Poz Focus Standing Tall

Understanding lipodystrophy and HIV

1 POZ FOCUS LIPOATROPHY (ABBOTT) www.poz.com

Supplement to POZ magazine

CREDIT TK HERE

Standing Tall

Lillibeth Gonzalez

LOWER YOUR VIRAL LOAD. AND MAKE UNDETECTABLE * A POSSIBILITY AGAIN. * Undetectable viral load is defined as fewer than 50 copies of HIV per mL of blood.

Ask your doctor about TROGARZO® – A breakthrough HIV-1 treatment designed specifically for those with treatment failures

TROGARZO.com

IMPORTANT SAFETY INFORMATION TROGARZO® can cause serious side effects, including changes in your immune system (Immune Reconstitution Inflammatory Syndrome), which can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. This may result in an inflammatory response which may require further evaluation and treatment.

Tell your healthcare provider right away if you start having new symptoms after receiving TROGARZO®.

The most common side effects of TROGARZO® include diarrhea, dizziness, nausea and rash. These are not all the possible side effects of TROGARZO®.

Before you receive TROGARZO®, tell your healthcare provider: About all your medical conditions.

About all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

If you are pregnant or plan to become pregnant. It is not known if TROGARZO® may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with TROGARZO®.

If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are receiving TROGARZO® as it is not known if TROGARZO® passes into breast milk. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

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.

TROGARZO® is a registered trademark of TaiMed Biologics Inc., under license to Theratechnologies Inc. © 2019 Theratechnologies Inc. All rights reserved.

719-01-01/20

WHAT IS TROGARZO®?

TROGARZO® (ibalizumab-uiyk) is a prescription medicine that is used in combination with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who: • have received several anti-HIV-1 regimens in the past, and • have HIV-1 virus that is resistant to many antiretroviral medicines, and • who are failing their current antiretroviral therapy.

It is not known if TROGARZO® is safe and effective in children.

PZA522227.pgs 04.24.2020 16:36

ESA

FROM THE EDITOR

Stand Back EDITOR-IN-CHIEF

ORIOL R. GUTIERREZ JR. MANAGING EDITOR

JENNIFER MORTON DEPUTY EDITOR

TRENT STRAUBE SCIENCE EDITOR

LIZ HIGHLEYMAN COPY CHIEF

JOE MEJÍA

ASSISTANT EDITOR

ALICIA GREEN ART DIRECTOR

MARK ROBINSON ART PRODUCTION MANAGER

MICHAEL HALLIDAY ADVISORY BOARD

A. CORNELIUS BAKER, GUILLERMO CHACÓN, KATHIE HIERS, TIM HORN, PAUL KAWATA, NAINA KHANNA, DANIEL TIETZ, MITCHELL WARREN FEEDBACK

POZ, 212 WEST 35TH STREET, 8TH FLOOR, NEW YORK, NY 10001, OR EMAIL NEWS@POZ.COM

SMART + STRONG PRESIDENT AND COO

IAN E. ANDERSON

EDITORIAL DIRECTOR

(COVER) JENSEN LARSON; (ILLUSTRATION) ISTOCK; (GUTIERREZ) JOAN LOBIS BROWN

ORIOL R. GUTIERREZ JR. EXECUTIVE EDITOR

BOB BARNETT

CHIEF TECHNOLOGY OFFICER

CHRISTIAN EVANS

VICE PRESIDENT, INTEGRATED SALES

DIANE ANDERSON

INTEGRATED ADVERTISING MANAGER

JONATHAN GASKELL

INTEGRATED ADVERTISING COORDINATOR

IVY PETERSON SALES OFFICE

212-938-2051, SALES@POZ.COM BULK SUBSCRIPTIONS

ORDER.POZ.COM, SUBSCRIPTION@POZ.COM

CDM PUBLISHING LLC CHIEF EXECUTIVE OFFICER

JEREMY GRAYZEL CONTROLLER

JOEL KAPLAN Published by Smart + Strong. Copyright © 2020 CDM Publishing LLC. All rights reserved. No part of this publication may be reproduced, stored in any retrieval system or transmitted, in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of the publisher. Smart + Strong® and POZ® are trademarks of CDM Publishing, LLC.

CONTENTS

I

’VE HAD THE GOOD FORTUNE of being physically healthy since I tested HIV positive in 1992. I can’t say the same of my mental state. Overcoming HIV stigma, even now, has been my greatest health challenge.

For many other long-term survivors, however, the virus has affected both their physical and mental health. In particular, some people living with HIV who survived by taking the early AIDS medications have paid a high price in the form of drug side effects and survivor’s guilt.

For most of us still here despite the virus, the reality is that we need to stay in long-term care.

One of the most difficult combinations of health challenges is when a visible ailment causes physical and mental distress.

The lesions of Kaposi sarcoma are arguably the best example, but perhaps just as compelling are the effects of lipodystrophy, an umbrella term that covers both fat loss and fat accumulation.

Thankfully, lipo is not as common as it used to be. Lipoatrophy (fat loss) is especially rare among those who did not take older AIDS drugs. That said, it is mostly a condition that doesn’t go away, so folks who deal with it do so on an ongoing basis.

Lipohypertrophy (fat accumulation), however, is more common. As a result, learning what makes it different from general weight gain is important.

Fat buildup can occur in two ways: subcutaneous and visceral. Subcutaneous fat builds up beneath the skin and is soft and squishy. Visceral fat builds up inside the abdomen and surrounds the internal organs. It pushes up against the abdominal wall, which results in a hard belly. HIVassociated lipohypertrophy is distinguished by visceral fat and a hard belly.

This special issue of POZ Focus is dedicated to understanding lipodystrophy.

Go to page 2 to learn about lipo basics and find answers to these questions: What is lipo? What causes it? And how can folks manage the condition?

We also spotlight a personal perspective.

Lillibeth Gonzalez, our cover subject, lives with lipo. She is doing well, but living with HIV for 28 years has taken its toll. Go to page 5 to read more about her journey.

HIV-related lipodystrophy can lead to loss of self-esteem and social withdrawal.

Lipo can be a constant reminder of living with HIV. It can reveal to others that you have the virus, which can deprive you of control over disclosing your status. Go to page 4 to read more on the stigma of lipo.

This print issue was adapted from the online version of the “Standing Tall” POZ Focus about living with lipodystrophy. Go to poz.com for the full version and to watch the related lipo episode of POZ at Home, a series of Zoom events that brings the HIV community together.

ORIOL R. GUTIERREZ JR. EDITOR-IN-CHIEF editor-in-chief@poz.com

Want to read more from Oriol? Follow him on Twitter @oriolgutierrez and at blogs.poz.com/oriol.

1 FROM THE EDITOR

2 FEATURE

5 PROFILE

Living with lipodystrophy

What is lipo? • What causes it?

• Can lipo be managed? • SIDEBAR: The stigma of lipo

Living with lipo won’t get Lillibeth Gonzalez down.

STANDING TALL POZ FOCUS 1

Understanding Lipodystrophy Abnormal body fat distribution includes visceral fat and a hard belly.

P

eople living with HIV—nearly half are now 50 or older—are prone to a variety of health conditions as they age. Research has shown that HIV-positive people may experience problems such as cardiovascular disease and non-AIDS-related cancers as much as a decade earlier than their HIV-negative peers.

One of these problems is lipodystrophy, or abnormal body fat distribution. Although not limited to older people, the chances of developing lipo increase with age. These days, lipodystrophy is most often seen among long-term survivors who took older antiretroviral drugs with more side effects.

Lipodystrophy is often accompanied by metabolic complications, such as diabetes, high cholesterol and hypertension, which raise the risk of cardiovascular disease and other health problems. What’s more, it can lead to emotional distress, reduced adherence to HIV treatment and poorer quality of life. (See “The Stigma of Lipo,” page 3, for more.)

What Is Lipo?

Lipodystrophy is an umbrella term that covers both fat loss (known as lipoatrophy), especially in the face, limbs and buttocks, and fat accumulation (known as lipohypertrophy), especially in the belly and breasts. Lipodystrophy was once thought of as body fat redistribution, but it is now understood that these conditions are independent—rather than reflecting a shift of fat from one area to another—and have different causes.

