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Serostim Generic Name & Formulations
Legal Class
Rx
General Description
Somatropin (rDNA origin) 4mg, 5mg, 6mg; per vial; for SC inj after reconstitution.
Pharmacological Class
Growth hormone (GH).
How Supplied
Single-dose vials (5mg, 6mg)—7 (w. diluent); Multi-dose vials (4mg)—7 (w. diluent)
Manufacturer
Serostim Indications
Indications
HIV patients with wasting or cachexia to increase lean body mass and weight, and improve physical endurance.
Serostim Dosage and Administration
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.
Serostim Contraindications
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.
Serostim Boxed Warnings
Not Applicable
Serostim Warnings/Precautions
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.
Serostim Pharmacokinetics
See Literature
Serostim Interactions
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.
Serostim Adverse Reactions
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.
Serostim Clinical Trials
See Literature
Serostim Note
Not Applicable
Serostim Patient Counseling
See Literature
