Omnitrope Side Effects
Generic Name: Somatropin
Please note - some side effects for Omnitrope may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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Omnitrope
As with all protein drugs, a small number of patients may develop antibodies to the protein. Growth hormone antibody with binding capacity lower than 2 mg/L has not been associated with growth attenuation. In some cases when binding capacity is > 2mg/L, interference with growth response has been observed.
Preparations of Omnitrope™ contain a small amount of host cell Escherichia coli peptides (HCP). Anti-HCP antibodies are found in a small number of patients treated with Omnitrope™, but these appear to be of no clinical significance.
The following events were observed during the Omnitrope™ clinical studies conducted in children with GHD:
| Adverse event | Number (%) |
|---|---|
| Hypothyroidism | 7 (16%) |
| Elevated HbA1c | 6 (14%) |
| Eosinophilia | 5 (11%) |
| Hematoma | 4 (9%) |
| Headache | 3 (7%) |
| Hypertriglyceridemia | 2 (5%) |
| Leg Pain | 2 (5%) |
In clinical trials with somatropin in 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, parethesia, and hypoesthesia. These events were reported early during therapy, and tended to be transient and/or responsive to dosage reduction.
The following events were observed in patients using somatropins:
- Short-term local injection site reactions, such as pain, numbness, redness and swelling. The subcutaneous administration of growth hormone at the same injection site over a long period may result in local lipoatrophy.
- Disturbances in fluid balance (swelling), joint pain, muscle pain, stiffness of the hands and feet, numbness. In general, these undesirable effects occur only at the beginning of therapy with growth hormones and also depend on the dose. They are common in adult patients, but uncommon in children.
- Carpal tunnel syndrome in adults.
- Benign intracranial hypertension, diabetes mellitus.
Due to the content of benzyl alcohol in Omnitrope™, rare general hypersensitivity reactions are possible. No case was observed during the clinical trials.
Leukemia has been reported in small number of pediatric patients who have been treated with growth hormone, including growth hormone of pituitary origin and recombinant GH. The relationship, if any, between leukemia and growth hormone therapy is uncertain.
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