Pituitary disorders:

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.

Adult Dosage:

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.

Children Dosage:

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.

HUMATROPE Contraindications:

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).

HUMATROPE Warnings/Precautions:

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.

HUMATROPE Classification:

Growth hormone (GH).

HUMATROPE Interactions:

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.

Adverse Reactions:

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).

How Supplied:

Vial kit (5mg)—1 (w. diluent); Cartridge kit (6mg, 12mg, 24mg)—1 (w. diluent in prefilled syringe; HumatroPen (device for use with cartridge)—1