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Treatment Results

In clinical trials, Serostim® increased lean body mass and body weight, and improved physical endurance

2 clinical trials tested the effects of Serostim® on lean body mass (LBM), body weight, and physical endurance. All study participants also received antiretroviral therapy during the course of the trials.

 

Clinical Trial 1

Study design

In Clinical Trial 1, Serostim® was studied in 178 participants living with HIV and diagnosed with HIV‑associated wasting. Participants received placebo for 12 weeks or Serostim® daily. Some participants continued on treatment for another 12 weeks, for a total of 24 weeks.

Results

Participants diagnosed with HIV‑associated wasting and treated with Serostim® daily for 12 weeks experienced:

Results at 12 weeks were evaluated in 70 participants treated with Serostim® and 71 participants who received placebo.

During the additional 12 weeks of the study, participants on Serostim® had no significant changes and maintained the increases in LBM and total body weight.

At 12 weeks of treatment, participants taking Serostim® significantly improved their physical endurance as measured by treadmill exercise.

Clinical Trial 2

Study design

In Clinical Trial 2, Serostim® was studied in 757 participants diagnosed with HIV‑associated wasting. Participants received placebo for 12 weeks, Serostim® every other day or Serostim® daily. Some participants continued on treatment to 24 weeks.

Results

After 12 weeks of treatment:

The average increases in LBM and total body weight were significantly greater in both Serostim® treatment groups compared with the placebo group after 12 weeks of treatment.

A total of 646 participants completed the 12-week study and continued on Serostim® treatment for an additional 12 weeks. 548 of these participants completed the additional 12 weeks of treatment. These participants maintained their increases in LBM and total body weight.

Participants taking Serostim® significantly improved their physical endurance as measured by a stationary bike exercise after 12 weeks of treatment. On average:

A total of 646 participants completed the 12-week study and continued on Serostim® treatment for an additional 12 weeks. 548 of these participants completed an additional 12 weeks of active treatment. Participants continuing on Serostim® treatment maintained or improved their physical endurance throughout the study extension period.

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® reported in clinical trials:

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

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 healthcare provider know about any side effects you experience. 

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

Important Safety Information and Indication

Expand

You should not take Serostim® (somatropin) if you have:

  • A critical illness from surgery, serious injuries, or a severe breathing problem
  • Cancer or undergoing treatment for cancer
  • Eye problems caused by diabetes
  • Allergies to growth hormone or other ingredients in Serostim® vials

What is the most important information I need to know about Serostim®?

  • For patients with critical illness caused by certain types of heart or stomach surgery, serious injury or a sudden and severe breathing problem, there was an increase in death in those treated with Serostim® compared to those patients not treated with Serostim® (42% vs 19%).
  • You must be on antiretroviral therapy.
  • Cancer: Certain types are more common in people living with HIV.
  • If you have, or are at high risk for, type 2 diabetes or have higher than normal blood sugar, talk to your doctor.
  • Tell your doctor if you have changes in vision, headache, nausea, and/or vomiting which may be signs of increased brain pressure.
  • Seek prompt medical attention if you have an allergic reaction while taking Serostim®.
  • You may have swelling, especially in the hands and feet, as well as discomfort in bones, joints, and muscles. This may lessen with analgesics or talk to your doctor about reducing Serostim® dosing frequency.
  • Carpal Tunnel Syndrome may occur, talk to your doctor about reducing the number of Serostim® doses in a week. If not resolved, treatment should be stopped.
  • If you have severe abdominal pain (possibly pancreatitis), call your doctor.

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 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. Talk to your doctor or pharmacist about the following before taking Serostim®

  • If you are taking any other medicines (prescription or over the counter), vitamins, or supplements as these may affect each other. Your doctor may need to adjust the dose of Serostim® or other medicines you are taking.
  • Serostim® should be used during pregnancy only if clearly needed.
  • Caution should be used in nursing mothers as it is unknown if Serostim® is passed in human milk.
  • Safety and effectiveness in pediatric HIV patients have not been established.
  • Unknown if HIV patients ≥ 65 years of age have a different response to Serostim® than those <65 years of age.

How should you administer Serostim®?

Patients and caregivers should be trained by a healthcare professional on how to mix and inject Serostim® prior to use. Never share Serostim® with another person, even if the needle is changed. Injection sites can include arms, legs, abdomen and should be changed daily to avoid injecting Serostim® in areas that are sore or bruised.

What is Serostim® (somatropin) for injection?

Serostim® is an injectable prescription medicine used for the treatment of HIV‑positive patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Treatment with antiretroviral therapy at the same time is necessary.

You are encouraged to report possible side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You can also contact EMD Serono at 1-800-283-8088 ext. 5563

Please see the full Prescribing Information for complete information on Serostim® risks.

Important Safety Information and Indication

What is Serostim® (somatropin) for injection?

Serostim® is an injectable prescription medicine used for the treatment of HIV-positive patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Treatment with antiretroviral therapy at the same time is necessary.

You should not take Serostim® if you have:

  • A critical illness from surgery, serious injuries, or a severe breathing problem
  • Cancer or undergoing treatment for cancer
  • Eye problems caused by diabetes
  • Allergies to growth hormone or other ingredients in Serostim® vials

What should I tell my doctor before using Serostim®?

  • If you have a critical illness from surgery, serious injury, or a severe breathing problem
  • If you have cancer or had cancer in the past.
  • If you have diabetes, are at risk for getting diabetes, or have blood sugar levels that are higher than normal. New cases of type 2 diabetes have been reported in patients taking Serostim®.
  • If you are allergic to growth hormone, benzyl alcohol, sucrose, phosphoric acid or sodium hydroxide.
  • If you are taking any other medicines (both prescription or over the counter), vitamins, or supplements because these medicines may affect each other. Your doctor may need to monitor for drug-drug interactions.
  • If you are nursing, pregnant, or plan to become pregnant. It is not known if Serostim® passes into your breast milk or could harm your unborn baby.

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 or around the eyes
  • Bone, muscle, and joint pain or stiffness
  • Tingling, numbness and pain in the fingers, thumb or wrist
  • 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
  • Serious allergic reactions that require immediate medical attention
  • Pain and tenderness in the abdomen
  • Headaches, changes in vision, nausea or vomiting, which requires immediate medical attention

These are not all of 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.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should you administer Serostim®?

Patients and caregivers should be trained by a healthcare professional on how to mix and inject Serostim® prior to use. Never share Serostim® with another person, even if the needle is changed. Injection sites can include arms, legs, abdomen and should be changed daily.

Avoid injecting Serostim® in areas that are sore or bruised.

What is Serostim® (somatropin) for injection?

Serostim® is an injectable prescription medicine used for the treatment of HIV‑positive patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Treatment with antiretroviral therapy at the same time is necessary.

 

Please see the full Prescribing Information and talk to your healthcare provider for complete information on Serostim® risks.

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