HUMATROPE 36 IU 12 MG
HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.
Dosage and administration
Management and use instructions
Treatment with HUMATROPE should be supervised by a physician experienced in diagnosing and treating patients for whom HUMATROPE is indicated. To rule out existing papilledema, a fundus examination should be performed regularly before starting treatment with Fumatrope and regularly thereafter. Leave HUMAT ROPE at room temperature for 10 minutes before administration. HUMATROPE is given by subcutaneous injection behind the upper arm, abdomen, buttocks, or thigh, and the injection site is rotated regularly to prevent fat atrophy.
Individualize each patient's dosing based on growth response. Divide the calculated weekly HUMATROPE dose into equal doses given 6 or 7 days a week. The recommended weekly doses in milligrams (mg) per kilogram (kg) of body weight for pediatric patients are:
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)
Low birth weight infant (SGA): up to 0.47 mg / kg / week (up to 0.067 mg / kg / day)
Consider starting treatment with higher doses of HUMATROPE (up to 0.067 mg / kg / day) in very small pediatric patients with SDS <3 and adolescent pediatric patients above. If significant compensatory growth is observed during the first few years of treatment, consider gradually reducing the dose. For less severe short stature and pediatric patients <4 years with a baseline SDS value of 2-3, treatment should be started at 0.033 mg / kg / day and the dose should be considered to be increased as needed. there is. Assess compliance and evaluate other causes of poor growth such as hypothyroidism, undernutrition, 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
Administer the prescribed dose daily.
Dosage Forms And Strengths
HUMATROPE for injection is a white lyophilized powder available in the following vial and cartridge sizes:
The following important adverse reactions are also described elsewhere in the labeling:
Increased mortality in patients with acute critical illness