Generic Name and Formulations:
Somatropin (rDNA origin) 10mg per vial; pwd for SC inj after reconstitution; diluent contains benzyl alcohol.
Indications for NUTROPIN:
Treatment of children with growth failure due to growth hormone deficiency (GHD), idiopathic short stature (ISS), Turner syndrome (TS), and chronic kidney disease (CKD) up to the time of renal transplantation. Treatment of adults with childhood-onset or adult-onset GHD.
Individualize. Rotate inj site. Weight-based regimen: initially not more than 0.006mg/kg SC daily, may increase to max 0.025mg/kg daily in adults ≤35yrs or 0.0125mg/kg daily in adults >35yrs. Non weight-based regimen: initially 0.2mg/day SC (range: 0.15–0.3mg/day); may increase gradually every 1–2 months by increments of approximately 0.1–0.2mg/day. Elderly or obese: may need lower dose.
Individualize. Rotate inj site. Give in daily divided doses by SC inj. GHD: up to 0.3mg/kg/week. Pubertal patients: up to 0.7mg/kg/week. ISS: up to 0.3mg/kg/week. CKD: up to 0.35mg/kg/week. Dialysis: see full labeling. TS: up to 0.375mg/kg/week divided into equal doses 3–7 times per week. Discontinue therapy for short stature when the epiphyses are fused.
Acute critical illness due to surgical complications or multiple accidental trauma or those with acute respiratory failure. Children with closed epiphysis. Active malignancy. Active proliferative or severe non-proliferative 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 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. Not for use in patients with functioning renal allografts. 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. Hypopituitarism. Hypothyroidism. Scoliosis. Obtain baseline hip X-ray and monitor for renal osteodystrophy or development of limp or hip/knee pain in CKD. Turner syndrome: 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. May elevate serum phosphate, alkaline phosphatase, parathyroid hormone, IGF-1. Elderly. Neonates. Pregnancy (Cat.C). Nursing mothers.
Growth hormone (GH).
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. Insulin and/or oral/IV hypoglycemic agents may require adjustment when somatropin initiated. Concomitant thyroid replacement therapy; adjust if needed. Women on oral estrogen: may need higher somatropin dose.
Inj site reactions, edema, arthralgia, gynecomastia, carpal tunnel syndrome; serious hypersensitivity reactions, fluid retention; rare: pancreatitis (monitor); also children: slipped capital femoral epiphysis.
Nutropin vial—1 (w. diluent); Nutropin AQ pen (2mL)—1; Nutropin AQ NuSpin (2mL)—1
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