SOGROYA is indicated for the:

{ "type": "p", "children": [], "text": " SOGROYA is indicated for the:" }

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

<div class="scrollingtable"><table width="100%"> <col width="31%"/> <col width="27%"/> <col width="30%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Strength</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Dose increments (mg)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Dose Delivery Range (mg)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">5 mg/1.5 mL (3.3 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.025</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.025 to 2</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">10 mg/1.5 mL (6.7 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.05</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.05 to 4</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15 mg/1.5 mL (10 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.1 to 8</p> </td> </tr> </tbody> </table></div>

Patients Aged 65 Years and Older

Initiate SOGROYA with a dosage of 1 mg once weekly and use smaller dose increment increases when titrating the dosage [see Use in Specific Populations (8.5)]. See above for monitoring recommendations and the maximum recommended dosage of SOGROYA [see Dosage and Administration (2.4)].

Patients with Hepatic Impairment

Women Receiving Oral Estrogen

Initiate SOGROYA with a dosage of 2 mg once weekly [see Drug Interactions (7)]. See above for titration and monitoring recommendations and the maximum recommended dosage of SOGROYA [see Dosage and Administration (2.4)].

SOGROYA is a clear to slightly opalescent and colorless to slightly yellow solution available as follows:

{ "type": "p", "children": [], "text": "SOGROYA is a clear to slightly opalescent and colorless to slightly yellow solution available as follows:" }

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

SOGROYA is contraindicated in patients with:

{ "type": "p", "children": [], "text": "SOGROYA is contraindicated in patients with:" }

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

Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery and multiple accidental trauma, as well as patients with acute respiratory failure [see Contraindications (4)]. The safety of continuing SOGROYA treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. SOGROYA is not indicated for the treatment of non-GH deficient adults.

Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin. Inform patients and/or caregivers that such reactions are possible, and that prompt medical attention should be sought if an allergic reaction occurs. SOGROYA is contraindicated in patients with known hypersensitivity to somatropin or any excipients in SOGROYA [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 SOGROYA. Discontinue SOGROYA if there is evidence of recurrent activity.

Risk of Second Neoplasm in Pediatric Patients

In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent growth hormone deficiency (GHD) and were treated with somatropin, an increased risk of second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on somatropin therapy for progression or recurrence of the tumor.

New Malignancy During Treatment

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

There is risk of malignant changes of preexisting nevi with somatropin treatment in patients. Monitor patients on SOGROYA therapy 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 the appearance of preexisting 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. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving SOGROYA, 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 pre-diabetes should be monitored closely. The doses of antidiabetic agents may require adjustment when SOGROYA is initiated.

Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in patients treated with somatropin. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, intracranial hypertension-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose.

Perform fundoscopic examination before initiating treatment with SOGROYA to exclude preexisting papilledema and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating SOGROYA. If papilledema is observed by fundoscopy during SOGROYA treatment, treatment should be stopped. If intracranial hypertension is confirmed, treatment with SOGROYA can be restarted at a lower dose after intracranial hypertension-associated signs and symptoms have resolved.

Fluid retention during SOGROYA replacement therapy may occur. Clinical manifestations of fluid retention (e.g. edema and 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 corticotropin deficiency 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 SOGROYA treatment. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases [see Drug Interactions (7)].

Undiagnosed/untreated hypothyroidism may prevent an optimal response to SOGROYA. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with somatropin therapy. 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 undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain.

Somatropin increases growth rate, and progression of preexisting 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 disease progression.

Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain.

When SOGROYA is administered subcutaneously at the same site over a long period of time, tissue lipohypertrophy or lipoatrophy may result. Rotate injection sites when administering SOGROYA to reduce this risk [see Dosage and Administration (2.1)].

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. SOGROYA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Serum levels of inorganic phosphorus and alkaline phosphatase may increase after SOGROYA therapy. Serum levels of parathyroid hormone may increase with somatropin treatment.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pediatric Patients with GHD

SOGROYA was studied in a 52-week randomized, open-label, active-controlled, parallel-group clinical study in 200 treatment naïve, prepubertal pediatric patients with growth hormone deficiency [see Clinical Studies (14.1)]. Table 2 shows common adverse reactions that occurred in ≥5% of patients treated with either SOGROYA or somatropin in this trial.

Table 2. Adverse Reactions occurring ≥5% in SOGROYA or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment)

<div class="scrollingtable"><table width="100%"> <col width="27%"/> <col width="27%"/> <col width="27%"/> <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"> <span class="Bold">Somatropin</span> </p> <p> <span class="Bold">(N=68)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">SOGROYA</span> </p> <p> <span class="Bold">(N=132)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Adverse Reactions</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">%</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">%</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Nasopharyngitis<span class="Sup"> a</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">16.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">16.7</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Headache</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.8</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">12.1</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Pyrexia<span class="Sup">b</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">11.8</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9.1</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Pain in extremity<span class="Sup">c</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9.8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Injection site reaction<span class="Sup">d</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6.1</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Diarrhea<span class="Sup">e</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Nausea/vomiting<span class="Sup">f</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Bronchitis</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">3</p> </td> </tr> </tbody> </table></div>

Adult Patients with GHD

SOGROYA was studied in adult patients with GHD in a 35-week, placebo-controlled, double-blind trial with an active-control arm [see Clinical Studies (14.2)]. Adverse reactions occurring >2% with SOGROYA are presented in Table 3.

Table 3. Adverse Reactions occurring >2% in Adults with GHD Treated with SOGROYA and More Frequently# than in Placebo-Treated Patients for 34 Weeks

<div class="scrollingtable"><table width="100%"> <col width="43%"/> <col width="17%"/> <col width="21%"/> <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"> <span class="Bold">Placebo</span> </p> <p> <span class="Bold">(N=61)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">SOGROYA</span> </p> <p> <span class="Bold">(N=120)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Adverse Reactions</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">%</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">%</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Back pain</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Arthralgia</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">6.7</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Dyspepsia</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Sleep disorder</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">4.2</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Dizziness</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">4.2</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Tonsillitis</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">3.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Peripheral edema</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">3.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Vomiting</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">3.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Adrenal insufficiency</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">3.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hypertension</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">3.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Blood creatine phosphokinase increase</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Weight increased</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3.3</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Anemia</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.5</p> </td> </tr> </tbody> </table></div>

More SOGROYA treated patients shifted from normal baseline levels to elevated phosphate and creatine phosphokinase levels at the end of the trial compared to the placebo group (17.5% vs 4.9% and 9.2% vs. 6.6%, respectively); these laboratory changes occurred intermittently, and were non-progressive.

Table 4 includes a list of drugs with clinically important drug interactions when administered concomitantly with SOGROYA and instructions for preventing or managing them.

{ "type": "p", "children": [], "text": "Table 4 includes a list of drugs with clinically important drug interactions when administered concomitantly with SOGROYA and instructions for preventing or managing them." }

Table 4. Clinically Important Drug Interactions with SOGROYA

{ "type": "p", "children": [], "text": "\nTable 4. Clinically Important Drug Interactions with SOGROYA \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">Replacement 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">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 inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of SOGROYA 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 SOGROYA <span class="Italics">[see Warnings and Precautions (</span><span class="Italics"><a href="#ID_7b79e861-b882-4a40-ac66-6cf4e8637a78">5.7</a></span><span class="Italics">)].</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 affected more than others because 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">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 GH treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. SOGROYA 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 SOGROYA 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 SOGROYA. </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 higher SOGROYA dosages <span class="Italics">[see Dosage and Administration <a href="#ID_3a67e495-c0f9-469a-8757-e187cc7f87ff">(2.5</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 SOGROYA 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 Warnings and Precautions (<a href="#ID_6acd9d0a-0e23-4569-89bc-d6ce95f81695">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\">Replacement 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\">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 inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of SOGROYA 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 SOGROYA <span class=\"Italics\">[see Warnings and Precautions (</span><span class=\"Italics\"><a href=\"#ID_7b79e861-b882-4a40-ac66-6cf4e8637a78\">5.7</a></span><span class=\"Italics\">)].</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 affected more than others because 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\">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 GH treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. SOGROYA 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 SOGROYA 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 SOGROYA. </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 higher SOGROYA dosages <span class=\"Italics\">[see Dosage and Administration <a href=\"#ID_3a67e495-c0f9-469a-8757-e187cc7f87ff\">(2.5</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 SOGROYA 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 Warnings and Precautions (<a href=\"#ID_6acd9d0a-0e23-4569-89bc-d6ce95f81695\">5.4</a>)].</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary

There are no available data on the use of SOGROYA during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week. No adverse developmental outcomes were observed in a pre- and post-natal development study with administration of somapacitan-beco to pregnant rats from organogenesis through lactation at approximately 275 times the clinical exposure at the MRHD (see Data).

The 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 to 4% and 15 to 20%, respectively.

Data

Animal Data

In an embryo-fetal development study in rats, somapacitan-beco was administered by subcutaneous injection at doses of 2, 6, and 18 mg/kg/day during the period of organogenesis from gestation day 6 to 17. Fetal viability and development were not affected at doses up to 6 mg/kg/day (31 times the MRHD, based on AUC). Transient, fetal skeletal variations (short/bent/thickened long bones) were observed at 18 mg/kg/day (261 times the MRHD, based on AUC).

In an embryo-fetal development study in rabbits, somapacitan-beco was administered by subcutaneous injection at doses of 1, 3, and 9 mg/kg every two days during the period of organogenesis from gestation day 6 to 18. Fetal viability and development were not adversely affected at somapacitan-beco dose of 1 mg/kg/every two days (12 times the MRHD, based on AUC). Reduced fetal growth was observed at doses ≥3 mg/kg/every two days (≥130 times the MRHD, based on C12h).

In a pre- and post-natal development study in pregnant rats, somapacitan-beco was administered by subcutaneous injection at doses of 4, 9, and 18 mg/kg twice a week from gestation day 6 through lactation day 18. No adverse developmental effects were observed in the offspring at doses up to 9 mg/kg (275 times the MRHD, based on AUC). Increased incidence of renal pelvic dilatation was observed on post-natal day 21 at 18 mg/kg (630 times the MRHD, based on AUC), but was not observed in the adult F1 generation.

Risk Summary

There is no information on the presence of somapacitan-beco in human milk, the effects on the breastfed infant, or the effects on milk production. Somapacitan-beco-related material was secreted into milk of lactating rats. When a substance is present in animal milk, it is likely that the substance will be present in human milk. Available published data describing administration of short-acting recombinant growth hormone (rhGH) to lactating women for 7 days reported that short-acting rhGH did not increase the normal breastmilk concentration of growth hormone and no adverse effects were reported in breastfed infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOGROYA and any potential adverse effects on the breastfed infant from SOGROYA or from the underlying maternal condition.

The safety and effectiveness of SOGROYA have been established for the treatment of growth failure due to inadequate secretion of endogenous growth hormone (GH) in pediatric patients 2.5 years of age and older. The use of SOGROYA for this indication is supported by evidence from a 52 week randomized, multi-center, open-label, active-controlled, parallel-group phase 3 trial in 200 treatment-naïve, pediatric patients with GHD. The safety profile from the pediatric trial was similar to that reported in adults [see Adverse Reactions (6.1) and Clinical Studies (14.1)].

Risks in pediatric patients associated with growth hormone use include:

The safety and effectiveness of SOGROYA for the treatment of growth failure due to inadequate secretion of endogenous growth hormone have not been established in pediatric patients less than 2.5 years of age.

In clinical studies a total of 52 (15.6%) of the 333 SOGROYA-treated patients were 65 years or older and 3 (0.9%) were 75 years or older [see Clinical Studies (14)]. Subjects older than 65 years appeared to have higher exposure than younger subjects at the same dose level. Elderly patients may be more sensitive to the action of somapacitan-beco, and therefore may be at increased risk for adverse reactions. Initiate SOGROYA with a dose of 1 mg once weekly and use smaller increments when increasing the dose [see Dosage and Administration (2.5)].

Adult patients: No dose adjustment of SOGROYA is required for patients with mild hepatic impairment. Higher somapacitan-beco exposure was observed in patients with moderate hepatic impairment. In patients with moderate hepatic impairment, initiate SOGROYA with a dose of 1 mg once weekly and use smaller increments when increasing the dose. The maximum dose should not exceed 4 mg once weekly. Somapacitan-beco was not studied in patients with severe hepatic impairment. Therefore, use of SOGROYA is not recommended in patients with severe hepatic impairment. [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].

Pediatric patients: Based on the hepatic impairment study in adults, no dose adjustment of SOGROYA is recommended for patients with mild hepatic impairment. Higher systemic exposure of SOGROYA is expected in pediatric patients with moderate and severe hepatic impairment; therefore, SOGROYA is not recommended in these pediatric patients [see Dosage and Administration (2.5)].

SOGROYA contains somapacitan-beco, which is not a controlled substance.

Inappropriate use of SOGROYA may result in significant negative health consequences.

SOGROYA is not associated with drug related withdrawal adverse reactions.

Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with SOGROYA 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 endogenous growth hormone.

{ "type": "p", "children": [], "text": "Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with SOGROYA 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 endogenous growth hormone." }

Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol.

{ "type": "p", "children": [], "text": " Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology. The molecular formula (including the albumin-binding moiety) is C1038H1609N273O319S9 and the molecular weight is 23305.10 g/mol, of which the albumin-binding moiety is 1191.39 g/mol." }

Structural Formula:

{ "type": "p", "children": [], "text": "Structural Formula: " }

SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL.

{ "type": "p", "children": [], "text": "SOGROYA (somapacitan-beco) injection is supplied as a sterile, clear to slightly opalescent and colorless to slightly yellow solution for subcutaneous use in a single-patient-use prefilled pen with a deliverable volume of 1.5 mL." }

Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

{ "type": "p", "children": [], "text": "Each mL of SOGROYA 5 mg/1.5 mL prefilled pen contains 3.3 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH." }

Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

{ "type": "p", "children": [], "text": "Each mL of SOGROYA 10 mg/1.5 mL prefilled pen contains 6.7 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH." }

Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

{ "type": "p", "children": [], "text": "Each mL of SOGROYA 15 mg/1.5 mL prefilled pen contains 10 mg of somapacitan-beco, histidine (0.68 mg), mannitol (44 mg), phenol (4 mg), poloxamer 188 (1 mg), and Water for Injection, USP. The pH is approximately 6.8. Hydrochloric acid and sodium hydroxide may be added to adjust the pH." }

Somapacitan-beco binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by insulin-like growth factor-1 (IGF-1) produced in the liver, while others are primarily a consequence of the direct effects of somapacitan-beco.

IGF-1 was measured to assess the pharmacodynamic (PD) properties of somapacitan-beco. Somapacitan-beco normalizes the mean IGF-1 standard deviation score (SDS) level from a baseline value below -2 to a value within the reference range (-2 to +2) in treatment-naïve adult patients with GHD [see Clinical Studies (14)].

In adult patients with GHD (n=26), somapacitan-beco induces a less than dose proportional IGF-1 response at steady state. Maximum IGF-1 concentrations were observed within 2 to 4 days after dosing. Similar to the somapacitan-beco exposure time course, a steady state IGF-1 response was reached after 1 to 2 weekly doses with limited cumulative IGF-1 response.

In pediatric patients with GHD aged 2.5 to 11 years, somapacitan-beco produces a dose linear IGF-1 response, with a change of 0.02 mg/kg on average resulting in a change in IGF-1 standard deviation score (SDS) of 0.32. Approximately 97% of pediatric patients achieved an average IGF-1 SDS level within normal range after 52 weeks of treatment with once weekly Sogroya in Study NCT03811535. IGF-1 SDS levels were -2.03 at baseline and the IGF-1 SDS level change from baseline was 2.36.

Somapacitan-beco has pharmacokinetic properties compatible with once weekly administration. The reversible binding to endogenous albumin delays elimination of somapacitan and thereby prolongs the in vivo half-life and duration of action.

The pharmacokinetics (PK) of somapacitan-beco following subcutaneous administration have been investigated at clinically relevant doses (e.g., 0.01 to 0.32 mg/kg in healthy adults, 0.02 to 0.12 mg/kg in adults with GHD, and 0.02 to 0.16 mg/kg in pediatric patient with GHD)‎.

Overall, somapacitan-beco displays non-linear pharmacokinetics, however in the clinically relevant dose range of somapacitan-beco in adults with GHD, somapacitan-beco pharmacokinetics are approximately linear. After subcutaneous administration of 0.02 – 0.16 mg/kg/week somapacitan-beco in pediatric patients with GHD, a non-linear dose-exposure relationship with a greater than dose proportional increase in exposure was observed.

Absorption

In adults with GHD, a maximum concentration of somapacitan-beco is reached 4 to 24 hours post dose.

Steady state exposure is achieved following 1 to 2 weeks of once weekly administration of subcutaneous somapacitan-beco.

In pediatric patients with GHD, maximum somapacitan-beco concentrations occurred 8 to 25 hours after dosing at doses from 0.02 mg/kg/week to 0.16 mg/kg/week and increased with increasing dose level. Steady state was achieved following 1 to 2 weekly administration.

Distribution

Somapacitan-beco is extensively bound (>99%) to plasma proteins.

Based on population PK analyses, the estimated volume of distribution (V/F) of somapacitan-beco in adult GHD patients is approximately 14.6 L and 1.7 L in pediatric patients with GHD.

Elimination

The plasma elimination half-life of somapacitan-beco is approximately 2 to 3 days in adult patients with GHD. Following a dose of 0.16 mg/kg/week, the terminal half-life of somapacitan-beco was about 34 hours in pediatric patients with GHD. Somapacitan-beco was cleared within one week after treatment discontinuation.

Metabolism: Somapacitan-beco is metabolized via proteolytic cleavage of the linker sequence between the peptide backbone and albumin binder sidechain.

Excretion: The primary excretion routes of somapacitan-beco-related material are via the urine and feces. Approximately 81% of the dose is excreted in the urine and approximately 13% is excreted in the feces. No intact somapacitan-beco is excreted indicating full breakdown of somapacitan-beco prior to excretion.

Specific Populations

Body weight: Adults with GHD -The exposure of somapacitan-beco decreases with increasing body weight. However, the somapacitan-beco dose range of 0.1 to 8 mg/week provides adequate systemic exposure to reach target IGF-1 levels over the weight range of 34.5-150.5 kg evaluated in the clinical trials.

Pediatric patients with GHD: Based on pharmacokinetic analysis, gender and race do not have a clinically meaningful effect on the pharmacokinetics. The exposure of somapacitan-beco decreases with increasing body weight. However, the somapacitan-beco dose of 0.16 mg/kg/week provides adequate systemic exposure for pediatrics to reach target IGF-1 levels over the weight range of 9.9 to 61.8 kg evaluated in the clinical trials.

Geriatric patients: Adult patients greater than 65 years of age and geriatric patients have a higher exposure than younger subjects at the same somapacitan-beco dose [see Dosage and Administration (2.5) and Use in Specific Populations (8.5)].

Female patients receiving estrogen: Female patients and in particular female patients on oral estrogen, have lower exposure than males at the same somapacitan-beco dose [see Dosage and Administration (2.5) and Drug Interactions (7)].

Hepatic impairment: A somapacitan-beco dose of 0.08 mg/kg at steady state resulted in comparable somapacitan-beco exposure between patients with normal hepatic function and mild hepatic impairment (Child-Pugh A). However, higher exposure was observed in patients with moderate hepatic impairment (Child-Pugh B) (ratios to normal hepatic function were 4.69 and 3.52-fold increase for AUC0-168h and Cmax, respectively). Lower somapacitan-beco stimulated IGF-1 levels were observed in patients with mild and moderate hepatic impairment (ratios to normal hepatic function were 0.85 and 0.75, respectively) [see Dosage and Administration (2.5) and Use in Specific Populations (8.6)].

Renal impairment: In general, somapacitan-beco exposure tended to increase with decreasing estimated glomerular filtration rate. A somapacitan-beco dose of 0.08 mg/kg at steady state resulted in higher exposures in patients with renal impairment, that was most pronounced for patients with severe renal impairment and patients requiring hemodialysis (AUC0-168h ratios to normal renal function were 1.75 and 1.63, respectively). Higher IGF-1 AUC0-168h levels were also observed in patients with moderate and severe renal impairment and in patients requiring hemodialysis (ratios to normal renal function were 1.35, 1.40 and 1.24, respectively).

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, include those of SOGROYA or other growth hormone analogs.

No anti-somapacitan-beco antibodies were detected in the clinical trials in adult patients with GHD.

Anti-somapacitan-beco binding antibodies were evaluated in samples collected at baseline, week 13, and week 52 of treatment in the 52-week main period of the phase 3 trial in pediatric patients with GHD receiving somapacitan-beco. Of the 132 subjects exposed to somapacitan-beco, 16 (12.1%) showed detectable binding antibodies to somapacitan-beco at any time during the main period of the trial following exposure to SOGROYA. 14 out of 16 subjects showed detectable binding antibodies to somapacitan-beco only at one timepoint. Of the 68 patients exposed to daily somatropin, detectable binding antibodies were detected in 7 (10.3%) children. Of these, 6 children had positive antibody samples only at one timepoint. There was no identified clinically significant effect of anti-drug antibodies on pharmacokinetics, pharmacodynamics, safety, or effectiveness of SOGROYA over the treatment duration. No neutralizing antibodies to somapacitan-beco were detected.

Long term studies in animals with somapacitan-beco to evaluate carcinogenic potential have not been conducted.

Somapacitan-beco was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus).

In rat studies evaluating male and female fertility, somapacitan-beco was administered by subcutaneous injection at doses of 1, 2, and 4 mg/kg twice weekly. Males were dosed from four weeks before pairing until termination and females were dosed beginning two weeks prior to mating through gestation day 7. No adverse effects were observed on male or female fertility in rats at doses up to 4 mg/kg (29 times the MRHD, based on AUC).

A randomized, open-label, active-controlled, parallel-group phase 3 study was conducted in 200 treatment-naïve, pediatric patients with growth hormone deficiency (GHD) (NCT03811535). The primary efficacy endpoint was annualized height velocity at Week 52.

One hundred thirty two patients (132) received 0.16 mg/kg/week SOGROYA, and 68 received 0.034 mg/kg/day daily somatropin. The patients ranged in age from 2.5 to 11 years with a mean of 6.4 years. Of these patients, 74.5% were male and 25.5% were female. Fifty-seven percent (57%) of patients were Caucasian, 37% of patients were Asian, 0.5% of patients were Black or African American, 5.0% were not reported, and 0.5% were categorized as “other.” The mean baseline height standard deviation score (SDS) of -2.99 (1.02) in SOGROYA group and -3.47 (1.52) in daily somatropin group.

Treatment with once-weekly SOGROYA for 52 weeks resulted in an annualized height velocity of 11.2 cm/year. Patients treated with daily somatropin achieved an annualized height velocity of 11.7 cm/year after 52 weeks of treatment. Refer to Table 5.

Table 5. Annualized Height Velocity at Week 52 in pediatric patients with GHD

<div class="scrollingtable"><table cellpadding="0pt" width="471pt"> <col width="25%"/> <col width="21%"/> <col width="19%"/> <col width="34%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Once-Weekly SOGROYA</span> </p> <p> <span class="Bold">(N=132)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Daily somatropin</span> </p> <p> <span class="Bold">(N=68)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Estimate of treatment difference (95% CI) (somapacitan-beco minus somatropin)</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Annualized Height Velocity (cm/year)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">11.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">11.7</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.5 [-1.1; 0.2]</p> </td> </tr> </tbody> </table></div>

The mean increase in height SDS over the 52 week period was 1.25 and 1.30 in the once-weekly SOGROYA and daily somatropin groups, respectively.

In a 35-week, double-blind, placebo-controlled study, treatment-naïve adult patients with GHD were randomized (2:1:2) and exposed to once-weekly SOGROYA 10 mg/1.5mL (n=120) or placebo (n=60) or a daily somatropin product 10 mg/1.5mL (n=119) for a 34-week treatment period (NCT02229851).

In this study, patients were 51.7% female and had a mean age of 45.1 years. Most patients were 23 to 64 years old and most (69.7%) had adult onset GHD. The mean BMI was 27.4 kg/m2. Overall, 66.7% were White, 28.7% were Asian and 2.3% were Black or African American; 4.5% identified as Hispanic or Latino ethnicity.

Treatment with SOGROYA demonstrated superiority compared to placebo in reduction in truncal fat percentage (%) as assessed by dual X-ray absorptiometry, with a change of -1.06% for SOGROYA and +0.47% for placebo after 34 weeks (see Table 6). Patients treated with daily somatropin achieved a change in truncal fat % of -2.23% after 34 weeks.

Table 6. Truncal Fat % Results for weekly SOGROYA, weekly placebo and daily somatropin during the 34-week pivotal trial

<div class="scrollingtable"><table cellpadding="0pt" width="100%"> <col width="39%"/> <col width="13%"/> <col width="14%"/> <col width="16%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Change from baseline at 34 weeks </span></th><th align="center" class="Botrule Rrule Toprule" valign="middle"><span class="Bold">Weekly Placebo</span></th><th align="center" class="Botrule Rrule Toprule" valign="middle"><span class="Bold">Weekly</span> <br/> <span class="Bold">SOGROYA</span></th><th align="center" class="Botrule Rrule Toprule" valign="middle"><span class="Bold">Daily</span> <br/> <span class="Bold">Somatropin</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Number of subjects in FAS (N)</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">61</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">120</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">119</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Truncal fat % (baseline)</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">36.9</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">39.11</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">38.10</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Truncal fat %</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">0.47</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">-1.06</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">-2.23</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Absolute Treatment Difference (%)*</p> <p>[95% Confidence Interval]</p> <p>p-value</p> </td><td align="center" class="Botrule Rrule" colspan="2" valign="middle"> <p class="First">-1.53</p> <p>[-2.68; -0.38]</p> <p>0.0090</p> </td><td class="Botrule Rrule" valign="middle"></td> </tr> </tbody> </table></div>

After 34 weeks SOGROYA normalized the mean IGF-1 SDS level in treatment-naïve adult patients with GHD with a IGF-1 SDS of -0.17 in SOGROYA-treated patients compared to -2.62 in placebo-treated patients (see Table 7). The mean IGF-1 SDS levels in daily somatropin-treated patients was -2.53 at baseline and -0.23 at 34 weeks.

Table 7. IGF-1 SDS for SOGROYA compared to placebo during the 34-week pivotal trial

<div class="scrollingtable"><table cellpadding="2.85pt" width="369pt"> <col width="47%"/> <col width="14%"/> <col width="16%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule Toprule" valign="middle"></th><th align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">SOGROYA</span></th><th align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Placebo</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Number of subjects in FAS (N)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">120</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">61</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">IGF-1 SDS values at baseline, mean</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-2.54</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-2.64</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">IGF-1 SDS value at week 34, mean</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.17</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-2.62</p> </td> </tr> </tbody> </table></div>

How Supplied

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SOGROYA (somapacitan-beco) injection is a clear to slightly opalescent and colorless to slightly yellow solution available as one 1.5 mL single-patient-use prefilled pen per carton:

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Storage and Handling

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Before and during use: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) with the cap on and in the original carton to protect from light. Do not freeze. Do not use SOGROYA if it has been frozen. Discard prefilled pen if kept above 86°F (30°C). Avoid direct or excessive heat. Avoid sunlight. Refer to storage conditions for SOGROYA (Table 8).

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Write the date of first use in the space provided on the carton.

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Always remove and safely discard the needle after each injection and store the SOGROYA prefilled pen without an injection needle attached. Always use a new needle for each injection to prevent contamination.

{ "type": "p", "children": [], "text": "Always remove and safely discard the needle after each injection and store the SOGROYA prefilled pen without an injection needle attached. Always use a new needle for each injection to prevent contamination." }

Table 8. Storage conditions for SOGROYA

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<div class="scrollingtable"><table width="100%"> <col width="15%"/> <col width="21%"/> <col width="23%"/> <col width="20%"/> <col width="21%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Before first use (unopened)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">After first use (opened)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Refrigerated</span> </p> <p> <span class="Bold">36°F to 46°F</span> </p> <p> <span class="Bold">(2°C to 8°C)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Room Temperature</span> </p> <p> <span class="Bold">up to 77°F (25°C)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Refrigerated</span> </p> <p> <span class="Bold">36°F to 46°F</span> </p> <p> <span class="Bold">(2°C to 8°C)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Room Temperature</span> </p> <p> <span class="Bold">up to 77°F (25°C)</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">SOGROYA </span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Until expiration date</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Maximum 72 hours (3 days)*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">up to 6 weeks</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Maximum 72 hours (3 days)*</p> </td> </tr> </tbody> </table></div>

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

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Novo Nordisk® and PenMate® are registered trademarks of Novo Nordisk A/S.

{ "type": "p", "children": [], "text": "\nNovo Nordisk® and PenMate® are registered trademarks of Novo Nordisk A/S.\n" }

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

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

© 2025 Novo Nordisk Health Care AG

{ "type": "p", "children": [], "text": "© 2025 Novo Nordisk Health Care AG" }

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

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For information about SOGROYA contact:

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Novo Nordisk Inc.

