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SEROSTIM
Pituitary disorders
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Drug Name:

SEROSTIM Rx

Generic Name and Formulations:
Somatropin (rDNA origin) 4mg, 5mg, 6mg; per vial; for SC inj after reconstitution.

Company:
EMD Serono, Inc.

Therapeutic Use:

Indications for SEROSTIM:

HIV patients with wasting or cachexia to increase lean body mass and weight, and improve physical endurance.

Adult:

Give by SC inj once daily at bedtime. Rotate inj sites. <35kg: 0.1mg/kg. 35–45kg: 4mg. 45–55kg: 5mg. >55kg: 6mg. Risk factors for adverse effects (eg, glucose intolerance): initially 0.1mg/kg every other day.

Children:

Not established; see full labeling.

Contraindications:

Acute critical illness due to surgical complications or multiple accidental trauma or those with acute respiratory failure. Active malignancy. Active proliferative or severe non-proliferative diabetic retinopathy.

Warnings/Precautions:

Increased mortality in those with acute critical illness (see Contraindications). Use only under guidance of a physician trained in HIV management. HIV patients should be maintained on antiretroviral therapy. Glucose intolerance. Diabetes. Perform baseline and periodic funduscopic evaluation for intracranial hypertension; discontinue if papilledema occurs; may restart at lower dose after resolution. Monitor for development, progression, or recurrence of neoplasms. Discontinue if carpal tunnel syndrome persists after dosage reduction. Turner syndrome. Elderly. Pregnancy (Cat.B). Nursing mothers.

Interactions:

May be antagonized by glucocorticoids. May affect CYP450 substrates (eg, corticosteroids, sex steroids, anticonvulsants, cyclosporine); monitor. Concomitant oral estrogens; may require larger somatropin doses. Concomitant insulin and/or hypoglycemics may require dose adjustment.

Pharmacological Class:

Growth hormone (GH).

Adverse Reactions:

Musculoskeletal discomfort, increased tissue turgor, edema, nausea, fatigue, gynecomastia, paresthesia, hypoesthesia, hyperglycemia, hypertriglyceridemia, carpal tunnel syndrome; intracranial hypertension, serious hypersensitivity reactions; rare: pancreatitis.

How Supplied:

Single-dose vials (5mg, 6mg)—7 (w. diluent); Multi-dose vials (4mg)—7 (w. diluent)

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