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GENOTROPIN®Highlights (somatropin)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GENOTROPIN safely and effectively. See full prescribing information for GENOTROPIN

GENOTROPIN® (somatropin) for injection, for subcutaneous use
Initial U.S. Approval: 1987

INDICATIONS AND USAGE

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)

DOSAGE AND ADMINISTRATION

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)

DOSAGE FORMS AND STRENGTHS

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

CONTRAINDICATIONS

  • Acute Critical Illness (4)
  • Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death (4)
  • Active Malignancy (4)
  • Hypersensitivity to somatropin or excipients (4)
  • Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4)
  • Children with closed epiphyses (4)

WARNINGS AND PRECAUTIONS

  • Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk (5.1)
  • 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)
  • 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)
  • Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention (5.6)
  • Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults): May occur frequently. Reduce dose as necessary (5.7)
  • Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism (5.8)
  • Hypothyroidism: May first become evident or worsen. Monitor thyroid function periodically (5.9)
  • Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain (5.10)
  • Progression of Preexisting Scoliosis: Monitor any child with scoliosis for progression of the curve (5.11)
  • Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.15)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2019

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch