What is Serostim® [somatropin (rDNA origin) for injection]?

Serostim® is human growth hormone and is the only FDA-approved medicine clinically proven to significantly increase lean body mass and body weight, and improve physical endurance. You must be on anti-retroviral therapy to be prescribed Serostim®.

IMPORTANT RISK INFORMATION

Before beginning treatment, patients should discuss with their clinician potential benefits and risks associated with Serostim®.

You should NOT take Serostim® if:

  • You are hospitalized with complications due to heart or abdominal surgery
  • You are hospitalized for serious injuries
  • You are hospitalized for respiratory failure
  • You currently have cancer. Any cancer treatment should be completed before starting Serostim®
  • You are allergic to Growth Hormone products or any materials associated with the product

You should tell your clinician if:

  • You are pregnant or breastfeeding
  • You are currently taking any medications for HIV
  • You have a history of diabetes

The most common adverse reactions associated with Serostim® are:

  • Muscle aches
  • Joint pain
  • Swelling (particularly of the hands or feet)

These side effects were generally mild-to-moderate in severity, and were often managed by lowering the dose.

High blood glucose (sugar levels) may occur in HIV-infected individuals for many reasons and has also been reported in Serostim® clinical studies. If you have a history of high blood glucose or have other risk factors for glucose intolerance, you should be monitored closely while on Serostim®. New onset type 2 diabetes or worsening of current diabetes has been reported with Serostim®. Patients have experienced complications of diabetes, some of which were serious and continued after stopping treatment with Serostim®.

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

This information is not intended to replace discussions with your clinician. For additional information about Serostim® please consult the Prescribing Information and ask your clinician if Serostim® is right for you. You can also call the AXIS Center toll-free at 1-877-714-AXIS (2947). Serostim® is available by prescription only.

Please click here to see Serostim® Prescribing Information: English and Spanish.

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