Hard Belly Egrifta Svtm

Home , Waist

Helping to reduce HARD BELLY How do I store EGRIFTA SV ™? Don’t delay. Talk to your healthcare (and maintain your results) provider today. • You will be given two boxes from the pharmacy when you get your prescription of EGRIFTA SV ™: EGRIFTA SV ™ (tesamorelin for injection) is an FDA approved Ask your healthcare provider about EGRIFTA SV ™. – Store the 2 mg EGRIFTA SV ™ vials in the Medication Box they come in, * To learn more, go to http://egriftasv.com. treatment used to reduce excess visceral abdominal fat in adult at room temperature between 68°F to 77°F (20°C to 25°C). patients living with HIV and lipodystrophy. EGRIFTA SV™ is a – Store the Sterile Water for Injection, syringes and needles that come in the Injection Box at room temperature between 68°F to 77°F (20°C to 25°C). prescription treatment that you inject daily subcutaneously Important Information for Patients about EGRIFTA SV™ (tesamorelin for injection) (under the skin) around your abdominal (belly) area. • Keep EGRIFTA SV ™ vials out of the light. What is EGRIFTA SV™ (tesamorelin for • Increased levels of your insulin-like growth • After mixing, use EGRIFTA SV ™ right away. Throw away any injection)? factor-1 (IGF-1). Your healthcare provider will Tesamorelin for injection was studied in two clinical trials in adult • EGRIFTA SV ™ is an injectable prescription do blood tests to check your IGF-1 levels unused EGRIFTA SV ™ after mixing. medicine used to reduce excess abdominal while you are taking EGRIFTA SV ™. patients living with HIV who developed HARD BELLY. • Do not store, freeze, or refrigerate EGRIFTA SV ™ after it has fat in adult patients living with HIV and • Serious allergic reaction such as rash or lipodystrophy. hives anywhere over the body or on the skin, • Each trial lasted 6 months, with an additional 6-month been mixed with the Sterile Water. EGRIFTA SV ™ is a growth hormone-releasing swelling of the face or throat, shortness of factor (GHRF) analog. breath or trouble breathing, fast heartbeat extension phase. • Throw away any Sterile Water for Injection left in the bottle • EGRIFTA SV ™ is not for weight loss feeling of faintness or fainting, itching and after use. management. reddening or flushing of the skin. If you have • Patients receiving tesamorelin for injection saw significant • The long-term safety of EGRIFTA SV ™ on the any of these symptoms, stop using reductions in HARD BELLY. • Do not use EGRIFTA SV ™ after the expiration date (EXP) heart and blood vessels (cardiovascular) is EGRIFTA SV™ and get emergency medical printed on the carton and vial labels. not known. help right away. EGRIFTA SV ™ is not indicated for weight loss management. • It is not known whether taking EGRIFTA SV ™ • Swelling or fluid retention. Call your helps improve how well you take your healthcare provider if you have swelling, an Keep EGRIFTA SV ™ and all medicines out of the reach antiretroviral medications. increase in joint pain, or pain or numbness WHEN IT’S of children. • It is not known if EGRIFTA SV ™ is safe and in your hands or wrist. effective in children, do not use in children. • Increase in blood sugar (glucose) or HARD BELLY General information about the safe and effective use You should not take EGRIFTA SV™ if you: diabetes. (EXCESS VISCERAL • Have a pituitary gland tumor, surgery, or • Injection site reactions. Injection site of EGRIFTA SV ™ other problems related to your pituitary reactions are a common side effect of ABDOMINAL FAT)� Average of Trial 1 Medicines are sometimes prescribed for purposes other than gland, or have had radiation treatment to EGRIFTA SV™, but may sometimes be serious. your head or head injury. • Increased risk of death in people who have those listed in a Patient Information leaflet. Do not use critical illness because of heart or stomach IT MAY BE TIME FOR • Have active cancer. TM • Are allergic to tesamorelin or any of the surgery, trauma or serious breathing 18% EGRIFTA SV ™ for a condition for which it was not prescribed. ingredients in EGRIFTA SV™. (respiratory) problems has happened when EGRIFTA SV Do not give EGRIFTA SV ™ to other people, even if they have • Are pregnant or become pregnant. If you taking certain growth hormone. Actual patient REDUCTION IN living with HIV. become pregnant, stop using EGRIFTA SV ™ The most common side effects of A different kind of fat HARD BELLY FAT the same symptoms you have. It may harm them. and talk with your healthcare provider. EGRIFTA SV ™ include: • Are less than 18 years of age. • Pain in legs and arms • Muscle