DOSAGE AND ADMINISTRATION
The dosage of GENOTROPIN Lyophilized Powder must be adjusted for the individual patient. The weekly dose should be divided into 6 or 7 subcutaneous injections. GENOTROPIN may be given in the thigh, buttocks, or abdomen; the site of SC injections should be rotated daily to help prevent lipoatrophy.
Pediatric GHD Patients:
Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended.
Pediatric PWS Patients:
Generally, a dose of 0.24 mg/kg body weight/week is recommended.
Pediatric SGA Patients:
Generally, a dose of 0.48 mg/kg body weight/week is recommended.
Adult GHD Patients:
The recommended dosage at the start of therapy is not more than 0.04 mg/kg/week. The dose may be increased at 4- to 8-week intervals according to individual patient requirements to a maximum of 0.08 mg/kg/week, depending upon patient tolerance of treatment. Clinical response, side effects, and determination of age-adjusted serum IGF-I may be used as guidance in dose titration. This approach will tend to result in weight-adjusted doses that are larger for women compared with men and smaller for older and obese patients. GENOTROPIN must not be injected intravenously.
GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. A reconstitution device is used to mix the diluent and powder.
Follow the directions for reconstitution provided with each device. Do not shake; shaking may cause denaturation of the active ingredient.
All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the solution is cloudy, the contents MUST NOT be injected.
Patients and caregivers who will administer GENOTROPIN in medically unsupervised situations should receive appropriate training and instruction on the proper use of GENOTROPIN from the physician or other suitably qualified health professional.
STABILITY AND STORAGE
Except as noted below, store GENOTROPIN Lyophilized Powder under refrigeration at 2° to 8°C (36° to 46°F). Do not freeze. Protect from light.
The 1.5-mg cartridge of GENOTROPIN contains a diluent with no preservative. After reconstitution, the cartridge may be stored under refrigeration for up to 24 hours. Use only once and discard any remaining solution.
The 5.8-mg and 13.8-mg cartridges of GENOTROPIN contain a diluent with a preservative. Thus, after reconstitution, they may be stored under refrigeration for up to 21 days.
The GENOTROPIN MINIQUICK Growth Hormone Delivery Device should be refrigerated prior to dispensing, but may be stored at or below 25°C (77°F) for up to three months after dispensing. The diluent has no preservative. After reconstitution, the GENOTROPIN MINIQUICK may be stored under refrigeration for up to 24 hours before use. The GENOTROPIN MINIQUICK should be used only once and then discarded.
|
