Serostim® [somatropin (rDNA origin) for injection] has been helping patients treat HIV-associated wasting for over a decade.
Serostim® 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.
Serostim® is the only rhGH approved to treat HIV-associated wasting. Its effects are both anabolic and anticatabolic. The anabolic effects promote tissue growth. Its effect on the metabolism increases protein synthesis which, in turn, promotes growth of LBM and results in the production of new LBM.1,2
The anticatabolic properties lead to decreased fat production and increased fat metabolism. When fat is metabolized, protein or muscle is spared, a process known as protein-sparing lipid oxidation. Results from studies have demonstrated improvement in muscle protein synthesis, reduced protein oxidation, and an increase in IGF-1 levels.1
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Increasing Weight and Lean Body Mass
Only Serostim® is indicated to increase LBM in patients with HIV-associated wasting.1
- Patients on Serostim® experienced clinically and statistically significant increases in LBM 4 times (alternate day) and 6 times (daily dose) that of placebo (P<0.0001) at 12 weeks
- Increases were maintained or improved through 24 weeks
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Improving Physical Endurance
Patients taking Serostim® experienced significant increases in physical endurance.1,2*
- Patients on Serostim® experienced clinically and statistically significant improvements in physical endurance (P<0.0001) at 12 weeks1
- Improvements were maintained or improved through 24 weeks
*Mean cycle work output (kJ).
The types and incidences of adverse events reported in the extension phase were not different from, or greater in frequency than, those observed during the initial 12-week placebo-controlled phase.1
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Improving Patient Perceptions
Patients treated with Serostim® reported improvements in their perceptions of their HIV-associated wasting symptoms.1*
Hyperglycemia may occur in HIV-infected individuals for a variety of reasons and has also been reported in Serostim® clinical trials.
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Important Considerations When Prescribing Serostim®
- Serostim® is contraindicated in patients with active neoplasia and in those with hypersensitivity to growth hormone1
- Serostim® should not be used in patients in intensive care units due to complications following open-heart surgery or abdominal surgery, multiple accidental trauma, or acute respiratory failure1
- The most common adverse reactions associated with Serostim® use were musculoskeletal (arthragia and myalgia) discomfort and increased tissue turgor (swelling or edema, particularly of the hands or feet)1
- Symptoms were dose-related and generally mild-to-moderate in severity, and often subsided with continued treatment or dose reduction1
- 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 for adverse events2
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 and new-onset impaired glucose tolerance and new-onset type 2 diabetes.1
Post-marketing cases of new-onset impaired glucose intolerance, new-onset type 2 diabetes mellitus, and exacerbation of pre-existing diabetes mellitus have been reported, some of which were serious and persisted following treatment discontinuation.1
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Tracking Patient Outcomes
How do you decide when to move your patients to Serostim® when they are on other therapies? Monitoring your patients' progress can help you determine treatment goals.
Methods for assessing whether patients reach treatment goals
- Measuring weight: How often are you weighing patients?
- Calculating BMI: How frequently do you calculate your patient's BMI?
- Visual examination of physical appearance for evidence of HIV-associated wasting: Are you assessing loose skin or hanging skin folds consistent with weight loss?
- Evaluating endurance: Are you talking to your patients about their level of physical endurance?
- Patient-reported outcomes: Are you talking to your patients about their perception of their HIV-associated wasting symptoms, including changes in appearance, improvements in how they feel, and a sense that changes in their weight are impacting their health?
If your goal for your patients with HIV-associated wasting is to increase weight and lean body mass and improve physical endurance it may be time to assess your patient's progress on their current therapy with
the weight tracker.
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Access the full prescribing information.
References:
- Serostim® [somatropin (rDNA origin) for injection] Prescribing Information. Rockland, MA: EMD Serono, Inc.; 2007.
- 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.
- Data on file, EMD Serono, Inc.