GENOTROPIN® Highlights

GENOTROPIN is a recombinant human growth hormone indicated for:

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Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1)

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Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2)

GENOTROPIN should be administered subcutaneously (2)

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Pediatric GHD: 0.16 to 0.24 mg/kg/week (2.1)

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Prader-Willi Syndrome: 0.24 mg/kg/week (2.1)

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Small for Gestational Age: Up to 0.48 mg/kg/week (2.1)

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Turner Syndrome: 0.33 mg/kg/week (2.1)

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Idiopathic Short Stature: up to 0.47 mg/kg/week (2.1)

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Adult GHD: Either a non-weight based or a weight based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-I concentrations (2.2)

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Non-weight based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1–2 months by increments of approximately 0.1–0.2 mg/day. (2.2)

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Weight based dosing: The recommended initial dose is not more than 0.04 mg/kg/week; the dose may be increased as tolerated to not more than 0.08 mg/kg/week at 4–8 week intervals. (2.2)

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GENOTROPIN cartridges are color-coded to correspond to a specific GENOTROPIN PEN delivery device (2.3)

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Injection sites should always be rotated to avoid lipoatrophy (2.3)

For injection: 5 mg or 12 mg lyophilized powder in a single‑patient‑use two‑chamber cartridge (3)

For injection: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg lyophilized powder in a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge (GENOTROPIN MINIQUICK) (3)

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Acute Critical Illness (4)

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Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death (4)

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Active Malignancy (4)

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Hypersensitivity to somatropin or excipients (4)

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Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4)

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Children with closed epiphyses (4)

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Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk (5.1)

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Prader-Willi Syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment
Discontinue treatment if these signs occur (5.2)

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Neoplasm: 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 (5.3)

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Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked
Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment (5.4)

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Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction (5.5)

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Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention (5.6)

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Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults): May occur frequently. Reduce dose as necessary (5.7)

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Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism (5.8)

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Hypothyroidism: May first become evident or worsen. Monitor thyroid function periodically (5.9)

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Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain (5.10)

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Progression of Preexisting Scoliosis: Monitor any child with scoliosis for progression of the curve (5.11)

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Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.15)

Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.2).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses (7.1, 7.2).

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Glucocorticoid Replacement: Should be carefully adjusted (7.2)

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Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin (7.3)

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Oral Estrogen: Larger doses of somatropin may be required in women (7.4)

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Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment (7.5)