keep moving forward with serostim · and lose weight without trying. it is more than just a loss of...

WHAT IS SEROSTIM®?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.

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®

Keep moving forward with Serostim®

A guide to gradual, unintentional weight loss in HIV

Please see Important Risk Information on pages 8–9 and enclosed Full Prescribing Information for Serostim®.

2 “What is going on?”As a person living with HIV, you have likely worked with your healthcare provider to manage your treatment. But, is there something that worries you beyond viral control? Do you have less physical endurance than you used to have? Perhaps you have noticed that you have recently lost weight without trying. Have your family and friends commented on how you look thinner?

Even though your medications and diet haven’t changed, you may be losing weight and feeling tired after certain activities when you didn’t used to feel that way in the past. If you’ve lost weight without trying or have less physical endurance, you might find yourself wondering “What is going on?” No one could blame you for being concerned. In fact, many other people living with HIV share this frustration of gradual, unintentional weight loss as well. If you are HIV-positive, on HIV meds, feeling loss of energy and are losing weight without trying, you may have a medical condition that impacts the HIV-positive population.

Your healthcare provider may refer to this as HIV-associated wasting, but your friends may refer to it as becoming too thin or having lost a lot of weight.

“So what is gradual, unintentional weight loss, and why does it happen?”People with HIV-associated wasting may have less physical endurance that they used to have and lose weight without trying. It is more than just a loss of weight; it is a loss of lean body mass, which is made up of muscles, organs, blood and water. This loss of lean body mass may impact the ability to complete tasks that need a certain level of physical endurance.

Like many medical conditions, experts are not sure what causes unintentional weight loss. There are several theories. One theory is that it is a condition of abnormal metabolism and that the way the body uses carbohydrates, fats and proteins to meet energy and tissue-building needs is altered. Unintentional weight loss can result from a change in the process your body uses to build up lean body mass or tissue (anabolic) and to break down lean body mass or tissue (catabolic). The change in metabolism can cause the body to draw less energy from lean body mass. As a result, people who are HIV-positive may have less physical endurance.

So instead of losing just fat, you could be losing weight and lean body mass that is critical to the function of the body. This can be a serious problem.

Other factors that have been identified as contributors to gradual, unintentional weight loss include:

• Dietary changes resulting from loss of appetite and difficulty swallowing

• Hormones and metabolic changes, including low testosterone, changes in metabolism, inflammation and growth hormone resistance

• Diarrhea

• Infections

• Substance abuse

• Other health problems, such as depression

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Key Terms

Anabolic process: Build up of lean body mass or tissue

Catabolic process: Breakdown of lean body mass or tissue

Physical endurance is the time that it takes from the start of a physical activity to completion of the activity because of exhaustion. Some people with gradual, unintentional weight loss find that they get tired more quickly than they used to when doing certain activities.

Lean body mass makes up a large proportion of body weight, including:

• Intracellular and extracellular water

• Blood and blood constituents

• Skeletal muscle

• Organ tissue

Metabolism is your body converting the food you eat into energy. With regular metabolism, the body also draws energy from stored fat and carbohydrates. When a person is HIV-positive, the body may draw energy from lean body mass. When you lose lean body mass, you lose muscle, organs, blood cells and water, which are all essential to energy production and physical endurance.

Inflammation is a natural body response to things like infection or cell injury that helps control tissue damage. If the body produces too much inflammation, it can change metabolism, break down muscle and can suppress appetite.

Individuals with HIV could have unintentional weight loss and decreased physical endurance, including: newly diagnosed patients on HIV meds, long term survivors with HIV, HIV-infected people who are undetectable and have normal CD4 counts, and people on HIV meds with acute infection.

“How do I know if I really have HIV-associated wasting?”

To determine whether you are experiencing symptoms of this condition, ask yourself: Do I have a loss of physical endurance, along with a loss of weight?

Are any activities difficult to perform?

Am I exercising less?

Do I need to rest more often?

Do I frequently feel tired after certain activities?

Do I have unintentional weight loss?

Do the changes in my weight negatively affect my health and how I feel?

Do my clothes fit more loosely than normal due to unintentional weight loss?

Have I lost weight without trying?

Have my family, friends or co-workers noticed any changes in the way I look or my body based on changes in my weight?

If you answered “yes” to some of these questions, you should talk to your healthcare provider; he or she can help determine what is happening to your body.

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MY WEIGHT AND ACTIVITIES TRACKER

If you feel you have been experiencing gradual, unintentional weight loss and a decrease in physical endurance, use this tracker to keep a weekly record of your weight, your level of physical activity and other important symptoms. This could be helpful information to supply to your healthcare provider at your next appointment.

NAME INITIAL WEIGHT INITIAL DATE

Keep a record of the changes you experience and share it with your healthcare provider at your next visit.

Date

Weight

Physical endurance

For example: Are any activities more difficult?

Physical activity

For example: Are you exercising less? Do you need to rest more frequently?

Appetite/meals

For example: Are you eating the same as you have before? Has your intake changed?

Use this space for any additional information or notes that you would like to share.

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“So, how do I keep moving forward?”HIV-associated wasting is treatable. If you think you are experiencing HIV-associated wasting, discuss your concerns with your healthcare provider and healthcare team (dietitian, nurse, social worker, case manager, etc.) at your next office visit. This may not come up during a visit, so it’s helpful to review this booklet and bring any notes or questions you have with you to your appointment. Clearly explain the symptoms you are experiencing and the concerns you have. If your healthcare provider thinks you have HIV-associated wasting, ask about different treatment options, including ones you have researched. Following are some questions you might want to ask your healthcare provider to get the conversation started:

“ Could I have HIV-associated wasting?”• I have lost weight recently without trying.

Could I have HIV-associated wasting?

• My family has noticed changes in my weight and in the way I look. Could I have HIV-associated wasting? How can I know for sure?

• I have less physical endurance than I used to have, could this be a sign of HIV-associated wasting?

• The changes in my weight negatively affect my health and how I feel.

“ What treatment options are available to me?”• My energy is still low. I’ve been exper-

iencing unintentional weight loss. I’ve tried changing my diet, but I haven’t seen results. Is there anything else I can try?

• Is there anything that can treat HIV-associated wasting? I would like to discuss this with you.

• You’ve prescribed other products to help me with my loss of weight, and I haven’t seen results. Is there another medication you can prescribe?

The goals of treatment for HIV-associated wasting may include:• Increasing physical endurance

• Increasing lean body mass

• Increasing body weight

“Is there really help available?”Serostim® [somatropin (rDNA origin) for injection] is a treatment that has been shown to be effective in treating HIV-associated wasting. Serostim® is the only FDA-approved treatment that has been proven to treat the three key elements of HIV-associated wasting:

• Improve physical endurance

• Increase lean body mass

• Increase weight

Serostim® is an injectable medication. It is injected every day or every other day for 12 to 24 weeks.

People being treated with Serostim® for HIV-associated wasting must also be taking antiretroviral therapy.

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 are undergoing treatment for cancer



Don’t be afraid to talk to your healthcare provider if you are experiencing unintentional weight loss. He or she can tell you if you have HIV-associated wasting and provide treatment options, as well as offer guidance on eating well and including physical activity in your routine.

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“How does Serostim® [somatropin (rDNA origin) for injection] work?”

Serostim® [somatropin (rDNA origin) for injection] is a human growth hormone. Growth hormone is naturally released by an area of the brain called the pituitary gland. Growth hormone impacts how the body uses building blocks for energy and can result in improved physical endurance, and an increase in lean body mass and weight.

Serostim® treats HIV-associated wasting in two different ways

Serostim® has anabolic and anticatabolic properties. The anabolic properties of the drug build up lean body mass, while the anticatabolic properties protect lean body mass from breaking down.

Serostim improves physical endurance and increases weight and LBM

The 12-week study also measured the work done by riders on a stationary bike (known as physical endurance). On average, those on Serostim® daily had a 9.1% increase in physical endurance, and those on every other day dosing increased physical endurance by 8.9%. Patients that were given placebo, or an inactive substance, had, on average, a decrease of 0.2% in their physical endurance.

After 12 weeks of therapy, those who were treated daily with Serostim® [somatropin (rDNA origin) for injection] experienced a median increase of 6.5 pounds in total weight and 11.5 pounds in lean body mass. Those treated with Serostim® every other day experienced a median increase of 4.9 pounds in total weight and 7.3 pounds in lean body mass.

The placebo-treated group experienced a median increase of 1.6 pounds in total weight and 1.4 pounds in lean body mass.

The average increase in weight and LBM were significantly greater in both, the Serostim® [somatropin (rDNA origin) for injection] treated groups than in the placebo group after 12 weeks of treatment.

Patients with HIV-associated wasting treated with Serostim® completed a questionnaire called the BACRI. Their perception of the impact of Serostim® therapy on their wasting symptoms was reported. Those treated with Serostim® reported improvements in their symptoms. After taking Serostim®, patients’ perceptions included:

• Having a better appetite

• More enjoyment in eating

• Positive changes in their appearance

• Improvements in how they felt

• That increases in weight significantly improved their health

The most common side effects of Serostim® include:

In clinical trials, the most common adverse reactions included swelling (particularly of the hands or feet), muscle pain, joint pain, numbness and pain in extremities

• Injection site reactions (pain, numbness, redness, swelling)

• 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

7“How is Serostim® [somatropin (rDNA origin) for injection] taken?”

Serostim® is injected under the skin, subcutaneously, through a short and thin needle. Serostim® can be self administered every day or every other day, usually at bedtime.

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 seizure

• Liver or kidney disease

• Over 65 years of age

• Have any other medical condition

“What if needles are not an option for me?”

Cool.click® 2 is a needle-free device for mixing and injecting Serostim® [somatropin (rDNA origin) for injection]. Your healthcare provider can prescribe a cool.click® 2 for you, and a trained professional, such as a nurse trainer, will teach you how to use this device.

“What if I need help injecting Serostim®?”

No matter which method you choose for administration of Serostim®, the AXIS Center offers in-home or in-office injection training provided through a national network of product administration trainers. Patient support is available 24/7 to assist patients with treatment education and support.

Important Risk Information for cool.click® 2

• Although infrequent, delivery-site reactions may occur.

• cool.click® 2 should not be used with patients who bruise or bleed easily or who are taking anticoagulants or any therapy that may contribute to excess

bruising or bleeding. Hemophiliacs should not use this device.

• cool.click® 2 is not recommended for patients who do not have adequate subcutaneous tissue or normal hematopoietic function.

• cool.click® 2 should not be used in patients for whom growth hormone is contraindicated.

• cool.click® 2 is available by prescription only. Please refer to cool.click® 2 instructions for use.

Not Comfortable Self-Injecting?If the thought of giving yourself an injection is scary, you are not alone. It’s natural to be uncomfortable about injecting yourself for the first time. The good news is that there are tools that can help you address your concerns about self-injection. It’s important to speak with your healthcare provider or nurse, or an administration trainer before beginning treatment. Trainers are available to you 24/7 for ongoing support.

8 IMPORTANT RISK 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.

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



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.

9

Please see the enclosed Full Prescribing Information for Serostim®.

• 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.

10 “What else do I need to know?”

Importance of Healthy Eating

As someone living with HIV, you probably already know that staying healthy can have an impact on managing your disease. In addition to keeping your medical appointments and staying on your antiretroviral regimen, other factors can have a beneficial effect on overall health, including nutrition and exercise.

Eating well is essential to maintaining strength, energy and a healthy immune system. HIV and many of its treatments can change the way the body processes nutrients and fat. This can affect metabolism and might cause HIV-associated wasting, so it’s important to pay attention to diet and eat properly on a daily basis.

Choosing a Healthy Diet

The general recommendations from U.S. government nutrition guidelines include:

• Choosing fruits, vegetables, whole grains and fat-free/low-fat milk and milk products

• Selecting lean meats, poultry, fish, beans, eggs and nuts in your diet

• Checking the nutrition facts label for foods that are:

• low in saturated fats, trans fats, cholesterol, salt and added sugars

• rich in potassium, fiber, vitamins A and C, calcium and iron

• Using the % Daily Value (DV) column when possible. Less than 5% DV is considered low; more than 29% DV is considered high.

Always talk to your healthcare provider about medications, any symptoms you may be experiencing, and before starting a new diet or exercise program.Combined with a proper diet and good lifestyle choices, daily exercise is important for staying healthy. Routine activities may improve the heart and circulation, strengthen muscles and bones, reduce body fat, and help maintain a healthy weight. Exercising routinely can also help prevent complications, including diabetes, obesity, hypertension, and high cholesterol.

People can benefit from some alternative forms of exercise as well, such as yoga and meditation. These activities not only provide physical exercise, but have been shown to have a positive effect on spiritual and mental well-being.

The Academy of Nutrition and Dietetics advises the following general guidelines for exercising:

• Learn proper exercise techniques

• As with any exercise program, always start slowly

• Stay hydrated. Drink plenty of water before, during, and after exercise

• Rest if you are tired or feel pain

In addition, it’s important to track your improvements over time. Make a habit of documenting your weight loss and changes in appetite or physical endurance, then share this information with your healthcare team. You can use the tracker found on page 4 to easily record your improvements.

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Getting Financial and Treatment Support

“Will I be able to afford Serostim® [somatropin (rDNA origin) for injection]?”

If your healthcare provider has prescribed Serostim® [somatropin (rDNA origin) for injection] for you, EMD Serono, the company that manufactures Serostim®, has created the AXIS Center to help you every step of the way—starting with help with prior authorization, navigating insurance coverage and training on how to inject Serostim® to giving you guidance on how to pay for it. Don’t let the fear of another expense keep you from talking to your healthcare provider about your unintentional weight loss.

Determining If Your Insurance Covers Serostim®

The AXIS Center:

Serostim® is covered by most insurance plans. In some states, Serostim® is covered by Medicaid and ADAP. The AXIS Center offers trained Reimbursement Specialists who can assist you with verifying your insurance benefits, determining coverage options and locating pharmacies in your area.

Patient Assistance Program

If you don’t have health insurance, the Serostim® Patient Assistance Program (PAP) helps people who have HIV-associated wasting get the Serostim® treatment they have been prescribed. Eligible patients who meet certain financial and medical criteria receive Serostim® free of charge.

Copay Assistance Program

The Copay Assistance Program can decrease or potentially eliminate out-of-pocket costs for eligible commercially or privately insured patients. Ask your healthcare provider for information about the Serostim® Copay Assistance Program.

• You must have a prescription drug benefit that covers Serostim® and a valid Serostim® prescription.

• You may not use card if you receive drug benefits from Medicaid, a Medicare drug benefit plan, or other federal or state programs (includes state Medicaid assistance program and/or pharmaceutical patient assistance programs).

EMD Serono Inc is a subsidiary of Merck KGaA,Darmstadt, Germany

©2015 EMD Serono, Inc. US-SER-0915-0002a All rights reserved.

It’s time to be more empowered! Be prepared for your next visit with your healthcare provider. Get more information about

Serostim® [somatropin (rDNA origin) for injection] at

www.Serostim.com

keep moving forward with serostim · and lose weight without trying. it is more than just a loss of...

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