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

800 Scudders Mill Road

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

Plainsboro, New Jersey 08536

{ "type": "p", "children": [], "text": "Plainsboro, New Jersey 08536" }

1-888-668-6444

{ "type": "p", "children": [], "text": "1-888-668-6444" }

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

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

U.S. License No. 1261

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

<div class="scrollingtable"><table width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">PATIENT INFORMATION</span> </p> <p>SOGROYA<span class="Sup">® </span>(suh-GROY-uh) </p> <p>(somapacitan-beco) injection, for subcutaneous use</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What is SOGROYA?</span> </p> <dl> <dt>•</dt> <dd>SOGROYA is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.</dd> <dt>•</dt> <dd>SOGROYA is given by injection under the skin (subcutaneous) and is used to treat adults and children 2.5 years and older who do not make enough growth hormone.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Do not use SOGROYA 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 have cancer or other tumors.</dd> <dt>•</dt> <dd>you are allergic to somapacitan-beco or any of the ingredients in SOGROYA. See the end of this Patient Information leaflet for a complete list of ingredients in SOGROYA.</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.</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).</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Before taking SOGROYA, 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 cancer or any tumor.</dd> <dt>•</dt> <dd>have diabetes.</dd> <dt>•</dt> <dd>have adrenal gland problems.</dd> <dt>•</dt> <dd>are taking replacement therapy with glucocorticoids.</dd> <dt>•</dt> <dd>have thyroid gland problems.</dd> <dt>•</dt> <dd>have liver problems.</dd> <dt>•</dt> <dd>are a child with a history of worsening of curvature of the spine (scoliosis).</dd> <dt>•</dt> <dd>are pregnant or plan to become pregnant. It is not known if SOGROYA 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 SOGROYA passes into your breast milk. You and your healthcare provider should decide if you will take SOGROYA 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. SOGROYA may affect how other medicines work, and other medicines may affect how SOGROYA works.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I use SOGROYA?</span> </p> <dl> <dt>•</dt> <dd>Read the detailed <span class="Bold">Instructions for Use </span>that come with SOGROYA.</dd> <dt>•</dt> <dd>SOGROYA comes in 3 strengths: 5 mg/1.5 mL (3.3 mg/mL) pen, 10 mg/1.5 mL (6.7 mg/mL) pen, and 15 mg/1.5 mL (10 mg/mL) pen. 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 SOGROYA.</dd> <dt>•</dt> <dd>Use SOGROYA exactly as your healthcare provider tells you to.</dd> <dt>•</dt> <dd>Use SOGROYA <span class="Bold">1 time each week.</span> </dd> <dt>•</dt> <dd>If you miss a dose of SOGROYA, the missed dose can be taken within <span class="Bold">3</span> days (72 hours) after the scheduled dosing day. One-time weekly dosing for the next dose can be started again on the regularly scheduled dosing day. </dd> <dt>•</dt> <dd>If more than 3 days (72 hours) have passed, skip the missed dose and take your next dose on the regularly scheduled dosing day.<dl> <dt>•</dt> <dd>SOGROYA pens are for use by 1 person only.</dd> <dt>•</dt> <dd> <span class="Bold">Do not share your SOGROYA 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="Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of SOGROYA?</span> </p> <p> <span class="Bold">SOGROYA 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>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 start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child’s skin.</dd> <dt>•</dt> <dd>new or worsening high blood sugar (hyperglycemia) or diabetes. You or your child’s blood sugar may need to be monitored during treatment with SOGROYA.</dd> <dt>•</dt> <dd>increase in pressure in the skull (intracranial hypertension). If you or your child have 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 have the following symptoms:</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <dl> <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> </dl> </td><td class="Botrule Rrule" valign="top"> <dl> <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> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>your or your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your or your child’s joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Tell your or your child’s healthcare provider if you or your child 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 SOGROYA works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels.</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 or your child inject. Talk to your or your child’s healthcare provider about rotating the areas where you or your child inject SOGROYA.</dd> <dt>•</dt> <dd>worsening of curvature of the spine in children (scoliosis).</dd> <dt>•</dt> <dd>hip and knee pain or a limp in children (slipped capital femoral epiphysis).</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. See “<span class="Bold">Do not use SOGROYA if</span>”.</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 class="First"> <span class="Bold">The most common side effects of SOGROYA in children include:</span> </p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <dl> <dt>o</dt> <dd>common cold</dd> <dt>o</dt> <dd>headache</dd> <dt>o</dt> <dd>fever</dd> </dl> </td><td class="Botrule Rrule Toprule" valign="top"> <dl> <dt>o</dt> <dd>pain in extremity</dd> <dt>o</dt> <dd>reaction to injection</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">The most common side effects of SOGROYA in adults include:</span> </p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <dl> <dt>o</dt> <dd>back pain</dd> <dt>o</dt> <dd>joint pain </dd> <dt>o</dt> <dd>indigestion</dd> <dt>o</dt> <dd>sleep problems</dd> <dt>o</dt> <dd>dizziness</dd> <dt>o</dt> <dd>swelling of the tonsils (tonsillitis)</dd> </dl> </td><td class="Botrule Rrule Toprule" valign="top"> <dl> <dt>o</dt> <dd>vomiting</dd> <dt>o</dt> <dd>high blood pressure</dd> <dt>o</dt> <dd>increase in the level of an enzyme in your blood called creatine phosphokinase </dd> <dt>o</dt> <dd>weight gain</dd> <dt>o</dt> <dd>low red blood cells (anemia)</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">These are not all the possible side effects of SOGROYA.</p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> <p>You may also report side effects to 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 store SOGROYA?</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Before you use SOGROYA pens for the first time:</span> </dd> <dt>o</dt> <dd>Store your new, unused SOGROYA pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).</dd> <dt>o</dt> <dd>Store your new, unused SOGROYA pen with the cap on and keep it in the original carton.</dd> <dt>o</dt> <dd>Do not freeze SOGROYA.</dd> <dt>o</dt> <dd>Keep SOGROYA away from direct heat and light.</dd> <dt>o</dt> <dd>Do not use SOGROYA that has been frozen or in temperatures warmer than 86ºF (30ºC).</dd> <dt>o</dt> <dd>Do not use SOGROYA after the expiration date printed on the carton and the pen.</dd> <dt>•</dt> <dd> <span class="Bold">After you use SOGROYA pens and there is still medicine left: </span> </dd> <dt>o</dt> <dd>Store remaining SOGROYA in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 6 weeks. </dd> <dt>o</dt> <dd>Store your in-use SOGROYA pen with the cap on and keep it in the original carton.</dd> <dt>•</dt> <dd>If needed, unused and in-use SOGROYA pens can be stored out of the refrigerator. SOGROYA pens can be stored at room temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator. </dd> </dl> <p> <span class="Bold">Keep SOGROYA 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">General information about the safe and effective use of SOGROYA.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOGROYA for a condition for which it was not prescribed. Do not give SOGROYA 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 SOGROYA that is written for health professionals.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in SOGROYA?</span> </p> <p> <span class="Bold">Active ingredient:</span> somapacitan-beco</p> <p> <span class="Bold">Inactive ingredients</span>: histidine, mannitol, phenol, poloxamer 188, Water for Injection, and hydrochloric acid and sodium hydroxide (as needed)</p> <p>Manufactured by: Novo Nordisk Inc., Plainsboro, NJ 08536 </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">PATIENT INFORMATION</span>\n</p>\n<p>SOGROYA<span class=\"Sup\">® </span>(suh-GROY-uh) </p>\n<p>(somapacitan-beco) injection, for subcutaneous use</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 is SOGROYA?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>SOGROYA is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.</dd>\n<dt>•</dt>\n<dd>SOGROYA is given by injection under the skin (subcutaneous) and is used to treat adults and children 2.5 years and older who do not make enough growth hormone.</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\">Do not use SOGROYA 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 have cancer or other tumors.</dd>\n<dt>•</dt>\n<dd>you are allergic to somapacitan-beco or any of the ingredients in SOGROYA. See the end of this Patient Information leaflet for a complete list of ingredients in SOGROYA.</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.</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).</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\">Before taking SOGROYA, 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 cancer or any tumor.</dd>\n<dt>•</dt>\n<dd>have diabetes.</dd>\n<dt>•</dt>\n<dd>have adrenal gland problems.</dd>\n<dt>•</dt>\n<dd>are taking replacement therapy with glucocorticoids.</dd>\n<dt>•</dt>\n<dd>have thyroid gland problems.</dd>\n<dt>•</dt>\n<dd>have liver problems.</dd>\n<dt>•</dt>\n<dd>are a child with a history of worsening of curvature of the spine (scoliosis).</dd>\n<dt>•</dt>\n<dd>are pregnant or plan to become pregnant. It is not known if SOGROYA 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 SOGROYA passes into your breast milk. You and your healthcare provider should decide if you will take SOGROYA 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. SOGROYA may affect how other medicines work, and other medicines may affect how SOGROYA works.</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 use SOGROYA?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Read the detailed <span class=\"Bold\">Instructions for Use </span>that come with SOGROYA.</dd>\n<dt>•</dt>\n<dd>SOGROYA comes in 3 strengths: 5 mg/1.5 mL (3.3 mg/mL) pen, 10 mg/1.5 mL (6.7 mg/mL) pen, and 15 mg/1.5 mL (10 mg/mL) pen. 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 SOGROYA.</dd>\n<dt>•</dt>\n<dd>Use SOGROYA exactly as your healthcare provider tells you to.</dd>\n<dt>•</dt>\n<dd>Use SOGROYA <span class=\"Bold\">1 time each week.</span>\n</dd>\n<dt>•</dt>\n<dd>If you miss a dose of SOGROYA, the missed dose can be taken within <span class=\"Bold\">3</span> days (72 hours) after the scheduled dosing day. One-time weekly dosing for the next dose can be started again on the regularly scheduled dosing day. </dd>\n<dt>•</dt>\n<dd>If more than 3 days (72 hours) have passed, skip the missed dose and take your next dose on the regularly scheduled dosing day.<dl>\n<dt>•</dt>\n<dd>SOGROYA pens are for use by 1 person only.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not share your SOGROYA 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=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of SOGROYA?</span>\n</p>\n<p>\n<span class=\"Bold\">SOGROYA 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>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 start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child’s skin.</dd>\n<dt>•</dt>\n<dd>new or worsening high blood sugar (hyperglycemia) or diabetes. You or your child’s blood sugar may need to be monitored during treatment with SOGROYA.</dd>\n<dt>•</dt>\n<dd>increase in pressure in the skull (intracranial hypertension). If you or your child have 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 have the following symptoms:</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<dl>\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</dl>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\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</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>your or your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your or your child’s joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Tell your or your child’s healthcare provider if you or your child 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 SOGROYA works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels.</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 or your child inject. Talk to your or your child’s healthcare provider about rotating the areas where you or your child inject SOGROYA.</dd>\n<dt>•</dt>\n<dd>worsening of curvature of the spine in children (scoliosis).</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>high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea. See “<span class=\"Bold\">Do not use SOGROYA if</span>”.</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 class=\"First\">\n<span class=\"Bold\">The most common side effects of SOGROYA in children include:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>common cold</dd>\n<dt>o</dt>\n<dd>headache</dd>\n<dt>o</dt>\n<dd>fever</dd>\n</dl>\n</td><td class=\"Botrule Rrule Toprule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>pain in extremity</dd>\n<dt>o</dt>\n<dd>reaction to injection</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\">The most common side effects of SOGROYA in adults include:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>back pain</dd>\n<dt>o</dt>\n<dd>joint pain </dd>\n<dt>o</dt>\n<dd>indigestion</dd>\n<dt>o</dt>\n<dd>sleep problems</dd>\n<dt>o</dt>\n<dd>dizziness</dd>\n<dt>o</dt>\n<dd>swelling of the tonsils (tonsillitis)</dd>\n</dl>\n</td><td class=\"Botrule Rrule Toprule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>vomiting</dd>\n<dt>o</dt>\n<dd>high blood pressure</dd>\n<dt>o</dt>\n<dd>increase in the level of an enzyme in your blood called creatine phosphokinase </dd>\n<dt>o</dt>\n<dd>weight gain</dd>\n<dt>o</dt>\n<dd>low red blood cells (anemia)</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">These are not all the possible side effects of SOGROYA.</p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p>\n<p>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\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store SOGROYA?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Before you use SOGROYA pens for the first time:</span>\n</dd>\n<dt>o</dt>\n<dd>Store your new, unused SOGROYA pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).</dd>\n<dt>o</dt>\n<dd>Store your new, unused SOGROYA pen with the cap on and keep it in the original carton.</dd>\n<dt>o</dt>\n<dd>Do not freeze SOGROYA.</dd>\n<dt>o</dt>\n<dd>Keep SOGROYA away from direct heat and light.</dd>\n<dt>o</dt>\n<dd>Do not use SOGROYA that has been frozen or in temperatures warmer than 86ºF (30ºC).</dd>\n<dt>o</dt>\n<dd>Do not use SOGROYA after the expiration date printed on the carton and the pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">After you use SOGROYA pens and there is still medicine left: </span>\n</dd>\n<dt>o</dt>\n<dd>Store remaining SOGROYA in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 6 weeks. </dd>\n<dt>o</dt>\n<dd>Store your in-use SOGROYA pen with the cap on and keep it in the original carton.</dd>\n<dt>•</dt>\n<dd>If needed, unused and in-use SOGROYA pens can be stored out of the refrigerator. SOGROYA pens can be stored at room temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator. </dd>\n</dl>\n<p>\n<span class=\"Bold\">Keep SOGROYA 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\">General information about the safe and effective use of SOGROYA.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOGROYA for a condition for which it was not prescribed. Do not give SOGROYA 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 SOGROYA that is written for health professionals.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in SOGROYA?</span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span> somapacitan-beco</p>\n<p>\n<span class=\"Bold\">Inactive ingredients</span>: histidine, mannitol, phenol, poloxamer 188, Water for Injection, and hydrochloric acid and sodium hydroxide (as needed)</p>\n<p>Manufactured by: Novo Nordisk Inc., Plainsboro, NJ 08536 </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: 04/2023

