alt="15mg-k" src="/dailymed/image.cfm?name=15mg-k.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id932716218"></a><img alt="info" src="/dailymed/image.cfm?name=info-28.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</dd> <dt> </dt> <dd>The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1556152270"></a><img alt="15mg-l" src="/dailymed/image.cfm?name=15mg-l.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 4. Inject your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Select the injection site.</dd> <dt>•</dt> <dd>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day.</dd> <dt>•</dt> <dd>Wipe the injection site with an alcohol swab and let the area dry</dd> <dt>•</dt> <dd>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</dd> <dt> </dt> <dd>Make sure you can see the dose counter. <span class="Bold">Do not cover it with your fingers</span>. This could block the injection. </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-665329626"></a><img alt="15mg-m" src="/dailymed/image.cfm?name=15mg-m.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Press and hold down the dose button until the dose counter shows “0”. See figure N. <span class="Bold">The “0” must line up with the dose pointer</span>. You may then hear or feel a “click”. </dd> <dt>•</dt> <dd> <span class="Bold">Continue to hold the needle in your skin. </span> </dd> <dt> </dt> <dd> <a name="id737523168"></a><img alt="info" src="/dailymed/image.cfm?name=info-29.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <span class="Bold">Frequently Asked Questions</span>.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id837357766"></a><img alt="15mg-n" src="/dailymed/image.cfm?name=15mg-n.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Keep the needle in your skin</span> after the dose counter has returned to “0”. <span class="Bold">Count slowly to 6</span> to ensure that the full dose has been delivered. See figure O.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-548152986"></a><img alt="15mg-o" src="/dailymed/image.cfm?name=15mg-o.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd> <dt> </dt> <dd> <a name="id2084873713"></a><img alt="info" src="/dailymed/image.cfm?name=info-30.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1152285710"></a><img alt="15mg-p" src="/dailymed/image.cfm?name=15mg-p.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 5. After your injection</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1526390651"></a><img alt="15mg-q" src="/dailymed/image.cfm?name=15mg-q.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</dd> <dt> </dt> <dd> <a name="id1430845178"></a><img alt="info" src="/dailymed/image.cfm?name=info-31.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>Always dispose of the needle after each injection.</dd> <dt> </dt> <dd>For further information about safe sharps disposal, see <span class="Bold">Frequently Asked Questions</span>.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1604835374"></a><img alt="15mg-r" src="/dailymed/image.cfm?name=15mg-r.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-925193008"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-12.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Do not try to put the needle cap back on</span>. You may stick yourself with the needle.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</dd> <dt> </dt> <dd>See <span class="Bold">“How should I store Norditropin?”.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1289706143"></a><img alt="15mg-s" src="/dailymed/image.cfm?name=15mg-s.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id464476158"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-13.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd> <dt> </dt> <dd> <span class="Bold">How should I store Norditropin?</span> </dd> </dl> <p class="First">•<span class="Bold">Before you use Norditropin FlexPro pens for the first time: </span> </p> <dl> <dt>o</dt> <dd>Store your new, unused <span class="Bold">Norditropin</span> pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).</dd> <dt>o</dt> <dd>Do not freeze Norditropin. </dd> <dt>o</dt> <dd>When stored in the refrigerator, do not store <span class="Bold">Norditropin</span> directly next to the cooling element.</dd> <dt>o</dt> <dd>Keep <span class="Bold">Norditropin</span> away from direct light.</dd> <dt>o</dt> <dd>Do not use <span class="Bold">Norditropin</span> that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd> <dt>o</dt> <dd>Do not use <span class="Bold">Norditropin</span> after the expiration date printed on the carton and the pen.</dd> <dt> </dt> <dd>•<span class="Bold">After you use Norditropin FlexPro pens and there is still medicine left: </span> </dd> <dt>o</dt> <dd>Store remaining <span class="Bold">Norditropin</span> in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd> <dt>o</dt> <dd>Store remaining <span class="Bold">Norditropin</span> at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. </dd> </dl> <p> <span class="Bold">Keep Norditropin and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Frequently Asked Questions</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I see how </span> </p> <p> <span class="Bold">much Norditropin is </span> </p> <p> <span class="Bold">left in my Pen?</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1037275073"></a><img alt="15mg-t" src="/dailymed/image.cfm?name=15mg-t.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with “8.0”, at least 8.0 mg are left in your Pen.</p> <p>If the dose counter stops with the dose pointer lined up with “3.8”, only 3.8 mg are left in your Pen. See figure U.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2018417270"></a><img alt="15mg-u" src="/dailymed/image.cfm?name=15mg-u.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if I need a larger dose than what is left in my Pen? </span> </p> <p>It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen.</p> <p>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <span class="Bold">Only split your dose if you have been trained or advised by your healthcare provider on how to do this.</span> You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</p> <p> <span class="Bold">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</span>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if no Norditropin appears when I check the flow?</span> </p> <p> <span class="Bold">A. Your needle may be blocked or damaged</span>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</p> <p> <span class="Bold">B. Your Pen may be defective</span>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if “0” does not appear after completing my injection?</span> </p> <p>The needle may be blocked or damaged, and <span class="Bold">you have not received any Norditropin</span> – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</p> <p>If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I take care of my Pen?</span> </p> <p>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</p> <p>See “<span class="Bold">How should I store Norditropin?”. </span> </p> <p>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “<span class="Bold">How do I dispose of used needles and Pens?</span>”.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Frequently Asked Questions</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if I drop my Pen?</span> </p> <p>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I clean my Pen?</span> </p> <p>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I dispose of used needles and Pens?</span> </p> <p>Put your used needles in an FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not throw away (dispose of) loose needles in your household trash</span>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </p> <p>• made of a heavy-duty plastic, </p> <dl> <dt> </dt> <dd>• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </dd> </dl> <p>• upright and stable during use, </p> <p>• leak-resistant, and </p> <p>• properly labeled to warn of hazardous waste inside the container.</p> <p>When your sharps disposal container is almost full, you will need to<span class="Underline"></span>follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: <a href="http://www.fda.gov/safesharpsdisposal">http://www.fda.gov/safesharpsdisposal</a>.</p> <p>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</p> <p>Do not recycle your used sharps disposal container.</p> <p>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id1290777661"></a><img alt="info" src="/dailymed/image.cfm?name=info-32.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Important information</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Caregivers must <span class="Bold">be very careful when handling needles</span> to reduce the risk of needle sticks and infection.</dd> <dt>•</dt> <dd>Norditropin<span class="Sup">®</span> FlexPro<span class="Sup">®</span> 15 mg/1.5 mL Pen <span class="Bold">is compatible with FlexPro<span class="Sup">®</span> PenMate<span class="Sup">®</span>.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id227658921"></a><img alt="15mg-phone-qrcode" src="/dailymed/image.cfm?name=15mg-phone-qrcode.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><p class="First">www.norditropin.com</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p> <span class="Italics">Norditropin</span><span class="Sup">®</span> and <span class="Italics">FlexPro</span><span class="Bold"><span class="Sup">®</span></span> are registered trademarks of Novo Nordisk Health Care AG.</p> <p> <span class="Italics">Novo Nordisk</span><span class="Bold"><span class="Sup">®</span></span> and <span class="Italics">PenMate</span><span class="Bold"><span class="Sup">® </span></span>are registered trademarks of Novo Nordisk A/S.</p> <p>PATENT Information: http://novonordisk-us.com/products/product-patents.html</p> <p>Manufactured by:</p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road</p> <p>Plainsboro, NJ 08536 </p> <p>U.S. License No. 1261</p> <p>For information about NORDITROPIN<span class="Sup">®</span> </p> <p>Visit: norditropin.com</p> <p>Or call: 1 (888) 668-6444</p> <p>Revised: 01/2025</p> <p>© 2025 Novo Nordisk A/S</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><a name=\"id260115962\"></a><img alt=\"15mg-overview\" src=\"/dailymed/image.cfm?name=15mg-overview.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id-238943898\"></a><img alt=\"15mg-example\" src=\"/dailymed/image.cfm?name=15mg-example.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Norditropin FlexPro Pen is for single-patient-use only.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Supplies you will need:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm </dd>\n<dt>•</dt>\n<dd>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</dd>\n<dt>•</dt>\n<dd>alcohol pad</dd>\n<dt>•</dt>\n<dd>gauze pad</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1279335656\"></a><img alt=\"15mg-supplies\" src=\"/dailymed/image.cfm?name=15mg-supplies.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How to use your Norditropin FlexPro Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">5 steps you should follow for a Norditropin injection:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>Step 1: Prepare your Norditropin FlexPro Pen </dd>\n<dt> </dt>\n<dd>Step 2: Check the Norditropin flow with each new Pen </dd>\n<dt> </dt>\n<dd>Step 3: Select your dose</dd>\n<dt> </dt>\n<dd>Step 4: Inject your dose</dd>\n<dt> </dt>\n<dd>Step 5: After your injection</dd>\n</dl>\n<p>\n<span class=\"Bold\">For further information about your Pen see:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>Frequently Asked Questions</dd>\n<dt> </dt>\n<dd>Important information</dd>\n<dt> </dt>\n<dd>Patient Information </dd>\n</dl>\n<p>\n<a name=\"id-1909449222\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-09.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Important information</span>\n</p>\n<p>Make sure that you read this information carefully.</p>\n<p>\n<a name=\"id1083576438\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-22.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Additional information</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Norditropin is for use under the skin only (subcutaneous).</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not</span> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </p>\n<p>\n<span class=\"Bold\">Do not use your Pen without proper training from your healthcare provider</span>. </p>\n<p>Make sure that you are confident in giving an injection with the Pen before you start your treatment. </p>\n<p>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 1. Prepare your Norditropin FlexPro Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Wash your hands with soap and water. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check the name, strength, and colored label </span>on your Pen to make sure that it contains Norditropin in the right strength. </dd>\n<dt>•</dt>\n<dd>Pull off the Pen cap. </dd>\n<dt>•</dt>\n<dd>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</dd>\n<dt>•</dt>\n<dd>See figure A. <span class=\"Bold\">If the Norditropin looks cloudy, do not use the Pen.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-617599951\"></a><img alt=\"15mg-a\" src=\"/dailymed/image.cfm?name=15mg-a.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </dd>\n<dt>•</dt>\n<dd>Push the needle straight onto the Pen. Turn the needle clockwise <span class=\"Bold\">until it is on tight</span>. See figure B.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id203768889\"></a><img alt=\"15mg-b\" src=\"/dailymed/image.cfm?name=15mg-b.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-1667928245\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-10.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Pull off the outer needle cap and <span class=\"Bold\">dispose of it</span>. See figure C.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2008433805\"></a><img alt=\"15mg-c\" src=\"/dailymed/image.cfm?name=15mg-c.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Pull off the inner needle cap and dispose of it. See figure D.