GENOTROPIN is a recombinant human growth hormone indicated for:

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

GENOTROPIN should be administered subcutaneously (2)

• Pediatric GHD: 0.16 to 0.24 mg/kg/week (2.1)
• Prader-Willi Syndrome: 0.24 mg/kg/week (2.1)
• Small for Gestational Age: Up to 0.48 mg/kg/week (2.1)
• Turner Syndrome: 0.33 mg/kg/week (2.1)
• Idiopathic Short Stature: up to 0.47 mg/kg/week (2.1)
• 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)
• Non-weight based dosing: A starting dose of approximately 0.2mg/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)
• 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)
• GENOTROPIN cartridges are color-coded to correspond to a specific GENOTROPIN PEN delivery device (2.3)
• Injection sites should always be rotated to avoid lipoatrophy (2.3)

GENOTROPIN lyophilized powder in a two-chamber color-coded cartridge (3):

• 5 mg (green tip) and 12 mg (purple tip) (with preservative)

GENOTROPIN MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge (without preservative):

• 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, and 2.0 mg

• Acute Critical Illness (4.1, 5.1)
• Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death (4.2, 5.2)
• Active Malignancy (4.3)
• Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4.4)
• Children with closed epiphyses (4.5)
• Known hypersensitivity to somatropin or m-cresol (4.6)

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

• Prader-Willi syndrome in Children: eva luate for signs of upper airway obstruction and sleep apnea before initiation of treatment.
  Discontinue treatment if these signs occur (5.2).
• 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).
• 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).
• Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction (5.5).
• Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults): May occur frequently. Reduce dose as necessary (5.6).
• Hypopituitarism: Closely monitor other hormone replacement therapies (5.7).
• Hypothyroidism: May first become evident or worsen (5.8).
• Slipped Capital Femoral Epiphysis: May develop. eva luate children with the onset of a limp or hip/knee pain (5.9).
• Progression of Preexisting Scoliosis: May develop (5.10)
• Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.14).

Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.3).

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).

• Glucocorticoid Replacement: Should be carefully adjusted (7.2)
• Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin (7.3)
• Oral Estrogen: Larger doses of somatropin may be required in women (7.4)
• Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment (7.5)