Generic Name and Formulations:
Somatropin (rDNA origin) 5mg, 10mg; lyophilized pwd for SC inj after reconstitution; contains mannitol; diluents contain benzyl alcohol or metacresol.
Ferring Pharmaceuticals, Inc.
Indications for ZOMACTON:
Growth failure in children due to inadequate endogenous GH secretion.
Individualize. Give by SC inj up to 0.1mg/kg 3 times per week; rotate inj site.
Acute critical illness due to surgical complications or multiple accidental trauma or those with acute respiratory failure. Children with closed epiphysis. Active malignancy or growing intracranial tumors. Diabetic retinopathy. Prader-Willi syndrome (severely obese or w. respiratory impairment); see full labeling.
Increased mortality in those with acute critical illness (see Contraindications); weigh potential treatment benefit vs the potential risk. PWS: evaluate baseline respiratory function; monitor weight and for respiratory infection; interrupt if signs of upper airway obstruction and/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. Obesity. Hypothyroidism. Scoliosis. Turner syndrome. Monitor bone age, thyroid function, glucose tolerance, and for intracranial hypertension (do baseline and periodic funduscopic exams). Hypoadrenalism: monitor for reduced serum cortisol levels. May elevate serum phosphate, alkaline phosphatase, IGF-1. Elderly. Neonates: reconstitute with normal saline for inj instead. Pregnancy (Cat.C). Nursing mothers.
May require increase in maintenance or stress doses of glucocorticoids in hypoadrenalism. May be antagonized by glucocorticoids; adjust doses. May affect CYP450 substrates (eg, corticosteroids, sex steroids, anticonvulsants, cyclosporine); monitor. Antihyperglycemic agents may need to be adjusted. Concomitant thyroid replacement therapy; adjust if needed.
Growth hormone (GH).
Headaches, inj site reactions, hypothyroidism, mild hyperglycemia, possible antibody formation; rare: pancreatitis (monitor); also children: slipped capital femoral epiphysis, gynecomastia. Long-term overdose may cause gigantism and/or acromegaly.
Vials—1 (w. diluent)