NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.

{ "type": "p", "children": [], "text": "NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone." }

NGENLA (somatrogon-ghla) is a clear and colorless to slightly light yellow solution available as:

{ "type": "p", "children": [], "text": "NGENLA (somatrogon-ghla) is a clear and colorless to slightly light yellow solution available as:" }

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

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

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported with somatropin [see Contraindications (4)]. The safety of continuing NGENLA treatment for the approved indication in patients who concurrently develop these illnesses has not been established.

Severe systemic hypersensitivity reactions including anaphylaxis and angioedema have been reported with somatropin. Inform patients and/or caregivers that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs. NGENLA is contraindicated in patients with known hypersensitivity to somatrogon-ghla or any excipients in NGENLA [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 should be completed prior to instituting therapy with NGENLA. Discontinue NGENLA if there is evidence of recurrent malignancy.

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 GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on NGENLA 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 NGENLA in these patients. If treatment with NGENLA is initiated, carefully monitor these patients for development of neoplasms.

Monitor patients on NGENLA therapy carefully for increased growth or potential malignant changes of preexisting nevi. Advise patients and/or caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of preexisting nevi.

Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients receiving growth hormone. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving NGENLA, 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 NGENLA is initiated.

Intracranial hypertension (IH) 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, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of somatropin dose.

Perform fundoscopic examination before initiating treatment with NGENLA to exclude preexisting papilledema and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating NGENLA. NGENLA should be temporarily discontinued in patients with clinical or fundoscopic evidence of IH. If IH is confirmed, restart treatment with NGENLA at a lower dose after IH-associated signs and symptoms have resolved.

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

Undiagnosed/untreated hypothyroidism may prevent an optimal response to NGENLA therapy. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone 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.

NGENLA increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Growth hormone treatment 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 NGENLA is administered subcutaneously at the same site over a long period of time, lipoatrophy may result. Rotate injection sites when administering NGENLA to reduce this risk [see Dosage and Administration (2.1)].

There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. NGENLA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. If a patient is found to have abnormal laboratory tests, monitor as appropriate.

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.

Safety data are derived from a safety and efficacy study in pediatric patients with GHD [see Clinical Studies (14.1)]. The data from the 12-month main study period reflect exposure of 109 patients to NGENLA administered once weekly (0.66 mg/kg/wk) and 115 patients to somatropin administered once daily (0.034 mg/kg/day).

The mean age across the treatment groups, was 7.7 years (min 3.01, max 11.96); 40.2% of patients were >3 years to ≤7 years, 59.8% were >7 years, 71.9% of patients were male, and 28.1% were female. In this study, 74.6% of patients were White, 20.1% were Asian, 0.9% were Black or African American, 0.5% were American Indian or Alaska Native, 0.5% were Native Hawaiian or Other Pacific Islander, and for 3.6% race information was missing; 10.7% of patients identified as Hispanic or Latino. Baseline disease characteristics were balanced across treatment groups.

Table 1 shows the adverse reactions that occurred in ≥5% of patients treated with NGENLA or daily somatropin during the 12-month main study period. Reporting of injection site reactions was solicited through the use of a patient diary after each weekly injection for patients administered NGENLA and once weekly for patients administered daily injections of somatropin.

<div class="scrollingtable"><table class="Noautorules" width="85%"> <caption> <span>Table 1  Adverse Reactions Occurring in ≥5% of NGENLA- or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment)</span> </caption> <col width="33%"/> <col width="32%"/> <col width="31%"/> <tfoot> <tr> <td align="left" colspan="3" valign="top">Adverse reactions that are medically related were grouped to a single preferred term.</td> </tr> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Injection site reactions included: injection site pain (39% somatrogon-ghla vs 25% daily somatropin), injection site swelling/induration/hypertrophy/inflammation (10% somatrogon-ghla vs 1% daily somatropin), injection site erythema (8% somatrogon-ghla vs none daily somatropin), injection site pruritus (5% somatrogon-ghla vs none daily somatropin), injection site hemorrhage (5% somatrogon-ghla vs none daily somatropin).</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic, pharyngitis streptococcal, viral pharyngitis, nasopharyngitis.</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Adverse Drug Reactions</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Daily Somatropin</span> </p> <p> <span class="Bold">(N=115)</span> </p> <p> <span class="Bold">n (%)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">NGENLA</span> </p> <p> <span class="Bold">(N=109)</span> </p> <p> <span class="Bold">n (%)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Injection site reactions<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">29 (25.2)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">46 (42.2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Nasopharyngitis<a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">33 (28.7)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">36 (33)</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="middle"> <p class="First">25 (21.7)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">18 (16.5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Pyrexia</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">17 (14.8)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">18 (16.5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Anemia</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">10 (8.7)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">10 (9.2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Cough</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">9 (7.8)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">9 (8.3)</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="middle"> <p class="First">9 (7.8)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">8 (7.3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hypothyroidism</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">3 (2.6)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">7 (6.4)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Abdominal pain</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">8 (7.0)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">7 (6.4)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Rash</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">7 (6.1)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">6 (5.5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Oropharyngeal pain</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">4 (3.5)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">6 (5.5)</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="middle"> <p class="First">8 (7.0)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">5 (4.6)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Otitis media</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">10 (8.7)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">5 (4.6)</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="middle"> <p class="First">6 (5.2)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">5 (4.6)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Bronchitis</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">9 (7.8)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">3 (2.8)</p> </td> </tr> </tbody> </table></div>

Laboratory Tests

More NGENLA-treated patients shifted from normal eosinophil levels at baseline to elevated eosinophil levels at the end of the 12-month study compared to the daily somatropin group (29% vs 12%).

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

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

<div class="scrollingtable"><table class="Noautorules" width="85%"> <caption> <span>Table 2  Clinically Significant Drug Interactions with NGENLA</span> </caption> <col width="29%"/> <col width="67%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Replacement Glucocorticoid Treatment</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <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. Growth hormone inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NGENLA may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA <span class="Italics">[see <a href="#S5.7">Warnings and Precautions (5.7)</a>]</span>.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <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="top"> <p class="First"> <span class="Bold">Supraphysiologic Glucocorticoid Treatment</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Supraphysiologic glucocorticoid treatment may attenuate the growth-promoting effects of NGENLA in pediatric patients.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid hypoadrenalism and an inhibitory effect on growth.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Cytochrome P450-Metabolized Drugs</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. NGENLA may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Careful monitoring is advisable when NGENLA is administered in combination with drugs metabolized by CYP450 liver enzymes.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Oral Estrogen</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Oral estrogens may reduce the serum IGF-1 response to NGENLA.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Patients receiving oral estrogen replacement may require higher NGENLA dosages.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Insulin and/or Other Antihyperglycemic Agents</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Treatment with NGENLA may decrease insulin sensitivity, particularly at higher doses.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents <span class="Italics">[see <a href="#S5.4">Warnings and Precautions (5.4)</a>]</span>.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"85%\">\n<caption>\n<span>Table 2  Clinically Significant Drug Interactions with NGENLA</span>\n</caption>\n<col width=\"29%\"/>\n<col width=\"67%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Replacement Glucocorticoid Treatment</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\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. Growth hormone inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NGENLA may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA <span class=\"Italics\">[see <a href=\"#S5.7\">Warnings and Precautions (5.7)</a>]</span>.</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\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=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Supraphysiologic Glucocorticoid Treatment</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Supraphysiologic glucocorticoid treatment may attenuate the growth-promoting effects of NGENLA in pediatric patients.</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid hypoadrenalism and an inhibitory effect on growth.</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\">Cytochrome P450-Metabolized Drugs</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. NGENLA may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes.</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Careful monitoring is advisable when NGENLA is administered in combination with drugs metabolized by CYP450 liver enzymes.</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\">Oral Estrogen</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Oral estrogens may reduce the serum IGF-1 response to NGENLA.</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Patients receiving oral estrogen replacement may require higher NGENLA dosages.</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\">Insulin and/or Other Antihyperglycemic Agents</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Treatment with NGENLA may decrease insulin sensitivity, particularly at higher doses.</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents <span class=\"Italics\">[see <a href=\"#S5.4\">Warnings and Precautions (5.4)</a>]</span>.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary

There are no available data on NGENLA use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In reproduction studies with pregnant rats, there was no evidence of embryo-fetal toxicity following administration of somatrogon-ghla subcutaneously during organogenesis at doses up to 45 times the maximum recommended human dose based on exposure (see Data).

The background risk of major birth defects and miscarriage in 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 toxicity study in rats, no adverse maternal or embryo-fetal effects were observed when somatrogon-ghla was administered via subcutaneous injection every 2 days from gestation day (GD) 6 to 18 at doses up to 30 mg/kg (45 times the maximum recommended human dose based on Cav exposure).

In a pre- and postnatal development study in rats, somatrogon-ghla was administered via subcutaneous injection to pregnant rats every 2 days from GD 6 to lactation day 20 at doses up to 30 mg/kg. There was no evidence of maternal toxicity and no adverse effects on the first generation (F1) offspring. Somatrogon-ghla elicited an increase in F1 mean body weights in both sexes and increased the mean copulatory interval in F1 females at the highest dose (30 mg/kg), consistent with a longer estrous cycle length. However, there were no effects on mating indices in F1 females.

Risk Summary

There are no data on the presence of somatrogon-ghla in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NGENLA and any potential adverse effects on the breastfed infant from NGENLA or from the underlying maternal condition.

Pregnancy Testing

Although somatrogon-ghla did not interfere with hCG pregnancy testing in a limited number of commercial tests, interference with hCG blood and urine pregnancy testing in patients receiving somatrogon-ghla may be possible, leading to either false positive or false negative results. Alternative methods (i.e., not reliant on hCG) are recommended to determine pregnancy.

The safety and effectiveness of NGENLA have been established for the treatment of growth failure due to inadequate secretion of endogenous growth hormone (GH) in pediatric patients aged 3 years and older [see Clinical Studies (14.1)]. The use of NGENLA for this indication is supported by evidence from a 52‑week, multi-center, randomized, open-label, active-controlled, parallel-group phase 3 study in 224 treatment-naïve, prepubertal pediatric subjects with growth hormone deficiency.

Risks in pediatric patients associated with growth hormone use include:

Acute overdosage may lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with growth hormone may cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism consistent with the effects of excess growth hormone.

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Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa.

{ "type": "p", "children": [], "text": "Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa." }

NGENLA (somatrogon-ghla) injection is a sterile, clear and colorless to slightly light yellow solution for subcutaneous use supplied in a 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen.

{ "type": "p", "children": [], "text": "NGENLA (somatrogon-ghla) injection is a sterile, clear and colorless to slightly light yellow solution for subcutaneous use supplied in a 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen." }

Each 1.2 mL of solution contains either 24 mg or 60 mg of somatrogon-ghla, and the inactive ingredients citric acid monohydrate (0.3 mg), histidine (1.9 mg), metacresol (4 mg, as a preservative), poloxamer 188 (2 mg), sodium chloride (10 mg) and sodium citrate (2.8 mg) in water for injection. NGENLA has a pH of approximately 6.6.

{ "type": "p", "children": [], "text": "Each 1.2 mL of solution contains either 24 mg or 60 mg of somatrogon-ghla, and the inactive ingredients citric acid monohydrate (0.3 mg), histidine (1.9 mg), metacresol (4 mg, as a preservative), poloxamer 188 (2 mg), sodium chloride (10 mg) and sodium citrate (2.8 mg) in water for injection. NGENLA has a pH of approximately 6.6." }

Somatrogon-ghla binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Somatrogon-ghla binding leads to activation of the STAT5b signaling pathway and increases the serum concentration of Insulin-like Growth Factor (IGF-1). GH and IGF-1 stimulate metabolic changes, linear growth, and enhance growth velocity in pediatric patients with GHD.

Following single dose administration of somatrogon, dose-dependent increases in IGF-1 response were observed.

Following multiple dosing, IGF-1 SDS levels were in the normal range for pediatric patients with GHD, similar to daily somatropin. IGF-1 levels peak approximately 2 days (48 hours) post-dose, with the average weekly IGF-1 occurring approximately 4 days post-dose.

Somatrogon-ghla pharmacokinetics (PK) was assessed using a population PK approach for NGENLA in 151 pediatric patients (aged 3 to 15.5 years) with GHD.

Absorption

Following subcutaneous injection, serum concentrations increased slowly, peaking 6 to 25 hours with a median of 11 hours after dosing.

In pediatric patients with GHD, somatrogon-ghla exposure increases in a dose-proportional manner for doses of 0.25 mg/kg/wk, 0.48 mg/kg/wk, and 0.66 mg/kg/wk. There is no accumulation of somatrogon-ghla after once weekly administration. In pediatric patients with GHD, the mean population PK estimated steady-state peak concentrations (mean ± SD) following 0.66 mg/kg/wk was 495 ± 90 ng/mL.

Distribution

In pediatric patients with GHD, the mean population PK estimated apparent central volume of distribution was 0.342 L/kg and apparent peripheral volume of distribution was 0.671 L/kg.

Elimination

In pediatric patients with GHD, the mean population PK estimated apparent clearance was 0.0398 L/h/kg. The mean population PK estimated effective half-life was 37.7 hours, which allows for weekly dosing. Somatrogon-ghla will be present in the circulation for about 8 days after the last dose.

Metabolism

The metabolism of somatrogon-ghla is believed to be classical protein catabolism, with subsequent recovery of the amino acids and return to the systemic circulation.

Excretion

Excretion was not evaluated in clinical studies.

Specific Populations

Based on population PK analyses, age, sex, race, and ethnicity do not have a clinically meaningful effect on the pharmacokinetics of somatrogon-ghla in pediatric patients with GHD. The exposure of somatrogon-ghla decreases with an increase in body weight. However, the somatrogon-ghla dosing regimen of 0.66 mg/kg/wk provides adequate systemic exposure over the body weight range of 10 to 54 kg evaluated in the clinical studies.

Renal or Hepatic Impairment

NGENLA has not been studied in patients with hepatic or renal impairment.

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

During the 12-month main period of study NCT 02968004, 84/109 (77.1%) of somatrogon-ghla‑treated patients tested positive for anti-drug antibodies, with most showing specificity to human growth hormone. The anti-drug antibodies persisted in most of the subjects during the study. Neutralizing antibodies developed in 8/217 (3.7%) of somatrogon-ghla-treated patients during the study for up to 42 months of exposure to somatrogon-ghla. The neutralizing antibodies were transient in all subjects. Anti-drug antibodies, including neutralizing-antibodies, did not appear to have a clinically significant impact on the safety or effectiveness of NGENLA during the 12‑month randomized treatment period. Additionally, no apparent effect of anti-drug antibodies on growth was observed for additional 30 months of exposure to somatrogon-ghla in the uncontrolled extension period of study NCT 02968004.

Anti-Drug Antibody Effects on Pharmacokinetics

The population pharmacokinetic analysis of data from study NCT 02968004 showed that patients who tested positive for anti-drug antibodies had an approximately 26% decrease in apparent clearance. These anti-drug antibody-associated pharmacokinetic changes are not considered to be clinically significant.

Carcinogenesis

No long term carcinogenicity studies have been performed with somatrogon-ghla.

Mutagenesis

Genotoxicity studies have not been performed.

Impairment of Fertility

The potential for somatrogon-ghla to affect fertility and early embryonic development was evaluated in male and female rats administered subcutaneously before cohabitation, through mating to implantation. Somatrogon‑ghla elicited an increase in estrous cycle length, copulatory interval, and number of corpora lutea at exposures ≥22-fold the MRHD, but there was no impact on female fertility, mating indices, number of viable embryos or early embryonic development, or on male fertility up to 30 mg/kg every two days (45-fold the MRHD based on exposure).

A multi-center, randomized, open-label, active-controlled, parallel-group phase 3 study (NCT 02968004) was conducted in 224 treatment-naïve, prepubertal pediatric subjects with growth hormone deficiency (GHD). The primary efficacy endpoint was annualized height velocity at Week 52.

One hundred nine (109) subjects received 0.66 mg/kg/week NGENLA, and 115 subjects received 0.034 mg/kg/day daily somatropin. The subjects age ranged from 3 to 12 years, with a mean of 7.7 years. One hundred sixty-one (71.9%) subjects were male and 63 (28.1%) were female. One hundred sixty-seven (74.6%) subjects were White, 45 (20.1%) subjects were Asian, 2 (0.9%) subjects were Black or African-American, 1 (0.5%) subject was American Indian or Alaska Native, 1 (0.5%) subject was Native Hawaiian or Other Pacific Islander, and for 8 (3.6%) subjects race information was missing; 24 (10.7%) subjects identified as Hispanic or Latino. The subjects had a mean baseline height standard deviation score (SDS) of -2.9.

Treatment with once-weekly NGENLA for 52 weeks resulted in an annualized height velocity of 10.1 cm/year. Patients treated with daily somatropin achieved an annualized height velocity of 9.8 cm/year after 52 weeks of treatment. Refer to Table 3.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 3. Annualized Height Velocity at Week 52 in Pediatric Patients with GHD </span> </caption> <col width="25%"/> <col width="24%"/> <col width="19%"/> <col width="17%"/> <tfoot> <tr class="First"> <td align="left" colspan="4" valign="top">Abbreviations: CI=confidence interval; LSM=least square mean; N=number of patients randomized and treated </td> </tr> <tr class="Last"> <td align="left" colspan="4" valign="top">The estimates of LSM are from analysis of covariance model with treatment, age group, gender, peak growth hormone levels, and region as fixed factors and baseline height SDS as a covariate. Missing data is imputed by multiple imputation using SAS PROC MI with MNAR/FCS Method.</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="right" class="Lrule Rrule Toprule" rowspan="2" valign="bottom"> <p class="First"> <span class="Bold">Treatment Parameter</span> </p> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Treatment Group</span> </p> </td><td align="center" class="Rrule Toprule" rowspan="2" valign="middle"> <p class="First"> <span class="Bold">LSM Treatment Difference </span> <br/> <span class="Bold">(95% CI) (NGENLA minus Daily Somatropin)</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">NGENLA </span> <br/> <span class="Bold">(N=109)</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">Daily Somatropin</span> <br/> <span class="Bold">(N=115)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">LSM Estimate</span> </p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">LSM Estimate</span> </p> </td><td class="Botrule Rrule" valign="top"></td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Annualized Height Velocity (cm/yr)</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">10.1</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">9.8</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">0.3 (-0.2, 0.9)</p> </td> </tr> </tbody> </table></div>

The mean height SDS at Week 52 was -1.94 in NGENLA arm and -1.99 in the daily somatropin arm. The mean increase in height SDS from baseline at Week 52 was 0.92 in NGENLA arm and 0.87 in the daily somatropin arm, respectively.

How Supplied

NGENLA (somatrogon-ghla) injection is a clear and colorless to slightly light yellow solution containing a preservative and supplied as one single-patient-use disposable prefilled pen per carton available in the following packages:

<div class="scrollingtable"><table width="75%"> <col width="29%"/> <col width="28%"/> <col width="28%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule Toprule" valign="top"></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">24 mg/1.2 mL Prefilled Pen<br/> <br/>NDC: 0069-0505-02</span></th><th align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">60 mg/1.2 mL Prefilled Pen<br/> <br/>NDC: 0069-0520-02</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Somatrogon-ghla solution concentration</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">20 mg/mL</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">50 mg/mL</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Color scheme</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">Lilac pen cap, injection button and label</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">Blue pen cap, injection button and label</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Dose increments</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0.2 mg/0.01 mL</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0.5 mg/0.01 mL</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Maximum dose</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 mg (0.6 mL)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">30 mg (0.6 mL)</p> </td> </tr> </tbody> </table></div>

Not made with natural rubber latex.

Sterile needles are required for administration but not included. Consult the Instructions for Use for needles that can be used.

Storage and Handling

Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days.

Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight.

Always remove and safely discard the needle after each injection and store the NGENLA prefilled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on your prefilled pen when it is not in use. Write the date of first use in the space provided on the pen label. The prefilled pen should not be used more than 28 days after first use.

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

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

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

Manufactured by:Pfizer Ireland PharmaceuticalsRingaskiddy,Cork,Ireland

{ "type": "p", "children": [], "text": "Manufactured by:Pfizer Ireland PharmaceuticalsRingaskiddy,Cork,Ireland" }

