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.
ADULT PATIENTS
Growth hormone-deficient adult patients -- The recommended dosage at the start of therapy is not more than 0.006 mg/kg/day (0.018 IU/kg/day) given as a daily subcutaneous injection. The dose may be increased according to individual patient requirements to a maximum of 0.0125 mg/kg/day (0.0375 IU/kg/day).
During therapy, dosage should be titrated if required by the occurrence of side effects or to maintain the IGF-I response below the upper limit of normal IGF-I levels, matched for age and sex. To minimize the occurrence of adverse events in patients with increasing age or excessive body weight, dose reductions may be necessary.
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 and the diluent connector which accompany the cartridge and should not be reconstituted with the Diluent for Humatrope provided with Humatrope Vials. (See WARNINGS section.) See the HumatroPen™ User Guide 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 HumatroPen allows the somatropin dosage volume to be dialed in increments of 0.048 mL per click of dosage knob, and the maximum dosage volume that can be injected is 0.576 mL (based on a 12-click maximum). (See Table 10 for additional information.)
Table 10
Concentration of Reconstituted Humatrope Solutions, Incremental Dosage and Maximum Injectable Dose for Each Cartridge
| Cartridge |
Somatropin Concentration |
Dose Per Click of Dosage Knob |
Maximum Injectable Dose |
|
6 mg |
2.08 mg/mL
|
0.1 mg
|
1.2 mg
|
| 12 mg |
4.17 mg/mL
|
0.2 mg
|
2.4 mg
|
| 24 mg |
8.33 mg/mL
|
0.4 mg
|
4.8 mg
|
|
This cartridge has been designed for use only with the HumatroPen. A sterile disposable needle should be used for each administration 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 vial and 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 HumatroPen without the needle attached. Avoid freezing the reconstituted cartridge of Humatrope.
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