Prescribing Information

Indications and safety information

Omnitrope is a recombinant human growth hormone indicated for the treatment of children with growth failure due to growth hormone deficiency (GHD) and for the treatment of adults with either adult onset or childhood onset GHD.

Somatropin should not be used for patients with acute critical illness. Somatropin should not be used for children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients. Somatropin should not be used for patients with active malignancy. Somatropin should not be used for patients with active proliferative or severe non-proliferative diabetic retinopathy. Somatropin should not be used for children with closed epiphyses.

Somatropin should not be used for patients with known hypersensitivity to somatropin or excipients. Formulations containing benzyl alcohol (5 mg/1.5 mL Omnitrope Cartridges and the Bacteriostatic Water for Injection diluent for the 5.8 mg/vial Omnitrope) should not be used in premature babies or neonates.

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin. The potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against potential risk.

Patients with preexisting tumors or GHD secondary to an intracranial lesion should be monitored routinely for progression or recurrence of the underlying disease process.

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.

Intracranial Hypertension may develop and is usually reversible after discontinuation or dose reduction. Exclude preexisting papilledema.

Fluid retention (i.e., edema, arthralgia, carpal tunnel syndrome, especially in adults) may occur frequently. Reduce dose as necessary.

Hypothyroidism may first become evident or worsen during somatropin treatment.

Slipped Capital Femoral Epiphysis may develop.

Evaluate children with the onset of a limp or hip/knee pain.

Progression of preexisting Scoliosis may develop.

Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy and headaches. The following events were observed during clinical studies with Omnitrope conducted in children with GHD: hypothyroidism, elevated HgbA1c, eosinophilia, hematoma, headache, hypertriglyceridemia and leg pain.

In clinical trials with somatropin on GHD adults, the majority of the adverse events consisted of mild to moderate symptoms of fluid retention, including peripheral swelling, arthralgia, pain and stiffness of the extremities, peripheral edema, myalgia, paresthesia and hypoesthesia.

Somatropin inhibits 11ßhydroxysteroid dehydrogenase type I and may require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid for previously diagnosed hypoadrenalism may require an increase in their maintenance doses. Glucocorticoid replacement should be carefully adjusted.

Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CYP450 liver enzymes.

In adult women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal.

In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral agent may require adjustment when somatropin therapy is initiated.

Limitations on Distribution of Omnitrope:   Section 333(e) of the FDCA prohibits knowing distribution by any person of a growth hormone product for any use other than the treatment of a disease or other recognized medical condition authorized by the FDA. Omnitrope shall not therefore knowingly be distributed for an off-label use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.gov/medwatch, or call 1-800-FDA-1088.