US License No: 2060

{ "type": "p", "children": [], "text": "US License No: 2060" }

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

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

LAB-1433-1.0

{ "type": "p", "children": [], "text": "LAB-1433-1.0" }

<div class="scrollingtable"><table width="100%"> <col width="100%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="1" valign="top">This Patient Information has been approved by the U.S. Food and Drug Administration.     Issued: 6/2023</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">PATIENT INFORMATION</span> <br/> <span class="Bold">NGENLA<span class="Sup">®</span> (en’ JEN-lah)</span> </p> <p> <span class="Bold">(somatrogon-ghla)</span> </p> <p> <span class="Bold">injection, for subcutaneous use</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What is NGENLA?</span> <br/>NGENLA is a prescription medicine that contains a form of human growth hormone, like the growth hormone made by the human body. NGENLA is given by injection under the skin (subcutaneous) in children who are not growing because of low or no growth hormone levels.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Do not use NGENLA if:</span> </p> <dl> <dt>•</dt> <dd>your child has a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.</dd> <dt>•</dt> <dd>your child is allergic to somatrogon-ghla or any of the ingredients in NGENLA. See the end of this leaflet for a complete list of ingredients in NGENLA.</dd> <dt>•</dt> <dd>your child has closed bone growth plates (epiphyses).</dd> <dt>•</dt> <dd>your child has cancer or other tumors.</dd> <dt>•</dt> <dd>your child’s healthcare provider tells you that your child has certain types of eye problems caused by diabetes (diabetic retinopathy).</dd> <dt>•</dt> <dd>your child has Prader-Willi syndrome, is severely obese, or has breathing problems including sleep apnea (briefly stop breathing during sleep).<br/> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Before using NGENLA, tell your child’s healthcare provider about all of your child’s medical conditions, including if your child:</span> </p> <dl> <dt>•</dt> <dd>has had heart or stomach surgery, trauma or serious breathing (respiratory) problems.</dd> <dt>•</dt> <dd>has had a history of problems breathing while they slept (sleep apnea).</dd> <dt>•</dt> <dd>has or has had cancer or any tumor.</dd> <dt>•</dt> <dd>has diabetes.</dd> <dt>•</dt> <dd>is pregnant or plans to become pregnant. It is not known if NGENLA will harm your child’s unborn baby. Talk to your child’s healthcare provider if your child is pregnant or plans to become pregnant.</dd> <dt>•</dt> <dd>is breastfeeding or plans to breastfeed. It is not known if NGENLA passes into breast milk. You and your child’s healthcare provider should decide if they will take NGENLA while breastfeeding.</dd> </dl> <p> <span class="Bold">Tell your child’s healthcare provider about all the medicines your child takes</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NGENLA may affect how other medicines work, and other medicines may affect how NGENLA works.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">How should I use NGENLA?</span> </p> <dl> <dt>•</dt> <dd>Read the detailed <span class="Bold">Instructions for Use</span> that come with NGENLA.</dd> <dt>•</dt> <dd>NGENLA comes in 2 different dosage strengths. Your child’s healthcare provider will prescribe the dose of medicine and the dosage strength that is right for your child.</dd> <dt>•</dt> <dd>Your child’s healthcare provider will show you how to inject NGENLA before it is used for the first time. <span class="Bold">Do not</span> try to inject NGENLA until you have been shown the right way by your child’s healthcare provider.</dd> <dt>•</dt> <dd>Inject NGENLA exactly as your child’s healthcare provider tells you to.</dd> <dt>•</dt> <dd>NGENLA is injected under the skin (subcutaneously) and can be given in the stomach (abdomen), thighs, buttocks, or upper arms. Rotate the site of injection weekly.</dd> <dt>•</dt> <dd>Inject NGENLA 1 time each week, on the same day each week, at any time of the day.</dd> <dt>•</dt> <dd>You may change the day of the week NGENLA is used as long as the last dose was injected 3 or more days before. After the new day of the week has been chosen, continue with the 1 time a week schedule.</dd> <dt>•</dt> <dd>If your child misses a dose of NGENLA the missed dose should be injected as soon as possible within 3 days after the missed dose. If more than 3 days have passed, skip your child’s missed dose. Inject the next dose on the regularly scheduled day.</dd> <dt>•</dt> <dd>NGENLA prefilled pens are for use by 1 person only.</dd> <dt>•</dt> <dd> <span class="Bold">Do not share your child’s NGENLA prefilled pens and needles with another person, even if the needle has been changed. Your child may give another person an infection or get an infection from them.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of NGENLA?</span> </p> <p> <span class="Bold">NGENLA 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>serious allergic reactions. Get medical help right away if your child has the following symptoms:<dl> <dt>o</dt> <dd>swelling of the face, lips, mouth, or tongue</dd> <dt>o</dt> <dd>trouble breathing</dd> <dt>o</dt> <dd>wheezing</dd> <dt>o</dt> <dd>severe itching</dd> <dt>o</dt> <dd>skin rashes, redness, or swelling</dd> <dt>o</dt> <dd>dizziness or fainting</dd> <dt>o</dt> <dd>fast heartbeat or pounding in the chest</dd> <dt>o</dt> <dd>sweating</dd> </dl> </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 child’s healthcare provider will need to monitor your child for a return of cancer or a tumor. Contact your child’s healthcare provider if your child starts to have headaches, or has changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of the skin. </dd> <dt>•</dt> <dd>new or worsening high blood sugar (hyperglycemia) or diabetes. Your child’s blood sugar may need to be monitored during treatment with NGENLA.</dd> <dt>•</dt> <dd>increase in pressure inside the skull (intracranial hypertension). If your child has headaches, eye problems, nausea or vomiting, contact your child’s healthcare provider.</dd> <dt>•</dt> <dd>your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in the joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in children during treatment with NGENLA. Tell your child’s healthcare provider if your child has any of these signs or symptoms of fluid retention.</dd> <dt>•</dt> <dd>decrease in a hormone called cortisol. Your child’s healthcare provider will do blood tests to check your child’s cortisol levels. Tell your child’s healthcare provider if your child has severe fatigue, dizziness, weakness, vomiting, dehydration, or weight loss.</dd> <dt>•</dt> <dd>decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NGENLA works. Your child’s healthcare provider will do blood tests to check your child’s hormone levels.</dd> <dt>•</dt> <dd>hip and knee pain or limp (slipped capital femoral epiphysis). Tell your child’s healthcare provider if your child has any of these signs or symptoms.</dd> <dt>•</dt> <dd>worsening of curvature of the spine (scoliosis). If your child has scoliosis, your child will need to be checked often for an increase in the curve of the spine.</dd> <dt>•</dt> <dd>severe and constant stomach (abdominal) pain. This could be a sign of pancreatitis. Tell your child’s healthcare provider if your child has any new abdominal pain.</dd> <dt>•</dt> <dd>loss of fat and tissue weakness in the area of skin you inject. Talk to your child’s healthcare provider about rotating the areas where you inject NGENLA.</dd> <dt>•</dt> <dd>high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.