pain may need a different Do not share your syringe or needles with other people, even Before using EGRIFTA SV™, tell your These are not all of the possible side effects of kind of treatment if the needle has been changed. You may give other people a healthcare provider if you: EGRIFTA SV ™. For more information, ask your Average of Trial 2 • Have or have had cancer. healthcare provider or pharmacist. Call your serious infection or get a serious infection from them. • Have problems with blood sugar or diabetes. doctor for medical advice about side effects. • Have scheduled heart or stomach surgery. You may report side effects to FDA at FIND A SPECIALIST IMPORTANT SAFETY INFORMATION • Have breathing problems. 1-800-FDA-1088 or to THERA patient support® AT EGRIFTASV.COM 14% • Are breastfeeding or plan to breastfeed. toll-free at 1-833-23THERA (1-833-238-4372). The most common side effects of EGRIFTA SV ™ include: • Pain in legs and arms • Muscle pain • Are taking any other prescription and This information is not intended to replace REDUCTION IN non-prescription medicines, vitamins, and discussions with your doctor. For additional HARD BELLY FAT These are not all of the possible side effects of EGRIFTA SV™. For more information, ask your herbal supplements. information about EGRIFTA SV ™, go to: IF YOU ARE LIVING WITH healthcare provider or pharmacist. Call your doctor for medical advice about side effects. EGRIFTA SV ™ may cause serious side effects http://egriftasv.com for the full Prescribing HIV AND LIPODYSTROPHY You may report side effects to FDA at 1-800-FDA-1088 or to THERA patient support® including: Information, Patient Information and Patient * This 2 mg/vial strength of tesamorelin has the same toll-free at 1-833-23THERA (1-833-238-4372). • Increased risk of new cancer in HIV positive Instructions for Use, and talk to your doctor. For ASK YOUR HEALTHCARE PROVIDER TM efficacy and safety of tesamorelin 1 mg/vial. The patients or your cancer coming back more information about EGRIFTA SV ™ contact ABOUT EGRIFTA SV . 2 mg/vial is more concentrated than the 1 mg/vial, This information is not intended to replace discussions with your doctor. For additional ® and the recommended daily dose is 1.4 mg. (reactivation). Stop using EGRIFTA SV™ if any THERA patient support toll-free at information about EGRIFTA SV™, go to: http://egriftasv.com for the full Prescribing cancer symptoms come back. 1-833-23THERA (1-833-238-4372). Information, Patient Information and Patient Instructions for Use, and talk to your Please see Important Safety Information throughout, and the enclosed full Actual patient living with HIV. doctor. For more information about EGRIFTA SV ™ contact THERA patient support® Prescribing Information, Patient Information, and Patient Instructions for Use. toll-free at 1-833-23THERA (1-833-238-4372). These documents are also available at http://egriftasv.com.

If you are living with HIV, one issue that may be challenging If you are living with HIV, one issue that may be challenging HARD BELLY may be hard for you to accurately describe and HARD BELLY may be hard for you to accurately describe and is lipodystrophy. Lipodystrophy refers to changes in body fat is lipodystrophy. Lipodystrophy refers to changes in body fat can be mistaken for general weight gain or obesity. Talk to can be mistaken for general weight gain or obesity. Talk to that include buildup or loss of fat in certain areas of the body. that include buildup or loss of fat in certain areas of the body. your healthcare provider about what you’re feeling and ask your healthcare provider about what you’re feeling and ask HARD BELLY (excess visceral abdominal fat) results when the HARD BELLY (excess visceral abdominal fat) results when the them to check for HARD BELLY. them to check for HARD BELLY. buildup of extra hard fat in the abdominal (belly) area pushes buildup of extra hard fat in the abdominal (belly) area pushes up against the abdominal wall and stretches the muscles until up against the abdominal wall and stretches the muscles until they become taut. they become taut. Your healthcare provider can check for HARD BELLY in Your healthcare provider can check for HARD BELLY in a few simple ways, including: a few simple ways, including: HARD BELLY fat is not like regular fat. Regular fat sits just HARD BELLY fat is not like regular fat. Regular fat sits just under the skin (subcutaneous fat) and is soft and squishy or under the skin (subcutaneous fat) and is soft and squishy or easy to pinch or move around. easy to pinch or move around.