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 04/2023" }

<div class="scrollingtable"><table width="100%"> <col width="37%"/> <col width="63%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Instructions for Use</span> </p> <p> <span class="Bold">SOGROYA<span class="Sup">® </span>5 mg</span> </p> <p> <span class="Bold">(suh-GROY-uh) </span> </p> <p> <span class="Bold">(somapacitan-beco) injection</span> </p> <p> <span class="Bold">5 mg/1.5 mL (3.3 mg/mL)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id137690321"></a><img alt="5mg-pen-body" src="/dailymed/image.cfm?name=5mg-pen-body.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id-1807457816"></a><img alt="5mg-pen-cap" src="/dailymed/image.cfm?name=5mg-pen-cap-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id747927138"></a><img alt="5mg-needle-parts" src="/dailymed/image.cfm?name=5mg-needle-parts-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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>SOGROYA prefilled Pen</dd> <dt>•</dt> <dd>new injection needle. SOGROYA 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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-432441128"></a><img alt="supplies" src="/dailymed/image.cfm?name=supplies-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How to use your SOGROYA Pen</span> </p> <p> <span class="Bold">5 steps you should follow for a SOGROYA injection:</span> </p> <p> <span class="Bold">Step 1</span>: Prepare your SOGROYA Pen </p> <p> <span class="Bold">Step 2</span>: Check the SOGROYA flow with each new Pen</p> <p> <span class="Bold">Step 3</span>: Select your dose</p> <p> <span class="Bold">Step 4</span>: Inject your dose</p> <p> <span class="Bold">Step 5</span>: After your injection</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">For further information about your Pen see:</span> Frequently Asked Questions and</p> <p>Important information </p> <p> <span class="Bold"><a name="id-1566644085"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></span><span class="Bold">Important information</span> </p> <p>Pay special attention to these notes as they are important for safe use of the Pen.</p> <p> <a name="id-1404360618"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Additional information</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">SOGROYA is a prefilled growth hormone Pen. It contains 5 mg of somapacitan-beco and delivers doses from 0.025 mg to 2.0 mg, in increments of 0.025 mg. <span class="Bold">SOGROYA is for use under the skin only (subcutaneous) for injection 1 time each week.</span> </p> <p> <span class="Bold">Do not</span> share your SOGROYA 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>Make sure that you are confident in giving an injection with the Pen before you start your treatment. 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 SOGROYA 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 SOGROYA 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 SOGROYA in your Pen is clear to almost clear and colorless to slightly yellow (See Figure A). <span class="Bold">If SOGROYA looks cloudy or you see particles, do not use the Pen.</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1455836123"></a><img alt="figure-a" src="/dailymed/image.cfm?name=figure-a-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>When you are ready to give your injection, get 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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1572070712"></a><img alt="figure-b" src="/dailymed/image.cfm?name=figure-b-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <a name="id-1447463898"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-01.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Make sure the right pen is used. </span>Especially if you use more than one type of injection medicine. Using the wrong medicine could be harmful to your health.</dd> </dl> <p class="First"> <span class="Bold"><a name="id916974975"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-02.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></span><span class="Bold">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the outer needle cap and throw it away (dispose of) (See Figure C).</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-272638383"></a><img alt="figure-c" src="/dailymed/image.cfm?name=figure-c-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the inner needle cap and throw it away (dispose of) (See Figure D).</dd> </dl> <p class="First"> <a name="id-170254963"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> A drop of SOGROYA may appear at the needle tip. This is normal, but you must still check the SOGROYA flow with each new Pen (See Step 2).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id719260621"></a><img alt="figure-d" src="/dailymed/image.cfm?name=figure-d-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id-206573694"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-03.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Never use a bent or damaged needle.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2. Check the SOGROYA flow with each new Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id-2064017047"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">If your Pen is already in use</span>, go to Step 3.</p> <dl> <dt>•</dt> <dd> <span class="Bold">Before using a new Pen</span>, check the SOGROYA flow to make sure the growth hormone can flow through the Pen and needle.</dd> <dt>•</dt> <dd>Turn the dose selector clockwise 1 marking on the dose counter to select 0.025 mg. You may hear a faint “click” when you turn the dose selector (See Figure E).</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id174625473"></a><img alt="figure-e" src="/dailymed/image.cfm?name=figure-e-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id455917109"></a><img alt="figure-f" src="/dailymed/image.cfm?name=figure-f-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1588111248"></a><img alt="figure-g" src="/dailymed/image.cfm?name=figure-g-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check that a drop of SOGROYA appears at the needle tip (See Figure H).</dd> </dl> <p class="First"> <a name="id-1289429207"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> If no SOGROYA appears</span>, repeat Step 2 up to 6 times. </p> <p>If you still do not see a drop of SOGROYA, <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>Repeat Step 2 again.</dd> </dl> <p> <span class="Bold">Do not use the Pen if a drop of SOGROYA still does not appear after changing the needle and repeating Step 2. Call Novo Nordisk at 1-888-668-6444 for help.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1519884199"></a><img alt="figure-h" src="/dailymed/image.cfm?name=figure-h-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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). When you have selected your dose, you can go to Step 4. </dd> </dl> <p class="First"> <a name="id-2091925024"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-04.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> If there is not enough SOGROYA left </span>to select a full dose, see <span class="Bold">Frequently Asked Questions</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id257487903"></a><img alt="figure-i" src="/dailymed/image.cfm?name=figure-i-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id288564578"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-05.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> The dose counter shows the dose in “mg” (See Figure J and Figure 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 to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id560073539"></a><img alt="figure-j" src="/dailymed/image.cfm?name=figure-i-04.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id-1420402032"></a><img alt="figure-k" src="/dailymed/image.cfm?name=figure-k-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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"> <a name="id1594123171"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-06.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose (See Figure L).</p> <p>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.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id898181591"></a><img alt="figure-l" src="/dailymed/image.cfm?name=figure-l-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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>SOGROYA can be injected under the skin (subcutaneously) of your stomach area (abdomen) or upper legs (thighs) as instructed by your healthcare provider (See Figure M). <span class="Bold">Change the injection site every week.</span> </dd> <dt>•</dt> <dd>Wipe the injection site with an alcohol pad and let the area dry.</dd> <dt>•</dt> <dd>Insert the needle into your skin as your healthcare provider has shown you (See Figure N).</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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1544558797"></a><img alt="figure-m" src="/dailymed/image.cfm?name=figure-m-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id-1102172957"></a><img alt="figure-n" src="/dailymed/image.cfm?name=figure-n-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 O). <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 down the dose button with the needle in your skin.</span> </dd> </dl> <p class="First"> <a name="id-876389152"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-07.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> If “0” does not appear in the dose</p> <p>counter after continuously pressing the dose button, your needle may be blocked or damaged. See <span class="Bold">Frequently Asked Questions</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1658490848"></a><img alt="figure-o" src="/dailymed/image.cfm?name=figure-o-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Keep holding down the dose button with the needle in your skin and</span><span class="Bold">slowly count to 6</span> to make sure that the full dose has been delivered (See Figure P).</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id909123774"></a><img alt="figure-p" src="/dailymed/image.cfm?name=figure-o-04.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from your skin (See Figure Q). If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd> </dl> <p class="First"> <a name="id1324080303"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-08.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> You may see a drop of SOGROYA at the needle tip after injecting. This is normal and does not affect your dose.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-827214435"></a><img alt="figure-q" src="/dailymed/image.cfm?name=figure-q-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 R).</dd> <dt>•</dt> <dd>Place the needle in an FDA-cleared sharps disposal container immediately to reduce the risk of a needle stick (See Figure R).</dd> </dl> <p class="First"> <a name="id-1647203593"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-09.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> Always throw away (dispose of) the needle after each injection. </p> <p>For further information about safe sharps disposal, see <span class="Bold">Frequently Asked Questions</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-685824391"></a><img alt="figure-r" src="/dailymed/image.cfm?name=figure-r-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 SOGROYA from direct light (See Figure S). </dd> <dt> </dt> <dd>See “<span class="Bold">How should I store my SOGROYA Pen?</span>”.</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1194116182"></a><img alt="figure-s" src="/dailymed/image.cfm?name=figure-s-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id417444282"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-04.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Do not try to put the needle cap back on.</span> You may stick yourself with the needle.</p> <p> <a name="id-1713028074"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-05.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/>Always remove the needle from your Pen immediately after each injection. This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I store my SOGROYA Pen?</span> </p> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <span class="Bold">Before you use SOGROYA Pen for the first time: </span> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> <dt>•</dt> <dd>Store your new, unused SOGROYA Pen in a refrigerator between 36°F to 46°F (2°C to 8°C). </dd> <dt>•</dt> <dd>Store your new, unused SOGROYA Pen with the cap on and in the original carton.</dd> <dt>•</dt> <dd>Do not freeze SOGROYA. </dd> <dt>•</dt> <dd>When stored in the refrigerator, do not store the SOGROYA Pen directly next to the cooling element. </dd> <dt>•</dt> <dd>Keep SOGROYA away from direct heat and light.</dd> <dt>•</dt> <dd>Do not use SOGROYA if it has been frozen or in temperatures warmer than 86ºF (30°C). </dd> <dt>•</dt> <dd>Do not use SOGROYA after the expiration date printed on the carton and the Pen. </dd> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <span class="Bold">After you use SOGROYA Pen and there is still medicine left:</span> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> <dt>•</dt> <dd>Store remaining SOGROYA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 6 weeks.</dd> <dt>•</dt> <dd>Store your in-use SOGROYA Pen with the cap on and keep it in the original carton.</dd> </dl> <p> <span class="Bold">Do not store SOGROYA Pen with the needle attached. </span> </p> <p>If needed, unused and in-use SOGROYA pens can be stored out of the refrigerator. SOGROYA pens can be stored at room temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator. Throw away (dispose of) SOGROYA if it has been stored above 77°F (25°C) for more than 3 days (72 hours) <span class="Bold">or </span>in temperatures warmer than 86°F (30°C).</p> <p> <span class="Bold">Always keep your SOGROYA Pen and needles out of reach of others, especially children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 much SOGROYA is 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 SOGROYA is left in your Pen (See Figure T).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1630203507"></a><img alt="figure-t" src="/dailymed/image.cfm?name=figure-t-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">To see how much SOGROYA is left in your Pen, use the dose counter:</p> <p>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”, at least 2.0 mg are left in your Pen.</p> <p>If the dose counter stops with the dose pointer lined up with “1.7”, only 1.7 mg are left in your Pen (See Figure U).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id718635904"></a><img alt="figure-u" src="/dailymed/image.cfm?name=figure-u-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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. If you need more SOGROYA 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 </span>so that you do not give the wrong dose. If you are not sure how to split your dose using 2 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 SOGROYA appears when I check the flow?</span> </p> <p> <span class="Bold">A. Your needle may be blocked or damaged,</span> if no SOGROYA appears at the needle tip. Remove the needle as described in Step 5 and repeat Step 1 and Step 2.</p> <p> <span class="Bold">B. Your Pen may be defective,</span> if SOGROYA 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 SOGROYA</span>,<span class="Bold"></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 Step 1 to Step 4.</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. See “<span class="Bold">How should I store SOGROYA?</span>” Do not try to refill your Pen, it is prefilled.</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 SOGROYA flow before you inject (See Step 1 and Step 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"></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 throw away (dispose of) used SOGROYA</span><span class="Bold">needles and Pens?</span> </p> <p>Put your used needles and Pens in an 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> 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: </p> <p> <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. Do not recycle your used sharps disposal container.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id1415671656"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-06.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> Important information</span> </p> <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> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">PATENT Information: http://novonordisk-us.com/products/product-patents.html</p> <p>SOGROYA<span class="Sup">®</span> is a registered trademark of Novo Nordisk Health Care AG.</p> <p>Novo Nordisk<span class="Sup">®</span> is a registered trademark of Novo Nordisk A/S.</p> <p>© 2004-2023 Novo Nordisk Health Care AG</p> <p>For further information contact:</p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road </p> <p>Plainsboro, NJ 08536, USA </p> <p>1-888-668-6444</p> <p>Sogroya.com</p> <p>Manufactured by:</p> <p>Novo Nordisk Inc.</p> <p>Plainsboro, NJ 08536</p> <p>U.S. License No. 1261</p> <p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p>Issued: 10/2021</p> <p>Version: 1</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"37%\"/>\n<col width=\"63%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Instructions for Use</span>\n</p>\n<p>\n<span class=\"Bold\">SOGROYA<span class=\"Sup\">® </span>5 mg</span>\n</p>\n<p>\n<span class=\"Bold\">(suh-GROY-uh) </span>\n</p>\n<p>\n<span class=\"Bold\">(somapacitan-beco) injection</span>\n</p>\n<p>\n<span class=\"Bold\">5 mg/1.5 mL (3.3 mg/mL)</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id137690321\"></a><img alt=\"5mg-pen-body\" src=\"/dailymed/image.cfm?name=5mg-pen-body.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id-1807457816\"></a><img alt=\"5mg-pen-cap\" src=\"/dailymed/image.cfm?name=5mg-pen-cap-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id747927138\"></a><img alt=\"5mg-needle-parts\" src=\"/dailymed/image.cfm?name=5mg-needle-parts-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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>SOGROYA prefilled Pen</dd>\n<dt>•</dt>\n<dd>new injection needle. SOGROYA 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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-432441128\"></a><img alt=\"supplies\" src=\"/dailymed/image.cfm?name=supplies-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 SOGROYA Pen</span>\n</p>\n<p>\n<span class=\"Bold\">5 steps you should follow for a SOGROYA injection:</span>\n</p>\n<p>\n<span class=\"Bold\">Step 1</span>: Prepare your SOGROYA Pen </p>\n<p>\n<span class=\"Bold\">Step 2</span>: Check the SOGROYA flow with each new Pen</p>\n<p>\n<span class=\"Bold\">Step 3</span>: Select your dose</p>\n<p>\n<span class=\"Bold\">Step 4</span>: Inject your dose</p>\n<p>\n<span class=\"Bold\">Step 5</span>: After your injection</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\">For further information about your Pen see:</span> Frequently Asked Questions and</p>\n<p>Important information </p>\n<p>\n<span class=\"Bold\"><a name=\"id-1566644085\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></span><span class=\"Bold\">Important information</span>\n</p>\n<p>Pay special attention to these notes as they are important for safe use of the Pen.</p>\n<p>\n<a name=\"id-1404360618\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><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\">SOGROYA is a prefilled growth hormone Pen. It contains 5 mg of somapacitan-beco and delivers doses from 0.025 mg to 2.0 mg, in increments of 0.025 mg. <span class=\"Bold\">SOGROYA is for use under the skin only (subcutaneous) for injection 1 time each week.</span>\n</p>\n<p>\n<span class=\"Bold\">Do not</span> share your SOGROYA 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>Make sure that you are confident in giving an injection with the Pen before you start your treatment. 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 SOGROYA 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 SOGROYA 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 SOGROYA in your Pen is clear to almost clear and colorless to slightly yellow (See Figure A). <span class=\"Bold\">If SOGROYA looks cloudy or you see particles, do not use the Pen.</span>\n</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1455836123\"></a><img alt=\"figure-a\" src=\"/dailymed/image.cfm?name=figure-a-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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, get 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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1572070712\"></a><img alt=\"figure-b\" src=\"/dailymed/image.cfm?name=figure-b-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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-1447463898\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-01.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Make sure the right pen is used. </span>Especially if you use more than one type of injection medicine. Using the wrong medicine could be harmful to your health.</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\"><a name=\"id916974975\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-02.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></span><span class=\"Bold\">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p>\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 throw it away (dispose of) (See Figure C).</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-272638383\"></a><img alt=\"figure-c\" src=\"/dailymed/image.cfm?name=figure-c-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 (dispose of) (See Figure D).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-170254963\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> A drop of SOGROYA may appear at the needle tip. This is normal, but you must still check the SOGROYA flow with each new Pen (See Step 2).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id719260621\"></a><img alt=\"figure-d\" src=\"/dailymed/image.cfm?name=figure-d-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-206573694\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-03.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Never use a bent or damaged needle.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 SOGROYA flow with each new Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-2064017047\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">If your Pen is already in use</span>, go to Step 3.</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Before using a new Pen</span>, check the SOGROYA 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 marking on the dose counter to select 0.025 mg. You may hear a faint “click” when you turn the dose selector (See Figure E).</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id174625473\"></a><img alt=\"figure-e\" src=\"/dailymed/image.cfm?name=figure-e-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id455917109\"></a><img alt=\"figure-f\" src=\"/dailymed/image.cfm?name=figure-f-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1588111248\"></a><img alt=\"figure-g\" src=\"/dailymed/image.cfm?name=figure-g-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 SOGROYA appears at the needle tip (See Figure H).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-1289429207\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> If no SOGROYA appears</span>, repeat Step 2 up to 6 times. </p>\n<p>If you still do not see a drop of SOGROYA, <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>Repeat Step 2 again.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Do not use the Pen if a drop of SOGROYA still does not appear after changing the needle and repeating Step 2. Call Novo Nordisk at 1-888-668-6444 for help.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1519884199\"></a><img alt=\"figure-h\" src=\"/dailymed/image.cfm?name=figure-h-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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). When you have selected your dose, you can go to Step 4. </dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-2091925024\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-04.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> If there is not enough SOGROYA left </span>to select a full dose, see <span class=\"Bold\">Frequently Asked Questions</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id257487903\"></a><img alt=\"figure-i\" src=\"/dailymed/image.cfm?name=figure-i-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id288564578\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-05.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> The dose counter shows the dose in “mg” (See Figure J and Figure 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 to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id560073539\"></a><img alt=\"figure-j\" src=\"/dailymed/image.cfm?name=figure-i-04.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id-1420402032\"></a><img alt=\"figure-k\" src=\"/dailymed/image.cfm?name=figure-k-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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\">\n<a name=\"id1594123171\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-06.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose (See Figure L).</p>\n<p>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.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id898181591\"></a><img alt=\"figure-l\" src=\"/dailymed/image.cfm?name=figure-l-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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>SOGROYA can be injected under the skin (subcutaneously) of your stomach area (abdomen) or upper legs (thighs) as instructed by your healthcare provider (See Figure M). <span class=\"Bold\">Change the injection site every week.</span>\n</dd>\n<dt>•</dt>\n<dd>Wipe the injection site with an alcohol pad 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 N).</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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1544558797\"></a><img alt=\"figure-m\" src=\"/dailymed/image.cfm?name=figure-m-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id-1102172957\"></a><img alt=\"figure-n\" src=\"/dailymed/image.cfm?name=figure-n-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 O). <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 down the dose button with the needle in your skin.</span>\n</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-876389152\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-07.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> If “0” does not appear in the dose</p>\n<p>counter after continuously pressing the dose button, your needle may be blocked or damaged. See <span class=\"Bold\">Frequently Asked Questions</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1658490848\"></a><img alt=\"figure-o\" src=\"/dailymed/image.cfm?name=figure-o-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 holding down the dose button with the needle in your skin and</span><span class=\"Bold\">slowly count to 6</span> to make sure that the full dose has been delivered (See Figure P).</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id909123774\"></a><img alt=\"figure-p\" src=\"/dailymed/image.cfm?name=figure-o-04.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 Q). If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id1324080303\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-08.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> You may see a drop of SOGROYA at the needle tip after injecting. This is normal and does not affect your dose.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-827214435\"></a><img alt=\"figure-q\" src=\"/dailymed/image.cfm?name=figure-q-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 R).</dd>\n<dt>•</dt>\n<dd>Place the needle in an FDA-cleared sharps disposal container immediately to reduce the risk of a needle stick (See Figure R).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-1647203593\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-09.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> Always throw away (dispose of) the needle after each injection. </p>\n<p>For further information about safe sharps disposal, see <span class=\"Bold\">Frequently Asked Questions</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-685824391\"></a><img alt=\"figure-r\" src=\"/dailymed/image.cfm?name=figure-r-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 SOGROYA from direct light (See Figure S). </dd>\n<dt> </dt>\n<dd>See “<span class=\"Bold\">How should I store my SOGROYA Pen?</span>”.</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1194116182\"></a><img alt=\"figure-s\" src=\"/dailymed/image.cfm?name=figure-s-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id417444282\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-04.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Do not try to put the needle cap back on.</span> You may stick yourself with the needle.</p>\n<p>\n<a name=\"id-1713028074\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-05.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/>Always remove the needle from your Pen immediately after each injection. This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 SOGROYA Pen?</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Before you use SOGROYA Pen for the first time: </span>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>Store your new, unused SOGROYA Pen in a refrigerator between 36°F to 46°F (2°C to 8°C). </dd>\n<dt>•</dt>\n<dd>Store your new, unused SOGROYA Pen with the cap on and in the original carton.</dd>\n<dt>•</dt>\n<dd>Do not freeze SOGROYA. </dd>\n<dt>•</dt>\n<dd>When stored in the refrigerator, do not store the SOGROYA Pen directly next to the cooling element. </dd>\n<dt>•</dt>\n<dd>Keep SOGROYA away from direct heat and light.</dd>\n<dt>•</dt>\n<dd>Do not use SOGROYA if it has been frozen or in temperatures warmer than 86ºF (30°C). </dd>\n<dt>•</dt>\n<dd>Do not use SOGROYA after the expiration date printed on the carton and the Pen. </dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">After you use SOGROYA Pen and there is still medicine left:</span>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>Store remaining SOGROYA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 6 weeks.</dd>\n<dt>•</dt>\n<dd>Store your in-use SOGROYA Pen with the cap on and keep it in the original carton.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Do not store SOGROYA Pen with the needle attached. </span>\n</p>\n<p>If needed, unused and in-use SOGROYA pens can be stored out of the refrigerator. SOGROYA pens can be stored at room temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator. Throw away (dispose of) SOGROYA if it has been stored above 77°F (25°C) for more than 3 days (72 hours) <span class=\"Bold\">or </span>in temperatures warmer than 86°F (30°C).</p>\n<p>\n<span class=\"Bold\">Always keep your SOGROYA Pen and needles out of reach of others, especially children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 much SOGROYA is 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 SOGROYA is left in your Pen (See Figure T).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1630203507\"></a><img alt=\"figure-t\" src=\"/dailymed/image.cfm?name=figure-t-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">To see how much SOGROYA is left in your Pen, use the dose counter:</p>\n<p>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”, 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 “1.7”, only 1.7 mg are left in your Pen (See Figure U).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id718635904\"></a><img alt=\"figure-u\" src=\"/dailymed/image.cfm?name=figure-u-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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. If you need more SOGROYA 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 </span>so that you do not give the wrong dose. If you are not sure how to split your dose using 2 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 SOGROYA 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 SOGROYA appears at the needle tip. Remove the needle as described in Step 5 and repeat Step 1 and Step 2.</p>\n<p>\n<span class=\"Bold\">B. Your Pen may be defective,</span> if SOGROYA 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 SOGROYA</span>,<span class=\"Bold\"></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 Step 1 to Step 4.</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. See “<span class=\"Bold\">How should I store SOGROYA?</span>” Do not try to refill your Pen, it is prefilled.</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 SOGROYA flow before you inject (See Step 1 and Step 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\"></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 throw away (dispose of) used SOGROYA</span><span class=\"Bold\">needles and Pens?</span>\n</p>\n<p>Put your used needles and Pens in an 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> 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: </p>\n<p>\n<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. Do not recycle your used sharps disposal container.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id1415671656\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-06.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> Important information</span>\n</p>\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</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">PATENT Information: http://novonordisk-us.com/products/product-patents.html</p>\n<p>SOGROYA<span class=\"Sup\">®</span> is a registered trademark of Novo Nordisk Health Care AG.</p>\n<p>Novo Nordisk<span class=\"Sup\">®</span> is a registered trademark of Novo Nordisk A/S.</p>\n<p>© 2004-2023 Novo Nordisk Health Care AG</p>\n<p>For further information contact:</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road </p>\n<p>Plainsboro, NJ 08536, USA </p>\n<p>1-888-668-6444</p>\n<p>Sogroya.com</p>\n<p>Manufactured by:</p>\n<p>Novo Nordisk Inc.</p>\n<p>Plainsboro, NJ 08536</p>\n<p>U.S. License No. 1261</p>\n<p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>Issued: 10/2021</p>\n<p>Version: 1</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col width="48%"/> <col width="52%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Instructions for Use</span> </p> <p> <span class="Bold">SOGROYA<span class="Sup">® </span>10 mg</span> </p> <p> <span class="Bold">(suh-GROY-uh)</span> </p> <p> <span class="Bold">(somapacitan-beco) injection</span> </p> <p> <span class="Bold">10 mg/1.5 mL (6.7 mg/mL)</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id985053617"></a><img alt="10mg-pen-body" src="/dailymed/image.cfm?name=10mg-pen-body.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id316850042"></a><img alt="10mg-pen-cap" src="/dailymed/image.cfm?name=10mg-pen-cap-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id-1361353688"></a><img alt="pen-needle" src="/dailymed/image.cfm?name=pen-needle-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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>SOGROYA prefilled Pen</dd> <dt>•</dt> <dd>new injection needle. SOGROYA 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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1849365925"></a><img alt="supplies" src="/dailymed/image.cfm?name=supplies.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How to use your SOGROYA Pen</span> </p> <p> <span class="Bold">5 steps you should follow for a SOGROYA injection:</span> </p> <p> <span class="Bold">Step 1</span>: Prepare your SOGROYA Pen </p> <p> <span class="Bold">Step 2</span>: Check the SOGROYA flow with each new Pen</p> <p> <span class="Bold">Step 3</span>: Select your dose</p> <p> <span class="Bold">Step 4</span>: Inject your dose</p> <p> <span class="Bold">Step 5</span>: After your injection</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">For further information about your Pen see:</span> Frequently Asked Questions and</p> <p>Important information</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold"><a name="id1768113925"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-07.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></span><span class="Bold">Important information</span> </p> <p>Pay special attention to these notes as they are important for safe use of the Pen.</p> <p> <span class="Bold"><a name="id-568729354"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-10.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></span><span class="Bold">Additional information</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">SOGROYA is a prefilled growth hormone Pen. It contains 10 mg of somapacitan-beco and delivers doses from 0.05 mg to 4.0 mg, in increments of 0.05 mg. <span class="Bold">SOGROYA is for use under the skin only (subcutaneous) for injection 1 time each week.</span> </p> <p> <span class="Bold">Do not</span> share your SOGROYA 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>Make sure that you are confident in giving an injection with the Pen before you start your treatment. 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"></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1. Prepare your SOGROYA 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 SOGROYA 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 SOGROYA in your Pen is clear to almost clear and colorless to slightly yellow (See Figure A). <span class="Bold">If SOGROYA looks cloudy or you see particles, do not use the Pen.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id812215329"></a><img alt="figure-a" src="/dailymed/image.cfm?name=figure-a-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>When you are ready to give your injection, get 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="id1346820679"></a><img alt="figure-b" src="/dailymed/image.cfm?name=figure-b-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold"><a name="id-1616819486"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-08.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></span><span class="Bold">Make sure the right pen is used</span>. Especially if you use more than one type of injection medicine. Using the wrong medicine could be harmful to your health.</p> <p> <a name="id563838519"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-09.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the outer needle cap and throw it away (dispose of) (See Figure C).</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1386712032"></a><img alt="figure-c" src="/dailymed/image.cfm?name=figure-c-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the inner needle cap and throw it away (dispose of) (See Figure D).</dd> </dl> <p class="First"> <a name="id1415743691"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-11.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> A drop of SOGROYA may appear at the needle tip. This is normal, but you must still check the SOGROYA flow with each new Pen (See Step 2).</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-412315721"></a><img alt="figure-d" src="/dailymed/image.cfm?name=figure-d-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="ID0EE2BO"></a><img alt="Important-information_small" src="/dailymed/image.cfm?name=export-00.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Never use a bent or damaged needle.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2. Check the SOGROYA flow with each new Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id776912518"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-12.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> If your Pen is already in use</span>, go to Step 3.</p> <dl> <dt>•</dt> <dd> <span class="Bold">Before using a new Pen</span>, check the SOGROYA flow to make sure the growth hormone can flow through the Pen and needle.</dd> <dt>•</dt> <dd>Turn the dose selector clockwise 1 marking on the dose counter to select 0.05 mg. You may 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="id753394465"></a><img alt="figure-e" src="/dailymed/image.cfm?name=figure-e-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id-590625508"></a><img alt="figure-f" src="/dailymed/image.cfm?name=figure-f-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id306365268"></a><img alt="figure-g" src="/dailymed/image.cfm?name=figure-g-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check that a drop of SOGROYA appears at the needle tip (See Figure H).</dd> </dl> <p class="First"> <a name="id-1827740530"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-13.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> If no SOGROYA appears</span>, repeat Step 2 up to 6 times. </p> <p>If you still do not see a drop of SOGROYA, <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>Repeat Step 2 again.</dd> </dl> <p> <span class="Bold">Do not use the Pen if a drop of SOGROYA still does not appear after changing the needle and repeating Step 2. Call Novo Nordisk at 1-888-668-6444 for help.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2008589390"></a><img alt="figure-h" src="/dailymed/image.cfm?name=figure-h-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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). When you have selected your dose, you can go to Step 4. </dd> </dl> <p class="First"> <a name="id2112544011"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-14.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> If there is not enough SOGROYA left </span>to select a full dose, see <span class="Bold">Frequently Asked Questions</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id523059532"></a><img alt="figure-i" src="/dailymed/image.cfm?name=figure-i-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id-2066395988"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-15.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> The dose counter shows the dose in “mg” (See Figure J and Figure 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 to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2091657652"></a><img alt="figure-j" src="/dailymed/image.cfm?name=figure-j-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1126514040"></a><img alt="figure-k" src="/dailymed/image.cfm?name=figure-k-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id-1079445950"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-16.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose (See Figure L).</p> <p>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.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1940673111"></a><img alt="figure-l" src="/dailymed/image.cfm?name=figure-l-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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>SOGROYA can be injected under the skin (subcutaneously) of your stomach area (abdomen) or upper legs (thighs) as instructed by your healthcare provider (See Figure M). <span class="Bold">Change the injection site every week.</span> </dd> <dt>•</dt> <dd>Wipe the injection site with an alcohol pad and let the area dry.</dd> <dt>•</dt> <dd>Insert the needle into your skin as your healthcare provider has shown you (See Figure N).</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="id601991845"></a><img alt="figure-m" src="/dailymed/image.cfm?name=figure-m-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id-697706751"></a><img alt="figure-n" src="/dailymed/image.cfm?name=figure-n-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 O). <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 down the dose button with the needle in your skin.</span> </dd> </dl> <p class="First"> <a name="id-1054235372"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-17.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> 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>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-531950177"></a><img alt="figure-o" src="/dailymed/image.cfm?name=figure-o-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Keep holding down the dose button with the needle in your skin</span><span class="Bold">and slowly count to 6</span> to make sure that the full dose has been delivered (See Figure P).</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2018835901"></a><img alt="figure-p" src="/dailymed/image.cfm?name=figure-p-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from your skin (See Figure Q). If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd> </dl> <p class="First"> <a name="id1480963539"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-18.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> You may see a drop of SOGROYA at the needle tip after injecting. This is normal and does not affect your dose.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1196821136"></a><img alt="figure-q" src="/dailymed/image.cfm?name=figure-q-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 R).</dd> <dt>•</dt> <dd>Place the needle in an FDA-cleared sharps disposal container immediately to reduce the risk of a needle stick (See Figure R).</dd> </dl> <p class="First"> <a name="id-690835083"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-19.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> Always throw away (dispose of) the needle after each injection. </p> <p>For further information about safe sharps disposal, see <span class="Bold">Frequently Asked Questions</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id105313682"></a><img alt="figure-r" src="/dailymed/image.cfm?name=figure-r-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 SOGROYA from direct light (See Figure S). </dd> <dt> </dt> <dd>See “<span class="Bold">How should I store my SOGROYA Pen?</span>”.</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-743974"></a><img alt="figure-s" src="/dailymed/image.cfm?name=figure-s-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id815373528"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-10.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Do not try to put the needle cap back on.</span> You may stick yourself with the needle.</p> <p> <a name="id1493839325"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-11.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/>Always remove the needle from your Pen immediately after each injection. This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I store my SOGROYA Pen?</span> </p> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <span class="Bold">Before you use SOGROYA Pen for the first time:</span> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> <dt>•</dt> <dd>Store your new, unused SOGROYA Pen in a refrigerator between 36°F to 46°F (2°C to 8°C).</dd> <dt>•</dt> <dd>Store your new, unused SOGROYA Pen with the cap on and in the original carton.</dd> <dt>•</dt> <dd>Do not freeze SOGROYA.</dd> <dt>•</dt> <dd>When stored in the refrigerator, do not store the SOGROYA Pen directly next to the cooling element.</dd> <dt>•</dt> <dd>Keep SOGROYA away from direct heat and light.</dd> <dt>•</dt> <dd>Do not use SOGROYA if it has been frozen or in temperatures warmer than 86ºF (30°C).</dd> <dt>•</dt> <dd>Do not use SOGROYA after the expiration date printed on the carton and the Pen. </dd> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <span class="Bold">After you use SOGROYA Pen and there is still medicine left:</span> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> <dt>•</dt> <dd>Store remaining SOGROYA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 6 weeks.</dd> <dt>•</dt> <dd>Store your in-use SOGROYA Pen with the cap on and keep it in the original carton.</dd> </dl> <p> <span class="Bold">Do not store SOGROYA Pen with the needle attached.</span> </p> <p>If needed, unused and in-use SOGROYA pens can be stored out of the refrigerator. SOGROYA pens can be stored at room temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator. Throw away (dispose of) SOGROYA if it has been stored above 77°F (25°C) for more than 3 days (72 hours) <span class="Bold">or </span>in temperatures warmer than 86°F (30°C).</p> <p> <span class="Bold">Always keep your SOGROYA Pen and needles out of reach of others, especially children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 much SOGROYA is 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 SOGROYA is left in your Pen (See Figure T).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1396858406"></a><img alt="figure-t" src="/dailymed/image.cfm?name=figure-t-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">To see how much SOGROYA is left in your Pen, use the dose counter:</p> <p>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”, at least 4.0 mg are left in your Pen.</p> <p>If the dose counter stops with the dose pointer lined up with “2.8”, only 2.8 mg are left in your Pen (See Figure U).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1161689861"></a><img alt="figure-u" src="/dailymed/image.cfm?name=figure-u-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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. If you need more SOGROYA 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 </span>so that you do not give the wrong dose. If you are not sure how to split your dose using 2 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 SOGROYA appears when I check the flow?</span> </p> <p> <span class="Bold">A. Your needle may be blocked or damaged,</span> if no SOGROYA appears at the needle tip. Remove the needle as described in Step 5 and repeat Step 1 and Step 2.</p> <p> <span class="Bold">B. Your Pen may be defective,</span> if SOGROYA 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 SOGROYA</span>,<span class="Bold"></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 Step 1 to Step 4.</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. See “<span class="Bold">How should I store SOGROYA?</span>” Do not try to refill your Pen, it is prefilled.</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 SOGROYA flow before you inject (See Step 1 and Step 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"></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 throw away (dispose of) used SOGROYA</span><span class="Bold">needles and Pens?</span> </p> <p>Put your used needles and Pens in an 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> 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: </p> <p> <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. Do not recycle your used sharps disposal container.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id438576411"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-12.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> Important information</span> </p> <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> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">PATENT Information: http://novonordisk-us.com/products/product-patents.html</p> <p>SOGROYA<span class="Sup">®</span> is a registered trademark of Novo Nordisk Health Care AG.</p> <p>Novo Nordisk<span class="Sup">®</span> is a registered trademark of Novo Nordisk A/S.</p> <p>© 2004-2023 Novo Nordisk Health Care AG</p> <p>For further information contact:</p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road </p> <p>Plainsboro, NJ 08536, USA </p> <p>1-888-668-6444</p> <p>Sogroya.com</p> <p>Manufactured by:</p> <p>Novo Nordisk Inc.</p> <p>Plainsboro, NJ 08536</p> <p>U.S. License No. 1261</p> <p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p>Revised: 10/2021</p> <p>Version: 2</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"48%\"/>\n<col width=\"52%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Instructions for Use</span>\n</p>\n<p>\n<span class=\"Bold\">SOGROYA<span class=\"Sup\">® </span>10 mg</span>\n</p>\n<p>\n<span class=\"Bold\">(suh-GROY-uh)</span>\n</p>\n<p>\n<span class=\"Bold\">(somapacitan-beco) injection</span>\n</p>\n<p>\n<span class=\"Bold\">10 mg/1.5 mL (6.7 mg/mL)</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id985053617\"></a><img alt=\"10mg-pen-body\" src=\"/dailymed/image.cfm?name=10mg-pen-body.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id316850042\"></a><img alt=\"10mg-pen-cap\" src=\"/dailymed/image.cfm?name=10mg-pen-cap-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id-1361353688\"></a><img alt=\"pen-needle\" src=\"/dailymed/image.cfm?name=pen-needle-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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>SOGROYA prefilled Pen</dd>\n<dt>•</dt>\n<dd>new injection needle. SOGROYA 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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1849365925\"></a><img alt=\"supplies\" src=\"/dailymed/image.cfm?name=supplies.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 SOGROYA Pen</span>\n</p>\n<p>\n<span class=\"Bold\">5 steps you should follow for a SOGROYA injection:</span>\n</p>\n<p>\n<span class=\"Bold\">Step 1</span>: Prepare your SOGROYA Pen </p>\n<p>\n<span class=\"Bold\">Step 2</span>: Check the SOGROYA flow with each new Pen</p>\n<p>\n<span class=\"Bold\">Step 3</span>: Select your dose</p>\n<p>\n<span class=\"Bold\">Step 4</span>: Inject your dose</p>\n<p>\n<span class=\"Bold\">Step 5</span>: After your injection</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\">For further information about your Pen see:</span> Frequently Asked Questions and</p>\n<p>Important information</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\"><a name=\"id1768113925\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-07.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></span><span class=\"Bold\">Important information</span>\n</p>\n<p>Pay special attention to these notes as they are important for safe use of the Pen.</p>\n<p>\n<span class=\"Bold\"><a name=\"id-568729354\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-10.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></span><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\">SOGROYA is a prefilled growth hormone Pen. It contains 10 mg of somapacitan-beco and delivers doses from 0.05 mg to 4.0 mg, in increments of 0.05 mg. <span class=\"Bold\">SOGROYA is for use under the skin only (subcutaneous) for injection 1 time each week.</span>\n</p>\n<p>\n<span class=\"Bold\">Do not</span> share your SOGROYA 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>Make sure that you are confident in giving an injection with the Pen before you start your treatment. 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\"></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 SOGROYA 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 SOGROYA 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 SOGROYA in your Pen is clear to almost clear and colorless to slightly yellow (See Figure A). <span class=\"Bold\">If SOGROYA looks cloudy or you see particles, do not use the Pen.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id812215329\"></a><img alt=\"figure-a\" src=\"/dailymed/image.cfm?name=figure-a-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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, get 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=\"id1346820679\"></a><img alt=\"figure-b\" src=\"/dailymed/image.cfm?name=figure-b-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><a name=\"id-1616819486\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-08.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></span><span class=\"Bold\">Make sure the right pen is used</span>. Especially if you use more than one type of injection medicine. Using the wrong medicine could be harmful to your health.</p>\n<p>\n<a name=\"id563838519\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-09.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p>\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 throw it away (dispose of) (See Figure C).</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1386712032\"></a><img alt=\"figure-c\" src=\"/dailymed/image.cfm?name=figure-c-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 (dispose of) (See Figure D).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id1415743691\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-11.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> A drop of SOGROYA may appear at the needle tip. This is normal, but you must still check the SOGROYA flow with each new Pen (See Step 2).</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-412315721\"></a><img alt=\"figure-d\" src=\"/dailymed/image.cfm?name=figure-d-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"ID0EE2BO\"></a><img alt=\"Important-information_small\" src=\"/dailymed/image.cfm?name=export-00.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Never use a bent or damaged needle.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 SOGROYA flow with each new Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id776912518\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-12.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> If your Pen is already in use</span>, go to Step 3.</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Before using a new Pen</span>, check the SOGROYA 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 marking on the dose counter to select 0.05 mg. You may 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=\"id753394465\"></a><img alt=\"figure-e\" src=\"/dailymed/image.cfm?name=figure-e-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id-590625508\"></a><img alt=\"figure-f\" src=\"/dailymed/image.cfm?name=figure-f-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id306365268\"></a><img alt=\"figure-g\" src=\"/dailymed/image.cfm?name=figure-g-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 SOGROYA appears at the needle tip (See Figure H).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-1827740530\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-13.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> If no SOGROYA appears</span>, repeat Step 2 up to 6 times. </p>\n<p>If you still do not see a drop of SOGROYA, <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>Repeat Step 2 again.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Do not use the Pen if a drop of SOGROYA still does not appear after changing the needle and repeating Step 2. Call Novo Nordisk at 1-888-668-6444 for help.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2008589390\"></a><img alt=\"figure-h\" src=\"/dailymed/image.cfm?name=figure-h-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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). When you have selected your dose, you can go to Step 4. </dd>\n</dl>\n<p class=\"First\">\n<a name=\"id2112544011\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-14.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> If there is not enough SOGROYA left </span>to select a full dose, see <span class=\"Bold\">Frequently Asked Questions</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id523059532\"></a><img alt=\"figure-i\" src=\"/dailymed/image.cfm?name=figure-i-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-2066395988\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-15.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> The dose counter shows the dose in “mg” (See Figure J and Figure 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 to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2091657652\"></a><img alt=\"figure-j\" src=\"/dailymed/image.cfm?name=figure-j-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1126514040\"></a><img alt=\"figure-k\" src=\"/dailymed/image.cfm?name=figure-k-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-1079445950\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-16.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose (See Figure L).</p>\n<p>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.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1940673111\"></a><img alt=\"figure-l\" src=\"/dailymed/image.cfm?name=figure-l-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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>SOGROYA can be injected under the skin (subcutaneously) of your stomach area (abdomen) or upper legs (thighs) as instructed by your healthcare provider (See Figure M). <span class=\"Bold\">Change the injection site every week.</span>\n</dd>\n<dt>•</dt>\n<dd>Wipe the injection site with an alcohol pad 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 N).</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=\"id601991845\"></a><img alt=\"figure-m\" src=\"/dailymed/image.cfm?name=figure-m-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id-697706751\"></a><img alt=\"figure-n\" src=\"/dailymed/image.cfm?name=figure-n-03.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 O). <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 down the dose button with the needle in your skin.</span>\n</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-1054235372\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-17.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> 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>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-531950177\"></a><img alt=\"figure-o\" src=\"/dailymed/image.cfm?name=figure-o-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 holding down the dose button with the needle in your skin</span><span class=\"Bold\">and slowly count to 6</span> to make sure that the full dose has been delivered (See Figure P).</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2018835901\"></a><img alt=\"figure-p\" src=\"/dailymed/image.cfm?name=figure-p-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 Q). If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id1480963539\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-18.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> You may see a drop of SOGROYA at the needle tip after injecting. This is normal and does not affect your dose.