</dd> <dt>•</dt> <dd>increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in the blood. Your child’s healthcare provider will do blood tests to check this. </dd> </dl> <p> <span class="Bold">The most common side effects of NGENLA include:</span> </p> <dl> <dt> </dt> <dd> <dl> <dt>o</dt> <dd>injection site reactions (such as pain, swelling, rash, itching, bleeding)</dd> <dt>o</dt> <dd>common cold</dd> <dt>o</dt> <dd>headache</dd> <dt>o</dt> <dd>fever</dd> <dt>o</dt> <dd>low red blood cells (anemia)</dd> <dt>o</dt> <dd>cough</dd> <dt>o</dt> <dd>vomiting</dd> <dt>o</dt> <dd>decrease in thyroid hormone levels</dd> <dt>o</dt> <dd>stomach (abdominal) pain</dd> <dt>o</dt> <dd>rash</dd> <dt>o</dt> <dd>throat pain</dd> </dl> </dd> </dl> <p>These are not all the possible side effects of NGENLA. You should tell your child’s healthcare provider if your child has any side effect that bothers them or that does not go away.<br/> <br/>Call your child’s doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">How should I store NGENLA?</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Do not</span> freeze your pen or expose it to heat.</dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> use your pen if it has been frozen or stored in direct sunlight.</dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> use after the expiration date printed on the label has passed or if it has been more than 28 days after first use.</dd> </dl> <p> <span class="Bold">Before you use NGENLA pens for the first time (unused pens):</span> </p> <dl> <dt>•</dt> <dd>Store in the original carton.</dd> <dt>•</dt> <dd>Store the new, unused NGENLA pen in the refrigerator between 36°F to 46°F (2°C to 8°C).</dd> <dt>•</dt> <dd>Unused prefilled pens may be used until the expiration date printed on the pen label, if kept in the refrigerator.</dd> </dl> <p> <span class="Bold">After you use NGENLA pens and there is still medicine left (up to 28 days of use):</span> </p> <dl> <dt>•</dt> <dd>To help you remember when to dispose of (throw away) the pen, write the date of first use on the pen label.</dd> <dt>•</dt> <dd>Store remaining NGENLA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 28 days.</dd> <dt>•</dt> <dd>Keep the pen cap on the NGENLA pen when it is not in use.</dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> store the remaining NGENLA pen with a needle attached.</dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> use the NGENLA pen if it has been <span class="Bold">more than 28 days</span> after first use, even if it contains unused medicine.</dd> </dl> <p> <span class="Bold">Keep NGENLA and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of NGENLA.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. <span class="Bold">Do not</span> use NGENLA for a condition for which it was not prescribed. Do not give NGENLA to other people, even if they have the same symptoms because it may harm them. You can ask your pharmacist or healthcare provider for information about NGENLA that is written for health professionals.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in NGENLA?</span> </p> <p> <span class="Bold">Active ingredient:</span> somatrogon-ghla</p> <p> <span class="Bold"> <br/>Inactive ingredients: </span>citric acid monohydrate, histidine, metacresol (as a preservative), poloxamer 188, sodium chloride, sodium citrate, water for injection.<br/> <br/>This product's labeling may have been updated. For the most recent prescribing information, please visit <a href="http://www.pfizer.com">www.pfizer.com</a>.</p> <p> <br/>Manufactured by: <br/>Pfizer Ireland Pharmaceuticals<br/>Ringaskiddy,<br/>Cork,<br/>Ireland<br/> <br/>US License No: 2060<br/> <br/> <a name="id1569301689"></a><img alt="Logo" src="/dailymed/image.cfm?name=somatrogon-02.jpg&amp;setid=06dce529-b741-4a1b-8842-3ad77be6e308"/></p> <p> <br/>LAB-1449-1.0<br/> <br/>For more information, go to website <a href="http://www.NGENLA.com">www.NGENLA.com</a> or call 1-800-438-1985.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"100%\"/>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" colspan=\"1\" valign=\"top\">This Patient Information has been approved by the U.S. Food and Drug Administration.     Issued: 6/2023</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">PATIENT INFORMATION</span>\n<br/>\n<span class=\"Bold\">NGENLA<span class=\"Sup\">®</span> (en’ JEN-lah)</span>\n</p>\n<p>\n<span class=\"Bold\">(somatrogon-ghla)</span>\n</p>\n<p>\n<span class=\"Bold\">injection, for subcutaneous use</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is NGENLA?</span>\n<br/>NGENLA is a prescription medicine that contains a form of human growth hormone, like the growth hormone made by the human body. NGENLA is given by injection under the skin (subcutaneous) in children who are not growing because of low or no growth hormone levels.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not use NGENLA if:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>your child has a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.</dd>\n<dt>•</dt>\n<dd>your child is allergic to somatrogon-ghla or any of the ingredients in NGENLA. See the end of this leaflet for a complete list of ingredients in NGENLA.</dd>\n<dt>•</dt>\n<dd>your child has closed bone growth plates (epiphyses).</dd>\n<dt>•</dt>\n<dd>your child has cancer or other tumors.</dd>\n<dt>•</dt>\n<dd>your child’s healthcare provider tells you that your child has certain types of eye problems caused by diabetes (diabetic retinopathy).</dd>\n<dt>•</dt>\n<dd>your child has Prader-Willi syndrome, is severely obese, or has breathing problems including sleep apnea (briefly stop breathing during sleep).<br/>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Before using NGENLA, tell your child’s healthcare provider about all of your child’s medical conditions, including if your child:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>has had heart or stomach surgery, trauma or serious breathing (respiratory) problems.</dd>\n<dt>•</dt>\n<dd>has had a history of problems breathing while they slept (sleep apnea).</dd>\n<dt>•</dt>\n<dd>has or has had cancer or any tumor.</dd>\n<dt>•</dt>\n<dd>has diabetes.</dd>\n<dt>•</dt>\n<dd>is pregnant or plans to become pregnant. It is not known if NGENLA will harm your child’s unborn baby. Talk to your child’s healthcare provider if your child is pregnant or plans to become pregnant.</dd>\n<dt>•</dt>\n<dd>is breastfeeding or plans to breastfeed. It is not known if NGENLA passes into breast milk. You and your child’s healthcare provider should decide if they will take NGENLA while breastfeeding.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Tell your child’s healthcare provider about all the medicines your child takes</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NGENLA may affect how other medicines work, and other medicines may affect how NGENLA works.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I use NGENLA?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Read the detailed <span class=\"Bold\">Instructions for Use</span> that come with NGENLA.</dd>\n<dt>•</dt>\n<dd>NGENLA comes in 2 different dosage strengths. Your child’s healthcare provider will prescribe the dose of medicine and the dosage strength that is right for your child.</dd>\n<dt>•</dt>\n<dd>Your child’s healthcare provider will show you how to inject NGENLA before it is used for the first time. <span class=\"Bold\">Do not</span> try to inject NGENLA until you have been shown the right way by your child’s healthcare provider.</dd>\n<dt>•</dt>\n<dd>Inject NGENLA exactly as your child’s healthcare provider tells you to.</dd>\n<dt>•</dt>\n<dd>NGENLA is injected under the skin (subcutaneously) and can be given in the stomach (abdomen), thighs, buttocks, or upper arms. Rotate the site of injection weekly.</dd>\n<dt>•</dt>\n<dd>Inject NGENLA 1 time each week, on the same day each week, at any time of the day.