HARD BELLY is found HARD BELLY is found deeper and: Liver deeper and: Liver Feeling your abdomen Measuring your Calculating your Feeling your abdomen Measuring your Calculating your Stomach Stomach (belly) for hardness waist and hips waist-to-hip ratio (belly) for hardness waist and hips waist-to-hip ratio • Is surrounding organs • Is surrounding organs and firmness circumference and firmness circumference • May be associated • May be associated with fat accumulation with fat accumulation in organs in organs Intestines Intestines How to measure: How to measure: • Feels harder and firmer • Feels harder and firmer Waist: Measure at the belly button. Make sure the tape is Waist: Measure at the belly button. Make sure the tape is than regular fat than regular fat horizontal to the floor and around the waist. horizontal to the floor and around the waist. • May be hard to reduce • May be hard to reduce Hips: Measure at the widest portion of the buttocks, making Hips: Measure at the widest portion of the buttocks, making with diet and exercise with diet and exercise sure the tape is horizontal. sure the tape is horizontal. alone Hard alone Hard Belly Fat Belly Fat Waist-to-hip ratio = waist circumference ÷ hip circumference Waist-to-hip ratio = waist circumference ÷ hip circumference

HARD BELLY may be associated with: HARD BELLY may be associated with: * * Indicators of HARD BELLY: Indicators of HARD BELLY: • Serious health issues* • Serious health issues* • A decrease in physical abilities • A decrease in physical abilities MEN WOMEN MEN WOMEN * EGRIFTA SV™ is not approved to reduce the health consequences of HARD BELLY. * EGRIFTA SV™ is not approved to reduce the health consequences of HARD BELLY. Waist circumference Waist circumference Waist circumference Waist circumference ≥37.4 in (95 cm) ≥37 in (94 cm) ≥37.4 in (95 cm) ≥37 in (94 cm) IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION Waist-to-hip ratio ≥0.94 Waist-to-hip ratio ≥0.88 Waist-to-hip ratio ≥0.94 Waist-to-hip ratio ≥0.88 What is EGRIFTA SV ™ (tesamorelin for injection)? What is EGRIFTA SV ™ (tesamorelin for injection)? • EGRIFTA SV ™ is an injectable prescription medicine used to reduce excess • EGRIFTA SV ™ is an injectable prescription medicine used to reduce excess * Based on inclusion criteria in clinical trials. * Based on inclusion criteria in clinical trials. abdominal fat in adult patients living with HIV and lipodystrophy. EGRIFTA SV ™ abdominal fat in adult patients living with HIV and lipodystrophy. EGRIFTA SV ™ is a growth hormone-releasing factor (GHRF) analog. is a growth hormone-releasing factor (GHRF) analog. • EGRIFTA SV ™ is not for weight loss management. • EGRIFTA SV ™ is not for weight loss management. Have you noticed your waist circumference has gotten larger Have you noticed your waist circumference has gotten larger • The long-term safety of EGRIFTA SV ™ on the heart and blood vessels (cardiovascular) • The long-term safety of EGRIFTA SV ™ on the heart and blood vessels (cardiovascular) and the shape of your abdomen has changed? If so, it could be and the shape of your abdomen has changed? If so, it could be is not known. is not known. HARD BELLY. If you have trouble managing HARD BELLY on your HARD BELLY. If you have trouble managing HARD BELLY on your • It is not known whether taking EGRIFTA SV ™ helps improve how well you take your • It is not known whether taking EGRIFTA SV ™ helps improve how well you take your antiretroviral medications. antiretroviral medications. own with exercise and a healthy diet, ask your healthcare own with exercise and a healthy diet, ask your healthcare • It is not known if EGRIFTA SV ™ is safe and effective in children, do not use in children. • It is not known if EGRIFTA SV ™ is safe and effective in children, do not use in children. provider about EGRIFTA SV TM. provider about EGRIFTA SV TM.