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1196821136\"></a><img alt=\"figure-q\" src=\"/dailymed/image.cfm?name=figure-q-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 R).</dd>\n<dt>•</dt>\n<dd>Place the needle in an FDA-cleared sharps disposal container immediately to reduce the risk of a needle stick (See Figure R).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-690835083\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-19.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> Always throw away (dispose of) the needle after each injection. </p>\n<p>For further information about safe sharps disposal, see <span class=\"Bold\">Frequently Asked Questions</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id105313682\"></a><img alt=\"figure-r\" src=\"/dailymed/image.cfm?name=figure-r-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 SOGROYA from direct light (See Figure S). </dd>\n<dt> </dt>\n<dd>See “<span class=\"Bold\">How should I store my SOGROYA Pen?</span>”.</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-743974\"></a><img alt=\"figure-s\" src=\"/dailymed/image.cfm?name=figure-s-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id815373528\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-10.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Do not try to put the needle cap back on.</span> You may stick yourself with the needle.</p>\n<p>\n<a name=\"id1493839325\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-11.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/>Always remove the needle from your Pen immediately after each injection. This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 SOGROYA Pen?</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Before you use SOGROYA Pen for the first time:</span>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>Store your new, unused SOGROYA Pen in a refrigerator between 36°F to 46°F (2°C to 8°C).</dd>\n<dt>•</dt>\n<dd>Store your new, unused SOGROYA Pen with the cap on and in the original carton.</dd>\n<dt>•</dt>\n<dd>Do not freeze SOGROYA.</dd>\n<dt>•</dt>\n<dd>When stored in the refrigerator, do not store the SOGROYA Pen directly next to the cooling element.</dd>\n<dt>•</dt>\n<dd>Keep SOGROYA away from direct heat and light.</dd>\n<dt>•</dt>\n<dd>Do not use SOGROYA if it has been frozen or in temperatures warmer than 86ºF (30°C).</dd>\n<dt>•</dt>\n<dd>Do not use SOGROYA after the expiration date printed on the carton and the Pen. </dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">After you use SOGROYA Pen and there is still medicine left:</span>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>Store remaining SOGROYA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 6 weeks.</dd>\n<dt>•</dt>\n<dd>Store your in-use SOGROYA Pen with the cap on and keep it in the original carton.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Do not store SOGROYA Pen with the needle attached.</span>\n</p>\n<p>If needed, unused and in-use SOGROYA pens can be stored out of the refrigerator. SOGROYA pens can be stored at room temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator. Throw away (dispose of) SOGROYA if it has been stored above 77°F (25°C) for more than 3 days (72 hours) <span class=\"Bold\">or </span>in temperatures warmer than 86°F (30°C).</p>\n<p>\n<span class=\"Bold\">Always keep your SOGROYA Pen and needles out of reach of others, especially children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 much SOGROYA is 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 SOGROYA is left in your Pen (See Figure T).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1396858406\"></a><img alt=\"figure-t\" src=\"/dailymed/image.cfm?name=figure-t-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">To see how much SOGROYA is left in your Pen, use the dose counter:</p>\n<p>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”, 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 “2.8”, only 2.8 mg are left in your Pen (See Figure U).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1161689861\"></a><img alt=\"figure-u\" src=\"/dailymed/image.cfm?name=figure-u-02.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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. If you need more SOGROYA 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 </span>so that you do not give the wrong dose. If you are not sure how to split your dose using 2 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 SOGROYA 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 SOGROYA appears at the needle tip. Remove the needle as described in Step 5 and repeat Step 1 and Step 2.</p>\n<p>\n<span class=\"Bold\">B. Your Pen may be defective,</span> if SOGROYA 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 SOGROYA</span>,<span class=\"Bold\"></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 Step 1 to Step 4.</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. See “<span class=\"Bold\">How should I store SOGROYA?</span>” Do not try to refill your Pen, it is prefilled.</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 SOGROYA flow before you inject (See Step 1 and Step 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\"></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 throw away (dispose of) used SOGROYA</span><span class=\"Bold\">needles and Pens?</span>\n</p>\n<p>Put your used needles and Pens in an 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> 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: </p>\n<p>\n<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. Do not recycle your used sharps disposal container.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id438576411\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-12.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> Important information</span>\n</p>\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</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">PATENT Information: http://novonordisk-us.com/products/product-patents.html</p>\n<p>SOGROYA<span class=\"Sup\">®</span> is a registered trademark of Novo Nordisk Health Care AG.</p>\n<p>Novo Nordisk<span class=\"Sup\">®</span> is a registered trademark of Novo Nordisk A/S.</p>\n<p>© 2004-2023 Novo Nordisk Health Care AG</p>\n<p>For further information contact:</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road </p>\n<p>Plainsboro, NJ 08536, USA </p>\n<p>1-888-668-6444</p>\n<p>Sogroya.com</p>\n<p>Manufactured by:</p>\n<p>Novo Nordisk Inc.</p>\n<p>Plainsboro, NJ 08536</p>\n<p>U.S. License No. 1261</p>\n<p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>Revised: 10/2021</p>\n<p>Version: 2</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col width="49%"/> <col width="51%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Instructions for Use</span> </p> <p> <span class="Bold">SOGROYA<span class="Sup">®</span> 15 mg</span> </p> <p> <span class="Bold">(suh-GROY-uh)</span> </p> <p> <span class="Bold">(somapacitan-beco) injection</span> </p> <p> <span class="Bold">15 mg/1.5 mL (10 mg/mL)</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id774836558"></a><img alt="15mg-pen-body" src="/dailymed/image.cfm?name=15mg-pen-body.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id747619088"></a><img alt="15mg-pen-cap" src="/dailymed/image.cfm?name=15mg-pen-cap-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id-1072199485"></a><img alt="15mg-needle-parts" src="/dailymed/image.cfm?name=15mg-needle-parts-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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>SOGROYA prefilled Pen</dd> <dt>•</dt> <dd>new injection needle. SOGROYA 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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-394042290"></a><img alt="15mg-supplies" src="/dailymed/image.cfm?name=15mg-supplies.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td align="justify" class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How to use your SOGROYA Pen</span> </p> <p> <span class="Bold">5 steps you should follow for a SOGROYA injection:</span> </p> <p> <span class="Bold">Step 1</span>: Prepare your SOGROYA Pen </p> <p> <span class="Bold">Step 2</span>: Check the SOGROYA flow with each new Pen</p> <p> <span class="Bold">Step 3</span>: Select your dose</p> <p> <span class="Bold">Step 4</span>: Inject your dose</p> <p> <span class="Bold">Step 5</span>: After your injection</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">For further information about your Pen see:</span> Frequently Asked Questions and</p> <p>Important information </p> <p> <span class="Bold"><a name="id-993802387"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-13.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></span><span class="Bold">Important information</span> </p> <p>Pay special attention to these notes as they are important for safe use of the Pen.</p> <p> <span class="Bold"><a name="id134460939"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-20.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></span><span class="Bold">Additional information</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">SOGROYA is a prefilled growth hormone Pen. It contains 15 mg of somapacitan-beco and delivers doses from 0.1 mg to 8.0 mg, in increments of 0.1 mg. <span class="Bold">SOGROYA is for use under the skin only (subcutaneous) for injection 1 time each week.</span> </p> <p> <span class="Bold">Do not</span> share your SOGROYA 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>Make sure that you are confident in giving an injection with the Pen before you start your treatment. 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"></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1. Prepare your SOGROYA 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 SOGROYA 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 SOGROYA in your Pen is clear to almost clear and colorless to slightly yellow (See Figure A). <span class="Bold">If SOGROYA looks cloudy or you see particles, do not use the Pen.</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-459720688"></a><img alt="figure-a" src="/dailymed/image.cfm?name=figure-a.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>When you are ready to give your injection, get 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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1675566836"></a><img alt="figure-b" src="/dailymed/image.cfm?name=figure-b.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold"><a name="id932477071"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-14.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></span><span class="Bold">Make sure the right pen is used</span>. Especially if you use more than one type of injection medicine. Using the wrong medicine could be harmful to your health.</p> <p> <a name="id1734357067"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-15.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the outer needle cap and throw it away (dispose of) (See Figure C).</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-313100030"></a><img alt="figure-c" src="/dailymed/image.cfm?name=figure-c.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Pull off the inner needle cap and throw it away (dispose of) (See Figure D).</dd> </dl> <p class="First"> <a name="id-340547409"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-21.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/>A drop of SOGROYA may appear at the needle tip. This is normal, but you must still check the SOGROYA flow with each new Pen (See Step 2).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1592595307"></a><img alt="figure-d" src="/dailymed/image.cfm?name=figure-d.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id-1229609139"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-16.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Never use a bent or damaged needle.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2. Check the SOGROYA flow with each new Pen</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id-1693682113"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=image-03.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> If your Pen is already in use</span>, go to Step 3.</p> <dl> <dt>•</dt> <dd> <span class="Bold">Before using a new Pen</span>, check the SOGROYA flow to make sure the growth hormone can flow through the Pen and needle.</dd> <dt>•</dt> <dd>Turn the dose selector clockwise 1 marking on the dose counter to select 0.1 mg. You may hear a faint “click” when you turn the dose selector (See Figure E).</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2094312163"></a><img alt="figure-e" src="/dailymed/image.cfm?name=figure-e-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1322577740"></a><img alt="figure-f" src="/dailymed/image.cfm?name=figure-f-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1003786847"></a><img alt="figure-g" src="/dailymed/image.cfm?name=figure-g-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check that a drop of SOGROYA appears at the needle tip (See Figure H).</dd> </dl> <p class="First"> <a name="id-1592619046"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-22.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> If no SOGROYA appears</span>, repeat Step 2 up to 6 times. </p> <p>If you still do not see a drop of SOGROYA, <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>Repeat Step 2 again.</dd> </dl> <p> <span class="Bold">Do not use the Pen if a drop of SOGROYA still does not appear after changing the needle and repeating Step 2. Call Novo Nordisk at 1-888-668-6444 for help.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1969803419"></a><img alt="figure-h" src="/dailymed/image.cfm?name=figure-h-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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). When you have selected your dose, you can go to Step 4. </dd> </dl> <p class="First"> <a name="id106173024"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-23.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> If there is not enough SOGROYA left </span>to select a full dose, see <span class="Bold">Frequently Asked Questions</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2017566628"></a><img alt="figure-i" src="/dailymed/image.cfm?name=figure-i-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id978584056"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-24.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> The dose counter shows the dose in “mg” (See Figure J and Figure 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 to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2092495299"></a><img alt="figure-j" src="/dailymed/image.cfm?name=figure-j-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1964878351"></a><img alt="figure-k" src="/dailymed/image.cfm?name=figure-k-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <a name="id-918170724"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-25.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose (See Figure L).</p> <p>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.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1668555688"></a><img alt="figure-l" src="/dailymed/image.cfm?name=figure-l-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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>SOGROYA can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper arms, upper legs (thighs) or buttocks as instructed by your healthcare provider (See Figure M). <span class="Bold">Change the injection site every week.</span> </dd> <dt>•</dt> <dd>Wipe the injection site with an alcohol pad and let the area dry.</dd> <dt>•</dt> <dd>Insert the needle into your skin as your healthcare provider has shown you (See Figure N). </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 align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id842366769"></a><img alt="figure-m" src="/dailymed/image.cfm?name=figure-m-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><a name="id-1889099745"></a><img alt="figure-n" src="/dailymed/image.cfm?name=figure-n-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 O). <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 down the dose button with the needle in your skin.</span> </dd> </dl> <p class="First"> <a name="id1908337710"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-26.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> If “0” does not appear in the dose</p> <p>counter after continuously pressing the dose button, your needle may be blocked or damaged. See <span class="Bold">Frequently Asked Questions</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1122879556"></a><img alt="figure-o" src="/dailymed/image.cfm?name=figure-o-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Keep holding down the dose button with the needle in your skin</span><span class="Bold">and slowly count to 6</span> to make sure that the full dose has been delivered (See Figure P).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1751272225"></a><img alt="figure-p" src="/dailymed/image.cfm?name=figure-p-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Carefully remove the needle from your skin (See Figure Q). If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd> </dl> <p class="First"> <a name="id384995530"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-27.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> You may see a drop of SOGROYA at the needle tip after injecting. This is normal and does not affect your dose.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1839924986"></a><img alt="figure-q" src="/dailymed/image.cfm?name=figure-q-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 R).</dd> <dt>•</dt> <dd>Place the needle in an FDA-cleared sharps disposal container immediately to reduce the risk of a needle stick (See Figure R).</dd> </dl> <p class="First"> <a name="id64997497"></a><img alt="letteri-bullet" src="/dailymed/image.cfm?name=letteri-bullet-28.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> Always throw away (dispose of) the needle after each injection. </p> <p>For further information about safe sharps disposal, see <span class="Bold">Frequently Asked Questions</span>.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-842015937"></a><img alt="figure-r" src="/dailymed/image.cfm?name=figure-r-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 SOGROYA from direct light (See Figure S). </dd> <dt> </dt> <dd>See “<span class="Bold">How should I store my SOGROYA Pen?</span>”.</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1874375307"></a><img alt="figure-s" src="/dailymed/image.cfm?name=figure-s-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id642782652"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-17.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold">Do not try to put the needle cap back on.</span> You may stick yourself with the needle.</p> <p> <a name="id416059490"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-18.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/> Always remove the needle from your Pen immediately after each injection. This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I store my SOGROYA Pen?</span> </p> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <span class="Bold">Before you use SOGROYA Pen for the first time: </span> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> <dt>•</dt> <dd>Store your new, unused SOGROYA Pen in a refrigerator between 36°F to 46°F (2°C to 8°C). </dd> <dt>•</dt> <dd>Store your new, unused SOGROYA Pen with the cap on and in the original carton.</dd> <dt>•</dt> <dd>Do not freeze SOGROYA. </dd> <dt>•</dt> <dd>When stored in the refrigerator, do not store the SOGROYA Pen directly next to the cooling element. </dd> <dt>•</dt> <dd>Keep SOGROYA away from direct heat and light.</dd> <dt>•</dt> <dd>Do not use SOGROYA if it has been frozen or in temperatures warmer than 86ºF (30°C). </dd> <dt>•</dt> <dd>Do not use SOGROYA after the expiration date printed on the carton and the Pen. </dd> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <dl> <dt> </dt> <dd> <span class="Bold">After you use SOGROYA Pen and there is still medicine left:</span> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> </dl> </dd> <dt>•</dt> <dd>Store remaining SOGROYA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 6 weeks.</dd> <dt>•</dt> <dd>Store your in-use SOGROYA Pen with the cap on and keep it in the original carton.</dd> </dl> <p> <span class="Bold">Do not store SOGROYA Pen with the needle attached. </span> </p> <p>If needed, unused and in-use SOGROYA pens can be stored out of the refrigerator. SOGROYA pens can be stored at room temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator. Throw away (dispose of) SOGROYA if it has been stored above 77°F (25°C) for more than 3 days (72 hours) <span class="Bold">or </span>in temperatures warmer than 86°F (30°C).</p> <p> <span class="Bold">Always keep your SOGROYA Pen and needles out of reach of others, especially children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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 much SOGROYA is 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 SOGROYA is left in your Pen (See Figure T).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-153763264"></a><img alt="figure-t" src="/dailymed/image.cfm?name=figure-t-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">To see how much SOGROYA is left in your Pen, use the dose counter:</p> <p>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”, at least 8.0 mg are left in your Pen.</p> <p>If the dose counter stops with the dose pointer lined up with “4.8”, only 4.8 mg are left in your Pen (See Figure U).</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id208311297"></a><img alt="figure-u" src="/dailymed/image.cfm?name=figure-u-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></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. If you need more SOGROYA 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 </span>so that you do not give the wrong dose. If you are not sure how to split your dose using 2 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 SOGROYA appears when I check the flow?</span> </p> <p> <span class="Bold">A. Your needle may be blocked or damaged,</span> if no SOGROYA appears at the needle tip. Remove the needle as described in Step 5 and repeat Step 1 and Step 2.</p> <p> <span class="Bold">B. Your Pen may be defective,</span> if SOGROYA 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 SOGROYA</span>,<span class="Bold"></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 Step 1 to Step 4.</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. See “<span class="Bold">How should I store SOGROYA?</span>” Do not try to refill your Pen, it is prefilled.</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 SOGROYA flow before you inject (See Step 1 and Step 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"></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 throw away (dispose of) used SOGROYA</span><span class="Bold">needles and Pens?</span> </p> <p>Put your used needles and Pens in an 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> 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: </p> <p> <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. Do not recycle your used sharps disposal container.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id1541854483"></a><img alt="triangle-bullet" src="/dailymed/image.cfm?name=triangle-bullet-19.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><span class="Bold"> Important information</span> </p> <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> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"></td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><a name="id-1626527701"></a><img alt="phone-qrcode" src="/dailymed/image.cfm?name=phone-qrcode.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/><p class="First">www.sogroya.com</p> <p> </p> <p>PATENT Information: http://novonordisk-us.com/products/product-patents.html</p> <p> </p> <p>SOGROYA<span class="Sup">®</span> is a registered trademark of Novo Nordisk Health Care AG.</p> <p> </p> <p>Novo Nordisk<span class="Sup">®</span> is a registered trademark of Novo Nordisk A/S.</p> <p> </p> <p>© 2004-2023 Novo Nordisk Health Care AG</p> <p> </p> <p>For further information contact:</p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road </p> <p>Plainsboro, NJ 08536, USA </p> <p>1-888-668-6444</p> <p>Sogroya.com</p> <p> </p> <p>Manufactured by:</p> <p>Novo Nordisk Inc.</p> <p>Plainsboro, NJ 08536</p> <p>U.S. License No. 1261</p> <p> </p> <p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p>Issued: 4/2023</p> <p>Version: 1</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"49%\"/>\n<col width=\"51%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Instructions for Use</span>\n</p>\n<p>\n<span class=\"Bold\">SOGROYA<span class=\"Sup\">®</span> 15 mg</span>\n</p>\n<p>\n<span class=\"Bold\">(suh-GROY-uh)</span>\n</p>\n<p>\n<span class=\"Bold\">(somapacitan-beco) injection</span>\n</p>\n<p>\n<span class=\"Bold\">15 mg/1.5 mL (10 mg/mL)</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id774836558\"></a><img alt=\"15mg-pen-body\" src=\"/dailymed/image.cfm?name=15mg-pen-body.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id747619088\"></a><img alt=\"15mg-pen-cap\" src=\"/dailymed/image.cfm?name=15mg-pen-cap-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id-1072199485\"></a><img alt=\"15mg-needle-parts\" src=\"/dailymed/image.cfm?name=15mg-needle-parts-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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>SOGROYA prefilled Pen</dd>\n<dt>•</dt>\n<dd>new injection needle. SOGROYA 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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-394042290\"></a><img alt=\"15mg-supplies\" src=\"/dailymed/image.cfm?name=15mg-supplies.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 align=\"justify\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How to use your SOGROYA Pen</span>\n</p>\n<p>\n<span class=\"Bold\">5 steps you should follow for a SOGROYA injection:</span>\n</p>\n<p>\n<span class=\"Bold\">Step 1</span>: Prepare your SOGROYA Pen </p>\n<p>\n<span class=\"Bold\">Step 2</span>: Check the SOGROYA flow with each new Pen</p>\n<p>\n<span class=\"Bold\">Step 3</span>: Select your dose</p>\n<p>\n<span class=\"Bold\">Step 4</span>: Inject your dose</p>\n<p>\n<span class=\"Bold\">Step 5</span>: After your injection</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\">For further information about your Pen see:</span> Frequently Asked Questions and</p>\n<p>Important information </p>\n<p>\n<span class=\"Bold\"><a name=\"id-993802387\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-13.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></span><span class=\"Bold\">Important information</span>\n</p>\n<p>Pay special attention to these notes as they are important for safe use of the Pen.</p>\n<p>\n<span class=\"Bold\"><a name=\"id134460939\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-20.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></span><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\">SOGROYA is a prefilled growth hormone Pen. It contains 15 mg of somapacitan-beco and delivers doses from 0.1 mg to 8.0 mg, in increments of 0.1 mg. <span class=\"Bold\">SOGROYA is for use under the skin only (subcutaneous) for injection 1 time each week.</span>\n</p>\n<p>\n<span class=\"Bold\">Do not</span> share your SOGROYA 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>Make sure that you are confident in giving an injection with the Pen before you start your treatment. 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\"></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 SOGROYA 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 SOGROYA 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 SOGROYA in your Pen is clear to almost clear and colorless to slightly yellow (See Figure A). <span class=\"Bold\">If SOGROYA looks cloudy or you see particles, do not use the Pen.</span>\n</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-459720688\"></a><img alt=\"figure-a\" src=\"/dailymed/image.cfm?name=figure-a.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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, get 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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1675566836\"></a><img alt=\"figure-b\" src=\"/dailymed/image.cfm?name=figure-b.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><a name=\"id932477071\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-14.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></span><span class=\"Bold\">Make sure the right pen is used</span>. Especially if you use more than one type of injection medicine. Using the wrong medicine could be harmful to your health.</p>\n<p>\n<a name=\"id1734357067\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-15.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Always use a new needle for each injection.</span> This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p>\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 throw it away (dispose of) (See Figure C).</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-313100030\"></a><img alt=\"figure-c\" src=\"/dailymed/image.cfm?name=figure-c.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 (dispose of) (See Figure D).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-340547409\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-21.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/>A drop of SOGROYA may appear at the needle tip. This is normal, but you must still check the SOGROYA flow with each new Pen (See Step 2).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1592595307\"></a><img alt=\"figure-d\" src=\"/dailymed/image.cfm?name=figure-d.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-1229609139\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-16.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Never use a bent or damaged needle.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 SOGROYA flow with each new Pen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-1693682113\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=image-03.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> If your Pen is already in use</span>, go to Step 3.</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Before using a new Pen</span>, check the SOGROYA 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 marking on the dose counter to select 0.1 mg. You may hear a faint “click” when you turn the dose selector (See Figure E).