Serostim® [somatropin (rDNA origin) for injection] is a growth hormone proven to increase lean body mass and weight and improve physical endurance. Serostim® is the only medicine approved by the FDA for HIV-associated wasting that builds lean body mass (anabolic) and also prevents lean body mass from breaking down (anticatabolic). You must be on antiretroviral therapy while you are taking Serostim for the treatment of HIV-associated wasting.1

 

  • Physical endurance
  • Lean body mass
  • Weight

Serostim® Clinical Trial Results

To test how well Serostim® works, it was studied in 757 people with HIV-associated wasting. This clinical trial took place across multiple sites in 8 countries. Participants in the study received Serostim® every day, every other day, or a placebo (an inactive substance) for 12 weeks. A subset of patients continued on treatment to 24 or 48 weeks. Serostim® improved physical endurance and increased lean body mass and weight.

Serostim® improved physical endurance in people with HIV-associated wasting2

physical-endurance

In this study, people taking Serostim® significantly improved their physical endurance as assessed by a stationary bike exercise after 12 weeks of treatment. On average, those patients who received Serostim® daily had a 9.1% increase in physical endurance, and those who received the drug every other day increased physical endurance by 8.9%. Participants that were given a placebo had an average 0.2% decrease in their physical endurance.

Serostim® increased lean body mass and weight in people with HIV-associated wasting1,2

lean-body-mass-data-2

In the same study, those who were treated daily with Serostim® experienced a median increase of 6.5 pounds in total weight and 11.5 pounds in lean body mass after 12 weeks. Those treated with Serostim® every other day experienced a median increase of 4.9 pounds in total weight and 7.3 pounds in lean body mass.

The placebo-treated group experienced a median increase of 1.6 pounds in total weight and 1.4 pounds in lean body mass. The average increase in weight and lean body mass were significantly greater in both Serostim treatment groups compared to the placebo group after 12 weeks of treatment. Increases in lean body mass and weight were maintained through 24 weeks in study patients who completed an additional 12 weeks of active treatment.

Patient Reported Outcomes

Patients with HIV-associated wasting treated with Serostim® completed a questionnaire called the BACRI*. Their perception of the impact of Serostim® therapy on their wasting symptoms was reported. Those treated with Serostim® reported improvements in their symptoms. After taking Serostim®, patients’ perceptions included: 2

  • Having a better appetite
  • More enjoyment in eating
  • Positive changes in appearance
  • Improvements in how they felt
  • That increases in weight significantly improved their health

*The Bristol-Myers Anorexia/Cachexia Recovery Instrument

What are the most common side effects of Serostim reported in clinical trials in patients treated for HIV-associated wasting or cachexia?

  • Swelling, especially in the hands or feet
  • Bone, muscle, and joint pain or stiffness
  • Tingling and numbness
  • Unusual skin sensations
  • Breast enlargement in men
  • Nausea
  • Extreme tiredness

Other less common but serious side effects of Serostim are:

  • An increased amount of HIV virus, so it is important to continue taking antiretroviral therapy during treatment with Serostim
  • High blood sugar (hyperglycemia/diabetes) which can include symptoms of increased thirst and urination, tiredness, or trouble concentrating
  • Headaches, changes in vision, nausea or vomiting, which requires immediate medical attention
  • Numbness and tingling in the hand or arm caused by a pinched nerve in the wrist
  • Injection site reactions (such as pain, numbness, redness, and swelling)
  • Tumors or cancerous growths
  • Pain and tenderness in the abdomen, which could be a sign of a problem with the pancreas

These are not all of the possible side effects. Let your doctor know about your side effects.