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-294919016\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-23.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-611982190\"></a><img alt=\"15mg-d\" src=\"/dailymed/image.cfm?name=15mg-d.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id1345820290\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-11.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Never use a bent or damaged needle</span>.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2. Check the Norditropin flow with each new Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-162862457\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-24.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If your Pen is already in use</span>, go to step 3.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Before using a new Pen</span>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</dd>\n<dt>•</dt>\n<dd>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint “click” when you turn the dose selector. See figure E.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id200983904\"></a><img alt=\"15mg-e\" src=\"/dailymed/image.cfm?name=15mg-e.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">1 marking on the dose counter equals 0.1 mg</span>. See figure F.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id85427497\"></a><img alt=\"15mg-f\" src=\"/dailymed/image.cfm?name=15mg-f.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. <span class=\"Bold\">The “0” must line up with the dose pointer</span>. See figure G.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1080332586\"></a><img alt=\"15mg-g\" src=\"/dailymed/image.cfm?name=15mg-g.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Check that a drop of Norditropin appears at the needle tip. See figure H.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id825247375\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-25.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If no Norditropin appears</span>, repeat step 2 up to 6 times.</dd>\n</dl>\n<p class=\"First\">If you still do not see a drop of Norditropin, <span class=\"Bold\">change the needle:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</dd>\n<dt>•</dt>\n<dd>And repeat step 2 again.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </span>\n</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">1-888-668-6444 for help.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2113012975\"></a><img alt=\"15mg-h\" src=\"/dailymed/image.cfm?name=15mg-h.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. Select your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>To start, check that the dose pointer is set at <span class=\"Bold\">“0”.</span>\n</dd>\n<dt>•</dt>\n<dd>When you have selected your dose, you can go to step 4. </dd>\n<dt> </dt>\n<dd>\n<a name=\"id-1885632805\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-26.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If there is not enough Norditropin left </span>to select a full dose, see <span class=\"Bold\">Frequently Asked Questions</span><span class=\"Italics\">.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id185570163\"></a><img alt=\"15mg-i\" src=\"/dailymed/image.cfm?name=15mg-i.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id401184343\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-27.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>The dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose<span class=\"Bold\">. Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose.</span><span class=\"Bold\">Only the dose pointer on the dose counter will show the exact dose selected.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-314567994\"></a><img alt=\"15mg-j\" src=\"/dailymed/image.cfm?name=15mg-j.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2091002338\"></a><img alt=\"15mg-k\" src=\"/dailymed/image.cfm?name=15mg-k.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id932716218\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-28.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</dd>\n<dt> </dt>\n<dd>The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1556152270\"></a><img alt=\"15mg-l\" src=\"/dailymed/image.cfm?name=15mg-l.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4. Inject your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Select the injection site.</dd>\n<dt>•</dt>\n<dd>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day.</dd>\n<dt>•</dt>\n<dd>Wipe the injection site with an alcohol swab and let the area dry</dd>\n<dt>•</dt>\n<dd>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</dd>\n<dt> </dt>\n<dd>Make sure you can see the dose counter. <span class=\"Bold\">Do not cover it with your fingers</span>. This could block the injection. </dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-665329626\"></a><img alt=\"15mg-m\" src=\"/dailymed/image.cfm?name=15mg-m.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Press and hold down the dose button until the dose counter shows “0”. See figure N. <span class=\"Bold\">The “0” must line up with the dose pointer</span>. You may then hear or feel a “click”. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Continue to hold the needle in your skin. </span>\n</dd>\n<dt> </dt>\n<dd>\n<a name=\"id737523168\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-29.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <span class=\"Bold\">Frequently Asked Questions</span>.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id837357766\"></a><img alt=\"15mg-n\" src=\"/dailymed/image.cfm?name=15mg-n.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep the needle in your skin</span> after the dose counter has returned to “0”. <span class=\"Bold\">Count slowly to 6</span> to ensure that the full dose has been delivered. See figure O.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-548152986\"></a><img alt=\"15mg-o\" src=\"/dailymed/image.cfm?name=15mg-o.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id2084873713\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-30.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1152285710\"></a><img alt=\"15mg-p\" src=\"/dailymed/image.cfm?name=15mg-p.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5. After your injection</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1526390651\"></a><img alt=\"15mg-q\" src=\"/dailymed/image.cfm?name=15mg-q.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id1430845178\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-31.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>Always dispose of the needle after each injection.</dd>\n<dt> </dt>\n<dd>For further information about safe sharps disposal, see <span class=\"Bold\">Frequently Asked Questions</span>.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1604835374\"></a><img alt=\"15mg-r\" src=\"/dailymed/image.cfm?name=15mg-r.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-925193008\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-12.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Do not try to put the needle cap back on</span>. You may stick yourself with the needle.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</dd>\n<dt> </dt>\n<dd>See <span class=\"Bold\">“How should I store Norditropin?”.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1289706143\"></a><img alt=\"15mg-s\" src=\"/dailymed/image.cfm?name=15mg-s.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id464476158\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-13.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">How should I store Norditropin?</span>\n</dd>\n</dl>\n<p class=\"First\">•<span class=\"Bold\">Before you use Norditropin FlexPro pens for the first time: </span>\n</p>\n<dl>\n<dt>o</dt>\n<dd>Store your new, unused <span class=\"Bold\">Norditropin</span> pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).</dd>\n<dt>o</dt>\n<dd>Do not freeze Norditropin. </dd>\n<dt>o</dt>\n<dd>When stored in the refrigerator, do not store <span class=\"Bold\">Norditropin</span> directly next to the cooling element.</dd>\n<dt>o</dt>\n<dd>Keep <span class=\"Bold\">Norditropin</span> away from direct light.</dd>\n<dt>o</dt>\n<dd>Do not use <span class=\"Bold\">Norditropin</span> that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd>\n<dt>o</dt>\n<dd>Do not use <span class=\"Bold\">Norditropin</span> after the expiration date printed on the carton and the pen.</dd>\n<dt> </dt>\n<dd>•<span class=\"Bold\">After you use Norditropin FlexPro pens and there is still medicine left: </span>\n</dd>\n<dt>o</dt>\n<dd>Store remaining <span class=\"Bold\">Norditropin</span> in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd>\n<dt>o</dt>\n<dd>Store remaining <span class=\"Bold\">Norditropin</span> at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. </dd>\n</dl>\n<p>\n<span class=\"Bold\">Keep Norditropin and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Frequently Asked Questions</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I see how </span>\n</p>\n<p>\n<span class=\"Bold\">much Norditropin is </span>\n</p>\n<p>\n<span class=\"Bold\">left in my Pen?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1037275073\"></a><img alt=\"15mg-t\" src=\"/dailymed/image.cfm?name=15mg-t.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with “8.0”, at least 8.0 mg are left in your Pen.</p>\n<p>If the dose counter stops with the dose pointer lined up with “3.8”, only 3.8 mg are left in your Pen. See figure U.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2018417270\"></a><img alt=\"15mg-u\" src=\"/dailymed/image.cfm?name=15mg-u.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if I need a larger dose than what is left in my Pen? </span>\n</p>\n<p>It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen.</p>\n<p>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <span class=\"Bold\">Only split your dose if you have been trained or advised by your healthcare provider on how to do this.</span> You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</p>\n<p>\n<span class=\"Bold\">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</span>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if no Norditropin appears when I check the flow?</span>\n</p>\n<p>\n<span class=\"Bold\">A. Your needle may be blocked or damaged</span>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</p>\n<p>\n<span class=\"Bold\">B. Your Pen may be defective</span>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if “0” does not appear after completing my injection?</span>\n</p>\n<p>The needle may be blocked or damaged, and <span class=\"Bold\">you have not received any Norditropin</span> – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</p>\n<p>If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take care of my Pen?</span>\n</p>\n<p>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</p>\n<p>See “<span class=\"Bold\">How should I store Norditropin?”. </span>\n</p>\n<p>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “<span class=\"Bold\">How do I dispose of used needles and Pens?</span>”.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Frequently Asked Questions</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if I drop my Pen?</span>\n</p>\n<p>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I clean my Pen?</span>\n</p>\n<p>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I dispose of used needles and Pens?</span>\n</p>\n<p>Put your used needles in an FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not throw away (dispose of) loose needles in your household trash</span>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </p>\n<p>•\tmade of a heavy-duty plastic, </p>\n<dl>\n<dt> </dt>\n<dd>•\tcan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </dd>\n</dl>\n<p>•\tupright and stable during use, </p>\n<p>•\tleak-resistant, and </p>\n<p>•\tproperly labeled to warn of hazardous waste inside the container.</p>\n<p>When your sharps disposal container is almost full, you will need to<span class=\"Underline\"></span>follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: <a href=\"http://www.fda.gov/safesharpsdisposal\">http://www.fda.gov/safesharpsdisposal</a>.</p>\n<p>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</p>\n<p>Do not recycle your used sharps disposal container.</p>\n<p>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id1290777661\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-32.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Important information</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Caregivers must <span class=\"Bold\">be very careful when handling needles</span> to reduce the risk of needle sticks and infection.</dd>\n<dt>•</dt>\n<dd>Norditropin<span class=\"Sup\">®</span> FlexPro<span class=\"Sup\">®</span> 15 mg/1.5 mL Pen <span class=\"Bold\">is compatible with FlexPro<span class=\"Sup\">®</span> PenMate<span class=\"Sup\">®</span>.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id227658921\"></a><img alt=\"15mg-phone-qrcode\" src=\"/dailymed/image.cfm?name=15mg-phone-qrcode.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><p class=\"First\">www.norditropin.com</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>\n<span class=\"Italics\">Norditropin</span><span class=\"Sup\">®</span> and <span class=\"Italics\">FlexPro</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> are registered trademarks of Novo Nordisk Health Care AG.</p>\n<p>\n<span class=\"Italics\">Novo Nordisk</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> and <span class=\"Italics\">PenMate</span><span class=\"Bold\"><span class=\"Sup\">® </span></span>are registered trademarks of Novo Nordisk A/S.</p>\n<p>PATENT Information: http://novonordisk-us.com/products/product-patents.html</p>\n<p>Manufactured by:</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road</p>\n<p>Plainsboro, NJ 08536 </p>\n<p>U.S. License No. 1261</p>\n<p>For information about NORDITROPIN<span class=\"Sup\">®</span>\n</p>\n<p>Visit: norditropin.com</p>\n<p>Or call: 1 (888) 668-6444</p>\n<p>Revised: 01/2025</p>\n<p>© 2025 Novo Nordisk A/S</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

