Generic Name and Formulations:
Somatropin (rDNA origin) lyophilized pwd 5.8mg (5mg/mL after reconstitution, preserved with m-Cresol), 13.8mg (12mg/mL after reconstitution, preserved with m-Cresol); for SC inj.
Indications for GENOTROPIN:
Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Small for Gestational Age (SGA), Turner syndrome (TS), and Idiopathic Short Stature (ISS). Treatment of adults with either adult onset or childhood onset GHD.
Give by SC inj into thigh, buttocks, or abdomen; rotate inj site. Non-weight based dosing: initially 0.2mg/day (range: 0.15–0.3mg/day) may be used and gradually increased every 1–2 months by increments of approx. 0.1–0.2mg/day. Weight based dosing: initially not more than 0.04mg/kg/week; dose may be increased as tolerated to not more than 0.08mg/kg/week at 4–8 week intervals.
Give by SC inj into thigh, buttocks, or abdomen; rotate inj site. Individualize based on growth response. GHD: 0.16–0.24mg/kg/week. PWS: 0.24mg/kg/week. SGA: up to 0.48mg/kg/week. TS: 0.33mg/kg/week. ISS: up to 0.47mg/kg/week.
Children with closed epiphyses. Active malignancy. Acute critical illness due to surgical complications or multiple accidental trauma or those with acute respiratory failure. Severe obesity or severe respiratory impairment in PWS patients. Active proliferative or severe non-proliferative diabetic retinopathy.
Increased mortality in those with acute critical illness (see Contraindications); weigh potential treatment benefit against the potential risk. PWS: evaluate for upper airway obstruction before starting; monitor weight, for sleep apnea, respiratory impairment/obstruction (eg, snoring; suspend therapy if occurs) or respiratory infection (treat aggressively if occurs). 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). Monitor gait, thyroid function, glucose tolerance, and for leukemia, scoliosis progression, malignant transformation of skin lesions, intracranial lesion progression or recurrence or intracranial hypertension (do funduscopic exam at baseline then periodically). Hypoadrenalism: monitor for reduced serum cortisol levels. Slipped capital femoral epiphyses (in ped patients). TS patients: may increase occurrence of otitis media and cardiovascular disorders. Pregnancy (Cat.B). Nursing mothers.
Growth hormone (GH).
May be antagonized by glucocorticoids. Monitor drugs metabolized by CYP450 (eg, steroids, anticonvulsants, cyclosporine). Concomitant oral estrogen replacement: may require larger dose of somatropin. Antidiabetic agents may require adjustment.
Inj site reactions/rashes, lipoatrophy, headaches; fluid retention (esp. in adults), serious hypersensitivity reactions; rare: pancreatitis.
Pen (5mg/mL, 12mg/mL)—1; MiniQuick (0.25mL)—7 ; All: as two-chambered cartridge w. diluent