HUMATROPE 72 IU 24 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. Pediatric medication

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:

5 mg vial and a 5mL vial of Diluent for HUMATROPE

6 mg cartridge (gold) and a prefilled syringe of Diluent for HUMATROPE

12 mg cartridge (teal) and a prefilled syringe of Diluent for HUMATROPE

24 mg cartridge (purple) and a prefilled syringe of Diluent for HUMATROPE

SIDE EFFECTS

The following important adverse reactions are also described elsewhere in the labeling:

• Increased mortality in patients with acute critical illness
• Fatalities in children with PraderWilli syndrome
• Neoplasms
• Glucose intolerance and diabetes mellitus
• Intracranial hypertension
• Severe hypersensitivity
• Fluid retention
• Hypoadrenalism
• Hypothyroidism
• Slipped capital femoral epiphysis in pediatric patients
• Progression of preexisting scoliosis in pediatric patients
• Pancreatitis
• Lipoatrophy