INSTRUCTIONS FOR USE

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USE\n" }

NORDETROPIN®[nor-dee-tro-pin](somatropin)injection, for subcutaneous use30mg

{ "type": "p", "children": [], "text": "\nNORDETROPIN®[nor-dee-tro-pin](somatropin)injection, for subcutaneous use30mg" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><a name="id-10913472"></a><img alt="30mg-overview" src="/dailymed/image.cfm?name=30mg-overview.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id-2071269716"></a><img alt="30mg-needle-example" src="/dailymed/image.cfm?name=30mg-needle-example.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">Norditropin FlexPro Pen is for single-patient-use only.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Supplies you will need:</span> </p> <dl> <dt>•</dt> <dd>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm</dd> <dt>•</dt> <dd>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</dd> <dt>•</dt> <dd>alcohol pad</dd> <dt>•</dt> <dd>gauze pad</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id215639427"></a><img alt="30mg-supplies" src="/dailymed/image.cfm?name=30mg-supplies.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How to use your Norditropin FlexPro Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">5 steps you should follow for a Norditropin injection:</span> </p> <dl> <dt> </dt> <dd>Step 1: Prepare your Norditropin FlexPro Pen </dd> <dt> </dt> <dd>Step 2: Check the Norditropin flow with each new Pen </dd> <dt> </dt> <dd>Step 3: Select your dose</dd> <dt> </dt> <dd>Step 4: Inject your dose</dd> <dt> </dt> <dd>Step 5: After your injection</dd> </dl> <p> <span class="Bold">For further information about your Pen see:</span> </p> <dl> <dt> </dt> <dd>Frequently Asked Questions</dd> <dt> </dt> <dd>Important information</dd> <dt> </dt> <dd>Patient Information</dd> <dt> </dt> <dd> <a name="id-768852807"></a><img alt="info" src="/dailymed/image.cfm?name=info-33.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Important information</span> </dd> <dt> </dt> <dd>Make sure that you read this information carefully.</dd> </dl> <p> <a name="id987906099"></a><img alt="info" src="/dailymed/image.cfm?name=info-34.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Additional information</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">Norditropin is for use under the skin only (subcutaneous). </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Do not</span> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </p> <p> <span class="Bold">Do not use your Pen without proper training from your healthcare provider</span>. </p> <p>Make sure that you are confident in giving an injection with the Pen before you start your treatment. </p> <p>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1. Prepare your Norditropin FlexPro Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Wash your hands with soap and water.</dd> <dt>•</dt> <dd> <span class="Bold">Check the name, strength, and colored label </span>on your Pen to make sure that it contains Norditropin in the right strength.</dd> <dt>•</dt> <dd>Pull off the Pen cap.</dd> <dt>•</dt> <dd>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</dd> <dt> </dt> <dd>See figure A. <span class="Bold">If the Norditropin looks cloudy, do not use the Pen.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1201469679"></a><img alt="30mg-a" src="/dailymed/image.cfm?name=30mg-a.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>When you are ready to give your injection, take a new disposable needle, and remove the paper tab.</dd> <dt>•</dt> <dd>Push the needle straight onto the Pen. Turn the needle clockwise <span class="Bold">until it is on tight</span>. See figure B.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1015065117"></a><img alt="30mg-b" src="/dailymed/image.cfm?name=30mg-b.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id1897399488"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-14.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the outer needle cap and <span class="Bold">dispose of it</span>. See figure C.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1246610432"></a><img alt="30mg-c" src="/dailymed/image.cfm?name=30mg-c.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-868678666"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-15.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Never use a bent or damaged needle.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2. Check the Norditropin flow with each new Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id-527793618"></a><img alt="info" src="/dailymed/image.cfm?name=info-35.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If your Pen is already in use</span>, go to step 3.</dd> <dt> </dt> <dd> <span class="Bold">Before using a new Pen</span>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</dd> <dt>•</dt> <dd>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint “click” when you turn the dose selector. See figure E.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2017883406"></a><img alt="30mg-e" src="/dailymed/image.cfm?name=30mg-e.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">1 marking on the dose counter equals 0.1 mg</span>. See figure F.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1668361742"></a><img alt="30mg-f" src="/dailymed/image.cfm?name=30mg-f.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. <span class="Bold">The “0” must line up with the dose pointer</span>. See figure G.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id845368041"></a><img alt="30mg-g" src="/dailymed/image.cfm?name=30mg-g.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check that a drop of Norditropin appears at the needle tip. See figure H.</dd> <dt> </dt> <dd> <a name="id-1191373512"></a><img alt="info" src="/dailymed/image.cfm?name=info-36.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">If no Norditropin appears</span>, repeat step 2 up to 6 times.</dd> </dl> <p class="First">If you still do not see a drop of Norditropin, <span class="Bold">change the needle:</span> </p> <dl> <dt>•</dt> <dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</dd> <dt>•</dt> <dd>and repeat step 2 again</dd> <dt> </dt> <dd> <span class="Bold">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </span> </dd> <dt> </dt> <dd> <span class="Bold">1-888-668-6444 for help.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-482464315"></a><img alt="30mg-h" src="/dailymed/image.cfm?name=30mg-h.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 3. Select your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>To start, check that the dose pointer is set at <span class="Bold">“0”.</span> </dd> <dt>•</dt> <dd>Turn the dose selector clockwise to select the dose you need. See figure I.<p class="First">When you have selected your dose, you can go to step 4.</p> </dd> <dt> </dt> <dd> <a name="id-1839297259"></a><img alt="info" src="/dailymed/image.cfm?name=info-37.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>I<span class="Bold">f there is not enough Norditropin left </span>to select a full dose, see <span class="Bold">Frequently Asked Questions</span><span class="Italics">.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1989699225"></a><img alt="30mg-i" src="/dailymed/image.cfm?name=30mg-i.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id-2133846140"></a><img alt="info" src="/dailymed/image.cfm?name=info-38.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>The dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose<span class="Bold">. Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2060130231"></a><img alt="30mg-j" src="/dailymed/image.cfm?name=30mg-j.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id506325649"></a><img alt="30mg-k" src="/dailymed/image.cfm?name=30mg-k.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <a name="id1704216411"></a><img alt="info" src="/dailymed/image.cfm?name=info-39.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</dd> <dt> </dt> <dd>The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id647861705"></a><img alt="30mg-l" src="/dailymed/image.cfm?name=30mg-l.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 4. Inject your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Select the injection site.</dd> <dt>•</dt> <dd>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day.</dd> <dt>•</dt> <dd>Wipe the injection site with an alcohol swab and let the area dry.</dd> <dt>•</dt> <dd>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</dd> <dt> </dt> <dd>Make sure you can see the dose counter. <span class="Bold">Do not cover it with your fingers</span>. This could block the injection.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1669398985"></a><img alt="30mg-m" src="/dailymed/image.cfm?name=30mg-m.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Press and hold down the dose button until the dose counter shows “0”. See figure N. <span class="Bold">The “0” must line up with the dose pointer</span>. You may then hear or feel a “click”.</dd> <dt>•</dt> <dd> <span class="Bold">Continue to hold the needle in your skin.</span> </dd> <dt> </dt> <dd> <a name="id118880492"></a><img alt="info" src="/dailymed/image.cfm?name=info-40.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <span class="Bold">Frequently Asked Questions</span>.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-92021422"></a><img alt="30mg-n" src="/dailymed/image.cfm?name=30mg-n.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Keep the needle in your skin</span> after the dose counter has returned to “0”. <span class="Bold">Count slowly to 6</span> to ensure that the full dose has been delivered. See figure O.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id656958973"></a><img alt="30mg-o." src="/dailymed/image.cfm?name=30mg-o.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd> <dt> </dt> <dd> <a name="id1530370635"></a><img alt="info" src="/dailymed/image.cfm?name=info-41.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-891878015"></a><img alt="30mg-p" src="/dailymed/image.cfm?name=30mg-p.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 5. After your injection</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2013827780"></a><img alt="30mg-q" src="/dailymed/image.cfm?name=30mg-q.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</dd> <dt> </dt> <dd> <a name="id-598327460"></a><img alt="info" src="/dailymed/image.cfm?name=info-42.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>Always dispose of the needle after each injection.</dd> <dt> </dt> <dd>For further information about safe sharps disposal, see <span class="Bold">Frequently Asked Questions</span>.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1236318319"></a><img alt="30mg-r" src="/dailymed/image.cfm?name=30mg-r.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id785773873"></a><img alt="alert" src="/dailymed/image.cfm?name=alert-16.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><span class="Bold">Do not try to put the needle cap back on</span>. You may stick yourself with the needle.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</dd> <dt> </dt> <dd>See <span class="Bold">“How should I store Norditropin?”.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-417178495"></a><img alt="30mg-s" src="/dailymed/image.cfm?name=30mg-s.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id1389686473"></a><img alt="info" src="/dailymed/image.cfm?name=info-43.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd> <dt> </dt> <dd> <span class="Bold">How should I store Norditropin?</span> </dd> <dt> </dt> <dd>•<span class="Bold">Before you use Norditropin FlexPro pens for the first time: </span> </dd> <dt>o</dt> <dd>Store your new, unused <span class="Bold">Norditropin</span> pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). </dd> <dt>o</dt> <dd>Do not freeze <span class="Bold">Norditropin</span>. </dd> <dt>o</dt> <dd>When stored in the refrigerator, do not store <span class="Bold">Norditropin</span> directly next to the cooling element.</dd> <dt>o</dt> <dd>Keep <span class="Bold">Norditropin</span> away from direct light.</dd> <dt>o</dt> <dd>Do not use <span class="Bold">Norditropin</span> that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd> <dt>o</dt> <dd>Do not use <span class="Bold">Norditropin</span> after the expiration date printed on the carton and the pen.</dd> <dt> </dt> <dd>•<span class="Bold">After you use Norditropin FlexPro pens and there is still medicine left: </span> </dd> <dt>o</dt> <dd>Store remaining <span class="Bold">Norditropin</span> in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd> <dt>o</dt> <dd>Store remaining <span class="Bold">Norditropin</span> at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.</dd> <dt> </dt> <dd> <span class="Bold">Keep Norditropin and all medicines out of the reach of children.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Frequently Asked Questions</span> </p> <p> <span class="Bold">How do I see how </span> </p> <p> <span class="Bold">much Norditropin is </span> </p> <dl> <dt> </dt> <dd> <span class="Bold">left in my Pen?</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1719657317"></a><img alt="30mg-t" src="/dailymed/image.cfm?name=30mg-t.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with “8.0”, at least 8.0 mg are left in your Pen. </p> <p>If the dose counter stops with the dose pointer lined up with “3.8”, only 3.8 mg are left in your Pen. See figure U.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1174331466"></a><img alt="30mg-u" src="/dailymed/image.cfm?name=30mg-u.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if I need a larger dose than what is left in my Pen? </span> </p> <p>It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen.</p> <p>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <span class="Bold">Only split your dose if you have been trained or advised by your healthcare provider on how to do this. </span>You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</p> <p> <span class="Bold">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</span>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if no Norditropin appears when I check the flow?</span> </p> <p> <span class="Bold">A. Your needle may be blocked or damaged</span>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</p> <p> <span class="Bold">B. Your Pen may be defective</span>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if “0” does not appear after completing my injection?</span> </p> <p>The needle may be blocked or damaged, and <span class="Bold">you have not received any Norditropin</span> – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</p> <p>If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I take care of my Pen?</span> </p> <p>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</p> <p>See “<span class="Bold">How should I store Norditropin?”. </span> </p> <p>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See <span class="Bold">“How do I dispose of used needles and Pens?</span>”.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Frequently Asked Questions</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What if I drop my Pen?</span> </p> <p>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I clean my Pen?</span> </p> <p>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How do I dispose of used needles and Pens?</span> </p> <p>Put your used needles in an FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not throw away (dispose of) loose needles in your household trash</span>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:</p> <p>• made of a heavy-duty plastic, </p> <dl> <dt> </dt> <dd>• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </dd> </dl> <p>• upright and stable during use, </p> <p>• leak-resistant, and </p> <p>• properly labeled to warn of hazardous waste inside the container.</p> <p>When your sharps disposal container is almost full, you will need to<span class="Underline"></span>follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: <a href="http://www.fda.gov/safesharpsdisposal">http://www.fda.gov/safesharpsdisposal</a>.</p> <p>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</p> <p>Do not recycle your used sharps disposal container.</p> <p>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Important information</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Caregivers must <span class="Bold">be very careful when handling needles</span> to reduce the risk of needle sticks and infection.</dd> <dt>•</dt> <dd>Norditropin<span class="Sup">®</span> FlexPro<span class="Sup">®</span> 30 mg/3 mL Pen <span class="Bold">is not compatible with FlexPro<span class="Sup">®</span> PenMate<span class="Sup">®</span>.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id-1464492750"></a><img alt="30mg-phoneqrcode" src="/dailymed/image.cfm?name=30mg-phoneqrcode.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/><p class="First">www.norditropin.com</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p> <span class="Italics">Norditropin</span><span class="Sup">®</span> and <span class="Italics">FlexPro</span><span class="Bold"><span class="Sup">®</span></span> are registered trademarks of Novo Nordisk Health Care AG.</p> <p> <span class="Italics">Novo Nordisk</span><span class="Bold"><span class="Sup">®</span></span> and <span class="Italics">PenMate</span><span class="Bold"><span class="Sup">® </span></span>are registered trademarks of Novo Nordisk A/S.</p> <p>PATENT Information: <a href="http://novonordisk-us.com/products/product-patents.html">http://novonordisk-us.com/products/product-patents.html</a> </p> <p>Manufactured by:</p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road</p> <p>Plainsboro, NJ 08536 </p> <p>U.S. License No. 1261</p> <p>For information about NORDITROPIN<span class="Sup">®</span> </p> <p>Visit: norditropin.com</p> <p>Or call: 1 (888) 668-6444</p> <p>Revised: 01/2025</p> <p>© 2025 Novo Nordisk A/S</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><a name=\"id-10913472\"></a><img alt=\"30mg-overview\" src=\"/dailymed/image.cfm?name=30mg-overview.