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Drug Description of Genotropin
Genotropin lyophilized powder contains somatropin which is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and a molecular weight of 22,124 daltons. The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin (somatropin). GENOTROPIN is synthesized in a strain of Escherichia coli that has been modified by the addition of the gene for human growth hormone. Genotropin is a sterile white lyophilized powder intended for subcutaneous injection
Uses Of Genotropin
Genotropin is indicated for the treatment of pediatric patients with:
- growth failure due to inadequate secretion of endogenous growth hormone (GH),
- short stature associated with Turner syndrome,
- Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range,
- short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
Genotropin 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)
Dosage and Administration
Dosing Of Pediatric Patients
The Genotropin dosage and administration schedule should be individualized based on the growth response of each patient.
- The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
- Pediatric GH Deficiency: a dose of 0.16 to 0.24 mg/kg body weight/week is recommended.
- Turner Syndrome: a dose of 0.33 mg/kg body weight/week is recommended.
- Idiopathic Short Stature: a dose up to 0.47 mg/kg body weight/week is recommended.
- Small for Gestational Age (SGA): a dose of up to 0.48 mg/kg body weight/week is recommended.
Either of two approaches to Genotropin dosing may be followed: a non-weight based regimen or a weight based regimen.
A starting dose of approximately 0.2 mg/day may be used without consideration of body weight. This dose can be increased gradually every 2 months by increments of approximately 0.5 to 1 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor I (IGF-I) concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients.
The recommended dosage at the start of treatment is not more than 0.04 mg/kg/week. The dose may be increased according to individual patient requirements to not more than 1.5 mg/kg/week within an interval of 2 weeks.
Side Effects of Use
The following important adverse reactions are also described elsewhere in the labeling:
- Increased mortality in patients with acute critical illness
- Fatalities in children with Prader-Willi syndrome
- Glucose intolerance and diabetes mellitus
- Intracranial hypertension
- Severe hypersensitivity