EMD Serono understands there is a high level of uncertainty related to the novel coronavirus (COVID-19) and is taking the situation seriously. We remain committed to those living with HIV wasting. For more information about our response to COVID-19, please visit EMDSerono.com. In addition to public health guidance issued by local medical or patient associations, more information about COVID-19 can be found on the Centers for Disease Control’s (CDC) website. For individual health concerns, please contact your healthcare provider.

TAKING SEROSTIM®

What can you gain with Serostim®?

For over 20 years, Serostim® has been prescribed to help patients with HIV-associated wasting. You must be on antiretroviral therapy while taking Serostim®.

TAKING SEROSTIM®

What can you gain with Serostim®?

For over 20 years, Serostim® has been prescribed to help patients with HIV-associated wasting. You must be on antiretroviral therapy while taking Serostim®.

Serostim® is the only medication approved by the FDA to increase lean body mass (LBM) and body weight, and improve energy in people living with HIV. You must be on antiretroviral therapy while taking Serostim®.

In clinical trials, Serostim® increased lean body mass and body weight, and improved energy.
The clinical efficacy of Serostim® for injection in HIV-associated wasting was assessed in two placebo-controlled trials. All study subjects also received antiretrovial therapy during the course of the trials.
Each study tested the effects of Serostim® on LBM, body weight, and physical endurance.

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In one trial, Serostim® was studied in 757 people diagnosed 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.

In this 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. Results based on a subset who completed the 12 week study and took at least 80% of their medicine (PI contains entire study population results).

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.

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

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.

A total of 646 patients completed the 12 week study and continued in the Serostim® treatment extension phase of the trial.

Patients with HIV-associated wasting treated with Serostim® completed a questionnaire called the Bristol-Myers Anorexia/Cachexia Recovery Instrument (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:

  • Having a better appetite
  • More enjoyment in eating
  • Positive change in appearance
  • Improvements in how they felt
  • Increases in weight that significantly improved their health

Common side effects of Serostim® were reported in clinical trials in patients treated for HIV-associated wasting

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

Other less common but serious side effects of Serostim® are:

  • 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 require immediate medical attention
  • Serious allergic reactions that require immediate medical attention
  • Pain and tenderness in the abdomen

These are not all the possible side effects. Let your doctor know about any side effects you experience. Your doctor may prescribe a pain reliever or may decrease your dose of Serostim® to help manage some side effects.

Learn more about what to expect with treatment with Serostim®.

Serostim® is a treatment you can take at home

Serostim® is self-injected, so you can inject it in the convenience of your home. It is injected under the skin (subcutaneously) through a short, thin needle.

  • Inject Serostim® every day or every other day, usually at bedtime, as prescribed by your doctor
  • Injection training is available should you need help learning how to give yourself injections
  • Depending on your weight, your doctor will prescribe one of 3 dosage strengths:
    • 4 mg
    • 5 mg
    • 6 mg

Need help injecting Serostim®?

You may feel nervous about giving yourself an injection. We have specialists who are ready to help you 24/7

  • The AXIS Center® offers injection training through a national network of registered nurses
  • Support is available 24/7 to assist you with treatment education and support
  • Call the AXIS Center® at 1-877-714-AXIS (2947)

Download the Serostim® Step By Step Injection Guide to get full instructions on how to inject Serostim®.

English (PDF) | Español (PDF)

Watch the Serostim® Step By Step Injection video