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. Replacement of endogenous GH in adults with GH deficiency.
Give by SC inj to the back of upper arm, abdomen, buttock, or thigh. Rotate inj sites. Non-weight based: initially ~0.2mg/day (range: 0.15–0.3mg/day); increase dose in increments of ~0.1–0.2mg/day every 1–2mos based on response and serum IGF-1 levels. Weight-based: initially 0.006mg/kg/day; increase dose based on individual requirements to max 0.0125mg/kg/day. Elderly: consider lower doses. Obese: weight-based dosing not recommended.
Individualize. Give by SC inj to the back of upper arm, abdomen, buttock, or thigh. Rotate inj sites. 0.18–0.3mg/kg weekly given either 3, 6, or 7 days per week (0.026–0.043mg/kg/day). Discontinue once epiphyseal fusion has occurred.
Acute critical illness due to open heart surgery, abdominal surgery, multiple accidental trauma or those with acute respiratory failure. Children with closed epiphysis. Active malignancy. 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 phosphorus, alkaline phosphatase, parathyroid hormone, IGF-1. Elderly. Neonates: reconstitute with normal saline for inj instead. Pregnancy, nursing mothers: reconstitute with normal saline or use benzyl alcohol-free formulation.
Growth hormone (GH).
May require increase in maintenance or stress doses of glucocorticoids in hypoadrenalism. May be antagonized by glucocorticoids, oral estrogens; adjust doses. May affect CYP450 substrates; monitor. Antihyperglycemic agents may need to be adjusted. Concomitant thyroid replacement therapy; adjust if needed.
Upper RTI, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, pain, rhinitis, peripheral edema, back pain, flu syndrome, AST increased; fluid retention, severe hypersensitivity reactions, pancreatitis (monitor); also in children: slipped capital femoral epiphysis.
Vials—1 (w. diluent)
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