Indications for HUMATROPE:
Growth failure in children due to inadequate endogenous GH secretion. Children with short stature associated with Turner syndrome. Children with idiopathic short stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range. Children with short stature homeobox-containing gene (SHOX) deficiency. Children with short stature born small for gestational age (SGA) with no catch-up growth by age 2–4yrs. Adults with GH deficiency, as replacement of endogenous GH.
Give by SC inj into back of upper arm, abdomen, buttock, or thigh; rotate inj sites. Individualize. Weight-based: initially 0.006mg/kg/day; may increase to max 0.0125mg/kg/day. Non-weight based: initiate at 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.
Give by SC inj into back of upper arm, abdomen, buttock, or thigh; rotate inj sites. Weekly dose should be divided over 6 or 7 days. GH deficient: 0.18–0.3mg/kg/week. Turner syndrome: up to 0.375mg/kg/week. ISS: up to 0.37mg/kg/week. SHOX deficiency: 0.35mg/kg/week. SGA: up to 0.47mg/kg/week; see full labeling. 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. Closed epiphyses. Active malignancy. Active proliferative or severe non-proliferative diabetic retinopathy. History of upper airway obstruction or sleep apnea, severe obesity, or severe respiratory impairment in children with Prader-Willi syndrome (PWS).
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. Not for treatment of children with growth failure due to PWS. History of GHD secondary to intracranial neoplasm: monitor routinely for tumor progression or recurrence. Increased risk of malignancies; if preexisting, complete treatment prior to somatropin initiation; discontinue if there is evidence of recurrent activity. Monitor for increased growth or malignant changes of preexisting nevi. Diabetes. Obesity. Intracranial hypertension (esp. in Turner syndrome): perform routine funduscopic exam at baseline and periodically thereafter; discontinue if papilledema develops. Hypoadrenalism: monitor for reduced serum cortisol levels. Scoliosis (monitor). Hypothyroidism. Monitor thyroid function, glucose tolerance. May increase serum phosphorous, alkaline phosphatase, parathyroid hormone, IGF-1 after therapy. Elderly. Pregnancy. Nursing mothers.
Growth hormone (GH).
May require increase in maintenance or stress doses of glucocorticoids in hypoadrenalism. May be antagonized by non-replacement glucocorticoids; adjust glucocorticoid dose in children. Concomitant drugs metabolized by CYP450 enzymes; monitor. Antidiabetic medications may need to be adjusted. Women on oral estrogen: may need higher somatropin dose.
Upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, carpal tunnel syndrome, flu syndrome, hypothyroidism, hyperglycemia, impaired glucose tolerance; neoplasms, intracranial hypertension, hypersensitivity reactions (may be severe), fluid retention, hypoadrenalism, pancreatitis, lipoatrophy. Children: also slipped capital femoral epiphysis (monitor).
Vial kit (5mg)—1 (w. diluent); Cartridge kit (6mg, 12mg, 24mg)—1 (w. diluent in prefilled syringe; HumatroPen (device for use with cartridge)—1