</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2094312163\"></a><img alt=\"figure-e\" src=\"/dailymed/image.cfm?name=figure-e-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1322577740\"></a><img alt=\"figure-f\" src=\"/dailymed/image.cfm?name=figure-f-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1003786847\"></a><img alt=\"figure-g\" src=\"/dailymed/image.cfm?name=figure-g-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 SOGROYA appears at the needle tip (See Figure H).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-1592619046\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-22.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> If no SOGROYA appears</span>, repeat Step 2 up to 6 times. </p>\n<p>If you still do not see a drop of SOGROYA, <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>Repeat Step 2 again.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Do not use the Pen if a drop of SOGROYA still does not appear after changing the needle and repeating Step 2. Call Novo Nordisk at 1-888-668-6444 for help.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1969803419\"></a><img alt=\"figure-h\" src=\"/dailymed/image.cfm?name=figure-h-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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). When you have selected your dose, you can go to Step 4. </dd>\n</dl>\n<p class=\"First\">\n<a name=\"id106173024\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-23.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> If there is not enough SOGROYA left </span>to select a full dose, see <span class=\"Bold\">Frequently Asked Questions</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2017566628\"></a><img alt=\"figure-i\" src=\"/dailymed/image.cfm?name=figure-i-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id978584056\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-24.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> The dose counter shows the dose in “mg” (See Figure J and Figure 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 to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2092495299\"></a><img alt=\"figure-j\" src=\"/dailymed/image.cfm?name=figure-j-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1964878351\"></a><img alt=\"figure-k\" src=\"/dailymed/image.cfm?name=figure-k-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-918170724\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-25.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose (See Figure L).</p>\n<p>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.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1668555688\"></a><img alt=\"figure-l\" src=\"/dailymed/image.cfm?name=figure-l-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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>SOGROYA can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper arms, upper legs (thighs) or buttocks as instructed by your healthcare provider (See Figure M). <span class=\"Bold\">Change the injection site every week.</span>\n</dd>\n<dt>•</dt>\n<dd>Wipe the injection site with an alcohol pad 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 N). </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 align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id842366769\"></a><img alt=\"figure-m\" src=\"/dailymed/image.cfm?name=figure-m-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><a name=\"id-1889099745\"></a><img alt=\"figure-n\" src=\"/dailymed/image.cfm?name=figure-n-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 O). <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 down the dose button with the needle in your skin.</span>\n</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id1908337710\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-26.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> If “0” does not appear in the dose</p>\n<p>counter after continuously pressing the dose button, your needle may be blocked or damaged. See <span class=\"Bold\">Frequently Asked Questions</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1122879556\"></a><img alt=\"figure-o\" src=\"/dailymed/image.cfm?name=figure-o-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Keep holding down the dose button with the needle in your skin</span><span class=\"Bold\">and slowly count to 6</span> to make sure that the full dose has been delivered (See Figure P).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1751272225\"></a><img alt=\"figure-p\" src=\"/dailymed/image.cfm?name=figure-p-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 Q). If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id384995530\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-27.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> You may see a drop of SOGROYA at the needle tip after injecting. This is normal and does not affect your dose.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1839924986\"></a><img alt=\"figure-q\" src=\"/dailymed/image.cfm?name=figure-q-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 R).</dd>\n<dt>•</dt>\n<dd>Place the needle in an FDA-cleared sharps disposal container immediately to reduce the risk of a needle stick (See Figure R).</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id64997497\"></a><img alt=\"letteri-bullet\" src=\"/dailymed/image.cfm?name=letteri-bullet-28.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> Always throw away (dispose of) the needle after each injection. </p>\n<p>For further information about safe sharps disposal, see <span class=\"Bold\">Frequently Asked Questions</span>.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-842015937\"></a><img alt=\"figure-r\" src=\"/dailymed/image.cfm?name=figure-r-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 SOGROYA from direct light (See Figure S). </dd>\n<dt> </dt>\n<dd>See “<span class=\"Bold\">How should I store my SOGROYA Pen?</span>”.</dd>\n</dl>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1874375307\"></a><img alt=\"figure-s\" src=\"/dailymed/image.cfm?name=figure-s-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id642782652\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-17.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\">Do not try to put the needle cap back on.</span> You may stick yourself with the needle.</p>\n<p>\n<a name=\"id416059490\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-18.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/> Always remove the needle from your Pen immediately after each injection. This reduces the risk of contamination, infection, leakage of SOGROYA, and blocked needles leading to incorrect dosing.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 SOGROYA Pen?</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Before you use SOGROYA Pen for the first time: </span>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>Store your new, unused SOGROYA Pen in a refrigerator between 36°F to 46°F (2°C to 8°C). </dd>\n<dt>•</dt>\n<dd>Store your new, unused SOGROYA Pen with the cap on and in the original carton.</dd>\n<dt>•</dt>\n<dd>Do not freeze SOGROYA. </dd>\n<dt>•</dt>\n<dd>When stored in the refrigerator, do not store the SOGROYA Pen directly next to the cooling element. </dd>\n<dt>•</dt>\n<dd>Keep SOGROYA away from direct heat and light.</dd>\n<dt>•</dt>\n<dd>Do not use SOGROYA if it has been frozen or in temperatures warmer than 86ºF (30°C). </dd>\n<dt>•</dt>\n<dd>Do not use SOGROYA after the expiration date printed on the carton and the Pen. </dd>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">After you use SOGROYA Pen and there is still medicine left:</span>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>Store remaining SOGROYA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 6 weeks.</dd>\n<dt>•</dt>\n<dd>Store your in-use SOGROYA Pen with the cap on and keep it in the original carton.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Do not store SOGROYA Pen with the needle attached. </span>\n</p>\n<p>If needed, unused and in-use SOGROYA pens can be stored out of the refrigerator. SOGROYA pens can be stored at room temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator. Throw away (dispose of) SOGROYA if it has been stored above 77°F (25°C) for more than 3 days (72 hours) <span class=\"Bold\">or </span>in temperatures warmer than 86°F (30°C).</p>\n<p>\n<span class=\"Bold\">Always keep your SOGROYA Pen and needles out of reach of others, especially children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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 much SOGROYA is 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 SOGROYA is left in your Pen (See Figure T).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-153763264\"></a><img alt=\"figure-t\" src=\"/dailymed/image.cfm?name=figure-t-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">To see how much SOGROYA is left in your Pen, use the dose counter:</p>\n<p>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”, 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 “4.8”, only 4.8 mg are left in your Pen (See Figure U).</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id208311297\"></a><img alt=\"figure-u\" src=\"/dailymed/image.cfm?name=figure-u-01.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></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. If you need more SOGROYA 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 </span>so that you do not give the wrong dose. If you are not sure how to split your dose using 2 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 SOGROYA 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 SOGROYA appears at the needle tip. Remove the needle as described in Step 5 and repeat Step 1 and Step 2.</p>\n<p>\n<span class=\"Bold\">B. Your Pen may be defective,</span> if SOGROYA 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 SOGROYA</span>,<span class=\"Bold\"></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 Step 1 to Step 4.</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. See “<span class=\"Bold\">How should I store SOGROYA?</span>” Do not try to refill your Pen, it is prefilled.</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 SOGROYA flow before you inject (See Step 1 and Step 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\"></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 throw away (dispose of) used SOGROYA</span><span class=\"Bold\">needles and Pens?</span>\n</p>\n<p>Put your used needles and Pens in an 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> 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: </p>\n<p>\n<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. Do not recycle your used sharps disposal container.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id1541854483\"></a><img alt=\"triangle-bullet\" src=\"/dailymed/image.cfm?name=triangle-bullet-19.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><span class=\"Bold\"> Important information</span>\n</p>\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</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"></td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><a name=\"id-1626527701\"></a><img alt=\"phone-qrcode\" src=\"/dailymed/image.cfm?name=phone-qrcode.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/><p class=\"First\">www.sogroya.com</p>\n<p> </p>\n<p>PATENT Information: http://novonordisk-us.com/products/product-patents.html</p>\n<p> </p>\n<p>SOGROYA<span class=\"Sup\">®</span> is a registered trademark of Novo Nordisk Health Care AG.</p>\n<p> </p>\n<p>Novo Nordisk<span class=\"Sup\">®</span> is a registered trademark of Novo Nordisk A/S.</p>\n<p> </p>\n<p>© 2004-2023 Novo Nordisk Health Care AG</p>\n<p> </p>\n<p>For further information contact:</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road </p>\n<p>Plainsboro, NJ 08536, USA </p>\n<p>1-888-668-6444</p>\n<p>Sogroya.com</p>\n<p> </p>\n<p>Manufactured by:</p>\n<p>Novo Nordisk Inc.</p>\n<p>Plainsboro, NJ 08536</p>\n<p>U.S. License No. 1261</p>\n<p> </p>\n<p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>Issued: 4/2023</p>\n<p>Version: 1</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">INSTRUCTIONS FOR USE</span> </p> <p> <span class="Bold">Norditropin</span><span class="Sup">®</span> (nor-dee-tro-pin) <span class="Bold">FlexPro</span><span class="Sup">®</span><span class="Bold"></span> </p> <p> <span class="Bold">(somatropin) </span> </p> <p> <span class="Bold">injection</span> </p> <p> <span class="Bold">prefilled pen with PenMate<span class="Sup">®</span></span> </p> <p> <span class="Bold">and</span> </p> <p> <span class="Bold">Sogroya<span class="Sup">® </span></span>(suh-GROY-uh)<span class="Bold"></span> </p> <p> <span class="Bold">(somapacitan-beco) </span> </p> <p> <span class="Bold">injection </span> </p> <p> <span class="Bold">prefilled pen with PenMate<span class="Sup">® </span></span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" 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> <dt>•</dt> <dd>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.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id-1678803146"></a><img alt="figure-a-penmate" src="/dailymed/image.cfm?name=figure-a-penmate.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Pen:</span> </p> <p>This pen represents Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL or 15 mg/1.5 mL Pen and Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pen</p> </td> </tr> <tr> <td align="center" class="Lrule Rrule" colspan="2" valign="top"><a name="id569012014"></a><img alt="figure-b-pen" src="/dailymed/image.cfm?name=figure-b-pen.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Needle parts and supplies:</span> </p> <a name="id-1084453599"></a><img alt="figure-c-needleparts" src="/dailymed/image.cfm?name=figure-c-needleparts.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="2" valign="top"><a name="id-650441013"></a><img alt="figure-d-pencase" src="/dailymed/image.cfm?name=figure-d-pencase.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1:</span><span class="Bold">Preparing</span><span class="Bold">your</span><span class="Bold">Pen</span><span class="Bold">with</span><span class="Sup"></span><span class="Bold">PenMate</span><span class="Bold">:</span> </p> <p>Wash your hands with soap and water and dry them. Check the name and the colored label on your Pen to make sure it contains the growth hormone strength prescribed by your healthcare provider.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">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="id293808103"></a><img alt="figure-e" src="/dailymed/image.cfm?name=figure-e.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id-1283422346"></a><img alt="figure-f" src="/dailymed/image.cfm?name=figure-f.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id-1696523678"></a><img alt="figure-g" src="/dailymed/image.cfm?name=figure-g.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td align="justify" class="Botrule Lrule Rrule" valign="top"> <p class="First">Wipe the front stopper on the needle thread of the Pen with an alcohol swab. </p> <p> <span class="Bold">See Figure H.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id854768346"></a><img alt="figure-h" src="/dailymed/image.cfm?name=figure-h.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Insert the Pen into the PenMate. Twist the Pen clockwise until you hear or feel a click.</p> <dl> <dt> </dt> <dd> <span class="Bold">See Figure I.</span> </dd> </dl> <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="id-78677814"></a><img alt="figure-i" src="/dailymed/image.cfm?name=figure-i.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" 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> <span class="Bold"> </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Get a new disposable needle 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="id-1679504468"></a><img alt="figure-j" src="/dailymed/image.cfm?name=figure-j.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id-747650742"></a><img alt="figure-k" src="/dailymed/image.cfm?name=figure-k.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id510271514"></a><img alt="figure-l" src="/dailymed/image.cfm?name=figure-l.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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> </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-1800442603"></a><img alt="figure-m" src="/dailymed/image.cfm?name=figure-m.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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> <p> <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> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">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="id-551622613"></a><img alt="figure-n" src="/dailymed/image.cfm?name=figure-n.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 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="id-1895265496"></a><img alt="figure-o" src="/dailymed/image.cfm?name=figure-o.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">This lowest dose will be used for your Norditropin or Sogroya flow check dose.</p> <p>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 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-723678319"></a><img alt="figure-p" src="/dailymed/image.cfm?name=figure-p.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id-869136600"></a><img alt="figure-q" src="/dailymed/image.cfm?name=figure-q.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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 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> <p>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> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">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="id-471438654"></a><img alt="figure-r" src="/dailymed/image.cfm?name=figure-r.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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> <p>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> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">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="id-993338990"></a><img alt="figure-s" src="/dailymed/image.cfm?name=figure-s.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" 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> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hold the PenMate firmly with 1 hand and pull the Pen out with your other hand 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-1855801300"></a><img alt="figure-t" src="/dailymed/image.cfm?name=figure-t.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" 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 until you hear or feel a click.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">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="id-1701543432"></a><img alt="figure-u" src="/dailymed/image.cfm?name=figure-u.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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">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="id735745948"></a><img alt="figure-v" src="/dailymed/image.cfm?name=figure-v.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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> <p> <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> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">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-466197482"></a><img alt="figure-w" src="/dailymed/image.cfm?name=figure-w.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id149800857"></a><img alt="figure-x" src="/dailymed/image.cfm?name=figure-x.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id248547114"></a><img alt="figure-y" src="/dailymed/image.cfm?name=figure-y.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Put the PenMate cap back on 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="id-892345886"></a><img alt="figure-z" src="/dailymed/image.cfm?name=figure-z.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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</span><span class="Bold">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 your Pen or needles with other people.</dd> <dt>•</dt> <dd>If your PenMate is damaged or lost, 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</span><span class="Bold">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="id732586465"></a><img alt="figure-aa" src="/dailymed/image.cfm?name=figure-aa.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id-1582834822"></a><img alt="figure-bb" src="/dailymed/image.cfm?name=figure-bb.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id1491135153"></a><img alt="figure-cc" src="/dailymed/image.cfm?name=figure-cc.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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="id732205721"></a><img alt="figure-dd" src="/dailymed/image.cfm?name=image-01.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa"/></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</span><span class="Bold">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 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. 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 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> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">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> <p>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> <p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p>Issued: 01/2025</p> </td> </tr> <tr class="Last"> <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 width=\"100%\">\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">INSTRUCTIONS FOR USE</span>\n</p>\n<p>\n<span class=\"Bold\">Norditropin</span><span class=\"Sup\">®</span> (nor-dee-tro-pin) <span class=\"Bold\">FlexPro</span><span class=\"Sup\">®</span><span class=\"Bold\"></span>\n</p>\n<p>\n<span class=\"Bold\">(somatropin) </span>\n</p>\n<p>\n<span class=\"Bold\">injection</span>\n</p>\n<p>\n<span class=\"Bold\">prefilled pen with PenMate<span class=\"Sup\">®</span></span>\n</p>\n<p>\n<span class=\"Bold\">and</span>\n</p>\n<p>\n<span class=\"Bold\">Sogroya<span class=\"Sup\">® </span></span>(suh-GROY-uh)<span class=\"Bold\"></span>\n</p>\n<p>\n<span class=\"Bold\">(somapacitan-beco) </span>\n</p>\n<p>\n<span class=\"Bold\">injection </span>\n</p>\n<p>\n<span class=\"Bold\">prefilled pen with PenMate<span class=\"Sup\">® </span></span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" 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<dt>•</dt>\n<dd>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.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id-1678803146\"></a><img alt=\"figure-a-penmate\" src=\"/dailymed/image.cfm?name=figure-a-penmate.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Pen:</span>\n</p>\n<p>This pen represents Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL or 15 mg/1.5 mL Pen and Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pen</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id569012014\"></a><img alt=\"figure-b-pen\" src=\"/dailymed/image.cfm?name=figure-b-pen.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Needle parts and supplies:</span>\n</p>\n<a name=\"id-1084453599\"></a><img alt=\"figure-c-needleparts\" src=\"/dailymed/image.cfm?name=figure-c-needleparts.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><a name=\"id-650441013\"></a><img alt=\"figure-d-pencase\" src=\"/dailymed/image.cfm?name=figure-d-pencase.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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:</span><span class=\"Bold\">Preparing</span><span class=\"Bold\">your</span><span class=\"Bold\">Pen</span><span class=\"Bold\">with</span><span class=\"Sup\"></span><span class=\"Bold\">PenMate</span><span class=\"Bold\">:</span>\n</p>\n<p>Wash your hands with soap and water and dry them. Check the name and the colored label on your Pen to make sure it contains the growth hormone strength prescribed by your healthcare provider.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">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=\"id293808103\"></a><img alt=\"figure-e\" src=\"/dailymed/image.cfm?name=figure-e.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id-1283422346\"></a><img alt=\"figure-f\" src=\"/dailymed/image.cfm?name=figure-f.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id-1696523678\"></a><img alt=\"figure-g\" src=\"/dailymed/image.cfm?name=figure-g.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td align=\"justify\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Wipe the front stopper on the needle thread of the Pen with an alcohol swab. </p>\n<p>\n<span class=\"Bold\">See Figure H.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id854768346\"></a><img alt=\"figure-h\" src=\"/dailymed/image.cfm?name=figure-h.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Insert the Pen into the PenMate. Twist the Pen clockwise until you hear or feel a click.</p>\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">See Figure I.</span>\n</dd>\n</dl>\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=\"id-78677814\"></a><img alt=\"figure-i\" src=\"/dailymed/image.cfm?name=figure-i.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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. 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>\n<span class=\"Bold\"> </span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Get a new disposable needle 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=\"id-1679504468\"></a><img alt=\"figure-j\" src=\"/dailymed/image.cfm?name=figure-j.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id-747650742\"></a><img alt=\"figure-k\" src=\"/dailymed/image.cfm?name=figure-k.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id510271514\"></a><img alt=\"figure-l\" src=\"/dailymed/image.cfm?name=figure-l.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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</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-1800442603\"></a><img alt=\"figure-m\" src=\"/dailymed/image.cfm?name=figure-m.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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<p>\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</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">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=\"id-551622613\"></a><img alt=\"figure-n\" src=\"/dailymed/image.cfm?name=figure-n.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 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=\"id-1895265496\"></a><img alt=\"figure-o\" src=\"/dailymed/image.cfm?name=figure-o.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">This lowest dose will be used for your Norditropin or Sogroya flow check dose.</p>\n<p>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 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-723678319\"></a><img alt=\"figure-p\" src=\"/dailymed/image.cfm?name=figure-p.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id-869136600\"></a><img alt=\"figure-q\" src=\"/dailymed/image.cfm?name=figure-q.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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 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<p>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</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">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=\"id-471438654\"></a><img alt=\"figure-r\" src=\"/dailymed/image.cfm?name=figure-r.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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<p>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</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">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=\"id-993338990\"></a><img alt=\"figure-s\" src=\"/dailymed/image.cfm?name=figure-s.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" 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</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Hold the PenMate firmly with 1 hand and pull the Pen out with your other hand 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-1855801300\"></a><img alt=\"figure-t\" src=\"/dailymed/image.cfm?name=figure-t.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" 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 until you hear or feel a click.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">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=\"id-1701543432\"></a><img alt=\"figure-u\" src=\"/dailymed/image.cfm?name=figure-u.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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\">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>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id735745948\"></a><img alt=\"figure-v\" src=\"/dailymed/image.cfm?name=figure-v.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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<p>\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</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">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-466197482\"></a><img alt=\"figure-w\" src=\"/dailymed/image.cfm?name=figure-w.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id149800857\"></a><img alt=\"figure-x\" src=\"/dailymed/image.cfm?name=figure-x.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id248547114\"></a><img alt=\"figure-y\" src=\"/dailymed/image.cfm?name=figure-y.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Put the PenMate cap back on 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=\"id-892345886\"></a><img alt=\"figure-z\" src=\"/dailymed/image.cfm?name=figure-z.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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</span><span class=\"Bold\">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 your Pen or needles with other people.</dd>\n<dt>•</dt>\n<dd>If your PenMate is damaged or lost, 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</span><span class=\"Bold\">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=\"id732586465\"></a><img alt=\"figure-aa\" src=\"/dailymed/image.cfm?name=figure-aa.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id-1582834822\"></a><img alt=\"figure-bb\" src=\"/dailymed/image.cfm?name=figure-bb.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id1491135153\"></a><img alt=\"figure-cc\" src=\"/dailymed/image.cfm?name=figure-cc.JPG.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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=\"id732205721\"></a><img alt=\"figure-dd\" src=\"/dailymed/image.cfm?name=image-01.jpg&amp;setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa\"/></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</span><span class=\"Bold\">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 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. 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 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</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">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<p>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<p>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<tr class=\"Last\">\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>" }

