Frequently Asked Questions

When managing any condition, it’s important to get answers to your questions. Below is a list of common questions that can help you learn more about HIV-associated wasting and Serostim®.

What is HIV-associated wasting?

HIV-associated wasting can be a serious problem. Individuals with HIV-associated wasting lose weight without trying. HIV-associated wasting also depletes the body of lean body mass, including muscle. This may cause individuals with HIV-associated wasting may have less physical endurance.1-3

What are the causes of HIV-associated wasting?

There are different theories on what may cause HIV-associated wasting, but experts have not figured out what exactly causes this condition. Potential causes include inadequate caloric intake and metabolic problems.1-3

Who can develop HIV-associated wasting?

HIV-associated wasting may impact any person living with HIV, even people with well-controlled HIV infection and those taking antiretroviral drugs can develop HIV-associated wasting.2,3

How common is HIV-associated wasting?

One research study from 2005 looking back at data from medical claims estimated that 7% to 8% of HIV/AIDS patients had a diagnosis of or treatment for cachexia or HIV-associated wasting. The report estimated that there was a higher prevalence in patients over the age of 45.4,5

What are the symptoms of HIV-associated wasting?

Possible symptoms can include1-3:

  • Involuntary weight loss
  • Negative changes to health and how you feel due to weight loss
  • Changes in appearance due to weight loss
  • Decreased physical endurance

What is Serostim®?

Serostim® is a human growth hormone and is the only FDA-approved medicine clinically proven to significantly increase weight, lean body mass, and improve physical endurance. You must be on antiretroviral therapy to be prescribed Serostim®.1

Why would my doctor recommend Serostim® treatment?

Your doctor may recommend Serostim® because you are losing weight, lean body mass and possibly physical endurance in patients with HIV-associated wasting. This condition is sometimes referred to as HIV-associated wasting, and Serostim® can help increase weight and lean body mass and improve physical endurance.1

Are there any precautions with the use of Serostim®?

Serostim® can cause fluid to collect in the skin and joints, which can build up pressure in these tissues. These adverse events often resolve with continued treatment, pain medication or after lowering the dose of the drug.1

Patients with a history of elevated blood sugar, such as diabetes, or other risk factors for glucose intolerance should be monitored closely during Serostim® therapy. There have been cases of diabetes occurring in patients receiving Serostim®.1

Growth hormone products have the potential to increase HIV virus load or increase the spread of cancer. As a precaution, patients taking Serostim® should use antiretroviral therapy. Patients should inform their doctor of a history of cancer before starting Serostim® treatment.1

What is growth hormone?

Growth hormone is naturally secreted by an area of the brain called the pituitary gland. Growth hormone impacts how the body uses building blocks for energy.6

How does Serostim® work?

Serostim® helps your body build and maintain weight and lean body mass. It allows your metabolism to function appropriately, using fat for energy instead of lean body mass.1

Studies have shown that patients with HIV-associated wasting who were given Serostim® for 12 weeks increased their weight and lean body mass and improved physical endurance. Increases in weight, lean body mass and improvements in physical endurance were maintained or improved through 24 weeks of treatment.1

How can Serostim® help me?

Serostim® has been shown to increase weight, increase LBM and improve physical endurance. Patients treated with Serostim® reported improvements in their perceptions of their HIV-associated wasting symptoms. These perceptions were reported after 12 weeks at both doses of Serostim® and included1:

  • Better appetite and more enjoyment in eating
  • Favorable changes in appearance
  • Improvements in how they felt
  • Changes in weight that impacted health

Should I continue to take my usual HIV drugs during Serostim® treatment?

Please be sure to ask your doctor or healthcare provider any questions you may have about your HIV medications. Serostim® only helps control HIV-associated wasting. Your other medications help control HIV.1

What are the risks associated with Serostim®?

Serostim® should not be used in patients with active cancer or in patients hospitalized in intensive care.

  • Patients with a history of diabetes or related glucose intolerance problems should be monitored closely during Serostim® treatment
  • Common side effects with Serostim® include muscle aches, joint pain, and 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.7 Contact your physician should you experience any side effects or discomfort during treatment with Serostim®

Could I have an allergic reaction?

Yes, it is possible to have an allergic reaction. Make sure to tell your doctor if you experience a skin rash, swelling, or difficulty breathing.1

Is there anything else my doctor needs to know?

Make sure your doctor knows about any of the following1:

  • A diagnosis of any form of cancer
  • You become pregnant or start breastfeeding
  • Continued weight loss
  • Any infection—caused by a virus, bacteria, or fungus
  • Any tingling feeling in your hands or wrists
  • Dizziness
  • History of diabetes
  • Increased thirst
  • Increased urination
  • Swelling in your face, head, hands, or feet
  • Headaches
  • Vision problems
  • Nausea or vomiting

How do I get Serostim®?

Serostim® is a prescription medication. Once your doctor or healthcare provider has determined that you are experiencing HIV-associated wasting, he or she may write you a prescription.

How do I take Serostim®?

Serostim® is injected under the skin each day, usually at bedtime. Treatment can be administered by using either the Serostim® needle injection or a needle-free delivery device called cool.click 2®. These types of injections are simpler and less penetrating than injections that are given directly into the muscle or a vein.1

Will my insurance cover Serostim®?

Serostim® is covered by most insurance plans. EMD Serono offers support services that can provide access information and financial assistance.1

References:

  1. Serostim® [somatropin (rDNA origin) for injection] Prescribing Information, EMD Serono, Inc., 2007.
  2. Roubenoff R, Grinspoon S, Skolnik PR, et al. Role of cytokines and testosterone in regulating lean body mass and resting energy expenditure in HIV-infected men. Am J Physiol Endocrinol Metab. 2002;283:E138-E145.
  3. Gelato M, McNurlan M, Freedland E. Role of recombinant human growth hormone in HIV-associated wasting and cachexia: pathophysiology and rationale for treatment. Clin Ther. 2007;29:2269-2288.
  4. Boulanger L, Miller JD, MacEachern S, et al. Prevalence of cachexia (wasting syndrome) diagnosis and treatment among patients with HIV/AIDS: a medical claims database analysis. Poster presented at the 12th International Society for Pharmacoeconomics and Outcomes Research; May 19-23, 2007; Arlington, VA.
  5. Siddiqui J, Phillips AL, Freedland ES, et al. Prevalence and cost of HIV-associated weight loss in a managed care population. Curr Med Res Opin. 2009;25:1307-1317.
  6. Dudgeon WD, Phillips KD, Carson JA, et al. Counteracting muscle wasting in HIV-infected individuals. HIV Med. 2006;7:299-310.
  7. Moyle GJ, Daar ES, Gertner JM, et al. Growth hormone improves lean body mass, physical performance, and quality of life in subjects with HIV-associated weight loss or wasting on highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2004;35:367-375.
Important Risk Information and IndicationToggle Button

Important Risk Information and Indication

Before beginning treatment, patients should discuss with their clinician potential benefits and risks associated with Serostim® [somatropin (rDNA origin) for injection].

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.1

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®.

What is Serostim®?

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®.

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 doctor. For additional information about Serositm® please consult the Prescribing Information and ask your doctor 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 see Serostim® Prescribing Information available in English and Spanish

Reference:

  1. Moyle GJ, Daar ES, Gertner JM, et al. Growth hormone improves lean body mass, physical performance, and quality of life in subjects with HIV-associated weight loss or wasting on highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2004;35:367-375.

Indication

Serostim® is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.