</dd>\n<dt>•</dt>\n<dd>You may change the day of the week NGENLA is used as long as the last dose was injected 3 or more days before. After the new day of the week has been chosen, continue with the 1 time a week schedule.</dd>\n<dt>•</dt>\n<dd>If your child misses a dose of NGENLA the missed dose should be injected as soon as possible within 3 days after the missed dose. If more than 3 days have passed, skip your child’s missed dose. Inject the next dose on the regularly scheduled day.</dd>\n<dt>•</dt>\n<dd>NGENLA prefilled pens are for use by 1 person only.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not share your child’s NGENLA prefilled pens and needles with another person, even if the needle has been changed. Your child may give another person an infection or get an infection from them.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of NGENLA?</span>\n</p>\n<p>\n<span class=\"Bold\">NGENLA 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>serious allergic reactions. Get medical help right away if your child has the following symptoms:<dl>\n<dt>o</dt>\n<dd>swelling of the face, lips, mouth, or tongue</dd>\n<dt>o</dt>\n<dd>trouble breathing</dd>\n<dt>o</dt>\n<dd>wheezing</dd>\n<dt>o</dt>\n<dd>severe itching</dd>\n<dt>o</dt>\n<dd>skin rashes, redness, or swelling</dd>\n<dt>o</dt>\n<dd>dizziness or fainting</dd>\n<dt>o</dt>\n<dd>fast heartbeat or pounding in the chest</dd>\n<dt>o</dt>\n<dd>sweating</dd>\n</dl>\n</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 child’s healthcare provider will need to monitor your child for a return of cancer or a tumor. Contact your child’s healthcare provider if your child starts to have headaches, or has changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of the skin. </dd>\n<dt>•</dt>\n<dd>new or worsening high blood sugar (hyperglycemia) or diabetes. Your child’s blood sugar may need to be monitored during treatment with NGENLA.</dd>\n<dt>•</dt>\n<dd>increase in pressure inside the skull (intracranial hypertension). If your child has headaches, eye problems, nausea or vomiting, contact your child’s healthcare provider.</dd>\n<dt>•</dt>\n<dd>your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in the joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in children during treatment with NGENLA. Tell your child’s healthcare provider if your child has any of these signs or symptoms of fluid retention.</dd>\n<dt>•</dt>\n<dd>decrease in a hormone called cortisol. Your child’s healthcare provider will do blood tests to check your child’s cortisol levels. Tell your child’s healthcare provider if your child has severe fatigue, dizziness, weakness, vomiting, dehydration, or weight loss.</dd>\n<dt>•</dt>\n<dd>decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NGENLA works. Your child’s healthcare provider will do blood tests to check your child’s hormone levels.</dd>\n<dt>•</dt>\n<dd>hip and knee pain or limp (slipped capital femoral epiphysis). Tell your child’s healthcare provider if your child has any of these signs or symptoms.</dd>\n<dt>•</dt>\n<dd>worsening of curvature of the spine (scoliosis). If your child has scoliosis, your child will need to be checked often for an increase in the curve of the spine.</dd>\n<dt>•</dt>\n<dd>severe and constant stomach (abdominal) pain. This could be a sign of pancreatitis. Tell your child’s healthcare provider if your child has any new abdominal pain.</dd>\n<dt>•</dt>\n<dd>loss of fat and tissue weakness in the area of skin you inject. Talk to your child’s healthcare provider about rotating the areas where you inject NGENLA.</dd>\n<dt>•</dt>\n<dd>high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.</dd>\n<dt>•</dt>\n<dd>increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in the blood. Your child’s healthcare provider will do blood tests to check this. </dd>\n</dl>\n<p>\n<span class=\"Bold\">The most common side effects of NGENLA include:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>o</dt>\n<dd>injection site reactions (such as pain, swelling, rash, itching, bleeding)</dd>\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<dt>o</dt>\n<dd>low red blood cells (anemia)</dd>\n<dt>o</dt>\n<dd>cough</dd>\n<dt>o</dt>\n<dd>vomiting</dd>\n<dt>o</dt>\n<dd>decrease in thyroid hormone levels</dd>\n<dt>o</dt>\n<dd>stomach (abdominal) pain</dd>\n<dt>o</dt>\n<dd>rash</dd>\n<dt>o</dt>\n<dd>throat pain</dd>\n</dl>\n</dd>\n</dl>\n<p>These are not all the possible side effects of NGENLA. You should tell your child’s healthcare provider if your child has any side effect that bothers them or that does not go away.<br/>\n<br/>Call your child’s doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store NGENLA?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> freeze your pen or expose it to heat.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> use your pen if it has been frozen or stored in direct sunlight.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> use after the expiration date printed on the label has passed or if it has been more than 28 days after first use.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Before you use NGENLA pens for the first time (unused pens):</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Store in the original carton.</dd>\n<dt>•</dt>\n<dd>Store the new, unused NGENLA pen in the refrigerator between 36°F to 46°F (2°C to 8°C).</dd>\n<dt>•</dt>\n<dd>Unused prefilled pens may be used until the expiration date printed on the pen label, if kept in the refrigerator.</dd>\n</dl>\n<p>\n<span class=\"Bold\">After you use NGENLA pens and there is still medicine left (up to 28 days of use):</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>To help you remember when to dispose of (throw away) the pen, write the date of first use on the pen label.</dd>\n<dt>•</dt>\n<dd>Store remaining NGENLA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 28 days.</dd>\n<dt>•</dt>\n<dd>Keep the pen cap on the NGENLA pen when it is not in use.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> store the remaining NGENLA pen with a needle attached.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> use the NGENLA pen if it has been <span class=\"Bold\">more than 28 days</span> after first use, even if it contains unused medicine.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Keep NGENLA and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of NGENLA.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. <span class=\"Bold\">Do not</span> use NGENLA for a condition for which it was not prescribed. Do not give NGENLA to other people, even if they have the same symptoms because it may harm them. You can ask your pharmacist or healthcare provider for information about NGENLA that is written for health professionals.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in NGENLA?</span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span> somatrogon-ghla</p>\n<p>\n<span class=\"Bold\">\n<br/>Inactive ingredients: </span>citric acid monohydrate, histidine, metacresol (as a preservative), poloxamer 188, sodium chloride, sodium citrate, water for injection.<br/>\n<br/>This product's labeling may have been updated. For the most recent prescribing information, please visit <a href=\"http://www.pfizer.com\">www.pfizer.com</a>.</p>\n<p>\n<br/>Manufactured by: <br/>Pfizer Ireland Pharmaceuticals<br/>Ringaskiddy,<br/>Cork,<br/>Ireland<br/>\n<br/>US License No: 2060<br/>\n<br/>\n<a name=\"id1569301689\"></a><img alt=\"Logo\" src=\"/dailymed/image.cfm?name=somatrogon-02.jpg&amp;setid=06dce529-b741-4a1b-8842-3ad77be6e308\"/></p>\n<p>\n<br/>LAB-1449-1.0<br/>\n<br/>For more information, go to website <a href=\"http://www.NGENLA.com\">www.NGENLA.com</a> or call 1-800-438-1985.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

