NORDITROPIN FLEXPRO PEN Rx
Generic Name and Formulations:
Somatropin (rDNA origin) 5mg/1.5mL, 10mg/1.5mL, 15mg/1.5mL, 30mg/3mL; soln for SC inj.
Indications for NORDITROPIN FLEXPRO PEN:
Growth failure in children due to inadequate endogenous GH secretion. Children with short stature associated with Noonan or Turner syndrome. Children with short stature born small for gestational age (SGA) with no catch-up growth by age 2–4yrs. Adults with childhood-onset or adult-onset GH deficiency.
Inject SC; rotate sites. Weight-based: Initially up to max 0.004mg/kg per day; may increase after 6 weeks to max 0.016mg/kg per day. 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.
Inject SC; rotate sites. Individualize. GH deficient: 0.024–0.034mg/kg per day, 6–7 times/week. Short stature w. Noonan: up to 0.066mg/kg per day. Short stature w. Turner or SGA: up to 0.067mg/kg per day. 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. Closed epiphyses. 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 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. Obesity. Hypopituitarism. Hypothyroidism. Scoliosis. 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. Elderly (use lower starting dose). 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 CYP3A4 substrates (eg, corticosteroids, sex steroids, anticonvulsants, cyclosporine). Antidiabetic medications may need to be adjusted. Women on oral estrogen: may need higher somatropin dose.
Growth hormone (GH).
Headache, inj site reactions, localized muscle pain, weakness, hypothyroidism, mild hyperglycemia, glucosuria, arthralgia, myalgia, fluid retention, edema, antibody formation, serious hypersensitivity reactions, lipoatrophy, elevated serum phosphorous, alkaline phosphatase, and IGF-1; rare: pancreatitis; also children: slipped capital femoral epiphysis (monitor). Long-term overdose may cause gigantism and/or acromegaly.
FlexPro prefilled pen—1