Omnitrope

Generic Name: somatropin [rDNA origin] for injection
Date of Approval: May 30, 2006
Company: Sandoz

Treatment for: Growth Disorders

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The US Food and Drug Administration has granted approval for the recombinant human growth hormone Omnitrope for treatment of growth disorders in children and adults.

What is Omnitrope?

Omnitrope (somatropin [rDNA origin]) for injection is a polypeptide hormone of recombinant DNA origin. The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin (somatropin).

Indications

Omnitrope is indicated for:

Long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
Long-term replacement therapy in adults with growth hormone deficiency (GHD) of either childhood- or adult- onset etiology. GHD should be confirmed by an appropriate growth hormone stimulation test.

Contraindications

Omnitrope should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumor therapy complete prior to the institution of therapy. Omnitrope should be discontinued if there is evidence of tumor growth. Growth hormone should not be used for growth promotion in pediatric patients with fused epiphyses. Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental traumas, or to patients having acute respiratory failure. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients with these conditions revealed a significant increase in mortality among somatropin-treated patients compared to those receiving placebo. Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Treatment with Omnitrope is contraindicated in case of hypersensitivity to somatropin or to any of the excipients.

Precautions

Treatment with Omnitrope, as with other growth hormone preparations, should be directed by physicians who are experienced in the diagnosis and management of patients with GHD.

Adverse Reactions

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:
hypothyroidism, elevated HbA1c, eosinophilia, hematoma, headache, hypertriglyceridemia, leg pain.

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, paresthesia, 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 at the beginning of therapy with growth hormones and also depend on the dose. They are common in adult patients, but uncommon in children.

For more information, please see Omnitrope Product Label (PDF)

For additional information, please visit www.sandoz.com