Indications and clinical use:

^PrOmnitrope^® (somatropin for injection) is indicated for:

Children

The long-term treatment of children, who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency [GHD]). Other causes of short stature should be excluded.

SGA Indication

Omnitrope^® is indicated for the treatment of growth failure (current height standard deviation score [SDS] <-2) in short children born SGA (birth weight and/or length below -2 SD) and who fail to achieve catch-up growth (height velocity SDS <0 during the last year) by 2 to 4 years or later.

TS Indication

The treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed.

ISS Indication

The long-term treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. Omnitrope® treatment for ISS should be prescribed only for those patients whose epiphyses are not closed.

Adults

Omnitrope^® (somatropin [rDNA origin] for injection) is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Contraindications:

• •Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions should not be treated with somatropin.
• • Growth hormone is contraindicated in children with Prader-Willi Syndrome who are severely obese or have severe respiratory impairment.
• • Omnitrope^® should not be used for growth promotion in pediatric patients with closed epiphyses; in patients with any evidence of neoplastic activity; or in newborns or patients with a known sensitivity to benzyl alcohol (5 mg/1.5 mL only), somatropin, or to any other ingredient in the formulation.
• •Omnitrope^® should not be administered in patients with proliferative or preproliferative diabetic retinopathy.
• • Renal transplantation: Treatment with Omnitrope® should be discontinued at the time of renal transplantation.

Most serious warnings and precautions:

Prader-Willi Syndrome: There have been reports of fatalities associated with the use of growth hormone in pediatric patients with Prader-Willi syndrome who have one or more of the following risk factors: severe obesity, history of respiratory impairment or sleep apnea, or unidentified respiratory infection.

Patients with acute critical illness: A significant increase in mortality was reported among somatropin treated patients with acute critical illness in intensive care units due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure compared with those receiving placebo.

Antibody production: Any change in brand of somatropin products should be made cautiously and only under medical supervision.

Other relevant warnings and precautions:

• •Carcinogenesis and mutagenesis, due to increased risk of developing neoplasm with growth hormone treatment.
• •Need for periodic thyroid function tests in patients with Turner Syndrome.
• •Dependence/tolerance.
• •Serious AE risks associated with congenital disorders.
• •Endocrine and metabolism: patients with diabetes mellitus, glucose intolerance, and hypopituitarism should be monitored closely while on therapy.
• •Endocrine and metabolism: patients with diabetes mellitus, glucose intolerance, and hypopituitarism should be monitored closely while on therapy.
• •Thyroid function should be evaluated before starting somatropin therapy and should be monitored regularly during treatment, not less frequently than annually.
• •Risk of reduction of serum cortisol concentrations.
• •Risk of unmasking secondary hypoadrenalism.
• • Fluid retention.
• • Hematologic: Insulin-like Growth Factor-I (IGF-I) concentrations should be monitored regularly.
• •Intracranial hypertension.
• •Local or systemic allergic reactions (antibody testing should be considered).
• •Musculoskeletal.
• •Neurologic: Growth hormone deficiency secondary to an intracranial lesion should be examined frequently for progression or recurrence of the underlying disease process.
• •Patients taking oral estrogen.
• •Pancreatitis.
• •Prader-Willi syndrome.
• •Secondary neoplasm in survivors of childhood cancer.
• •Turner syndrome patients and the risk of otitis media and other ear disorders, cardiovascular disorders, and autoimmune thyroid disease.
• •Injection site should be rotated daily to help prevent lipoatrophy.
• •Obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen.
• •Evaluate pediatric patients with onset of a limp or complaints of hip or knee pain; risk of slipped capital femoral epiphysis.
• •Pregnant and nursing women.
• • Prudence is indicated for children <3 years of age.
• • Adult patients should be monitored for adverse events, IGF-1 levels and other parameters of GH response.
• • Children should be monitored with measurement of IGF-1/IGFBP-3 levels and assessed for height increase and velocity.

For more information:

Please consult the Product Monograph for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece.