Important Risk Information

Serostim^® [somatropin (rDNA origin) for injection] should not be used in patients with active malignancy, diabetic retinopathy, known hypersensitivity to somatropin or diluent, or hospitalized for acute critical illness.¹

Impaired glucose tolerance, new and exacerbation of diabetes mellitus and rare cases of pancreatitis have been reported. Glucose intolerance requiring initiation or adjustment of antidiabetic treatment has persisted following treatment discontinuation. Patients with risk factors for glucose intolerance should be monitored closely during Serostim^® therapy.¹

The most common adverse reactions associated with Serostim^® use were musculoskeletal discomfort (pain, swelling and/or stiffness) and increased tissue turgor (swelling, particularly in the hands and feet). Symptoms were dose-related and generally mild-to-moderate in severity, and often subsided with continued treatment, analgesic therapy, or dose reduction. If persistent tissue turgor occurs, treatment discontinuation is recommended.¹

Alternate-day treatment is associated with fewer side effects and resulted in a similar improvement in work output and should be considered in patients at increased risk of adverse events.²

Hyperglycemia may occur in HIV-infected individuals for a variety of reasons and has also been reported in Serostim^® clinical trials. Patients with a history of hyperglycemia or other risk factors for glucose intolerance should be monitored closely during Serostim^® use. Glucose complications include exacerbation of pre-existing diabetes mellitus, new-onset impaired glucose tolerance, and type 2 diabetes mellitus.¹

1. Serostim^® [somatropin (rDNA origin) for injection] Prescribing Information. Rockland, MA: EMD Serono; 2007.
2. Moyle GJ, Daar ES, Gertner JM, et al. Growth hormone improves lean body mass, physical performance, and quality of life in subjects with HIV-associated weight loss or wasting on highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2004;35:367-375.

Indication

Serostim^® [somatropin (rDNA origin) for injection] is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.

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