Indications & Uses
Pediatric Patients: Omnitrope injection is used to treat pediatric patients whose growth failure results from an inadequate supply of the body's own growth hormone (GH). It is also used to treat pediatric patients with short stature linked to Noonan syndrome, short stature linked to Turner syndrome, and short stature in children born small for gestational age (SGA) who have not shown catch-up growth by 2 to 4 years of age. Adult Patients: In adults, Omnitrope injection is used to replace the body's own GH in those with growth hormone deficiency (GHD) who meet one of two criteria. The first is Adult Onset (AO), covering patients whose GHD, whether occurring on its own or together with multiple hormone deficiencies (hypopituitarism), stems from pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma. The second is Childhood-Onset (CO), covering patients who were GH deficient as children for congenital, genetic, acquired, or idiopathic reasons. Patients who received Omnitrope for GHD in childhood and whose epiphyses have since closed should be reassessed before continuing therapy, at the lower dose recommended for adults with GHD. Under current standards, confirming adult GHD in both groups calls for an appropriate growth hormone provocative test, with two exceptions: (1) patients who have multiple other pituitary hormone deficiencies caused by organic disease, and (2) patients with congenital or genetic growth hormone deficiency.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Somatropin should be given as a subcutaneous injection. Injection sites should always be rotated to avoid lipoatrophy. For pediatric growth hormone deficiency, the dose is 0.024 to 0.034 mg/kg/day, given 6 to 7 times a week. For Noonan Syndrome, doses of up to 0.066 mg/kg/day may be used. For Turner Syndrome, doses of up to 0.067 mg/kg/day may be used. For short stature in children born small for gestational age (SGA), doses of up to 0.067 mg/kg/day may be used. For adult growth hormone deficiency, treatment may begin at 0.004 mg/kg/day and be increased as tolerated to no more than 0.016 mg/kg/day after approximately 6 weeks, or it may begin at approximately 0.2 mg/day (in a range of 0.15 to 0.30 mg/day) and be increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day.
Side Effects
The most commonly reported side effects with Omnitrope are headaches, muscle aches, and joint stiffness, along with elevated blood sugar (hyperglycemia) and sugar appearing in the urine (glucosuria).
Cautions & Contraindications
Warnings & Precautions
Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential riskPrader-Willi Syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment for GHD. Discontinue treatment if these signs occur.Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with Omnitrope- in particular meningiomas in patients treated with radiation to the head for their first neoplasm.Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked. Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment.Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction.Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention.Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome- especially in adults): May occur frequently. Reduce dose as necessary.Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.Hypothyroidism: May first become evident or worsen.Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain.Progression of Preexisting Scoliosis: May develop.Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain.
Contraindications
Acute Critical Illness Hypersensitivity to somatropin or any of its excipients Active malignancy Active proliferative or severe non-proliferative diabetic retinopathy Children with closed epiphyses (growth plates) Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment, due to reports of sudden death in this group