TREATMENT WITH SEROSTIM

Only Serostim® is FDA-approved to increase lean body mass (LBM) and body weight as well as improve physical endurance1,2

Serostim® is an injectable growth hormone indicated in the treatment of patients with HIV-associated wasting or cachexia to increase lean body mass (LBM) and weight, as well as improve physical endurance.

TREATMENT WITH SEROSTIM

Only Serostim® is FDA-approved to increase lean body mass (LBM) and body weight as well as improve physical endurance1,2

Serostim® is an injectable growth hormone indicated in the treatment of patients with HIV-associated wasting or cachexia to increase lean body mass (LBM) and weight, as well as improve physical endurance.

Only Serostim® has anabolic and anticatabolic properties to promote new LBM growth and preserve existing LBM3

Anabolic
  • Increases protein synthesis
  • Promotes growth of LBM, much of which is protein
  • Leads to the production of new LBM
Anticatabolic
  • Decreases fat production and increases fat burning for energy
  • Fat is burned for energy rather than protein (protein-sparing lipid oxidation

In clinical trials, patients with HIV-associated wasting taking Serostim® showed statistically and clinically significant increases in lean body mass and body weight, as well as improvement in physical endurance1

The clinical efficacy of Serostim® for injection for HIV-associated wasting was assessed in two placebo-controlled trials. All study participants received concomitant antiretroviral therapy. The first study enrolled 178 patients with severe HIV wasting taking nucleoside analogue therapy (pre-HAART era). The second study enrolled 757 patients with HIV-associated wasting, 88% of which were also being treated with HAART.

Clinical Trial 1

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  • 12-week, randomized, double-blind, placebo-controlled study followed by an open-label extension phase
  • 178 patients with severe HIV wasting taking nucleoside analogue therapy (pre-HAART era)
  • Primary endpoint body weight
  • Body composition assessed using dual energy X-ray absorptiometry (DXA) and physical function assessed by treadmill exercise testing
  • Patients treated with
    • Serostim® 0.1 mg/kg daily
    • Placebo
  • 96% were male
  • The results from one hundred forty (140) evaluable patients were analyzed (those completing the 12-week course of treatment and who were at least 80% compliant with study drug).
  • Average difference in LBM change between the Serostim-treated group and the placebo-treated group was 3.1 kg (6.8 lbs)
  • Average increase in weight and LBM, and average decrease in body fat, were significantly greater in the Serostim-treated group than in the placebo group after 12 weeks of treatment
  • There were no significant changes with continued treatment beyond 12 weeks suggesting that the original gains of weight and LBM were maintained
  • Serostim® improved physical endurance
    • Serostim® once daily: median treadmill work output increased 13% after 12 weeks of treatment
    • Placebo: no improvement in endurance
Clinical Trial 2

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  • 12-week, randomized, double-blind, placebo-controlled study
  • 757 patients with HIV-associated wasting
  • Primary endpoint—physical function as measured by cycle ergometry work output
  • Body composition assessed using bioelectrical impedance spectroscopy (BIS) and dual energy X-ray absorptiometry (DXA)
  • Patients treated with
    • Serostim® 0.1 mg/kg daily
    • Serostim® 0.1 mg/kg every other day
    • Placebo
  • 646 patients completed the 12-week placebo-controlled phase and continued in a 12-week open-label extension phase
  • 548 of these patients completed an additional 12 weeks of treatment
  • 91% of these patients were male
  • LBM and total weight were assessed in people who completed the 12-week study and took at least 80% of their medication
  • Serostim® increased LBM and weight
    • Daily Serostim®: median increase of 6.5 pounds in total weight and 11.5 pounds in LBM
    • Serostim® every other day: median increase of 4.9 pounds in total weight and  7.3 pounds in LBM
    • Placebo: median increase of 1.6 pounds in total weight and 1.4 pounds in LBM
  • Average increase in total weight and LBM significantly greater in both Serostim® groups vs placebo group
  • Patients treated through 24 weeks maintained their increases in total weight and LBM

Flexed arm and scale to represent gains in weight and lean body mass made possible by Serostim

  • Serostim® improved physical endurance
    • Serostim® once daily: 9.1% average increase in endurance
    • Serostim® every other day: 8.9% average increase in endurance
    • Placebo: 0.2% average decrease in endurance
  • Improvements maintained or improved through 24 weeks of the extension phase

Patients’ perceptions of the impact of 12 weeks of treatment on their wasting symptoms as assessed by the Bristol-Meyers Anorexia/Cachexia Recovery Instrument improved with both doses of Serostim® in Clinical Trial 2.

Common side effects of Serostim® were reported in clinical trials with patients2

  • Arthralgia
  • Fatigue
  • Myalgia
  • Gynecomastia
  • Arthrosis
  • Paresthesia
  • Nausea
  • Hypoesthesia
  • Peripheral edema
  • Generalized Edema

These are not all the possible side effects of Serostim®. Counsel your patients to speak with you about any side effects they are experiencing. Please see the Serostim® Full Prescribing Information and Important Risk Information.

Important considerations when prescribing Serostim®2

  • Serostim® is contraindicated in patients with active malignancy, diabetic retinopathy, and in those with hypersensitivity to growth hormone
  • Serostim® should not be used in patients with acute critical illness due to complications following open-heart surgery or abdominal surgery, multiple accidental trauma, or acute respiratory failure
  • Symptoms were dose-related and generally mild to moderate in severity, and often subsided with continued treatment or dose reduction
  • 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 events
  • Postmarketing 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
  • Hyperglycemia has 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
For more information about prescribing Serostim® for your patients, download these helpful guides
Serostim® Dosing Card
Serostim® Step By Step Injection Guide
Statement of Medical Necessity (SMN)

Help your patients set goals and track outcomes of their treatment

As you know, setting treatment goals with your patients and monitoring their progress is a key part of their follow-up visits. Consider the following methods for monitoring and assessment of patients suspected of having HIV-associated wasting:

  • Measuring weight and reviewing weight history*
  • Calculating BMI
  • Evaluating physical endurance
  • Assessing patient-reported outcome
  • Visually examining physical appearance
  • DXA and Bio-electrical Impedance Spectroscopy (BIS)

*A weight history should include a premorbid or prediagnosis weight, as well as weight trends over time.

Show References

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  1. 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(4):367-375.
  2. Serostim® (somatropin) [prescribing information]. Rockland, MA: EMD Serono, Inc; 2018.
  3. Dudgeon WD, Phillips KD, Carson JA, Brewer JA, Durstine JL, Hand GA. Counteracting muscle wasting in HIV-infected individuals. HIV Med. 2006;7(5):299-310.