HUMATROPE Rx

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HUMATROPE

Pituitary disorders
Only 4 drugs may be compared at once

Generic Name and Formulations:

Somatropin 5mg (rDNA origin); pwd for SC or IM inj after reconstitution; diluent contains m-cresol.

Select therapeutic use:

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). Children with short stature homeobox-containing gene (SHOX) deficiency. Children with growth failure born small for gestational age (SGA) with no catch-up growth by age 2–4yrs. Adults with childhood-onset or adult-onset GH deficiency.

Adult:

Give by SC inj once daily; rotate inj sites. Individualize. Weight-based: Initially up to 0.006mg/kg/day; may increase to max 0.0125mg/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.

Children:

Rotate inj sites. Weekly dose should be divided over 6 or 7 days of SC inj. 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.

Contraindications:

Acute critical illness due to surgical complications or multiple accidental trauma or those with acute respiratory failure. Closed epiphyses. Active malignancy or growing intracranial tumors. Diabetic retinopathy. History of upper airway obstruction or sleep apnea, severe obesity, or severe respiratory impairment in Prader-Willi syndrome (PWS) patients. Not indicated for treatment of children with growth failure due to confirmed PWS.

Warnings/Precautions:

Increased mortality in those with acute critical illness (see Contraindications); weigh potential treatment benefit against the potential risk. 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. Hypopituitarism. Hypothyroidism. Scoliosis. Turner syndrome: evaluate for ear disorders (eg, otitis media); monitor for cardiovascular disorders (eg, stroke, aortic aneurysm/dissection, hypertension). Monitor thyroid function, glucose tolerance, and for intracranial hypertension (do baseline and periodic funduscopic exams). Hypoadrenalism: monitor for reduced serum cortisol levels. Elderly (use lower starting dose). Pregnancy (Cat.C). Nursing mothers.

Interactions:

May require increase in maintenance or stress doses of glucocorticoids in hypoadrenalism. May be antagonized by glucocorticoids. Concomitant drugs metabolized by CYP450 enzymes (eg, steroids, anticonvulsants, cyclosporine); monitor. Antidiabetic medications may need to be adjusted. Women on oral estrogen: may need higher somatropin dose.

Pharmacological Class:

Growth hormone (GH).

Adverse Reactions:

Inj site reactions, hypothyroidism, edema, myalgia, arthralgia, carpal tunnel syndrome, paresthesia, hyperglycemia, ear disorders, gynecomastia, headache, antibody formation; serious hypersensitivity reactions, lipoatrophy, elevated serum phosphorous, alkaline phosphatase, and IGF-1; rare: pancreatitis; also children: slipped capital femoral epiphysis (monitor). Long-term overdose may cause gigantism and/or acromegaly.

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

HUMATROPE 1 cartridge of 12mg kits (Qty:1)

appx. price $1400.00