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Omnitrope Generic Name & Formulations
Legal Class
Rx
General Description
Somatropin (rDNA origin) 5mg+, 10mg; per 1.5mL cartridge; 5.8mg/vial+; soln for SC inj; +contains benzyl alcohol.
Pharmacological Class
Growth hormone (GH).
How Supplied
Cartridges 5mg—1, 5 (use w. Omnitrope Pen 5), 10mg—1, 5 (use w. Omnitrope Pen 10); Vial—1 (w. diluent)
Manufacturer
Omnitrope Indications
Indications
Growth failure in children due to inadequate endogenous GH secretion. Children with growth failure due to Prader-Willi Syndrome (PWS). Children with growth failure associated with Turner syndrome (TS). Children with growth failure born small for gestational age (SGA) with no catch-up growth by age 2yrs. Children with idiopathic short stature (ISS) whose epiphyses are not closed. Adults with childhood-onset or adult-onset GH deficiency.
Omnitrope Dosage and Administration
Adult
Rotate inj sites. Weight-based: Initially up to max 0.04mg/kg/week given as a daily SC inj; may increase at 4–8 week intervals to max 0.08mg/kg/week. Non-weight based: approx. 0.2mg/day (range: 0.15–0.3mg/day), may increase gradually every 1–2 months by increments of approx. 0.1–0.2mg/day.
Children
Rotate inj sites. Weekly dose should be divided over 6 or 7 days of SC injections. GH deficient: 0.16–0.24mg/kg/week. PWS: 0.24mg/kg/week. SGA: up to 0.48mg/kg/week. TS: 0.33mg/kg/week. ISS: up to 0.47mg/kg/week.
Omnitrope Contraindications
Contraindications
Acute critical illness due to surgical complications or multiple accidental trauma or those with acute respiratory failure. Closed epiphyses. Active malignancy or growing intracranial tumors. Diabetic retinopathy. History of upper airway obstruction or sleep apnea, severe obesity, or severe respiratory impairment in PWS patients.
Omnitrope Boxed Warnings
Not Applicable
Omnitrope Warnings/Precautions
Warnings/Precautions
Increased mortality in those with acute critical illness (see Contraindications); weigh potential treatment benefit against the potential risk. PWS: evaluate baseline respiratory function; monitor weight and for respiratory infection; interrupt if signs of upper airway obstruction or sleep apnea occurs. History of GHD secondary to intracranial neoplasm: monitor routinely for tumor progression or recurrence. Increased risk of developing malignancies. Monitor for increased growth or malignant changes of preexisting nevi. Diabetes. Hypopituitarism. Hypothyroidism. Scoliosis. TS patients: evaluate for ear disorders (eg, otitis media); monitor for cardiovascular disorders (eg, stroke, aortic aneurysm/dissection, hypertension). Monitor thyroid function, glucose tolerance, and for intracranial hypertension (do baseline and periodic funduscopic exams). Hypoadrenalism: monitor for reduced serum cortisol levels. Elderly. Pregnancy (Cat.B). Nursing mothers.
Omnitrope Pharmacokinetics
See Literature
Omnitrope Interactions
Interactions
May require increase in maintenance or stress doses of glucocorticoids in hypoadrenalism. Antagonized by glucocorticoids. Concomitant drugs metabolized by CYP450 enzymes (eg, steroids, anticonvulsants, cyclosporine); monitor. Antidiabetic medications may need to be adjusted. Women on oral estrogen: may need higher somatropin dose.
Omnitrope Adverse Reactions
Adverse Reactions
Inj site reactions/rashes, lipoatrophy, headache, hyperglycemia, pancreatitis, fluid retention (esp. in adults), edema, arthralgia, myalgia, hypothyroidism, antibody formation, serious hypersensitivity reactions, elevated serum phosphorous, alkaline phosphatase, and IGF-1; also children: slipped capital femoral epiphysis (monitor). Long-term overdose may cause gigantism and/or acromegaly.
Omnitrope Clinical Trials
See Literature
Omnitrope Note
Not Applicable
Omnitrope Patient Counseling
See Literature