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id-2071269716\"></a><img alt=\"30mg-needle-example\" src=\"/dailymed/image.cfm?name=30mg-needle-example.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Norditropin FlexPro Pen is for single-patient-use only.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Supplies you will need:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm</dd>\n<dt>•</dt>\n<dd>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</dd>\n<dt>•</dt>\n<dd>alcohol pad</dd>\n<dt>•</dt>\n<dd>gauze pad</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id215639427\"></a><img alt=\"30mg-supplies\" src=\"/dailymed/image.cfm?name=30mg-supplies.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How to use your Norditropin FlexPro Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">5 steps you should follow for a Norditropin injection:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>Step 1: Prepare your Norditropin FlexPro Pen </dd>\n<dt> </dt>\n<dd>Step 2: Check the Norditropin flow with each new Pen </dd>\n<dt> </dt>\n<dd>Step 3: Select your dose</dd>\n<dt> </dt>\n<dd>Step 4: Inject your dose</dd>\n<dt> </dt>\n<dd>Step 5: After your injection</dd>\n</dl>\n<p>\n<span class=\"Bold\">For further information about your Pen see:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>Frequently Asked Questions</dd>\n<dt> </dt>\n<dd>Important information</dd>\n<dt> </dt>\n<dd>Patient Information</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-768852807\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-33.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Important information</span>\n</dd>\n<dt> </dt>\n<dd>Make sure that you read this information carefully.</dd>\n</dl>\n<p>\n<a name=\"id987906099\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-34.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Additional information</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Norditropin is for use under the skin only (subcutaneous). </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not</span> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </p>\n<p>\n<span class=\"Bold\">Do not use your Pen without proper training from your healthcare provider</span>. </p>\n<p>Make sure that you are confident in giving an injection with the Pen before you start your treatment. </p>\n<p>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 1. Prepare your Norditropin FlexPro Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Wash your hands with soap and water.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check the name, strength, and colored label </span>on your Pen to make sure that it contains Norditropin in the right strength.</dd>\n<dt>•</dt>\n<dd>Pull off the Pen cap.</dd>\n<dt>•</dt>\n<dd>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</dd>\n<dt> </dt>\n<dd>See figure A. <span class=\"Bold\">If the Norditropin looks cloudy, do not use the Pen.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1201469679\"></a><img alt=\"30mg-a\" src=\"/dailymed/image.cfm?name=30mg-a.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>When you are ready to give your injection, take a new disposable needle, and remove the paper tab.</dd>\n<dt>•</dt>\n<dd>Push the needle straight onto the Pen. Turn the needle clockwise <span class=\"Bold\">until it is on tight</span>. See figure B.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1015065117\"></a><img alt=\"30mg-b\" src=\"/dailymed/image.cfm?name=30mg-b.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id1897399488\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-14.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Pull off the outer needle cap and <span class=\"Bold\">dispose of it</span>. See figure C.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1246610432\"></a><img alt=\"30mg-c\" src=\"/dailymed/image.cfm?name=30mg-c.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-868678666\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-15.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Never use a bent or damaged needle.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2. Check the Norditropin flow with each new Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-527793618\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-35.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If your Pen is already in use</span>, go to step 3.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Before using a new Pen</span>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</dd>\n<dt>•</dt>\n<dd>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint “click” when you turn the dose selector. See figure E.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2017883406\"></a><img alt=\"30mg-e\" src=\"/dailymed/image.cfm?name=30mg-e.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">1 marking on the dose counter equals 0.1 mg</span>. See figure F.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1668361742\"></a><img alt=\"30mg-f\" src=\"/dailymed/image.cfm?name=30mg-f.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. <span class=\"Bold\">The “0” must line up with the dose pointer</span>. See figure G.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id845368041\"></a><img alt=\"30mg-g\" src=\"/dailymed/image.cfm?name=30mg-g.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Check that a drop of Norditropin appears at the needle tip. See figure H.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-1191373512\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-36.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">If no Norditropin appears</span>, repeat step 2 up to 6 times.</dd>\n</dl>\n<p class=\"First\">If you still do not see a drop of Norditropin, <span class=\"Bold\">change the needle:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</dd>\n<dt>•</dt>\n<dd>and repeat step 2 again</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </span>\n</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">1-888-668-6444 for help.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-482464315\"></a><img alt=\"30mg-h\" src=\"/dailymed/image.cfm?name=30mg-h.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. Select your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>To start, check that the dose pointer is set at <span class=\"Bold\">“0”.</span>\n</dd>\n<dt>•</dt>\n<dd>Turn the dose selector clockwise to select the dose you need. See figure I.<p class=\"First\">When you have selected your dose, you can go to step 4.</p>\n</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-1839297259\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-37.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>I<span class=\"Bold\">f there is not enough Norditropin left </span>to select a full dose, see <span class=\"Bold\">Frequently Asked Questions</span><span class=\"Italics\">.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1989699225\"></a><img alt=\"30mg-i\" src=\"/dailymed/image.cfm?name=30mg-i.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id-2133846140\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-38.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>The dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose<span class=\"Bold\">. Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2060130231\"></a><img alt=\"30mg-j\" src=\"/dailymed/image.cfm?name=30mg-j.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id506325649\"></a><img alt=\"30mg-k\" src=\"/dailymed/image.cfm?name=30mg-k.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id1704216411\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-39.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</dd>\n<dt> </dt>\n<dd>The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id647861705\"></a><img alt=\"30mg-l\" src=\"/dailymed/image.cfm?name=30mg-l.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4. Inject your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Select the injection site.</dd>\n<dt>•</dt>\n<dd>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day.</dd>\n<dt>•</dt>\n<dd>Wipe the injection site with an alcohol swab and let the area dry.</dd>\n<dt>•</dt>\n<dd>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</dd>\n<dt> </dt>\n<dd>Make sure you can see the dose counter. <span class=\"Bold\">Do not cover it with your fingers</span>. This could block the injection.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1669398985\"></a><img alt=\"30mg-m\" src=\"/dailymed/image.cfm?name=30mg-m.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Press and hold down the dose button until the dose counter shows “0”. See figure N. <span class=\"Bold\">The “0” must line up with the dose pointer</span>. You may then hear or feel a “click”.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Continue to hold the needle in your skin.</span>\n</dd>\n<dt> </dt>\n<dd>\n<a name=\"id118880492\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-40.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <span class=\"Bold\">Frequently Asked Questions</span>.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-92021422\"></a><img alt=\"30mg-n\" src=\"/dailymed/image.cfm?name=30mg-n.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep the needle in your skin</span> after the dose counter has returned to “0”. <span class=\"Bold\">Count slowly to 6</span> to ensure that the full dose has been delivered. See figure O.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id656958973\"></a><img alt=\"30mg-o.\" src=\"/dailymed/image.cfm?name=30mg-o.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id1530370635\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-41.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-891878015\"></a><img alt=\"30mg-p\" src=\"/dailymed/image.cfm?name=30mg-p.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5. After your injection</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2013827780\"></a><img alt=\"30mg-q\" src=\"/dailymed/image.cfm?name=30mg-q.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</dd>\n<dt> </dt>\n<dd>\n<a name=\"id-598327460\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-42.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>Always dispose of the needle after each injection.</dd>\n<dt> </dt>\n<dd>For further information about safe sharps disposal, see <span class=\"Bold\">Frequently Asked Questions</span>.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1236318319\"></a><img alt=\"30mg-r\" src=\"/dailymed/image.cfm?name=30mg-r.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id785773873\"></a><img alt=\"alert\" src=\"/dailymed/image.cfm?name=alert-16.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><span class=\"Bold\">Do not try to put the needle cap back on</span>. You may stick yourself with the needle.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</dd>\n<dt> </dt>\n<dd>See <span class=\"Bold\">“How should I store Norditropin?”.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-417178495\"></a><img alt=\"30mg-s\" src=\"/dailymed/image.cfm?name=30mg-s.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<a name=\"id1389686473\"></a><img alt=\"info\" src=\"/dailymed/image.cfm?name=info-43.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">How should I store Norditropin?</span>\n</dd>\n<dt> </dt>\n<dd>•<span class=\"Bold\">Before you use Norditropin FlexPro pens for the first time: </span>\n</dd>\n<dt>o</dt>\n<dd>Store your new, unused <span class=\"Bold\">Norditropin</span> pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). </dd>\n<dt>o</dt>\n<dd>Do not freeze <span class=\"Bold\">Norditropin</span>. </dd>\n<dt>o</dt>\n<dd>When stored in the refrigerator, do not store <span class=\"Bold\">Norditropin</span> directly next to the cooling element.</dd>\n<dt>o</dt>\n<dd>Keep <span class=\"Bold\">Norditropin</span> away from direct light.</dd>\n<dt>o</dt>\n<dd>Do not use <span class=\"Bold\">Norditropin</span> that has been frozen or in temperatures warmer than 77ºF (25ºC).</dd>\n<dt>o</dt>\n<dd>Do not use <span class=\"Bold\">Norditropin</span> after the expiration date printed on the carton and the pen.</dd>\n<dt> </dt>\n<dd>•<span class=\"Bold\">After you use Norditropin FlexPro pens and there is still medicine left: </span>\n</dd>\n<dt>o</dt>\n<dd>Store remaining <span class=\"Bold\">Norditropin</span> in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or </dd>\n<dt>o</dt>\n<dd>Store remaining <span class=\"Bold\">Norditropin</span> at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Keep Norditropin and all medicines out of the reach of children.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Frequently Asked Questions</span>\n</p>\n<p>\n<span class=\"Bold\">How do I see how </span>\n</p>\n<p>\n<span class=\"Bold\">much Norditropin is </span>\n</p>\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">left in my Pen?</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1719657317\"></a><img alt=\"30mg-t\" src=\"/dailymed/image.cfm?name=30mg-t.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with “8.0”, at least 8.0 mg are left in your Pen. </p>\n<p>If the dose counter stops with the dose pointer lined up with “3.8”, only 3.8 mg are left in your Pen. See figure U.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1174331466\"></a><img alt=\"30mg-u\" src=\"/dailymed/image.cfm?name=30mg-u.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if I need a larger dose than what is left in my Pen? </span>\n</p>\n<p>It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen.</p>\n<p>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <span class=\"Bold\">Only split your dose if you have been trained or advised by your healthcare provider on how to do this. </span>You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</p>\n<p>\n<span class=\"Bold\">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</span>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if no Norditropin appears when I check the flow?</span>\n</p>\n<p>\n<span class=\"Bold\">A. Your needle may be blocked or damaged</span>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</p>\n<p>\n<span class=\"Bold\">B. Your Pen may be defective</span>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if “0” does not appear after completing my injection?</span>\n</p>\n<p>The needle may be blocked or damaged, and <span class=\"Bold\">you have not received any Norditropin</span> – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</p>\n<p>If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take care of my Pen?</span>\n</p>\n<p>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</p>\n<p>See “<span class=\"Bold\">How should I store Norditropin?”. </span>\n</p>\n<p>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See <span class=\"Bold\">“How do I dispose of used needles and Pens?</span>”.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Frequently Asked Questions</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What if I drop my Pen?</span>\n</p>\n<p>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I clean my Pen?</span>\n</p>\n<p>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How do I dispose of used needles and Pens?</span>\n</p>\n<p>Put your used needles in an FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not throw away (dispose of) loose needles in your household trash</span>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:</p>\n<p>•\tmade of a heavy-duty plastic, </p>\n<dl>\n<dt> </dt>\n<dd>•\tcan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </dd>\n</dl>\n<p>•\tupright and stable during use, </p>\n<p>•\tleak-resistant, and </p>\n<p>•\tproperly labeled to warn of hazardous waste inside the container.</p>\n<p>When your sharps disposal container is almost full, you will need to<span class=\"Underline\"></span>follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: <a href=\"http://www.fda.gov/safesharpsdisposal\">http://www.fda.gov/safesharpsdisposal</a>.</p>\n<p>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</p>\n<p>Do not recycle your used sharps disposal container.</p>\n<p>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Important information</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Caregivers must <span class=\"Bold\">be very careful when handling needles</span> to reduce the risk of needle sticks and infection.</dd>\n<dt>•</dt>\n<dd>Norditropin<span class=\"Sup\">®</span> FlexPro<span class=\"Sup\">®</span> 30 mg/3 mL Pen <span class=\"Bold\">is not compatible with FlexPro<span class=\"Sup\">®</span> PenMate<span class=\"Sup\">®</span>.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id-1464492750\"></a><img alt=\"30mg-phoneqrcode\" src=\"/dailymed/image.cfm?name=30mg-phoneqrcode.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/><p class=\"First\">www.norditropin.com</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>\n<span class=\"Italics\">Norditropin</span><span class=\"Sup\">®</span> and <span class=\"Italics\">FlexPro</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> are registered trademarks of Novo Nordisk Health Care AG.</p>\n<p>\n<span class=\"Italics\">Novo Nordisk</span><span class=\"Bold\"><span class=\"Sup\">®</span></span> and <span class=\"Italics\">PenMate</span><span class=\"Bold\"><span class=\"Sup\">® </span></span>are registered trademarks of Novo Nordisk A/S.</p>\n<p>PATENT Information: <a href=\"http://novonordisk-us.com/products/product-patents.html\">http://novonordisk-us.com/products/product-patents.html</a>\n</p>\n<p>Manufactured by:</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road</p>\n<p>Plainsboro, NJ 08536 </p>\n<p>U.S. License No. 1261</p>\n<p>For information about NORDITROPIN<span class=\"Sup\">®</span>\n</p>\n<p>Visit: norditropin.com</p>\n<p>Or call: 1 (888) 668-6444</p>\n<p>Revised: 01/2025</p>\n<p>© 2025 Novo Nordisk A/S</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

INSTRUCTIONS FOR USE

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USE\n" }

Norditropin® (nor-dee-tro-pin) FlexPro®

{ "type": "p", "children": [], "text": "\nNorditropin® (nor-dee-tro-pin) FlexPro®\n" }

(somatropin)

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injection

{ "type": "p", "children": [], "text": "\ninjection\n" }

prefilled pen with PenMate®

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and

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Sogroya® (suh-GROY-uh)

{ "type": "p", "children": [], "text": "\nSogroya® (suh-GROY-uh)\n" }

(somapacitan-beco)

{ "type": "p", "children": [], "text": "\n(somapacitan-beco) \n" }

injection

{ "type": "p", "children": [], "text": "\ninjection \n" }

prefilled pen with PenMate®

{ "type": "p", "children": [], "text": "\nprefilled pen with PenMate®\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">Read this Instructions for Use before you start using your Pen with PenMate.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>PenMate hides the needle when you inject your Norditropin growth hormone with Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pens <span class="Bold">or</span> Sogroya growth hormone with Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pens, so that you cannot see the needle. </dd> <dt>•</dt> <dd>Use your PenMate only after you have been trained by a healthcare provider. </dd> <dt>•</dt> <dd>People who are blind or have poor eyesight should only use the PenMate and Pen with help from a person with good eyesight who is trained to use the PenMate and Pen.</dd> <dt> </dt> <dd></dd> <dt>•</dt> <dd>The figures in this Instructions for Use show PenMate being used with a Norditropin FlexPro 5 mg/1.5 mL Pen and a NovoFine needle that is <span class="Bold">8 mm</span> long. Even if you are using a Norditropin FlexPro 10 mg/1.5 mL or 15 mg/1.5 mL Pen or a Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL Pen or a different needle that is <span class="Bold">8 mm</span> long, the instructions are the same. </dd> <dt>•</dt> <dd> <span class="Bold">Do not </span>share your Norditropin FlexPro or Sogroya Pens and needles with another person. You may give another person an infection or get an infection from them.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Supplies you will need to use your Pen with PenMate: </span> </p> <dl> <dt>•</dt> <dd>1 PenMate. <span class="Bold">See Figure A.</span> </dd> <dt>•</dt> <dd>1 Norditropin FlexPro Pen or Sogroya Pen. <span class="Bold">See Figure B.</span> PenMate does not work with other injection devices.</dd> <dt>•</dt> <dd>1 disposable needle up to <span class="Bold">8 mm </span>long<span class="Bold">.</span><span class="Bold">See Figure C.</span> Needles are not included with your PenMate or Pen. </dd> <dt>•</dt> <dd>2 alcohol swabs. <span class="Bold">See Figure C.</span> </dd> </dl> <p>a sharps disposal container. <span class="Bold">See Figure C. </span>See <span class="Bold">“How should I dispose of my Pen and needles”</span> at the end of these instructions for information on how to throw away (dispose of) used Pens and needles.</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id420459265"></a><img alt="fig-a.jpg" src="/dailymed/image.cfm?name=fig-a.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Pen:</span> </p> <p>This pen represents<span class="Bold"></span>Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL or 15 mg/1.5 mL Pen<span class="Bold"></span>and<span class="Bold"></span>Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pen </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-897818757"></a><img alt="fig-b" src="/dailymed/image.cfm?name=fig-b.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Needle parts and supplies:</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-478309249"></a><img alt="fig-c" src="/dailymed/image.cfm?name=fig-c.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Pen case</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id813919139"></a><img alt="fig-d" src="/dailymed/image.cfm?name=fig-d.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Step 1: Preparing your Pen with</span><span class="Sup"></span><span class="Bold">PenMate:</span> </p> <p>Wash your hands<span class="Bold"></span>with soap and water and dry them. Check the name and the colored label<span class="Bold"></span>on your Pen to make sure it contains the growth hormone strength prescribed by your healthcare provider.</p> <p>Pull off the PenMate cap. </p> <p> <span class="Bold">See Figure E.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1501338527"></a><img alt="fig-e" src="/dailymed/image.cfm?name=fig-e.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Pull off the Pen cap and throw it away. </dd> <dt> </dt> <dd> <span class="Bold">See Figure F. </span> </dd> </dl> <p class="First">You will not need the Pen cap with your PenMate.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2004005822"></a><img alt="fig-f" src="/dailymed/image.cfm?name=fig-f.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Look in the Pen window. Check the liquid medicine in your Pen by turning it upside down 1 or 2 times. </p> <p> <span class="Bold">See Figure G.</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Norditropin FlexPro Pen</span>: the liquid in the Norditropin FlexPro Pen should be clear and colorless. <span class="Bold">If the liquid looks cloudy or you see particles, do not use the Norditropin FlexPro Pen</span>.</dd> <dt>•</dt> <dd> <span class="Bold">Sogroya Pen</span>: the liquid in the Sogroya Pen should be clear to almost clear and colorless to slightly yellow. <span class="Bold">If the liquid looks cloudy or you see particles, do not use the Sogroya Pen</span>.</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1991204896"></a><img alt="fig-g" src="/dailymed/image.cfm?name=fig-g.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Wipe the front stopper on the needle thread of the Pen with an alcohol swab. </dd> <dt> </dt> <dd> <span class="Bold">See Figure H.</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-110904245"></a><img alt="fig-h" src="/dailymed/image.cfm?name=fig-h.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Insert the Pen into the PenMate. Twist the Pen clockwise<span class="Bold"></span>until you hear or feel a click. </dd> <dt> </dt> <dd> <span class="Bold">See Figure I.</span> </dd> </dl> <p class="First">The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-370152431"></a><img alt="fig-i" src="/dailymed/image.cfm?name=fig-i.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Step 2. Attaching the needle to your Pen:</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Do not</span> place a needle on your Pen until you are ready to give an injection.</dd> <dt>•</dt> <dd>Always use a new needle for each injection.</dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> use a bent or damaged needle.</dd> </dl> <p>Get a new disposable needle<span class="Bold"></span>and tear off the paper tab. </p> <p> <span class="Bold">See Figure J.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id822702701"></a><img alt="fig-j" src="/dailymed/image.cfm?name=fig-j.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Holding the Pen with 1 hand, firmly press the needle onto the needle thread of the Pen. Screw the needle in a clockwise direction until the needle will not turn anymore. </p> <p> <span class="Bold">See Figure K.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1451661160"></a><img alt="fig-k" src="/dailymed/image.cfm?name=fig-k.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Pull off the outer needle cap and save it. </p> <p> <span class="Bold">See Figure L. </span> </p> <p>You will need the outer needle cap after the injection so you can safely remove the needle from the Pen.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1475908680"></a><img alt="fig-l" src="/dailymed/image.cfm?name=fig-l.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Pull off the inner needle cap and throw it away. </dd> <dt> </dt> <dd> <span class="Bold">See Figure M.</span> </dd> <dt> </dt> <dd></dd> </dl> <p class="First">A drop of liquid may appear at the needle tip. This is normal.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1523469356"></a><img alt="fig-m" src="/dailymed/image.cfm?name=fig-m.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 3. Priming a new Pen:</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Checking the growth hormone flow in the Pen (priming) is not needed for a Pen you have used before. </span> </p> <p> <span class="Bold">If the Pen has already been primed, go to Step 4.</span> </p> <p>Before you use a new Pen you must prepare it for use. Hold the Pen with 1 hand and turn the dose selector clockwise 1 marking to select the <span class="Bold">minimum</span><span class="Bold">dose.</span> </p> <p> <span class="Bold">See Figure N.</span> </p> <p>You may hear or feel a click when you turn the dose selector.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id928547409"></a><img alt="fig-n" src="/dailymed/image.cfm?name=fig-n.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">When you turn the dose selector 1 marking, you select the smallest amount of</p> <p>medicine for a dose.</p> <p> <span class="Bold">See Figure O.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id638303003"></a><img alt="fig-o" src="/dailymed/image.cfm?name=fig-o.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">This lowest dose will be used for your Norditropin or Sogroya flow check dose.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hold your Pen with PenMate with the needle pointing up. You may see air bubbles in the PenMate window. Gently tap the top of PenMate<span class="Bold"></span>a few times to let any air bubbles rise to the top. </p> <p> <span class="Bold">See Figure P.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1891187380"></a><img alt="fig-p" src="/dailymed/image.cfm?name=fig-p.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Press the dose button until the dose pointer lines up with the <span class="Bold">“0”</span> in the display window on the Pen and a drop of liquid appears at the needle tip. </p> <p> <span class="Bold">See Figure Q.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1829093627"></a><img alt="fig-q" src="/dailymed/image.cfm?name=fig-q.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">If no drop of liquid appears at the needle tip, </span>repeat Step 3 again<span class="Bold"></span>up to 6 times. </p> <p>If there is still no drop of liquid at the needle tip, <span class="Bold">change the needle</span> and repeat Step 3 again.</p> <p> <span class="Bold">If a drop of liquid still does not appear at the needle tip after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for help.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 4. Selecting the correct dose of Norditropin or Sogroya:</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Use the dose selector on your Pen to make sure you have the exact dose selected. Your dose will be in a certain number of mg (milligrams). </p> <p>To start, check that the dose pointer on the Pen is set at <span class="Bold">“0”.</span> </p> <p></p> <p>Select the dose you need by turning the dose selector clockwise. If you move past your dose, turn the dose selector counterclockwise until the right number of mg lines up with the dose pointer. <span class="Bold">See Figure R.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id312379635"></a><img alt="fig-r" src="/dailymed/image.cfm?name=fig-r.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">To guide you, the dose selector click sound is different when turned clockwise (softer click) or counterclockwise (louder click). You will hear a click for every single unit dialed.</p> <p>When dialing counterclockwise, be careful not to press the dose button as liquid will come out.</p> <p>You can use the growth hormone scale on the side of the Pen to see about how much growth hormone is left in the Pen. You can also use the dose selector to see exactly how much growth hormone is left in the Pen.</p> <p>If the Pen contains less than 2 mg, 4 mg, or 8 mg (depending on whether you use a 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL Pen), turn the dose selector until it stops. The number that lines up with the dose pointer shows how many mg are left in the Pen. You cannot set a dose higher than the number of mg left in the Pen.</p> <p>If there is not enough Norditropin or Sogroya left in the Pen for your full dose, use a new Norditropin FlexPro Pen or Sogroya Pen to inject the remaining amount of your dose or contact your healthcare provider.</p> <p>Remember to subtract the dose already received. For example, if the dose is 0.7 mg and you can only set the dose selector to 0.35 mg, you should inject another 0.35 mg with a new Norditropin FlexPro Pen or Sogroya Pen.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Important:</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Do not use the Pen clicks to count the number of mg you select. Only the display window and dose pointer will show the exact number.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Do not use the growth hormone scale to measure how much liquid to inject. Only the display window and dose pointer will show the exact number.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 5. Selecting your injection site and injecting the dose of Norditropin or Sogroya:</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Change your injection site every day. Select the injection site and wipe your skin with an alcohol swab as your healthcare provider showed you. </p> <p>Norditropin or Sogroya can be injected under your skin (subcutaneously) of your buttocks, stomach area (abdomen), upper legs (thighs), upper arms, or as instructed by your healthcare provider.</p> <p> <span class="Bold">See Figure S.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1623267184"></a><img alt="fig-s" src="/dailymed/image.cfm?name=fig-s.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hold onto both the PenMate and your Pen without touching the insertion button on the PenMate <span class="Bold">or</span> the dose button on the Pen.</p> <p> <span class="Bold">Do not press the insertion button on the PenMate before you are ready to inject your dose. </span>This lowers the risk of hurting yourself with the needle.</p> <p>Hold the PenMate firmly with 1 hand and pull the Pen out with your other hand<span class="Bold"></span>until you hear and feel a click. <span class="Bold">See Figure T.</span> </p> <p>The needle is now hidden in PenMate.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1069813147"></a><img alt="fig-t" src="/dailymed/image.cfm?name=fig-t.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Norditropin and Sogroya is for use under your skin only (subcutaneous). Hold the PenMate against your skin. Press the insertion button on the PenMate<span class="Bold"></span>until you hear or feel a click. </p> <p>When you hear or feel the click, the needle has been inserted automatically into your skin. </p> <p> <span class="Bold">See Figure U.</span> </p> <p>You are now ready to inject your dose.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1361312648"></a><img alt="fig-u" src="/dailymed/image.cfm?name=fig-u.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Press the dose button on the Pen to inject your dose.</span><span class="Bold">Do not</span> turn the dose button while you are pressing it. If you turn the dose button, you will not inject growth hormone.</p> <p>Make sure you can see the display window.<span class="Bold"></span><span class="Bold">Do not</span> cover it with your fingers.</p> <p> <span class="Bold">Press and hold down the dose button on the Pen until the display window returns to “0”. </span> </p> <p>The <span class="Bold">“0”</span> must line up with the dose pointer. You may then hear or feel a firm click.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">After the display window has returned to “0”, leave the needle under your skin for at least 6 seconds </span>to make sure you get your full dose. </p> <p> <span class="Bold">See Figure V.</span> </p> <p> <span class="Bold">Let go of the dose button while you wait.</span> </p> <p> <span class="Bold">See Figure V</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2007475590"></a><img alt="fig-v" src="/dailymed/image.cfm?name=fig-v.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">If the dose button cannot be pushed in completely or “0” does not appear in the display window, you did not receive the full dose. Call Novo Nordisk at 1-888-668-6444 for help. You may need a new Pen.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Important:</span> </p> <p> <span class="Bold">Always press the dose button to inject the dose. Turning the dose selector will not inject the dose.</span> </p> <p> <span class="Bold">Do not touch the display window when you inject, as this can block the injection.</span> </p> <p>Carefully lift the Pen to remove the needle from the skin. </p> <p> <span class="Bold">See Figure W.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-871773365"></a><img alt="fig-w" src="/dailymed/image.cfm?name=fig-w.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 6. What to do after your injection is completed:</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Carefully put the outer needle cap back on the needle. </p> <p>Remove the needle from the Pen after each injection. </p> <p> <span class="Bold">See Figure X.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1981065172"></a><img alt="fig-x" src="/dailymed/image.cfm?name=fig-x.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Unscrew the needle by turning it counterclockwise. Do not touch the needle. Hold the Pen with 1 hand and carefully remove the needle from the Pen with your other hand. </p> <p> <span class="Bold">See Figure Y.</span> </p> <p>Throw away (dispose of) the needle. See <span class="Bold">“How should I dispose of my Pen and needles?” </span>at the end of these instructions.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-377171975"></a><img alt="fig-y" src="/dailymed/image.cfm?name=fig-y.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Put the PenMate cap back on<span class="Bold"></span>your PenMate after each use to protect the growth hormone from direct light. </p> <p> <span class="Bold">See Figure Z.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id36404804"></a><img alt="fig-z" src="/dailymed/image.cfm?name=fig-z.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Important safety information to remember: </span> </p> <dl> <dt>•</dt> <dd>Be careful not to drop your PenMate and Pen or knock them against a hard surface. If this happens you will need to check the growth hormone flow. </dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> try to put the inner needle cap back on the needle. You may stick yourself with the needle. Be careful when handling used needles to avoid needle stick injuries.</dd> <dt>•</dt> <dd>After each use always remove and throw away (dispose of) the needle from your Pen. </dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> share<span class="Bold"></span>your Pen or needles with other people.</dd> <dt>•</dt> <dd>If your PenMate is damaged or lost,<span class="Bold"></span>you can still use your Pen without your PenMate.</dd> <dt>•</dt> <dd>Always keep your Pen and needles out of reach of others, especially children.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I replace an empty Pen?</span> </p> <p> <span class="Bold">PenMate is reusable </span>and should not be thrown away (disposed of). Reuse your PenMate by replacing your Pen when it is empty.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">When your Pen is empty, <span class="Bold">twist the Pen </span>counterclockwise<span class="Bold"></span>until you hear or feel a click. </p> <p> <span class="Bold">See Figure AA.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id513342774"></a><img alt="fig-aa" src="/dailymed/image.cfm?name=fig-aa.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Gently pull the Pen out of PenMate.</p> <p> <span class="Bold">See Figure BB.</span> </p> <p>Before throwing away (disposing of) your empty Pen, make sure the needle has been removed. See <span class="Bold">“How should I dispose of my Pen and needles?”</span> at the end of these instructions.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1089190729"></a><img alt="fig-bb" src="/dailymed/image.cfm?name=fig-bb.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Insert the new Pen into your PenMate. </p> <p> <span class="Bold">See Figure CC.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1082514785"></a><img alt="fig-cc" src="/dailymed/image.cfm?name=fig-cc.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Twist the Pen clockwise until you hear or feel a click. </p> <p> <span class="Bold">See Figure DD.</span> </p> <p>The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id505181497"></a><img alt="fig-dd" src="/dailymed/image.cfm?name=fig-dd.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I store my PenMate and Pen?</span> </p> <dl> <dt>•</dt> <dd>Do not expose your PenMate or Pen to dust, dirt, liquid, or direct light.</dd> <dt>•</dt> <dd>Store your PenMate and Pen in their case. See <span class="Bold">Figure D</span> at the beginning of these instructions.</dd> <dt>•</dt> <dd>When your Pen is inserted in PenMate, store it as described in the Patient Information leaflet that comes with your Pen.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I care for and clean my Pen with PenMate?</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Do not</span> try to refill your Pen. It is prefilled.</dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> try to repair your PenMate or your Pen.</dd> <dt>•</dt> <dd>Only clean your PenMate or Pen<span class="Bold"></span>with a mild detergent on a moistened cloth.</dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> wash, soak, or lubricate your PenMate or Pen.<span class="Bold"></span>Do not use products containing bleaching agents, such as chlorine, iodine, or alcohol to clean your PenMate or Pen. These products may damage them.</dd> <dt>•</dt> <dd>If there is liquid growth hormone on the outside of your PenMate or Pen, clean it<span class="Bold"></span>with a mild detergent on a moistened cloth <span class="Bold">before it dries up.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I throw away (dispose of) my Pen and needles? </span> </p> <dl> <dt>•</dt> <dd>Put your used needles and Pens in a FDA-cleared sharps disposal container right away after use. <span class="Bold">Do not throw away (dispose of) loose needles and Pens in your household trash.</span> </dd> <dt>•</dt> <dd>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<dl> <dt>o</dt> <dd>made of a heavy-duty plastic,</dd> <dt>o</dt> <dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</dd> <dt>o</dt> <dd>upright and stable during use,</dd> <dt>o</dt> <dd>leak-resistant, and</dd> <dt>o</dt> <dd>properly labeled to warn of hazardous waste inside the container.</dd> </dl> </dd> <dt>•</dt> <dd>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and Pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. </dd> <dt>•</dt> <dd>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Need help?</span> </p> <p>PenMate must only be used according to the instructions provided. The manufacturer cannot be held responsible for any problems with PenMate if these instructions have not been followed.</p> <p>If you find that your PenMate or case is defective, make sure to have Novo Nordisk replace it. Call the number below to order a new PenMate or case and arrange return of the defective item for inspection.</p> <p>For help or further information, write to:</p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road</p> <p>Plainsboro, NJ 08536, USA</p> <p>Visit norditropin.com or sogroya.com</p> <p>Or call: 1-888-668-6444</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">PATENT Information: http://novonordisk-us.com/products/product-patents.html</p> <p> <span class="Italics">Novo Nordisk<span class="Sup">®</span>, PenMate<span class="Sup">® </span>and <span class="Sup"></span>NovoFine<span class="Sup">®</span> are registered trademarks of Novo Nordisk A/S </span> </p> <p> <span class="Italics">Norditropin<span class="Sup">®</span>, Sogroya<span class="Sup">®</span> and FlexPro<span class="Sup">®</span> are registered trademarks of Novo Nordisk Health Care AG.</span> </p> <p>© 2025 Novo Nordisk A/S</p> <p>Manufactured by:</p> <p>Novo Nordisk A/S</p> <p>Novo Allé</p> <p>DK-2880 Bagsvaerd</p> <p>Denmark</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p>Issued: 01/2025</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Read this Instructions for Use before you start using your Pen with PenMate.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>PenMate hides the needle when you inject your Norditropin growth hormone with Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pens <span class=\"Bold\">or</span> Sogroya growth hormone with Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pens, so that you cannot see the needle. </dd>\n<dt>•</dt>\n<dd>Use your PenMate only after you have been trained by a healthcare provider. </dd>\n<dt>•</dt>\n<dd>People who are blind or have poor eyesight should only use the PenMate and Pen with help from a person with good eyesight who is trained to use the PenMate and Pen.</dd>\n<dt> </dt>\n<dd></dd>\n<dt>•</dt>\n<dd>The figures in this Instructions for Use show PenMate being used with a Norditropin FlexPro 5 mg/1.5 mL Pen and a NovoFine needle that is <span class=\"Bold\">8 mm</span> long. Even if you are using a Norditropin FlexPro 10 mg/1.5 mL or 15 mg/1.5 mL Pen or a Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL Pen or a different needle that is <span class=\"Bold\">8 mm</span> long, the instructions are the same. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not </span>share your Norditropin FlexPro or Sogroya Pens and needles with another person. You may give another person an infection or get an infection from them.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Supplies you will need to use your Pen with PenMate: </span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>1 PenMate. <span class=\"Bold\">See Figure A.</span>\n</dd>\n<dt>•</dt>\n<dd>1 Norditropin FlexPro Pen or Sogroya Pen. <span class=\"Bold\">See Figure B.</span> PenMate does not work with other injection devices.</dd>\n<dt>•</dt>\n<dd>1 disposable needle up to <span class=\"Bold\">8 mm </span>long<span class=\"Bold\">.</span><span class=\"Bold\">See Figure C.</span> Needles are not included with your PenMate or Pen. </dd>\n<dt>•</dt>\n<dd>2 alcohol swabs. <span class=\"Bold\">See Figure C.</span>\n</dd>\n</dl>\n<p>a sharps disposal container. <span class=\"Bold\">See Figure C. </span>See <span class=\"Bold\">“How should I dispose of my Pen and needles”</span> at the end of these instructions for information on how to throw away (dispose of) used Pens and needles.</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id420459265\"></a><img alt=\"fig-a.jpg\" src=\"/dailymed/image.cfm?name=fig-a.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Pen:</span>\n</p>\n<p>This pen represents<span class=\"Bold\"></span>Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL or 15 mg/1.5 mL Pen<span class=\"Bold\"></span>and<span class=\"Bold\"></span>Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pen </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-897818757\"></a><img alt=\"fig-b\" src=\"/dailymed/image.cfm?name=fig-b.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Needle parts and supplies:</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-478309249\"></a><img alt=\"fig-c\" src=\"/dailymed/image.cfm?name=fig-c.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Pen case</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id813919139\"></a><img alt=\"fig-d\" src=\"/dailymed/image.cfm?name=fig-d.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 1: Preparing your Pen with</span><span class=\"Sup\"></span><span class=\"Bold\">PenMate:</span>\n</p>\n<p>Wash your hands<span class=\"Bold\"></span>with soap and water and dry them. Check the name and the colored label<span class=\"Bold\"></span>on your Pen to make sure it contains the growth hormone strength prescribed by your healthcare provider.</p>\n<p>Pull off the PenMate cap. </p>\n<p>\n<span class=\"Bold\">See Figure E.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1501338527\"></a><img alt=\"fig-e\" src=\"/dailymed/image.cfm?name=fig-e.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>Pull off the Pen cap and throw it away. </dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">See Figure F. </span>\n</dd>\n</dl>\n<p class=\"First\">You will not need the Pen cap with your PenMate.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2004005822\"></a><img alt=\"fig-f\" src=\"/dailymed/image.cfm?name=fig-f.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Look in the Pen window. Check the liquid medicine in your Pen by turning it upside down 1 or 2 times. </p>\n<p>\n<span class=\"Bold\">See Figure G.</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Norditropin FlexPro Pen</span>: the liquid in the Norditropin FlexPro Pen should be clear and colorless. <span class=\"Bold\">If the liquid looks cloudy or you see particles, do not use the Norditropin FlexPro Pen</span>.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Sogroya Pen</span>: the liquid in the Sogroya Pen should be clear to almost clear and colorless to slightly yellow. <span class=\"Bold\">If the liquid looks cloudy or you see particles, do not use the Sogroya Pen</span>.</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1991204896\"></a><img alt=\"fig-g\" src=\"/dailymed/image.cfm?name=fig-g.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>Wipe the front stopper on the needle thread of the Pen with an alcohol swab. </dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">See Figure H.</span>\n</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-110904245\"></a><img alt=\"fig-h\" src=\"/dailymed/image.cfm?name=fig-h.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>Insert the Pen into the PenMate. Twist the Pen clockwise<span class=\"Bold\"></span>until you hear or feel a click. </dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">See Figure I.</span>\n</dd>\n</dl>\n<p class=\"First\">The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-370152431\"></a><img alt=\"fig-i\" src=\"/dailymed/image.cfm?name=fig-i.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2. Attaching the needle to your Pen:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> place a needle on your Pen until you are ready to give an injection.</dd>\n<dt>•</dt>\n<dd>Always use a new needle for each injection.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> use a bent or damaged needle.</dd>\n</dl>\n<p>Get a new disposable needle<span class=\"Bold\"></span>and tear off the paper tab. </p>\n<p>\n<span class=\"Bold\">See Figure J.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id822702701\"></a><img alt=\"fig-j\" src=\"/dailymed/image.cfm?name=fig-j.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Holding the Pen with 1 hand, firmly press the needle onto the needle thread of the Pen. Screw the needle in a clockwise direction until the needle will not turn anymore. </p>\n<p>\n<span class=\"Bold\">See Figure K.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1451661160\"></a><img alt=\"fig-k\" src=\"/dailymed/image.cfm?name=fig-k.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Pull off the outer needle cap and save it. </p>\n<p>\n<span class=\"Bold\">See Figure L. </span>\n</p>\n<p>You will need the outer needle cap after the injection so you can safely remove the needle from the Pen.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1475908680\"></a><img alt=\"fig-l\" src=\"/dailymed/image.cfm?name=fig-l.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>Pull off the inner needle cap and throw it away. </dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">See Figure M.</span>\n</dd>\n<dt> </dt>\n<dd></dd>\n</dl>\n<p class=\"First\">A drop of liquid may appear at the needle tip. This is normal.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1523469356\"></a><img alt=\"fig-m\" src=\"/dailymed/image.cfm?name=fig-m.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. Priming a new Pen:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Checking the growth hormone flow in the Pen (priming) is not needed for a Pen you have used before. </span>\n</p>\n<p>\n<span class=\"Bold\">If the Pen has already been primed, go to Step 4.