“While an individual may experience both, they are almost certainly separate processes,” says Marshall Glesby, MD,

2 POZ FOCUS STANDING TALL

PhD, a professor of medicine and health care policy and research at Weill Cornell Medical College in New York City.

A gaunt face with sunken cheeks was once a common sign of AIDS, attributable both to overall wasting and the side effects of certain early medications. Although these drugs are no longer widely used and are not recommended in the United States, the facial fat loss they caused may never be fully reversed.

The advent of protease inhibitors and modern combination antiretroviral therapy in the mid-1990s finally enabled people to maintain control of their HIV. But soon after the new drugs arrived, many people who took them started seeing unexpected new health problems, including unusual body shape changes.

People with HIV may experience weight loss as their immune function declines, followed by weight gain as they return to health after starting treatment. But HIV-related fat accumulation goes beyond that. (See “Standing Up,” page 5, for more.)

Some people with HIV experience a buildup of fat around the midsection that may have little connection with how much they eat or exercise. Both women and men may experience breast growth (known as gynecomastia when it occurs in men), or they may develop a fat pad on the upper back known as a “buffalo hump.” A combination of fat loss and gain can give the appearance of a potato on toothpicks.

“Lipoatrophy is generally something that we see in people who were treated with older drugs like stavudine [Zerit, or d4T] and zidovudine [Retrovir, or AZT]. It is rarely seen in people who have never been on these older drugs but is also not a problem that typically goes away,” Glesby explains.

ALISON SEIFFER

By Liz Highleyman

“Lipohypertrophy, in contrast, is something that still occurs and in many cases may be similar to the abdominal obesity and metabolic syndrome that is relatively common in the general population.”

In recent years, there’s been a growing recognition that weight gain—often as much as several pounds—is common among people starting treatment with modern meds. Black women living with HIV appear to be particularly susceptible.

Although this can occur after starting any type of antiretroviral drug, integrase inhibitors and the newer form of tenofovir (tenofovir alafenamide, a component of Descovy and other combination pills) are frequently implicated.

But general weight gain and normal obesity are not the same as lipohypertrophy.

Fat buildup can occur in two different patterns, one of which is linked to more health risks than the other. Subcutaneous fat builds up beneath the skin, often around the abdomen, hips, buttocks and thighs. It is soft and squishy, hence the nickname “love handles.” People with mostly subcutaneous fat often have a pear-shaped body.

Visceral fat builds up inside the abdomen and surrounds the internal organs. This extra fat pushes up against the muscles of the abdominal wall, resulting in a taut, hard belly. People with mostly visceral fat typically have an apple-shaped body and a larger waistline in relation to the size of their hips. This type of fat can be harder to reduce with diet and exercise.

While obesity and lipo both lead to large abdomens, people with normal obesity usually have pinchable fat under the skin and rolls of soft fat on their belly. HIV-associated lipohypertrophy, in contrast, is distinguished by the kind of fat that causes a hard belly.

In some cases, fat buildup can be severe enough to cause pain, limit movement or interfere with sleep. A protruding hard belly is especially worrisome because of its link to other health problems, including heart disease. And along with its physical effects, lipo can also lead to a poor body image and loss of self-esteem.

ISTOCK

What Causes Lipo?

Four decades into the HIV/AIDS epidemic, experts still do not fully understand the causes of lipodystrophy or the best ways to manage it.

Older individuals are more likely to develop lipo. Women more commonly have fat buildup in the belly or breasts. People who have lived with HIV or used antiretrovirals longer, those who have a high viral load before starting treatment and those with low CD4 counts—especially if they ever had advanced immune suppression with very low CD4s—are also at greater risk.

Fat buildup was initially blamed on early protease inhibitors— it was once dubbed “Crix belly” after Crixivan (indinavir), one of the first drugs in this class—which can cause metabolic abnormalities that contribute to fat gain. But it soon became clear that this was not the whole story.

“We do not fully understand the causes of lipohypertrophy,” Glesby says. “Unlike lipoatrophy, there are not clear associations with use of specific antiretroviral drugs or classes of drugs.

There are multiple hypotheses about the causes.”

HIV infection itself can lead to body fat changes. The virus can trigger chronic inflammation, raising the risk of health conditions including heart, liver and kidney disease. Inflammatory cytokines, or chemical messengers produced by immune cells,

The Stigma of Lipo Lipodystrophy can lead to social withdrawal and loss of self-esteem.

HIV-related lipodystrophy may have psychological as well as physical consequences, leading to feelings of stigma, social withdrawal and loss of self-esteem.

(See “Understanding Lipodystrophy,” page 2, for more about treatment.)

“Feelings of shame, anxiety, depression and disgust are not uncommon,” says Aaron Blashill, PhD, an associate professor in the Department of Psychology at San Diego State University. “Regarding lipohypertrophy [fat accumulation], it may not be stigma related to HIV per se but rather broader weight-based stigma, which is unfortunately common in our society.”

Lipo can be a constant reminder of living with HIV, and it can reveal to others that you have the virus, depriving you of control over when and to whom you disclose your status.

“It really affects you,” says Lillibeth Gonzalez. “I didn’t want to be seen because I felt like people were going to know I have lipodystrophy and HIV. They’re going to know I have a condition because of my stomach.” (See “Standing Up,” page 5, for more about Gonzalez.)

The gaunt appearance and sunken cheeks of lipoatrophy, or fat loss, in particular, can be a telltale sign that someone is a long-term HIV survivor.

Mark S. King, 59, the creator of the blog My Fabulous Disease and once an actor in television commercials, underwent treatment with the injectable facial fillers Radiesse and Sculptra to regain lost volume in his face, eventually opting for the longer-lasting Bellafill.

“In some ways, I feel like I just wasn’t up to it,” he says of living with the visible evidence of his long battle with HIV. “I’d rather have it fixed. It’s too painful of a reminder. I’m too self-conscious.”

For some people with lipodystrophy, counseling may help them come to terms with how their body looks.

“We’ve developed a type of psychotherapy called cognitive behavioral therapy for body image and selfcare for individuals living with HIV who report body image concerns,” Blashill says. “This type of therapy was found to be effective in improving body image, lowering depression and increasing antiretroviral treatment adherence.”

“This program encourages folks to confront situations they may avoid in their lives due to body image concerns—for example, not looking in the mirror or not going to the beach or the gym,” he adds. “We also encourage folks to practice mindfulness skills—staying in the moment and not judging one’s experience.

Reminding ourselves of what our bodies can do as opposed to what they look like can often be helpful.”

That’s a message Gonzalez takes to heart.

“I feel more comfortable with myself. I’m able to buy clothing that makes me feel more comfortable—loose clothing but in style, because I don’t want to lose my style,” she says. “I love myself either way, I really do. I celebrate every day that I’m alive, and I’ve tried to just be happy with who I am.”

—LH

STANDING TALL POZ FOCUS 3

can alter metabolism in ways that promote fat buildup.

Fat doesn’t just take up space in the body. Rather, it is active tissue that produces cytokines and hormones of its own.

Hormones made by fat tissue include estrogen, adiponectin (which regulates glucose and fat metabolism) and leptin (which controls appetite). Some of the cytokines released by fat cells can cause further inflammation, which, in a vicious cycle, can lead to more fat buildup.

HIV-related lipo often goes hand in hand with other metabolic abnormalities, such as insulin resistance, diabetes, high cholesterol and hypertension, collectively known as metabolic syndrome. It has been linked to health problems ranging from cardiovascular disease to dementia as well as to a higher risk of death. Visceral fat can sometimes accumulate inside the liver and other organs. Over time, fatty liver disease can lead to cirrhosis and liver cancer.

HIV can also affect hormones. For example, it has been linked to lower production of growth hormone by the pituitary gland in the brain or reduced responsiveness to it. This hormone helps build muscle and break down fat, and low levels can lead to excess belly fat.

Some experts think the seesaw effect of immune system damage caused by HIV, followed by immune reconstitution after starting treatment, also contributes to lipo—which helps explain why it occurs more often in those who have had low CD4 counts. Alterations in the gut microbiome related to HIV or antiretroviral drugs may also play a role, according to Glesby.

In addition, genetic traits, lifestyle factors such as diet and exercise, and being overweight or having normal obesity can affect the likelihood of developing lipodystrophy. But for reasons that remain unclear, many people with HIV who appear to be at risk never develop lipo.

Managing Lipo Suppressing HIV viral load, getting CD4 counts back into normal territory and adopting a healthy lifestyle are great for overall health, but they may not fully reverse body fat changes due to lipo.

People starting antiretrovirals for the first time or switching regimens should have their body weight and fat distribution monitored regularly, as it’s easier to address lipo early rather than trying to reverse belly fat buildup later.

The first step in managing lipodystrophy is a comprehensive checkup and discussion with your doctor. This can help determine which specific factors are contributing to your body fat changes and distinguish lipo from other conditions, including normal obesity. Your clinician will want to know about your HIV treatment history, diet, exercise, sleep, smoking, alcohol consumption and recreational drug use.

Your doctor will likely feel your belly to see whether it’s hard or soft and measure your waist and hips to calculate your waist-to-hip ratio. Having a bigger waistline relative to the size of the hips can be a sign of lipo. CT, MRI or DEXA imaging scans may help show how fat is distributed in the body.

Your clinician may run blood tests for metabolic or hormonal abnormalities. These include tests for blood sugar (glucose), lipids such as cholesterol and triglycerides, and certain hormones.

A sluggish thyroid can cause weight gain. Cushing syndrome, caused by high levels of the stress hormone cortisol, can lead to body fat changes that look like lipo. These conditions can be

4 POZ FOCUS STANDING TALL

treated with medications.

Your provider will likely suggest lifestyle changes, such as improving your diet, getting more exercise, getting enough sleep and quitting smoking. A combination of regular cardiovascular exercise and strength training to build muscles is key.

Experts recommend at least 30 minutes of moderate-intensity activity at least five times a week. Stick with a diet and exercise program for at least six months to give it time to work.

“Dietary modifications and exercise are important as general health measures to reduce cardiovascular risk, and they may specifically have an impact on lipohypertrophy, though there is a shortage of good data on this,” Glesby says. “Those with access to a registered dietitian could benefit from devising a tailored, balanced diet to reduce calories.”

However, lifestyle changes alone are often not enough to alleviate lipodystrophy. If that’s the case, adding medical treatments might help.

The medications Egrifta (tesamorelin) and Serostim (somatropin) may be helpful, especially if lipo is related to low growth hormone levels.

The Food and Drug Administration (FDA) approved Egrifta in 2010 to reduce excess belly fat in HIV-positive people with lipodystrophy. It’s self-administered as an injection under the skin of the belly, usually once daily. The newer formulation approved last year, Egrifta SV, is easier to prepare, does not require refrigeration and can be administered with a smaller needle.

Egrifta is a growth hormone–releasing factor analogue, meaning it mimics a natural hormone produced in the brain that triggers the release of growth hormone. Clinical studies showed that it reduced visceral hard belly fat by up to 18%, on average; some people have a better response than others. However, lost belly fat usually returns within a few months after stopping treatment. Recent research has shown that Egrifta can also reduce liver fat in HIV-positive people with non-alcoholic fatty liver disease, but it is not approved for this purpose.

The older drug Serostim is a synthetic version of growth hormone approved by the FDA in 1996 to treat HIV-related wasting. Studies suggest it may also reduce visceral abdominal fat. Like Egrifta, it is administered as a daily injection.

Other medications may be used to manage the metabolic problems that often accompany lipodystrophy and reduce the risk of cardiovascular disease and other health problems. For example, Glucophage (metformin) may be prescribed to control blood sugar, and statins may be used to lower cholesterol levels.

Some studies have found that Glucophage may help reduce visceral belly fat as well.

