Important Safety Information
Contraindications
Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
Somatropin is contraindicated in patients with active proliferative or severe nonproliferative diabetic retinopathy.
Somatropin is contraindicated in patients with active malignancy.
Because growth hormone deficiency may be a sign of pituitary or other brain tumors,
the presence of such tumors should be ruled out before treatment is initiated.
Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.
Somatropin should not be used to treat patients with acute critical illness due to
complications from surgery, trauma, or respiratory failure; the safety of continuing
somatropin treatment for approved uses in patients who develop these illnesses has not been established.
Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese or have respiratory impairment (see WARNINGS).
Additional Safety Information
Monitor patients with glucose intolerance closely; dosage of antihyperglycemic
drug may need to be adjusted. Monitor carefully if somatropin is administered in
combination with glucocorticoid therapy and/or other drugs metabolized by the CP450 pathway.
In childhood cancer survivors, an increased risk of a second neoplasm, in particular
meningiomas, has been reported in patients treated with somatropin after their
first neoplasm, particularly those who were treated with cranial radiation.
Intracranial hypertension (IH) has been reported in a small number of patients treated with somatropin.
If papilledema is observed during somatropin treatment, treatment should be stopped and reassessed.
Patients with Turner syndrome and Prader-Willi syndrome may be at increased risk for the development of IH.
Patients treated with somatropin should have periodic thyroid function tests and thyroid
hormone replacement therapy should be initiated or adjusted when indicated.
In patients with multiple hormone deficiencies, standard hormonal replacement
therapy should be monitored closely when somatropin therapy is administered.
Progression of scoliosis can occur in patients who experience rapid growth. Patients with scoliosis should be monitored for manifestation or progression during GH therapy.
Slipped capital femoral epiphyses may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth.
Somatropin should be used during pregnancy only if clearly needed and with caution in nursing mothers because it is not known whether somatropin is excreted in human milk.
In clinical trials with GENOTROPIN in pediatric GHD patients, the following events were reported infrequently: injection site reactions, including pain or burning associated with the injection, fibrosis, nodules, rash, inflammation, pigmentation, or bleeding; lipoatrophy; headache; hematuria; hypothyroidism; and mild hyperglycemia.
In clinical studies of 273 pediatric patients born SGA treated with GENOTROPIN, the following clinically significant events were reported: mild transient hyperglycemia; 1 patient with benign intracranial hypertension; 2 patients with central precocious puberty; 2 patients with jaw prominence; and several patients with aggravation of preexisting scoliosis, injection site reactions, and self-limited progression of pigmented nevi. Anti-hGH antibodies were not detected in any of the patients treated with GENOTROPIN.
Deaths have been reported with the use of a growth hormone in pediatric PWS patients with severe obesity, history of upper airway obstruction or sleep apnea, and/or unidentified respiratory infection. Therefore, all patients with PWS should be evaluated and monitored for signs of upper airway obstruction, sleep apnea, and respiratory infections, and have effective weight control.
In clinical trials with GENOTROPIN in pediatric patients with PWS, the following drug-related events were reported: edema, aggressiveness, arthralgia, benign intracranial hypertension, hair loss, headache, and myalgia.
Somatropin may increase the occurrence of otitis media in Turner syndrome patients.
In 2 clinical studies with GENOTROPIN in pediatric patients with Turner syndrome, the most frequently reported adverse events were respiratory illnesses (influenza, tonsillitis, otitis, sinusitis), joint pain, and urinary tract infection. The only treatment-related adverse event that occurred in more than 1 patient was joint pain.
In 2 clinical studies with GENOTROPIN in pediatric patients with ISS, the most commonly encountered adverse events included upper respiratory tract infections, influenza, tonsillitis, nasopharyngitis, gastroenteritis, headaches, increased appetite, pyrexia, fracture, altered mood, and arthralgia.
In clinical trials with GENOTROPIN adults with GHD, the majority of side effects were symptoms of fluid retention, including peripheral swelling/edema, arthralgia, pain and stiffness of the extremities, myalgia, paresthesia, and hypoesthesia.
In women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal (see DOSAGE AND ADMINISTRATION).
Elderly patients may be more sensitive to the action of somatropin, and therefore may be more prone to develop adverse reactions.
The cartridges of GENOTROPIN contain m-Cresol and should not be used by patients with a known sensitivity to this preservative.
Subcutaneous injection of somatropin at the same site repeatedly may result in tissue atrophy. This can be avoided by rotating the injection site.
Health care providers should supervise the first injection and provide appropriate training and instruction for the proper use of all devices for GENOTROPIN.
Rx only