Drug Detail:Humatrope (Somatropin [ soe-ma-troe-pin ])
Generic Name: Somatropin 5mg in 5mL;
Dosage Form: injection
Drug Class: Growth hormones
Administration and Use Instructions
- Therapy with HUMATROPE should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which HUMATROPE is indicated [see Indications and Usage (1)].
- Fundoscopic examination should be performed routinely before initiating treatment with HUMATROPE to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions (5.5)].
- Leave HUMATROPE at room temperature for 10 minutes prior to administration.
- Administer HUMATROPE by subcutaneous injection to the back of the upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy.
Pediatric Dosage
- 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.
- Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
- Discontinue HUMATROPE for stimulation of linear growth once epiphyseal fusion has occurred [see Contraindications (4)].
Adult Dosage
- Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults.
- Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with HUMATROPE than younger individuals [see Use in Specific Populations (8.5)].
- Women may require higher doses and patients receiving oral estrogen may require higher doses [see Drug Interactions (7)].
- Administer the prescribed dose daily.
- 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.
- Use the patient's clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
- Maintenance dosages will vary considerably from person to person, and between male and female patients.
- Weight-based:
- 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.
- Use the patient's clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
- 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.
- Non-weight based:
Reconstitution of Vials
- Reconstitute the 5-mg vial of HUMATROPE with 1.5 to 5 mL of Diluent for HUMATROPE.
- Inject the diluent into the vial by aiming the stream of liquid gently against the vial wall. Swirl the vial (do not shake) with a gentle rotary motion until the powder is completely dissolved into liquid and the solution is clear.
- Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use.
- Vials of HUMATROPE are stable for up to 14 days when reconstituted with Diluent for HUMATROPE and refrigerated at 36° to 46°F (2° to 8°C). Do not leave reconstituted vials at room temperature more than 30 minutes per day. Avoid freezing the reconstituted vial of HUMATROPE. Protect HUMATROPE from light during storage.
- For patients with known hypersensitivity to the Diluent for HUMATROPE [see Warnings and Precautions (5.6)], reconstitute the vial with Sterile Water for Injection. Use only one dose per vial, use immediately and discard the unused portion.
Reconstitution of Cartridges
- Each HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen®.
- Reconstitute each cartridge of HUMATROPE using only the diluent syringe that accompanies the cartridge. Do not shake. The reconstituted solution should be clear.
- Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use.
- The somatropin concentrations for the reconstituted HUMATROPE cartridges are as follows:
Cartridge Somatropin Concentration 6 mg 2.08 mg/mL 12 mg 4.17 mg/mL 24 mg 8.33 mg/mL
- Reconstituted cartridges of HUMATROPE are stable for up to 28 days when refrigerated at 36° to 46°F (2° to 8°C). Do not leave at room temperature more than 30 minutes per day. Avoid freezing the reconstituted cartridge. Protect HUMATROPE from light during storage.
- For patients with known hypersensitivity to the diluent supplied with the HUMATROPE cartridge [see Warnings and Precautions (5.6)], do not use HUMATROPE cartridge. Use the HUMATROPE vial and reconstitute with Sterile Water for Injection [see Dosage and Administration (2.4)].