Surgical approaches such as liposuction, which uses a suction technique to remove fat tissue, may be an option for reducing excess breast fat or a buffalo hump. But it is not a safe way to remove visceral fat deep within the abdomen. Breast reduction surgery is another option for those whose breasts have swelled enough to cause pain or limit movement.

The cost of medications and surgery can be a barrier, as many insurers consider them to be cosmetic. The manufacturers of Egrifta and Serostim offer patient assistance programs to help cover medication costs and insurance co-pays.

Managing lipodystrophy can be challenging, and you and your doctor may have to try a variety of approaches—or a combination of them—before finding a solution. ■

Standing Up Living with lipo won’t get long-term survivor Lillibeth Gonzalez down.

JENSEN LARSON

Lillibeth Gonzalez

Lillibeth Gonzalez, 65, celebrated her 28th “HIVersary” in early June by dancing in her New York City apartment and chatting with her son and her friends via Zoom. Having survived addiction, domestic violence and the AIDS-related deaths of three siblings, she is doing well today, but living with HIV for 28 years has taken its toll.

“There are days I wake up feeling well, and there are days I wake up feeling like I’m 90 years old,” she says. “The good part is that from zero [CD4] T cells, I was able to come up to 1,030, due to the medications. I’m healthy enough to work and exercise. When I feel good, I do as much as I can.”

As a long-term survivor, Gonzalez took older antiretroviral drugs with more side effects. One of them is abnormal body fat distribution, known as lipodystrophy. In particular, she has fat accumulation, known as lipohypertrophy. She struggles with a hard belly due to lipo as well as persistent gastrointestinal problems, arthritis and brain fog.

“This has changed my life in a terrible way,” Gonzalez says. “I used to model, so I was always a size 4 in clothing. But I saw my stomach growing and growing. The clothes that I liked didn’t fit me. I didn’t know how to shop for a size 10, 12 or even a 14. I got up to a size 14, but only because of my stomach. It’s the only thing that’s huge. My legs, hands and arms are slim.” But she doesn’t let that get her down.

“I look at myself in the mirror, and I say, ‘Oh my God! I’m getting old!’ I feel like I look like the man in Despicable Me, with the big stomach and the skinny legs,” says Gonzalez, who has worked as a community health educator at GMHC for 14 years, after starting out there as a client.

“I’ve come to just laugh about everything because I do not want to stress out,” she continues. “I’m happy to be 65 and alive. Aging is just something you have to deal with as it comes. My body reminds me every day that I’m getting old, but my mind is keeping me young.”

In addition to lifestyle changes, Gonzalez treated her lipo with the drug Egrifta (see “Understanding Lipodystrophy,” page 5, for more on treatment). “My doctor recommended Egrifta injections, but Medicaid did not approve them. I had to wait till I was over 65, when Medicare kicked in,” Gonzalez says. “Medicaid hardly approves anything, and it’s so difficult to find a doctor who accepts Medicaid. That’s why people are falling out of care, and it gets me very angry. I wish I could do something about this health system.”

“I took the shots for about six months, and it helped,” Gonzalez says. “This is a treatment that you must continue taking for the rest of your life, and I don’t know if I want to continue injecting my stomach for the rest of my life. My stomach was getting a little sore. So I changed my diet. People are telling me that my stomach has gone down. I exercise. I might ask my doctor to prescribe Egrifta again.”

In a follow-up interview on an episode of POZ at Home, a series of Zoom events that brings the HIV community together, Gonzalez confirmed that she is going on Egrifta SV, the new formulation that is easier to take.

Today, Gonzalez draws on her own experiences to help other people with HIV deal with the challenges of aging. “Helping others is what helps me,” she says.

“I’m on the long-term survivors page on Facebook. We discuss everything. I talk about my lipodystrophy and how I’ve managed it,” Gonzalez says. “I advise them to make sure they have a great rapport with their health care team. Look for what is best for you. You are the client.”

“What I can tell long-term survivors is that if we’ve come this far, we can continue living a healthy, happy life,” she continues. “What I offer them is to maintain a healthy mind, body and soul. It’s so important that you have a healthy spirit because your spirit is what’s going to lead you.”