</span>\n</p>\n<p>Before you use a new Pen you must prepare it for use. Hold the Pen with 1 hand and turn the dose selector clockwise 1 marking to select the <span class=\"Bold\">minimum</span><span class=\"Bold\">dose.</span>\n</p>\n<p>\n<span class=\"Bold\">See Figure N.</span>\n</p>\n<p>You may hear or feel a click when you turn the dose selector.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id928547409\"></a><img alt=\"fig-n\" src=\"/dailymed/image.cfm?name=fig-n.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">When you turn the dose selector 1 marking, you select the smallest amount of</p>\n<p>medicine for a dose.</p>\n<p>\n<span class=\"Bold\">See Figure O.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id638303003\"></a><img alt=\"fig-o\" src=\"/dailymed/image.cfm?name=fig-o.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">This lowest dose will be used for your Norditropin or Sogroya flow check dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Hold your Pen with PenMate with the needle pointing up. You may see air bubbles in the PenMate window. Gently tap the top of PenMate<span class=\"Bold\"></span>a few times to let any air bubbles rise to the top. </p>\n<p>\n<span class=\"Bold\">See Figure P.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1891187380\"></a><img alt=\"fig-p\" src=\"/dailymed/image.cfm?name=fig-p.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Press the dose button until the dose pointer lines up with the <span class=\"Bold\">“0”</span> in the display window on the Pen and a drop of liquid appears at the needle tip. </p>\n<p>\n<span class=\"Bold\">See Figure Q.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1829093627\"></a><img alt=\"fig-q\" src=\"/dailymed/image.cfm?name=fig-q.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">If no drop of liquid appears at the needle tip, </span>repeat Step 3 again<span class=\"Bold\"></span>up to 6 times. </p>\n<p>If there is still no drop of liquid at the needle tip, <span class=\"Bold\">change the needle</span> and repeat Step 3 again.</p>\n<p>\n<span class=\"Bold\">If a drop of liquid still does not appear at the needle tip after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for help.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4. Selecting the correct dose of Norditropin or Sogroya:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Use the dose selector on your Pen to make sure you have the exact dose selected. Your dose will be in a certain number of mg (milligrams). </p>\n<p>To start, check that the dose pointer on the Pen is set at <span class=\"Bold\">“0”.</span>\n</p>\n<p></p>\n<p>Select the dose you need by turning the dose selector clockwise. If you move past your dose, turn the dose selector counterclockwise until the right number of mg lines up with the dose pointer. <span class=\"Bold\">See Figure R.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id312379635\"></a><img alt=\"fig-r\" src=\"/dailymed/image.cfm?name=fig-r.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">To guide you, the dose selector click sound is different when turned clockwise (softer click) or counterclockwise (louder click). You will hear a click for every single unit dialed.</p>\n<p>When dialing counterclockwise, be careful not to press the dose button as liquid will come out.</p>\n<p>You can use the growth hormone scale on the side of the Pen to see about how much growth hormone is left in the Pen. You can also use the dose selector to see exactly how much growth hormone is left in the Pen.</p>\n<p>If the Pen contains less than 2 mg, 4 mg, or 8 mg (depending on whether you use a 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL Pen), turn the dose selector until it stops. The number that lines up with the dose pointer shows how many mg are left in the Pen. You cannot set a dose higher than the number of mg left in the Pen.</p>\n<p>If there is not enough Norditropin or Sogroya left in the Pen for your full dose, use a new Norditropin FlexPro Pen or Sogroya Pen to inject the remaining amount of your dose or contact your healthcare provider.</p>\n<p>Remember to subtract the dose already received. For example, if the dose is 0.7 mg and you can only set the dose selector to 0.35 mg, you should inject another 0.35 mg with a new Norditropin FlexPro Pen or Sogroya Pen.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not use the Pen clicks to count the number of mg you select. Only the display window and dose pointer will show the exact number.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not use the growth hormone scale to measure how much liquid to inject. Only the display window and dose pointer will show the exact number.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5. Selecting your injection site and injecting the dose of Norditropin or Sogroya:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Change your injection site every day. Select the injection site and wipe your skin with an alcohol swab as your healthcare provider showed you. </p>\n<p>Norditropin or Sogroya can be injected under your skin (subcutaneously) of your buttocks, stomach area (abdomen), upper legs (thighs), upper arms, or as instructed by your healthcare provider.</p>\n<p>\n<span class=\"Bold\">See Figure S.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1623267184\"></a><img alt=\"fig-s\" src=\"/dailymed/image.cfm?name=fig-s.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Hold onto both the PenMate and your Pen without touching the insertion button on the PenMate <span class=\"Bold\">or</span> the dose button on the Pen.</p>\n<p>\n<span class=\"Bold\">Do not press the insertion button on the PenMate before you are ready to inject your dose. </span>This lowers the risk of hurting yourself with the needle.</p>\n<p>Hold the PenMate firmly with 1 hand and pull the Pen out with your other hand<span class=\"Bold\"></span>until you hear and feel a click. <span class=\"Bold\">See Figure T.</span>\n</p>\n<p>The needle is now hidden in PenMate.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1069813147\"></a><img alt=\"fig-t\" src=\"/dailymed/image.cfm?name=fig-t.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Norditropin and Sogroya is for use under your skin only (subcutaneous). Hold the PenMate against your skin. Press the insertion button on the PenMate<span class=\"Bold\"></span>until you hear or feel a click. </p>\n<p>When you hear or feel the click, the needle has been inserted automatically into your skin. </p>\n<p>\n<span class=\"Bold\">See Figure U.</span>\n</p>\n<p>You are now ready to inject your dose.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1361312648\"></a><img alt=\"fig-u\" src=\"/dailymed/image.cfm?name=fig-u.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Press the dose button on the Pen to inject your dose.</span><span class=\"Bold\">Do not</span> turn the dose button while you are pressing it. If you turn the dose button, you will not inject growth hormone.</p>\n<p>Make sure you can see the display window.<span class=\"Bold\"></span><span class=\"Bold\">Do not</span> cover it with your fingers.</p>\n<p>\n<span class=\"Bold\">Press and hold down the dose button on the Pen until the display window returns to “0”. </span>\n</p>\n<p>The <span class=\"Bold\">“0”</span> must line up with the dose pointer. You may then hear or feel a firm click.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">After the display window has returned to “0”, leave the needle under your skin for at least 6 seconds </span>to make sure you get your full dose. </p>\n<p>\n<span class=\"Bold\">See Figure V.</span>\n</p>\n<p>\n<span class=\"Bold\">Let go of the dose button while you wait.</span>\n</p>\n<p>\n<span class=\"Bold\">See Figure V</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2007475590\"></a><img alt=\"fig-v\" src=\"/dailymed/image.cfm?name=fig-v.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">If the dose button cannot be pushed in completely or “0” does not appear in the display window, you did not receive the full dose. Call Novo Nordisk at 1-888-668-6444 for help. You may need a new Pen.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important:</span>\n</p>\n<p>\n<span class=\"Bold\">Always press the dose button to inject the dose. Turning the dose selector will not inject the dose.</span>\n</p>\n<p>\n<span class=\"Bold\">Do not touch the display window when you inject, as this can block the injection.</span>\n</p>\n<p>Carefully lift the Pen to remove the needle from the skin. </p>\n<p>\n<span class=\"Bold\">See Figure W.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-871773365\"></a><img alt=\"fig-w\" src=\"/dailymed/image.cfm?name=fig-w.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 6. What to do after your injection is completed:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Carefully put the outer needle cap back on the needle. </p>\n<p>Remove the needle from the Pen after each injection. </p>\n<p>\n<span class=\"Bold\">See Figure X.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1981065172\"></a><img alt=\"fig-x\" src=\"/dailymed/image.cfm?name=fig-x.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Unscrew the needle by turning it counterclockwise. Do not touch the needle. Hold the Pen with 1 hand and carefully remove the needle from the Pen with your other hand. </p>\n<p>\n<span class=\"Bold\">See Figure Y.</span>\n</p>\n<p>Throw away (dispose of) the needle. See <span class=\"Bold\">“How should I dispose of my Pen and needles?” </span>at the end of these instructions.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-377171975\"></a><img alt=\"fig-y\" src=\"/dailymed/image.cfm?name=fig-y.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Put the PenMate cap back on<span class=\"Bold\"></span>your PenMate after each use to protect the growth hormone from direct light. </p>\n<p>\n<span class=\"Bold\">See Figure Z.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id36404804\"></a><img alt=\"fig-z\" src=\"/dailymed/image.cfm?name=fig-z.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important safety information to remember: </span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Be careful not to drop your PenMate and Pen or knock them against a hard surface. If this happens you will need to check the growth hormone flow. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> try to put the inner needle cap back on the needle. You may stick yourself with the needle. Be careful when handling used needles to avoid needle stick injuries.</dd>\n<dt>•</dt>\n<dd>After each use always remove and throw away (dispose of) the needle from your Pen. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> share<span class=\"Bold\"></span>your Pen or needles with other people.</dd>\n<dt>•</dt>\n<dd>If your PenMate is damaged or lost,<span class=\"Bold\"></span>you can still use your Pen without your PenMate.</dd>\n<dt>•</dt>\n<dd>Always keep your Pen and needles out of reach of others, especially children.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I replace an empty Pen?</span>\n</p>\n<p>\n<span class=\"Bold\">PenMate is reusable </span>and should not be thrown away (disposed of). Reuse your PenMate by replacing your Pen when it is empty.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">When your Pen is empty, <span class=\"Bold\">twist the Pen </span>counterclockwise<span class=\"Bold\"></span>until you hear or feel a click. </p>\n<p>\n<span class=\"Bold\">See Figure AA.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id513342774\"></a><img alt=\"fig-aa\" src=\"/dailymed/image.cfm?name=fig-aa.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Gently pull the Pen out of PenMate.</p>\n<p>\n<span class=\"Bold\">See Figure BB.</span>\n</p>\n<p>Before throwing away (disposing of) your empty Pen, make sure the needle has been removed. See <span class=\"Bold\">“How should I dispose of my Pen and needles?”</span> at the end of these instructions.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1089190729\"></a><img alt=\"fig-bb\" src=\"/dailymed/image.cfm?name=fig-bb.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Insert the new Pen into your PenMate. </p>\n<p>\n<span class=\"Bold\">See Figure CC.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1082514785\"></a><img alt=\"fig-cc\" src=\"/dailymed/image.cfm?name=fig-cc.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Twist the Pen clockwise until you hear or feel a click. </p>\n<p>\n<span class=\"Bold\">See Figure DD.</span>\n</p>\n<p>The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id505181497\"></a><img alt=\"fig-dd\" src=\"/dailymed/image.cfm?name=fig-dd.jpg&amp;setid=1058e17c-9261-459c-a3e6-fae38d196c14\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store my PenMate and Pen?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Do not expose your PenMate or Pen to dust, dirt, liquid, or direct light.</dd>\n<dt>•</dt>\n<dd>Store your PenMate and Pen in their case. See <span class=\"Bold\">Figure D</span> at the beginning of these instructions.</dd>\n<dt>•</dt>\n<dd>When your Pen is inserted in PenMate, store it as described in the Patient Information leaflet that comes with your Pen.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I care for and clean my Pen with PenMate?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> try to refill your Pen. It is prefilled.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> try to repair your PenMate or your Pen.</dd>\n<dt>•</dt>\n<dd>Only clean your PenMate or Pen<span class=\"Bold\"></span>with a mild detergent on a moistened cloth.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> wash, soak, or lubricate your PenMate or Pen.<span class=\"Bold\"></span>Do not use products containing bleaching agents, such as chlorine, iodine, or alcohol to clean your PenMate or Pen. These products may damage them.</dd>\n<dt>•</dt>\n<dd>If there is liquid growth hormone on the outside of your PenMate or Pen, clean it<span class=\"Bold\"></span>with a mild detergent on a moistened cloth <span class=\"Bold\">before it dries up.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I throw away (dispose of) my Pen and needles? </span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Put your used needles and Pens in a FDA-cleared sharps disposal container right away after use. <span class=\"Bold\">Do not throw away (dispose of) loose needles and Pens in your household trash.</span>\n</dd>\n<dt>•</dt>\n<dd>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<dl>\n<dt>o</dt>\n<dd>made of a heavy-duty plastic,</dd>\n<dt>o</dt>\n<dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</dd>\n<dt>o</dt>\n<dd>upright and stable during use,</dd>\n<dt>o</dt>\n<dd>leak-resistant, and</dd>\n<dt>o</dt>\n<dd>properly labeled to warn of hazardous waste inside the container.</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and Pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. </dd>\n<dt>•</dt>\n<dd>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Need help?</span>\n</p>\n<p>PenMate must only be used according to the instructions provided. The manufacturer cannot be held responsible for any problems with PenMate if these instructions have not been followed.</p>\n<p>If you find that your PenMate or case is defective, make sure to have Novo Nordisk replace it. Call the number below to order a new PenMate or case and arrange return of the defective item for inspection.</p>\n<p>For help or further information, write to:</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road</p>\n<p>Plainsboro, NJ 08536, USA</p>\n<p>Visit norditropin.com or sogroya.com</p>\n<p>Or call: 1-888-668-6444</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">PATENT Information: http://novonordisk-us.com/products/product-patents.html</p>\n<p>\n<span class=\"Italics\">Novo Nordisk<span class=\"Sup\">®</span>, PenMate<span class=\"Sup\">® </span>and <span class=\"Sup\"></span>NovoFine<span class=\"Sup\">®</span> are registered trademarks of Novo Nordisk A/S </span>\n</p>\n<p>\n<span class=\"Italics\">Norditropin<span class=\"Sup\">®</span>, Sogroya<span class=\"Sup\">®</span> and FlexPro<span class=\"Sup\">®</span> are registered trademarks of Novo Nordisk Health Care AG.</span>\n</p>\n<p>© 2025 Novo Nordisk A/S</p>\n<p>Manufactured by:</p>\n<p>Novo Nordisk A/S</p>\n<p>Novo Allé</p>\n<p>DK-2880 Bagsvaerd</p>\n<p>Denmark</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>Issued: 01/2025</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Norditropin®  FlexPro®

