Pediatric Patients:

• Somatropin injection is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH).
• Somatropin injection is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome.
• Somatropin injection is indicated for the treatment of pediatric patients with short stature associated with Turner syndrome.
• Somatropin injection is indicated for the treatment of pediatric patients with short stature born small for gestational age (SGA) who fail to show catch-up growth by 2 to 4 years of age.

Adult Patients: Somatropin injection is indicated as replacement therapy for endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following criteria:

• Adult-Onset (AO): Patients with GHD, isolated or associated with multiple hormone deficiencies (hypopituitarism), due to pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma.
• Childhood-Onset (CO): Patients who had GH deficiency during childhood due to congenital, genetic, acquired, or idiopathic causes.

Patients previously treated with somatropin for childhood-onset GHD whose epiphyses are closed should be re-evaluated before continuing therapy at adult-recommended reduced doses. According to current standards, confirmation of adult GHD requires appropriate GH stimulation testing, except in (1) patients with multiple pituitary hormone deficiencies due to organic disease, and (2) patients with congenital/genetic GH deficiency.

Somatropin, similar to endogenous growth hormone, binds to a dimeric growth hormone receptor on target cell membranes, initiating intracellular signal transduction and producing multiple pharmacological effects. Some effects are mainly mediated through insulin-like growth factor-1 (IGF-1), produced in the liver and locally (e.g., skeletal growth and protein synthesis), while others are due to direct actions of somatropin itself (e.g., lipolysis).

Somatropin should be administered subcutaneously. Injection sites should always be rotated to avoid lipoatrophy.

• Pediatric growth hormone deficiency 0.024 to 0.034 mg/kg/day, 6 to 7 times a week.
• Noonan Syndrome Up to 0.066 mg/kg/day.
• Turner Syndrome Up to 0.067 mg/kg/day.
• Short stature born small for gestational age (SGA) Up to 0.067 mg/kg/day.
• Adult growth hormone deficiency 0.004 mg/kg/day to be increased as tolerated to not more than 0.016 mg/kg/day after approximately 6 weeks, or a starting dose of approximately 0.2 mg/day (range, 0.15 to 0.30 mg/day) increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day.

• Inhibition of 11β-Hydroxysteroid Dehydrogenase Type 1: May require initiation or adjustment of glucocorticoid replacement therapy. Patients already receiving glucocorticoids for hypoadrenalism may need an increased maintenance dose.
• Glucocorticoid Replacement: Dose should be carefully adjusted.
• Cytochrome P450–Metabolized Drugs: Careful monitoring is recommended when used concomitantly with somatropin.
• Oral Estrogen: Higher doses of somatropin may be required in female patients.
• Insulin and/or Oral/Injectable Hypoglycemic Agents: Dose adjustment may be necessary.

• Acute critical illness.
• Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment (reports of sudden death).
• Active malignancy.
• Hypersensitivity to somatropin or any excipients.
• Active proliferative or severe non-proliferative diabetic retinopathy.
• Children with closed epiphyses.

The most common adverse effects of somatropin include headache, muscle pain, joint stiffness, hyperglycemia, and glucosuria (sugar in urine).

Pregnancy Category C. No animal reproduction studies have been conducted with somatropin. It is unknown whether somatropin can harm the fetus or affect reproductive capacity. It should be used in pregnancy only if clearly necessary. It is not known whether somatropin is excreted in human breast milk. Because many drugs are excreted in breast milk, caution should be exercised in nursing mothers.

Acute Critical Illness: The potential benefit of continuing treatment should be weighed against possible risks.
Prader-Willi Syndrome (Children): Evaluate for upper airway obstruction and sleep apnea before starting therapy; discontinue if these occur.
Neoplasms: Monitor for tumor progression or recurrence. Increased risk of secondary neoplasms, especially meningioma in patients previously treated with cranial radiation.
Impaired Glucose Tolerance/Diabetes: May be unmasked; monitor blood glucose regularly and adjust antidiabetic therapy if needed.
Intracranial Hypertension: Exclude preexisting papilledema; may occur but is usually reversible after dose reduction or discontinuation.
Hypersensitivity: Serious allergic reactions may occur; seek immediate medical attention if they occur.
Fluid Retention: (edema, arthralgia, carpal tunnel syndrome—especially in adults) may occur; dose reduction may be required.
Hypoadrenalism: Monitor cortisol levels and adjust glucocorticoid dose if needed.
Hypothyroidism: May develop or worsen.
Slipped Capital Femoral Epiphysis: May occur in children with hip or knee pain or limping.
Scoliosis: Preexisting scoliosis may progress.
Pancreatitis: Consider if severe persistent abdominal pain occurs.

Drugs for growth failure

Store at 2–8°C. Do not freeze. Protect from light. Keep out of reach of children.