— Alicia Green

STANDING TALL POZ FOCUS 5

WHEN IT’S HARD BELLY (EXCESS VISCERAL ABDOMINAL FAT)

IT MAY BE TIME FOR EGRIFTA SV

TM

IF YOU ARE LIVING WITH HIV AND LIPODYSTROPHY ASK YOUR HEALTHCARE PROVIDER ABOUT EGRIFTA SV TM.

FIND A SPECIALIST AT EGRIFTASV.COM

Actual patient living with HIV.

IMPORTANT INFORMATION FOR PATIENTS ABOUT EGRIFTA SV (TESAMORELIN FOR INJECTION) TM

What is EGRIFTA SV (tesamorelin for injection)?

• EGRIFTA SV is an injectable prescription medicine used to reduce excess abdominal fat in adult patients living with HIV and lipodystrophy.

EGRIFTA SV is a growth hormone-releasing factor (GHRF) analog.

• EGRIFTA SV is not for weight loss management.

• The long-term safety of EGRIFTA SV on the heart and blood vessels (cardiovascular) is not known.

• It is not known whether taking EGRIFTA SV helps improve how well you take your antiretroviral medications.

• It is not known if EGRIFTA SV is safe and effective in children, do not use in children.

TM

TM

TM

TM

TM

TM

TM

Before using EGRIFTA SV , tell your healthcare provider if you: • Have or have had cancer.

• Have problems with blood sugar or diabetes.

• Have scheduled heart or stomach surgery.

• Have breathing problems.

• Are breastfeeding or plan to breastfeed.

• Are taking any other prescription and non-prescription medicines, vitamins, and herbal supplements.

TM

EGRIFTA SV may cause serious side effects including: • Increased risk of new cancer in HIV positive patients or your cancer coming back (reactivation). Stop using EGRIFTA SV if any cancer symptoms come back.

• Increased levels of your insulin-like growth factor-1 (IGF-1). Your healthcare provider will do blood tests to check your IGF-1 levels while you are taking EGRIFTA SV .

• Serious allergic reaction such as rash or hives anywhere over the body or on the skin, swelling of the face or throat, shortness of breath or trouble breathing, fast heartbeat, feeling of faintness or fainting, itching and reddening or flushing of the skin. If you have any of these symptoms, stop using EGRIFTA SV and get emergency medical help right away.

TM

TM

You should not take EGRIFTA SV if you: • Have a pituitary gland tumor, surgery, or other problems related to your pituitary gland, or have had radiation treatment to your head or head injury.

• Have active cancer.

• Are allergic to tesamorelin or any of the ingredients in EGRIFTA SV .

• Are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA SV and talk with your healthcare provider.

• Are less than 18 years of age.

TM

TM

TM

TM

TM

• Swelling or fluid retention. Call your healthcare provider if you have swelling, an increase in joint pain, or pain or numbness in your hands or wrist.

• Increase in blood sugar (glucose) or diabetes.

• Injection site reactions. Injection site reactions are a common side effect of EGRIFTA SV , but may sometimes be serious.

• Increased risk of death in people who have critical illness because of heart or stomach surgery, trauma of serious breathing (respiratory) problems has happened when taking certain growth hormones.

TM

The most common side effects of EGRIFTA SV include: • Pain in legs and arms • Muscle pain These are not all of the possible side effects of EGRIFTA SV . For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to THERA patient support® toll-free at 1-833-23THERA (1-833-238-4372).

This information is not intended to replace discussions with your doctor. For additional information about EGRIFTA SV , go to: www.egriftasv.com for the full Prescribing Information, Patient Information and Patient Instructions for Use, and talk to your doctor.

For more information about EGRIFTA SV contact THERA patient support® toll-free at 1-833-23THERA (1-833-238-4372).

TM

TM

TM

TM

EGRIFTA SV is a trademark of Theratechnologies Inc. THERA patient support is a registered trademark of Theratechnologies Inc. © 2020 Theratechnologies Inc. All rights reserved.

789-01-04/20 – 7,5x10

PZA522842.pgs 06.05.2020 15:03

ESA