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. Children with idiopathic short stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of normal adult height. Growth failure in children due to Prader-Willi syndrome (PWS). Adults with GH deficiency.
Inject SC into back of upper arm, abdomen, buttocks, or thigh. Rotate inj sites. Individualize. Weight-based: initially up to max 0.004mg/kg/day; may increase to max 0.016mg/kg/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. Elderly: consider using lower doses. Obesity: use non-weight based regimen.
Inject SC into back of upper arm, abdomen, buttocks, or thigh. Rotate inj sites. Individualize. Divide weekly dosage in equal doses given either 6, or 7 days per week. GH deficiency: 0.17–0.24mg/kg/week (0.024–0.034mg/kg/day). Noonan syndrome: up to 0.46mg/kg/week (up to 0.066mg/kg/day). Turner syndrome, ISS: up to 0.47mg/kg/week (up to 0.067mg/kg/day). SGA: up to 0.47mg/kg/week (0.067mg/kg/day); consider initiating at 0.033mg/kg/day if <4yrs with less severe short stature, or at higher doses with very short stature (see full labeling). PWS: 0.24mg/kg/week (0.034mg/kg/day). Discontinue therapy for linear growth stimulation when the epiphyses are fused.
Acute critical illness after open heart or abdominal surgery, or multiple accidental trauma or those with acute respiratory failure. Children with closed epiphyses. Active malignancy. Active proliferative or severe non-proliferative diabetic retinopathy. Prader-Willi syndrome (severely obese, history of upper airway obstruction or sleep apnea, or have severe respiratory impairment); see full labeling.
Increased mortality in those with acute critical illness (see Contraindications). 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. Intracranial hypertension (IH) with papilledema: perform funduscopic exam before initiation and periodically thereafter; discontinue if papilledema observed; if somatropin-induced IH is diagnosed, may restart at lower dose after symptoms resolved. Hypoadrenalism: monitor for reduced serum cortisol levels. Hypothyroidism. Monitor thyroid function, glucose tolerance. History of scoliosis (monitor). Elderly. Pregnancy. Nursing mothers.
Growth hormone (GH).
May require increase in maintenance or stress doses of glucocorticoids in hypoadrenalism. May be antagonized by glucocorticoids; adjust doses. Caution with concomitant CYP450 substrates (monitor). Antidiabetic medications may need to be adjusted. Women on oral estrogen: may need higher somatropin dose. May increase inorganic phosphorous, alkaline phosphatase, PTH, IGF-1 serum levels.
Upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, flu syndrome, impaired glucose tolerance; neoplasms, intracranial hypertension, serious hypersensitivity reactions, fluid retention, pancreatitis, lipoatrophy; also in children: slipped capital femoral epiphysis (monitor).
FlexPro prefilled pen—1