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.
Acute critical illness. Acute respiratory failure. Closed epiphyses. Active malignancy or growing intracranial tumors. Diabetic retinopathy. Prader-Willi syndrome (severely obese or w. respiratory impairment); see literature.
Monitor gait, thyroid function, glucose tolerance, for malignant transformation of skin lesions, and for intracranial hypertension (do baseline and periodic funduscopic exams). History of intracranial lesions: monitor for lesion progression or recurrence. Prader-Willi syndrome: evaluate baseline respiratory function; monitor weight and for respiratory infection. Discontinue if signs of upper airway obstruction or sleep apnea occurs. Diabetes. Hypothyroidism. Scoliosis. Turner syndrome: evaluate for ear disorders (eg, otitis media); monitor for cardiovascular disorders (eg, stroke, aortic aneurysm/dissection, hypertension). Monitor preexisting tumors for progression or recurrence; increased risk of second neoplasm in childhood cancer survivors (in particular meningiomas in patients treated with radiation to head for first neoplasm). Pregnancy (Cat.C). Nursing mothers.
Antagonized by glucocorticoids. Antidiabetic medications may need to be adjusted. May affect CYP3A4 substrates. 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, elevated serum phosphate, antibody formation, pancreatitis; also children: slipped capital femoral epiphysis. Long-term overdose may cause gigantism and/or acromegaly.
FlexPro prefilled pen—1
NordiFlex prefilled pen—1