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Drug Description of Humatrope
Humatrope is a polypeptide hormone of recombinant DNA origin. Humatrope is synthesized in a strain of Escherichia coli that has been modified by the addition of the gene for human Growth Hormone (GH). The peptide is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence of the peptide is identical to that of human GH of pituitary origin.
Humatrope is a sterile, white, lyophilized powder intended for subcutaneous or intramuscular administration after reconstitution to its liquid form. Humatrope is a highly purified preparation. This product is oxygen sensitive.
Uses Of Humatrope
Humatrope 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 or growth failure in short stature homeobox-containing gene (SHOX) deficiency,
- short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.
Dosage and Administration
- Individualize dosage for each patient based on the growth response.
- Divide the calculated weekly HUMATROPE dosage into equal doses given either 6 or 7 days per week.
- The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
- Pediatric GH Deficiency: 0.18 mg/kg/week to 0.3 mg/kg/week (0.026 to 0.043 mg/kg/day)
- Turner Syndrome: Up to 0.375 mg/kg/week (up to.054 mg/kg/day)
- Idiopathic Short Stature: Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
- SHOX Deficiency: 0.35 mg/kg/week (0.05 mg/kg/day)
- Small for Gestational Age (SGA): Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
- In very short pediatric patients, height SDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of HUMATROPE (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline height SDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
Either of two HUMATROPE dosing regimens may be used:
- Non-weight based:
- Initiate HUMATROPE with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations.
- Maintenance dosages will vary considerably from person to person, and between male and female patients.
- Initiate HUMATROPE at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily.
- Maintenance dosages will vary considerably from person to person, and between male and female patients
- Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen.
Side Effects of Use
The following important adverse reactions are also described elsewhere in the labeling: