ABOUT HIV-ASSOCIATED WASTING

When you have unintentional weight loss, the first step is understanding what is happening to your body.
If you are HIV positive, taking HIV meds, feeling a loss of energy, and are losing weight without trying, you may have a medical condition called HIV-associated wasting.1 Individuals with HIV who could have unintentional weight loss and decreased physical endurance include: newly diagnosed people on HIV meds, long-term survivors, those with undetectable viral loads and normal CD4 counts, and people on HIV meds with acute infection.2-5

The impact of HIV-associated wasting
Three key elements of HIV-associated wasting are1:

Decreased physical endurance
Physical endurance is the time it takes from when you start a physical activity to when you stop because of exhaustion. Some people living with HIV who have unintentional weight loss find that they get tired more quickly than they used to when performing certain activities.1

Weight loss
Have you noticed you’re losing weight without trying? This may be due to HIV-associated wasting. As your weight changes, your appearance may change as well. Friends, family, and coworkers may notice and express their concerns.

Loss of lean body mass
HIV-associated wasting involves more than just losing weight. It’s also a loss of lean body mass—or LBM. LBM includes your muscles, organs, blood, and water. In fact, 50% of lean body mass is made up of skeletal muscle, which makes up a large part of your overall body weight.1 Lean body mass is critical to the function of your body and when it’s decreased, it can affect your physical endurance or make you feel tired more quickly.

Possible contributors
Your healthcare provider is the only one who can diagnose HIV-associated wasting. Several factors have been identified as possible contributors. This is not intended to be a complete list and should not replace the advice of a healthcare professional.

  • Changes in metabolism5,6
  • Growth hormone resistance6,7
  • Low testosterone7-9
  • Inflammation7,10
  • Loss of appetite7,11
  • Difficulty swallowing7,11,12
  • Infections4,9,12,13
  • Diarrhea7,11
  • Depression14
  • Substance abuse12

All of these issues can contribute to loss of weight, loss of LBM, and a decrease in physical endurance. Only your healthcare provider can evaluate your symptoms and decide what may be causing them. If you have concerns about these conditions or unintentional weight loss, your healthcare provider can help.

Questions to ask yourself
HIV-associated wasting is treatable. However, you need to recognize the symptoms first. Start by asking yourself these questions:

Do you have a loss of physical endurance associated with unintentional weight loss?

  • Are any activities more difficult to perform?
  • Are you exercising less?
  • Do you need to rest more often?
  • Do you frequently feel tired after certain activities?

Have you had unintentional weight loss?

  • Have you recently lost weight without trying?
  • Do any changes in your weight negatively affect your health and how you feel?
  • Do your clothes fit more loosely than normal due to unintentional weight loss?
  • Have friends, family, or coworkers noticed any changes in the way that you look based on changes in your weight?

If you answered “yes” to any of these questions, and you’ve been losing weight without trying, you should talk to your healthcare provider. In addition, keeping track of your weight and reviewing changes with your healthcare provider will help determine if it’s HIV-associated wasting. Only he or she can determine if you have HIV-associated wasting and talk about treatment options, including Serostim.

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INDICATION AND IMPORTANT RISK INFORMATION

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.

IMPORTANT RISK INFORMATION

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 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 adjust the dose of Serostim or other medicines you are taking.
  • 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
  • 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 requires immediate medical attention
  • Serious allergic reactions that require immediate medical attention
  • Pain and tenderness in the abdomen

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.

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.

REFERENCES:

  1. Dudgeon WD, Phillips KD, Carson JA, et al. Counteracting muscle wasting in HIV-infected individuals. HIV Med. 2006;7:299-310.
  2. Mangili A, Muman DH, Zampini AM, et al. Nutrition and HIV infection: review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition in healthy living cohort. Clin Infect Dis. 2006;42:836-842.
  3. Wasserman P, Segal-Maurer S, Wehbeh W, et al. Wasting disease, chronic immune activation, and inflammation in the HIV-infected patient. Top Clin Nutr. 2011;26:14-28.
  4. Chang E, Sekhar R, Patel S, et al. Dysregulated energy expenditure in HIV-infected patients: a mechanistic review. Clin Infect Dis. 2007;44:1509-1517.
  5. 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.
  6. Gelato M, McNurlan M, Freedland E. Role of recombinant human growth hormone and HIV-associated wasting and cachexia: pathophysiology and rationale for treatment. Clin Ther. 2007;29:2269-2288.
  7. 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.
  8. Grinspoon S, Corcoran C, Lee K, et al. Loss of lean body and muscle mass correlates with androgen levels in hypogonadal men with acquired immunodeficiency syndrome and wasting. J Clin Endocrinol Metab. 1996;81:4051-4058.
  9. Grinspoon S, Mulligan K, for the Department of Health and Human Services Working Group on the Prevention and Treatment of Wasting and Weight Loss. Weight loss and wasting in patients infected with human immunodeficiency virus. Clin Infect Dis. 2003;36(Suppl 2):S69-S78.
  10. Deeks SG, Russell T, Douek DC. Systemic effects of inflammation on health during chronic HIV infection. Immunity. 2013;39:633-645.
  11. Mankal PK, Kotler DP. From wasting to obesity, changes in nutritional concerns in HIV/AIDS. Endocrinol Metab Clin N Am. 2014;43:647-633.
  12. Williams B, Waters D, Parker K. Evaluation and treatment of weight loss in adults with HIV disease. Am Fam Phys. 1999;60:843-854.
  13. Macallan DC, Noble C, Baldwin C. Energy expenditure and wasting in human immunodeficiency virus infection. N Engl J Med. 1995;333:83-88.
  14. Rabkin JG. HIV and depression: 2008 review and update. Curr HIV Rep. 2008;5:163-171.

Please see the Prescribing Information for complete Serostim Risk Information.

click to close

INDICATION AND IMPORTANT RISK INFORMATION

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.

IMPORTANT RISK INFORMATION

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 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 adjust the dose of Serostim or other medicines you are taking.
  • 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
  • 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 requires immediate medical attention
  • Serious allergic reactions that require immediate medical attention
  • Pain and tenderness in the abdomen

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.

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.

REFERENCES:

  1. Dudgeon WD, Phillips KD, Carson JA, et al. Counteracting muscle wasting in HIV-infected individuals. HIV Med. 2006;7:299-310.
  2. Mangili A, Muman DH, Zampini AM, et al. Nutrition and HIV infection: review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition in healthy living cohort. Clin Infect Dis. 2006;42:836-842.
  3. Wasserman P, Segal-Maurer S, Wehbeh W, et al. Wasting disease, chronic immune activation, and inflammation in the HIV-infected patient. Top Clin Nutr. 2011;26:14-28.
  4. Chang E, Sekhar R, Patel S, et al. Dysregulated energy expenditure in HIV-infected patients: a mechanistic review. Clin Infect Dis. 2007;44:1509-1517.
  5. 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.
  6. Gelato M, McNurlan M, Freedland E. Role of recombinant human growth hormone and HIV-associated wasting and cachexia: pathophysiology and rationale for treatment. Clin Ther. 2007;29:2269-2288.
  7. 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.
  8. Grinspoon S, Corcoran C, Lee K, et al. Loss of lean body and muscle mass correlates with androgen levels in hypogonadal men with acquired immunodeficiency syndrome and wasting. J Clin Endocrinol Metab. 1996;81:4051-4058.
  9. Grinspoon S, Mulligan K, for the Department of Health and Human Services Working Group on the Prevention and Treatment of Wasting and Weight Loss. Weight loss and wasting in patients infected with human immunodeficiency virus. Clin Infect Dis. 2003;36(Suppl 2):S69-S78.
  10. Deeks SG, Russell T, Douek DC. Systemic effects of inflammation on health during chronic HIV infection. Immunity. 2013;39:633-645.
  11. Mankal PK, Kotler DP. From wasting to obesity, changes in nutritional concerns in HIV/AIDS. Endocrinol Metab Clin N Am. 2014;43:647-633.
  12. Williams B, Waters D, Parker K. Evaluation and treatment of weight loss in adults with HIV disease. Am Fam Phys. 1999;60:843-854.
  13. Macallan DC, Noble C, Baldwin C. Energy expenditure and wasting in human immunodeficiency virus infection. N Engl J Med. 1995;333:83-88.
  14. Rabkin JG. HIV and depression: 2008 review and update. Curr HIV Rep. 2008;5:163-171.

Please see the Prescribing Information for complete Serostim Risk Information.

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