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5 mg / 1.5 mL (3.3 mg/mL) Prefilled Pen

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For subcutaneous Use Only

{ "type": "p", "children": [], "text": "\nFor subcutaneous Use Only\n" }

1x1.5 mL single-patient use prefilled pen

{ "type": "p", "children": [], "text": "1x1.5 mL single-patient use prefilled pen" }

Dials in 0.025 mg increments and contains 5 mg total

{ "type": "p", "children": [], "text": "Dials in 0.025 mg increments and contains 5 mg total" }

Rx only

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

once weekly

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

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

10 mg / 1.5 mL (6.7 mg/mL) Prefilled Pen

{ "type": "p", "children": [], "text": "\n10 mg / 1.5 mL (6.7 mg/mL) Prefilled Pen\n" }

For subcutaneous Use Only

{ "type": "p", "children": [], "text": "\nFor subcutaneous Use Only\n" }

1x1.5 mL single-patient use prefilled pen

{ "type": "p", "children": [], "text": "1x1.5 mL single-patient use prefilled pen" }

Dials in 0.05 mg increments and contains 10 mg total

{ "type": "p", "children": [], "text": "Dials in 0.05 mg increments and contains 10 mg total" }

Rx only

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

once weekly

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

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

15 mg / 1.5 mL (10 mg/mL) Prefilled Pen

{ "type": "p", "children": [], "text": "\n15 mg / 1.5 mL (10 mg/mL) Prefilled Pen\n" }

For subcutaneous Use Only

{ "type": "p", "children": [], "text": "\nFor subcutaneous Use Only\n" }

1x1.5 mL single-patient use prefilled pen

{ "type": "p", "children": [], "text": "1x1.5 mL single-patient use prefilled pen" }

Dials in 0.1 mg increments and contains 15 mg total

{ "type": "p", "children": [], "text": "Dials in 0.1 mg increments and contains 15 mg total" }

Rx only

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

once weekly

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