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: The possible benefit of continuing treatment should be weighed against the possible risk. Prader-Willi Syndrome in Children: Check for signs of upper airway obstruction and sleep apnea before starting treatment for GHD. If these signs appear, stop the treatment. Neoplasm: Keep an eye on patients who already have tumors, watching for progression or recurrence. Childhood cancer survivors treated with Omnitrope have a higher risk of a second neoplasm, in particular meningiomas in those who had radiation to the head for their first neoplasm. Impaired Glucose Tolerance and Diabetes Mellitus: These may be unmasked. Check glucose levels from time to time in all patients. People with diabetes who take other antihyperglycemic drugs may need their doses adjusted. Intracranial Hypertension: Rule out preexisting papilledema first. It may develop, but it is usually reversible after stopping the medicine or lowering the dose. Hypersensitivity: Serious hypersensitivity reactions may occur. If an allergic reaction happens, get medical help straight away. Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome, especially in adults): This may happen often. Reduce the dose if needed. Hypoadrenalism: In patients with known hypoadrenalism, watch for lower serum cortisol levels and any need to increase the glucocorticoid dose. Hypothyroidism: This may show up for the first time or get worse. Slipped Capital Femoral Epiphysis: This may develop. Check children who start limping or have hip or knee pain. Progression of Preexisting Scoliosis: This may develop. Pancreatitis: Think about 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