PACK3 HUMATROPE/72IU/24mg

Description

HUMATROPE is indicated for the treatment of pediatric patients with:
• growth failure due to inadequate secretion of endogenous growth hormone (GH),
• short stature associated with Turner syndrome,
• Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range,
• short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency,
• short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
1.2 Adult Patients
HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.
2 DOSAGE AND ADMINISTRATION
2.1 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.
2.2 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:
o Pediatric GH Deficiency: 0.18 mg/kg/week to 0.3 mg/kg/week (0.026 to 0.043 mg/kg/day)
o Turner Syndrome: Up to 0.375 mg/kg/week (up to.054 mg/kg/day)
o Idiopathic Short Stature: Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
o SHOX Deficiency: 0.35 mg/kg/week (0.05 mg/kg/day)
o 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
2.3 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
• Women may require higher doses and patients receiving oral estrogen may require higher doses
• Administer the prescribed dose daily.
• Either of two HUMATROPE dosing regimens may be used:
o 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.
4
 Maintenance dosages will vary considerably from person to person, and between male and female patients.
o 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.