NGENLA® (en’ JEN-lah)

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(somatrogon-ghla)

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24 mginjection, for subcutaneous use

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Read this Instructions for Use before you start using NGENLA and each time you get a new refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

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Important information about your NGENLA pen:

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Supplies you will need each time you inject

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Included in the carton:

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Not included in the carton:

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24 mg NGENLA pen:

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Needles to use

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Pen needles are not included with your NGENLA pen. You will need a prescription from your healthcare provider to get pen needles up to a length of 8 mm from your pharmacy. Talk with your healthcare provider about the right needle for you.

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Sterile needle (example) not supplied:

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Sterile needle with safety shield (example) not supplied:

{ "type": "p", "children": [], "text": "\nSterile needle with safety shield (example) not supplied:\n" }

Note: Needles with safety shield do not have an inner needle cap. Steps 5, 6 and 11 within these instructions relating to the inner needle cap may not apply when using a needle with safety shield. Refer to the safety shield needle manufacturer’s instructions for use (IFU) for more information on attaching and removing the safety needle. When using safety shield needles, priming is required only for the first use of a new pen; follow the NGENLA pen IFU for priming.

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Caution: Never use a bent or damaged needle. Always handle pen needles with care to make sure you do not prick yourself (or anyone else) with the needle. Do not attach a new needle to your pen until you are ready to take your injection.

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Preparing for your injection

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Step 1 - Getting ready

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Step 2 - Choose and clean your injection site

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Step 3 - Check medicine

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Step 4 - Attach needle

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Step 5 - Pull off outer needle cover

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Step 6 - Pull off inner needle cap

{ "type": "p", "children": [], "text": "\nStep 6 - Pull off inner needle cap\n" }

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Is this pen new?

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Yes: Go to new pen set up (arrow directing to “New pen set up (priming) - for the first use of a new pen only”)

{ "type": "p", "children": [], "text": "\nYes: Go to new pen set up (arrow directing to “New pen set up (priming) - for the first use of a new pen only”)\n" }

No (arrow directing to “Setting your prescribed dose”)

{ "type": "p", "children": [], "text": "\nNo (arrow directing to “Setting your prescribed dose”)\n" }

New pen set up (priming) – for the first use of a new pen only

{ "type": "p", "children": [], "text": "\nNew pen set up (priming) – for the first use of a new pen only\n" }

You must set up each new pen (priming) before using it for the first time

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A - Set priming dose

{ "type": "p", "children": [], "text": "\nA - Set priming dose\n" }

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

B - Tap cartridge holder

{ "type": "p", "children": [], "text": "\nB - Tap cartridge holder\n" }

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C - Press button and check for liquid

{ "type": "p", "children": [], "text": "\nC - Press button and check for liquid\n" }

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Setting your prescribed dose

{ "type": "p", "children": [], "text": "\nSetting your prescribed dose\n" }

Step 7 - Set your dose

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Example A:

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3.8 mg shown in the dose window

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Example B:

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

12.0 mg shown in the dose window

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

What should I do if I cannot set the dose I need?

{ "type": "p", "children": [], "text": "\nWhat should I do if I cannot set the dose I need?\n" }

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

What should I do if I do not have enough medicine left in my pen?

{ "type": "p", "children": [], "text": "\nWhat should I do if I do not have enough medicine left in my pen?\n" }

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

Only split your dose if you have been trained or told by your healthcare provider on how to do this.

{ "type": "p", "children": [], "text": "\nOnly split your dose if you have been trained or told by your healthcare provider on how to do this.\n" }

Injecting your dose

{ "type": "p", "children": [], "text": "\nInjecting your dose\n" }

Step 8 - Insert the needle

{ "type": "p", "children": [], "text": "\nStep 8 - Insert the needle\n" }

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

Step 9 - Inject your medicine

{ "type": "p", "children": [], "text": "\nStep 9 - Inject your medicine\n" }

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

Step 10 - Count to 10

{ "type": "p", "children": [], "text": "\nStep 10 - Count to 10\n" }

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

Step 11 - Attach outer needle cover

{ "type": "p", "children": [], "text": "\nStep 11 - Attach outer needle cover\n" }

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

Step 12 - Remove the needle

{ "type": "p", "children": [], "text": "\nStep 12 - Remove the needle\n" }

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

Step 13 - Replace the pen cap

{ "type": "p", "children": [], "text": "\nStep 13 - Replace the pen cap\n" }

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

Step 14 - After your injection

{ "type": "p", "children": [], "text": "\nStep 14 - After your injection\n" }

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

Storage and disposal:

{ "type": "p", "children": [], "text": "\nStorage and disposal:\n" }

How should I store my pen?

{ "type": "p", "children": [], "text": "\nHow should I store my pen?\n" }

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

Before first use (unused pens):

{ "type": "p", "children": [], "text": "\nBefore first use (unused pens):\n" }

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

After first use (up to 28 days of use):

{ "type": "p", "children": [], "text": "\nAfter first use (up to 28 days of use):\n" }

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

How should I dispose of the pen needles and pens?

{ "type": "p", "children": [], "text": "\nHow should I dispose of the pen needles and pens?\n" }

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

Manufactured by:Pfizer Ireland PharmaceuticalsRingaskiddy,Cork,Ireland

{ "type": "p", "children": [], "text": "Manufactured by:Pfizer Ireland PharmaceuticalsRingaskiddy,Cork,Ireland" }

US License No: 2060 LAB-1452-2.0

{ "type": "p", "children": [], "text": "US License No: 2060\n\n\nLAB-1452-2.0" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.     Revised: 7/2024

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration.     Revised: 7/2024" }

Instructions for Use NGENLA® (en’ JEN-lah)

{ "type": "p", "children": [], "text": "\nInstructions for Use\n\nNGENLA® (en’ JEN-lah)\n" }

(somatrogon-ghla)60 mginjection, for subcutaneous use

{ "type": "p", "children": [], "text": "(somatrogon-ghla)60 mginjection, for subcutaneous use" }

Read this Instructions for Use before you start using NGENLA and each time you get a new refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

{ "type": "p", "children": [], "text": "\nRead this Instructions for Use before you start using NGENLA and each time you get a new refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. " }

Important information about your NGENLA pen:

{ "type": "p", "children": [], "text": "\nImportant information about your NGENLA pen:\n" }

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Supplies you will need each time you inject

{ "type": "p", "children": [], "text": "\nSupplies you will need each time you inject\n" }

Included in the carton:

{ "type": "p", "children": [], "text": "\nIncluded in the carton:\n" }

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Not included in the carton:

{ "type": "p", "children": [], "text": "\nNot included in the carton:\n" }

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

60 mg NGENLA pen:

{ "type": "p", "children": [], "text": "\n60 mg NGENLA pen:\n" }

Needles to use

{ "type": "p", "children": [], "text": "\nNeedles to use\n" }

Pen needles are not included with your NGENLA pen. You will need a prescription from your healthcare provider to get pen needles up to a length of 8 mm from your pharmacy. Talk with your healthcare provider about the right needle for you.

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

Sterile needle (example) not supplied:

{ "type": "p", "children": [], "text": "\nSterile needle (example) not supplied:\n" }

Sterile needle with safety shield (example) not supplied:

{ "type": "p", "children": [], "text": "\nSterile needle with safety shield (example) not supplied:\n" }

Note: Needles with safety shield do not have an inner needle cap. Steps 5, 6 and 11 within these instructions relating to the inner needle cap may not apply when using a needle with safety shield. Refer to the safety shield needle manufacturer’s instructions for use (IFU) for more information on attaching and removing the safety needle. When using safety shield needles, priming is required only for the first use of a new pen; follow the NGENLA pen IFU for priming.

{ "type": "p", "children": [], "text": "\nNote: Needles with safety shield do not have an inner needle cap. Steps 5, 6 and 11 within these instructions relating to the inner needle cap may not apply when using a needle with safety shield. Refer to the safety shield needle manufacturer’s instructions for use (IFU) for more information on attaching and removing the safety needle. When using safety shield needles, priming is required only for the first use of a new pen; follow the NGENLA pen IFU for priming." }

Caution: Never use a bent or damaged needle. Always handle pen needles with care to make sure you do not prick yourself (or anyone else) with the needle. Do not attach a new needle to your pen until you are ready to take your injection.

