DOSAGE AND ADMINISTRATION
Pediatric Patients
The Humatrope dosage and administration schedule should be individualized for each patient. Therapy should not be continued if epiphyseal fusion has occurred. Response to growth hormone therapy tends to decrease with time. However, failure to increase growth rate, particularly during the first year of therapy, should prompt close assessment of compliance and evaluation of other causes of growth failure such as hypothyroidism, under–nutrition and advanced bone age.
Growth hormone–deficient pediatric patients — The recommended weekly dosage is 0.18 mg/kg (0.54 IU/kg) of body weight. The maximal replacement weekly dosage is 0.3 mg/kg (0.90 IU/kg) of body weight. It should be divided into equal doses given either on 3 alternate days, 6 times per week or daily. The subcutaneous route of administration is preferable; intramuscular injection is also acceptable. The dosage and administration schedule for Humatrope should be individualized for each patient.
Turner Syndrome — A weekly dosage of up to 0.375 mg/kg (1.125 IU/kg) of body weight administered by subcutaneous injection is recommended. It should be divided into equal doses given either daily or on 3 alternate days.
Patients with idiopathic short stature — A weekly dosage of up to 0.37 mg/kg of body weight administered by subcutaneous injection is recommended. It should be divided into equal doses given 6 to 7 times per week.
Patients with SHOX deficiency — A weekly dosage of 0.35 mg/kg of body weight is recommended. It should be divided into equal doses given by daily subcutaneous injection.
Adult Patients
Adult Growth Hormone Deficiency (GHD) — Based on the weight-based dosing utilized in the original pivotal studies described herein, the recommended dosage at the start of therapy is not more than 0.006 mg/kg given as a daily subcutaneous injection. The dose may be increased according to individual patient requirements to a maximum of 0.0125 mg/kg daily in patients. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I levels may be used as guidance in dose titration.
Alternatively, taking into account recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-I concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse events and/or serum IGF–I levels above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person.
A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.
Reconstitution
Vial — Each 5–mg vial of Humatrope should be reconstituted with 1.5 to 5 mL of Diluent for Humatrope. The diluent should be injected into the vial of Humatrope by aiming the stream of liquid against the glass wall. Following reconstitution, the vial should be swirled with a GENTLE rotary motion until the contents are completely dissolved. DO NOT SHAKE. The resulting solution should be inspected for clarity. It should be clear. If the solution is cloudy or contains particulate matter, the contents MUST NOT be injected.
Before and after injection, the septum of the vial should be wiped with rubbing alcohol or an alcoholic antiseptic solution to prevent contamination of the contents by repeated needle insertions. Sterile disposable syringes and needles should be used for administration of Humatrope. The volume of the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Cartridge — Each cartridge of Humatrope should only be reconstituted using the diluent syringe that accompanies the cartridge and should not be reconstituted with the Diluent for Humatrope provided with Humatrope Vials. (See WARNINGS section.) See Information for the Patient for comprehensive directions on Humatrope cartridge reconstitution.
The reconstituted solution should be inspected for clarity. It should be clear. If the solution is cloudy or contains particulate matter, the contents MUST NOT be injected.
The somatropin concentrations for the reconstituted Humatrope cartridges are as follows: 2.08 mg/mL for the 6 mg cartridge; 4.17 mg/mL for the 12 mg cartridge; and 8.33 mg/mL for the 24 mg cartridge.
This cartridge has been designed for use only with the Humatrope injection device. A sterile disposable needle should be used for each injection of Humatrope.
STABILITY AND STORAGE
Vials
Before Reconstitution — Vials of Humatrope and Diluent for Humatrope are stable when refrigerated [2° to 8°C (36° to 46°F)]. Avoid freezing Diluent for Humatrope. Expiration dates are stated on the labels.
After Reconstitution — Vials of Humatrope are stable for up to 14 days when reconstituted with Diluent for Humatrope or Bacteriostatic Water for Injection, USP and stored in a refrigerator at 2° to 8°C (36° to 46°F). Avoid freezing the reconstituted vial of Humatrope.
After Reconstitution with Sterile Water, USP — Use only one dose per Humatrope vialand discard the unused portion. If the solution is not used immediately, it must be refrigerated [2° to 8°C (36° to 46°F)] and used within 24 hours.
Cartridges
Before Reconstitution — Cartridges of Humatrope and Diluent for Humatrope are stable when refrigerated [2° to 8°C (36° to 46°F)]. Avoid freezing Diluent for Humatrope. Expiration dates are stated on the labels.
After Reconstitution — Cartridges of Humatrope are stable for up to 28 days when reconstituted with Diluent for Humatrope and stored in a refrigerator at 2° to 8°C (36° to 46°F). Store the Humatrope injection device without the needle attached. Avoid freezing the reconstituted cartridge of Humatrope.
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