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Indications and Important Safety Information for Humatrope
Humatrope® (somatropin for injection) is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:
- Growth hormone (GH) deficiency.
- Turner syndrome.
- Idiopathic short stature, defined by height standard deviation score ≤-2.25, associated with growth rates unlikely to result in normal adult height, in whom other causes of short stature have been excluded.
- SHOX deficiency.
- Small for gestational age birth, and fail to show catch-up growth by 2 to 4 years of age.
Humatrope is indicated for the replacement of endogenous GH in adults with GH deficiency, either:
- Adult-onset, as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
- Childhood-onset. Patients treated for GH deficiency in childhood who have closed epiphyses should be reevaluated to determine if they should continue growth hormone.
Important Safety Information for Humatrope
- Acute Critical Illness: Somatropin should not be used to treat patients with acute critical illness from complications after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure.
- Prader-Willi Syndrome in Children: Somatropin should not be used in pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. Humatrope is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
- Active Malignancy: Somatropin is contraindicated in patients with any evidence of active malignancy.
- Hypersensitivity: Humatrope is contraindicated in patients with a known hypersensitivity to somatropin or the supplied diluent.
- Diabetic Retinopathy or Closed Epiphyses: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. It should not be used for growth promotion in pediatric patients with closed epiphyses.
WARNINGS AND PRECAUTIONS
- Acute Critical Illness: Increased mortality in patients with acute critical illness from complications after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin.
- Prader-Willi Syndrome in Children: There have been reports of fatalities after starting therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin.
- Neoplasms: An increased risk of a second neoplasm has been reported for childhood cancer survivors treated with somatropin for GH deficiency that developed following radiation to the brain/head. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence. Monitor for progression or recurrence in all patients receiving somatropin therapy who have a history of GH deficiency secondary to an intracranial neoplasm.
- Glucose Intolerance and Diabetes Mellitus: Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. New-onset type 2 diabetes mellitus has been reported. Blood glucose concentrations should be monitored periodically in all patients taking somatropin, especially in those with risk factors for diabetes mellitus and those with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance. The dose of antihyperglycemic drugs may require adjustment when somatropin treatment is instituted.
- Intracranial Hypertension: Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting have been reported in a small number of patients treated with somatropin. If papilledema is observed by funduscopy during treatment with somatropin, treatment should be stopped and the patient’s condition should be reassessed before treatment is resumed.
- Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with use of somatropin products.
- Fluid Retention: Transient and dose-dependent fluid retention during somatropin replacement in adults may occur frequently.
- Hypoadrenalism: Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiencies may be at risk for reduced serum cortisol levels and/or unmasking of central hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment.
- Hypothyroidism: Patients treated with somatropin should have periodic thyroid function tests, and thyroid hormone replacement therapy should be initiated or adjusted in cases of unmasked or worsening hypothyroidism.
- Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders and in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.
- Progression of Scoliosis in Pediatric Patients: Progression of scoliosis can occur in patients who experience rapid growth. Patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. Somatropin has not been shown to increase the occurrence of scoliosis.
- Pancreatitis: Cases of pancreatitis have been reported rarely in children and adults receiving somatropin. Pancreatitis should be considered in any somatropin-treated patient, especially a child, who develops abdominal pain.
- Lipoatrophy: Tissue atrophy may result when somatropin is administrated subcutaneously at the same site over a long period of time. This can be avoided by rotating the injection site.
- Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions, hypersensitivity to the diluent, and hypothyroidism. Additional common adverse reactions in adults include edema, arthralgia, myalgia, carpal tunnel syndrome, paresthesias, and hyperglycemia.
HG HCP ISI 13JAN2017