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(somatropin) injection

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5 mg/1.5 mL Prefilled Pen

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1 x 1.5 mL prefilled pen

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Each 1.5 mL contains 5 mg somatropin

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CONTAINS ONE

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NORDITROPIN® FlexPro® 5 mg/1.5 mL

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Single patient use only

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Rx only

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NDC 0169-7704-21

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List: 770421

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Norditropin®  FlexPro®

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(somatropin) injection

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10 mg/1.5 mL Prefilled Pen

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1 x 1.5 mL prefilled disposable pen

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Each 1.5 mL contains 10 mg somatropin

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CONTAINS ONE

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NORDITROPIN® FlexPro® 10 mg/1.5 mL

{ "type": "p", "children": [], "text": "NORDITROPIN® FlexPro® 10 mg/1.5 mL" }

Single patient use only

{ "type": "p", "children": [], "text": "Single patient use only" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

NDC 0169-7705-21

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List: 770521

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Norditropin®  FlexPro®

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(somatropin) injection

{ "type": "p", "children": [], "text": "\n(somatropin) injection\n" }

15 mg/1.5 mL Prefilled Pen

{ "type": "p", "children": [], "text": "\n15 mg/1.5 mL Prefilled Pen\n" }

1 x 1.5 mL prefilled disposable pen

{ "type": "p", "children": [], "text": "1 x 1.5 mL prefilled disposable pen" }

Each 1.5 mL contains 15 mg somatropin

{ "type": "p", "children": [], "text": "Each 1.5 mL contains 15 mg somatropin" }

CONTAINS ONE

{ "type": "p", "children": [], "text": "CONTAINS ONE" }

NORDITROPIN® FlexPro® 15 mg/1.5 mL

{ "type": "p", "children": [], "text": "NORDITROPIN® FlexPro® 15 mg/1.5 mL" }

Single patient use only

{ "type": "p", "children": [], "text": "Single patient use only" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

NDC 0169-7708-21

{ "type": "p", "children": [], "text": "NDC 0169-7708-21" }

List: 770821

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Norditropin® FlexPro®

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(somatropin) injection

{ "type": "p", "children": [], "text": "(somatropin) injection" }

30 mg / 3 mLPrefilled Pen

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1x3 mL prefilled pen

{ "type": "p", "children": [], "text": "1x3 mL prefilled pen" }

Each 3 mL contains: 30 mg somatropin

{ "type": "p", "children": [], "text": "Each 3 mL contains: 30 mg somatropin" }

CONTAINS ONE NORDITROPIN® FlexPro® 30 mg / 3 mL

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Single patient use only

{ "type": "p", "children": [], "text": "Single patient use only" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

NDC 0169-7703-21

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List: 770321

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