HUMATROPE Dosage & Rx Info | Uses, Side Effects

Humatrope Generic Name & Formulations

Legal Class

General Description

Somatropin (rDNA origin) 6mg, 12mg, 24mg; per cartridge; lyophilized pwd for SC inj after reconstitution; diluent contains m-cresol, glycerin.

Pharmacological Class

Growth hormone (GH).

How Supplied

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

Manufacturer

Eli Lilly and Company

Mechanism of Action

Somatropin binds to dimeric GH receptors within the cell membranes of target tissue cells, resulting in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation of hepatic glucose output, protein synthesis and lipolysis. In children, somatropin stimulates skeletal growth as a result of effects on the growth plates (epiphyses) of long bones, causing an increase in linear growth rate (height velocity).

Humatrope Indications

Indications

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.

Humatrope Dosage and Administration

Adult

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

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

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 Boxed Warnings

Not Applicable

Humatrope Warnings/Precautions

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 Pharmacokinetics

Absorption

Absolute bioavailability: 75% (after SC admin).

Distribution

Volume of distribution: ~0.96 L/kg.

Metabolism

Extensive metabolism studies have not been conducted. The metabolic fate of somatropin involves classical protein catabolism in both the liver and kidneys.

Elimination

Half-life: 3.8 hours. Clearance: 0.18 L/hr/kg.

Humatrope Interactions

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.

Humatrope Adverse Reactions

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).

Humatrope Clinical Trials

See Literature

Humatrope Note