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Preparing for your injection

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Step 1 - Getting ready

{ "type": "p", "children": [], "text": "\nStep 1 - Getting ready\n" }

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

Step 2 - Choose and clean your injection site

{ "type": "p", "children": [], "text": "\nStep 2 - Choose and clean your injection site\n" }

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

Step 3 - Check medicine

{ "type": "p", "children": [], "text": "\nStep 3 - Check medicine\n" }

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

Step 4 - Attach needle

{ "type": "p", "children": [], "text": "\nStep 4 - Attach needle\n" }

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

Step 5 - Pull off outer needle cover

{ "type": "p", "children": [], "text": "\nStep 5 - Pull off outer needle cover\n" }

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

Step 6 - Pull off inner needle cap

{ "type": "p", "children": [], "text": "\nStep 6 - Pull off inner needle cap\n" }

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

Is this pen new?

{ "type": "p", "children": [], "text": "\nIs this pen new?\n" }

Yes: Go to new pen set up (arrow directing to “New pen set up (priming) - for the first use of a new pen only”)

{ "type": "p", "children": [], "text": "\nYes: Go to new pen set up (arrow directing to “New pen set up (priming) - for the first use of a new pen only”)\n" }

No (arrow directing to “Setting your prescribed dose”)

{ "type": "p", "children": [], "text": "\nNo (arrow directing to “Setting your prescribed dose”)\n" }

New pen set up (priming) – for the first use of a new pen only

{ "type": "p", "children": [], "text": "\nNew pen set up (priming) – for the first use of a new pen only\n" }

You must set up each new pen (priming) before using it for the first time

{ "type": "p", "children": [], "text": "\nYou must set up each new pen (priming) before using it for the first time\n" }

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

A - Set priming dose

{ "type": "p", "children": [], "text": "\nA - Set priming dose\n" }

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

B - Tap cartridge holder

{ "type": "p", "children": [], "text": "\nB - Tap cartridge holder\n" }

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

C - Press button and check for liquid

{ "type": "p", "children": [], "text": "\nC - Press button and check for liquid\n" }

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

Setting your prescribed dose

{ "type": "p", "children": [], "text": "\nSetting your prescribed dose\n" }

Step 7 - Set your dose

{ "type": "p", "children": [], "text": "\nStep 7 - Set your dose\n" }

Example A:

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

21.5 mg shown in the dose window

{ "type": "p", "children": [], "text": "21.5 mg shown in the dose window" }

Example B:

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

30.0 mg shown in the dose window

{ "type": "p", "children": [], "text": "30.0 mg shown in the dose window" }

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

What should I do if I cannot set the dose I need?

{ "type": "p", "children": [], "text": "\nWhat should I do if I cannot set the dose I need?\n" }

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

What should I do if I do not have enough medicine left in my pen?

{ "type": "p", "children": [], "text": "\nWhat should I do if I do not have enough medicine left in my pen?\n" }

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

Only split your dose if you have been trained or told by your healthcare provider on how to do this.

{ "type": "p", "children": [], "text": "\nOnly split your dose if you have been trained or told by your healthcare provider on how to do this.\n" }

Injecting your dose

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Step 8 - Insert the needle

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

Step 9 - Inject your medicine

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

Step 10 - Count to 10

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

Step 11 - Attach outer needle cover

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

Step 12 - Remove the needle

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

Step 13 - Replace the pen cap

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

Step 14 - After your injection

{ "type": "p", "children": [], "text": "\nStep 14 - After your injection\n" }

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

Storage and disposal:

{ "type": "p", "children": [], "text": "\nStorage and disposal:\n" }

How should I store my pen?

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

Before first use (unused pens):

{ "type": "p", "children": [], "text": "\nBefore first use (unused pens):\n" }

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

After first use (up to 28 days of use):

{ "type": "p", "children": [], "text": "\nAfter first use (up to 28 days of use):\n" }

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

How should I dispose of the pen needles and pens?

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

Manufactured by: Pfizer Ireland PharmaceuticalsRingaskiddy,Cork,Ireland

{ "type": "p", "children": [], "text": "Manufactured by: Pfizer Ireland PharmaceuticalsRingaskiddy,Cork,Ireland" }

US License No: 2060 LAB-1454-2.0

{ "type": "p", "children": [], "text": "US License No: 2060\n\n\nLAB-1454-2.0" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.     Revised: 7/2024

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NDC 0069-0505-01Store refrigerated

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24mg

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Ngenla® (somatrogon-ghla)Injection24 mg/1.2 mL (20 mg/mL)For Subcutaneous Injection Only

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mg

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Single-patient-useRx only

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One single-patient-usedisposable prefilled penRx onlyNDC 0069-0505-02

{ "type": "p", "children": [], "text": "One single-patient-usedisposable prefilled penRx onlyNDC 0069-0505-02" }

24mg

{ "type": "p", "children": [], "text": "24mg" }

Ngenla® (somatrogon-ghla)Injection24 mg/1.2 mL (20 mg/mL)For Subcutaneous Injection Only

{ "type": "p", "children": [], "text": "Ngenla®\n(somatrogon-ghla)Injection24 mg/1.2 mL (20 mg/mL)For Subcutaneous Injection Only" }

READ ENCLOSED INSTRUCTIONS BEFORE USE

{ "type": "p", "children": [], "text": "READ ENCLOSED INSTRUCTIONS BEFORE USE" }

Write the date of first use in the space provided on thepen label. Discard the pen 28 days after first use, even if itcontains unused medicine.

{ "type": "p", "children": [], "text": "Write the date of first use in the space provided on thepen label. Discard the pen 28 days after first use, even if itcontains unused medicine." }

Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) between each use for up to 28 days. Do not freeze or shake. Do not expose to heat.Store away from direct sunlight. Do not use if it has been frozen.

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NDC 0069-0520-01Store refrigerated

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60mg

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Ngenla® (somatrogon-ghla)Injection60 mg/1.2 mL (50 mg/mL)For Subcutaneous Injection Only

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mg

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Single-patient-useRx only

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

One single-patient-usedisposable prefilled penRx onlyNDC 0069-0520-02

{ "type": "p", "children": [], "text": "One single-patient-usedisposable prefilled penRx onlyNDC 0069-0520-02" }

60mg

{ "type": "p", "children": [], "text": "60mg" }

Ngenla® (somatrogon-ghla)Injection60 mg/1.2 mL (50 mg/mL)For Subcutaneous Injection Only

{ "type": "p", "children": [], "text": "Ngenla®\n(somatrogon-ghla)Injection60 mg/1.2 mL (50 mg/mL)For Subcutaneous Injection Only" }

READ ENCLOSED INSTRUCTIONS BEFORE USE

{ "type": "p", "children": [], "text": "READ ENCLOSED INSTRUCTIONS BEFORE USE" }

Write the date of first use in the space provided on thepen label. Discard the pen 28 days after first use, even ifit contains unused medicine.

{ "type": "p", "children": [], "text": "Write the date of first use in the space provided on thepen label. Discard the pen 28 days after first use, even ifit contains unused medicine." }

Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C)in the original carton to protect from light. After first use: Storerefrigerated at 36°F to 46°F (2°C to 8°C) between each use for upto 28 days. Do not freeze or shake. Do not expose to heat.Store away from direct sunlight. Do not use if it has been frozen.

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