Somatrogon

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 is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

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.

• NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency. • Administer NGENLA by subcutaneous injection once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site. • The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly. • Individualize dosage for each patient based on the growth response. • Patients switching from daily growth hormone may initiate treatment with once-weekly NGENLA on the day following their last daily injection. • If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.

• Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin. • Hypersensitivity to somatrogon-ghla or any of the excipients in NGENLA. • Closed epiphyses. • Active malignancy due to the risk of malignancy progression. • Active proliferative or severe non-proliferative diabetic retinopathy. • Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the risk of sudden death. • Acute critical illness. • Hypersensitivity to somatrogon-ghla or excipients.

• Severe Hypersensitivity: Severe hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention. • Increased Risk of Neoplasms: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm. • Glucose Intolerance and Diabetes Mellitus: NGENLA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NGENLA, especially in patients with existing diabetes mellitus or at risk for its development. • Intracranial Hypertension: Perform fundoscopic examinations prior to initiation of treatment with NGENLA and periodically thereafter.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Increased mortality in patients with acute critical illness • Severe hypersensitivity • Increased risk of neoplasm • Glucose intolerance and diabetes mellitus • Intracranial hypertension • Fluid retention • Hypoadrenalism • Hypothyroidism • Slipped capital femoral epiphysis • Progression of preexisting scoliosis • Pancreatitis • Lipoatrophy • Sudden death in pediatric patients with Prader-Willi syndrome Adverse reactions reported in ≥5% of patients treated with NGENLA are: injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain.

Table 2 includes a list of drugs with clinically significant drug interactions when administered concomitantly with NGENLA and instructions for preventing or managing them. Table 2 Clinically Significant Drug Interactions with NGENLA Replacement Glucocorticoid Treatment Clinical Impact: 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. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA.

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. 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.