How Do You Know If It's HIV-associated Wasting

If you are HIV positive, on antiretroviral therapy, have involuntary weight loss, and answered YES to any of the questions above—talk to your doctor about HIV-associated wasting.

References:
  1. Serostim® [somatropin (rDNA origin) for injection] Prescribing Information. Rockland, MA: EMD Serono; 2014.
  2. Dudgeon WD, Phillips KD, Carson JA, et al. Counteracting muscle wasting in HIV-infected individuals. HIV Med. 2006;7:299-310.
Important Risk Information and Indication Toggle Button

YOU SHOULD NOT TAKE SEROSTIM® IF YOU HAVE:

  • A critical illness due to complications after open heart surgery, abdominal surgery, serious injuries or have severe breathing problems
  • Cancer or undergoing treatment for cancer
  • Certain types of eye diseases caused by diabetes
  • Allergies to growth hormone or benzyl alcohol, an ingredient in the liquid used to mix Serostim®

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE USING SEROSTIM®? Before using SEROSTIM®, tell your doctor if you have or are:

  • A critical illness due to complications after open heart surgery, abdominal surgery or serious injuries or have severe breathing problems
  • Cancer or history of cancer
  • Skin lesions
  • Diabetes, a family history of diabetes or have been told by your doctor that you are at risk for diabetes
  • Multiple hormone deficiencies
  • Pregnant or nursing
  • Taking any medications, especially cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizures
  • Liver or kidney disease
  • Over 65 years of age
  • Have any other medical condition

WHAT ARE THE POSSIBLE SIDE EFFECTS OF SEROSTIM®?
SEROSTIM® MAY CAUSE SERIOUS SIDE EFFECTS INCLUDING:

  • In some experiments, somatropin has been shown to increase HIV replication. It is recommended that you continue on your antiretroviral therapy during treatment with Serostim®.
  • Cases of new onset impaired glucose tolerance (pre-diabetes), new onset type 2 diabetes mellitus and worsening of current diabetes mellitus have been reported in patients receiving Serostim®. Some patients developed diabetic complications (ketoacidosis and diabetic coma).
  • A rise in the pressure inside the skull, associated visual changes, headache, nausea, and/or vomiting have been reported.
  • Water retention and Carpal Tunnel Syndrome may occur in adults during Serostim® therapy. Increased swelling, particularly in the hands and feet, muscle or joint pain may occur during treatment with Serostim®.
  • Routinely check for the development of any abnormal growths and for progression or recurrence of a tumor and for increased growth, or potential malignant changes of preexisting mole or spots if treatment with somatropin is started.
  • Injection sites should be changed (rotated) to avoid tissue atrophy. Local and systemic reactions are possible and you should seek prompt medical attention if an allergic reaction occurs.
  • Inflammation of the pancreas (pancreatitis) has been reported rarely in adults receiving growth hormone.

THE MOST COMMON SIDE EFFECTS OF SEROSTIM® INCLUDE:

  • In clinical trials the most common adverse reactions included swelling (particularly of the hands or feet), numbness, and pain in extremities
  • Injection site reactions (pain, numbness, redness, swelling). Change (rotate) your injection site to help lower your risk for injection site reactions.
  • Fluid retention
  • Bone, joint or muscle pain
  • Swelling of the extremities
  • Carpal Tunnel Syndrome
  • Breast enlargement
  • Nausea
  • Fatigue
  • Increase in blood glucose
  • Increase in triglycerides

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. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563.

This information is not intended to replace discussions with your doctor. For additional information about Serostim®, please consult the Prescribing Information and talk to your doctor. You can also visit www.serostim.com. Serostim® is available by prescription only.

Please see the Full Prescribing Information.

WHAT IS SEROSTIM® [somatropin (rDNA origin) for injection]?

Serostim® is an injectable prescription medicine used for the treatment of HIV 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.

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