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Safety Profile 
Serostim® [somatropin (rDNA origin) for injection] is the only growth hormone approved by the U.S. Food and Drug Administration for the treatment of AIDS wasting or cachexia. This indication is based on the analysis of changes in body weight and lean body mass in studies of up to 12 weeks in duration. The continued use of Serostim® treatment should be reevaluated in patients who continue to lose weight in the first two weeks of treatment.
Click here for Serostim® Full Prescribing Information.

Serostim®, when taken as prescribed, is generally well tolerated. In clinical studies, 1.5% of patients stopped using Serostim® due to drug-related side effects. The most common adverse reactions to Serostim® are increased tissue turgor (generally swelling of hands and feet) and musculoskeletal discomfort (pain, swelling or stiffness). Generally mild to moderate in severity, these symptoms usually resolve spontaneously with continued treatment or are effectively managed with analgesic therapy. When unresponsive to symptomatic therapy, these side effects may also be managed by reducing the total daily dose of Serostim® or the number of doses given per week. Elevations in mean blood glucose levels can also occur. Patients with other risk factors for glucose intolerance should be monitored closely.

Serostim® must be given with concomitant antiviral therapy. There is no evidence of HIV replication with Serostim® therapy in the presence of any of the currently available nucleoside analogues in vitro. In the controlled clinical trials, no significant growth hormone-associated increase in viral burden was observed. However, growth hormone has been shown to increase HIV replication in some experimental systems.

Serostim® therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of AIDS. Inadequate nutritional intake, malabsorption and hypogonadism, which are common in individuals with AIDS and which may contribute to catabolism and weight loss, should also be monitored and treated. Patients should contact their physician should they experience any side effects or discomfort during treatment with Serostim®. Serostim®, like other growth hormones, should generally not be used in patients with acute critical illness in intensive care units since safety has not been established in this situation.
Rebuilding and retaining lean body mass is possible with Serostim® treatment. Muscle, organ tissue and body fluids are components of lean body mass. However, the impact of treatment-induced improvements in body weight and lean body mass on survival has not been established in placebo-controlled trials. next >>