IMPORTANT SAFETY INFORMATION
Acute Critical Illness: Humatrope should not be used to treat patients with acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin.
Prader-Willi Syndrome in Children: Humatrope 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 due to the risk of sudden death. Humatrope is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
Active Malignancy: Humatrope is contraindicated in patients with any evidence of active malignancy.
Hypersensitivity: Humatrope is contraindicated in patients with a known hypersensitivity to somatropin or any of the excipients in Humatrope.
Diabetic Retinopathy: Humatrope is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
Closed Epiphyses: Humatrope is contraindicated 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 Humatrope. Humatrope is not indicated for the treatment of non-GH deficient adults.
- Sudden Death in Patients with Prader-Willi Syndrome: There have been reports of sudden death 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.
- Increased risk of Neoplasms: There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with Humatrope. Discontinue Humatrope if there is evidence of recurrent activity. An increased risk of a second neoplasm has been reported for pediatric 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 Humatrope 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 Humatrope, 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 antidiabetic agents 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 fundoscopy during treatment with Humatrope, 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 therapy 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 Humatrope treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
- 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 in patients undergoing rapid growth. Evaluate any pediatric patient with the onset of a limp or complaints of hip or knee pain.
- Progression of Scoliosis in Pediatric Patients: Humatrope increases the growth rate and progression of existing scoliosis can occur in patients who experience rapid growth. Monitor patients with a history of scoliosis for progression of scoliosis. Somatropin has not been shown to increase the occurrence of scoliosis.
- Pancreatitis: Cases of pancreatitis have been reported in children and adults receiving somatropin products. Pancreatitis should be considered in patients who develop abdominal pain.
- Lipoatrophy: Tissue atrophy may result when somatropin products are administrated subcutaneously at the same site over a long period of time. Rotate injection sites when administering Humatrope to reduce this risk.
Common adverse reactions reported in adult and pediatric patients include upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, carpal tunnel syndrome, peripheral edema, flu syndrome, hypothyroidism, hyperglycemia, and impaired glucose tolerance.
HG HCP ISI 14SEP2022