Please see Important Safety Information throughout, and the enclosed Please see Important Safety Information throughout, and the enclosed full Prescribing Information, Patient Information, and Instructions for Use. full Prescribing Information, Patient Information, and Instructions for Use. These documents are also available at http://egriftasv.com. These documents are also available at http://egriftasv.com. AccessHelping and to reduceassistance HARD throughout BELLY How do I store EGRIFTA SV ™? Don’t delay. Talk to your healthcare treatment(and maintain your results) provider today. • You will be given two boxes from the pharmacy when you get your prescription of EGRIFTA SV ™: ExpertEGRIFTA Patient SV ™ (tesamorelin Care Coordinators for injection) are standing is an FDA by toapproved help you: EGRIFTA SV ™ may help reduce HARD BELLY by changing Ask your healthcare provider about EGRIFTA SV ™. – Store the 2 mg EGRIFTA SV ™ vials in the Medication Box they come in, * To learn more, go to http://egriftasv.com. •treatment Enroll in the used EGRIFTA to reduce SV ™ excess visceral abdominal fat in adult howat room certain temperature hormones between (chemicals 68°F to that77°F (20°Cyour bodyto 25°C). produces patientsCo-Pay livingAssistance with HIVProgram and lipodystrophy. EGRIFTA SV™ is a naturally)– Store the are Sterile released. Water for To Injection, maintain syringes any andreduction needles thatin HARD come in prescription treatment that you inject daily subcutaneously BELLYthe, Injectionyour healthcare Box at room providertemperature may between recommend 68°F to 77°F that (20°C you to 25°C). • Identify the best insurance Important Information for Patients about EGRIFTA SV™ (tesamorelin for injection) (underand coverage the skin) optionsaround your abdominal (belly) area. •continually Keep EGRIFTA use EGRIFTASV ™ vials SV out ™. of the light. What is EGRIFTA SV™ (tesamorelin for • Increased levels of your insulin-like growth • After mixing, use EGRIFTA SV ™ right away. Throw away any injection)? factor-1 (IGF-1). Your healthcare provider will Tesamorelin• Follow up aboutfor injection your insurance was studied benefits in two clinical trials in adult • EGRIFTA SV ™ is an injectable prescription do blood tests to check your IGF-1 levels • Find specialty pharmacies in your unused EGRIFTA SV ™ after mixing. medicine used to reduce excess abdominal while you are taking EGRIFTA SV ™. patients living with HIV who developed HARD BELLY. • Do Tesamorelinnot store, freeze, for injection or refrigerate reduced EGRIFTA HARD SV BELLY ™ after it has fat in adult patients living with HIV and • Serious allergic reaction such as rash or insurance network, so you can quickly lipodystrophy. hives anywhere over the body or on the skin, • Each trial lasted 6 months, with an additional 6-month been mixed with the SterilePeople Water. who used tesamorelin EGRIFTA SV ™ is a growth hormone-releasing swelling of the face or throat, shortness of receive your medication factor (GHRF) analog. breath or trouble breathing, fast heartbeat extension phase. • Prepare for therapy • Throw away any Sterile Waterfor injectionfor Injection continually left in the for bottle • EGRIFTA SV™ is not for weight loss feeling of faintness or fainting, itching and after use. management. reddening or flushing of the skin. If you have • VerifyPatients eligibility receiving to tesamorelinenroll in the forEGRIFTA injection SV ™ saw Financial significant 1 year maintained their • The long-term safety of EGRIFTA SV ™ on the any of these symptoms, stop using Assistancereductions inProgram, HARD BELLY which. may help with the cost of therapy • Do not use EGRIFTA SV ™ afterresults the over expiration this time date period (EXP) heart and blood vessels (cardiovascular) is EGRIFTA SV™ and get emergency medical printed on the carton and vial labels. not known. help right away. EGRIFTA SV ™ is not indicated for weight loss management. • It is not known whether taking EGRIFTA SV ™ • Swelling or fluid retention. Call your helps improve how well you take your healthcare provider if you have swelling, an Keep EGRIFTA SV ™ and all medicines out of the reach antiretroviral medications. increase in joint pain, or pain or numbness WHEN IT’S of children. • It is not known if EGRIFTA SV ™ is safe and in your hands or wrist. Without tesamorelin for injection, effective in children, do not use in children. • Increase in blood sugar (glucose) or HARD BELLY GeneralHARD information BELLY came about back the safe and effective use You should not take EGRIFTA SV™ if you: diabetes. (EXCESS VISCERAL • Have a pituitary gland tumor, surgery, or • Injection site reactions. Injection site of EGRIFTA SV ™ HARD BELLY returned when other problems related to your pituitary reactions are a common side effect of ABDOMINAL FAT)� Average of Trial 1 ® Our THERA patient support Staff Nurses are ready to help: Medicines are sometimes prescribedtesamorelin for forpurposes injection other was than gland, or have had radiation treatment to EGRIFTA SV™, but may sometimes be serious. your head or head injury. • Increased risk of death in people who have those listed in a Patient Information leaflet. Do not use critical illness because of heart or stomach IT MAY BE TIME FOR • Train on proper injection and reconstitution stopped after 6 months of • Have active cancer. TM • Are allergic to tesamorelin or any of the surgery, trauma or serious breathing 18% EGRIFTA SV ™ for a condition for which it was not prescribed. techniques, either on the phone or at home therapy ingredients in EGRIFTA SV™. (respiratory) problems has happened when EGRIFTA SV Do not give EGRIFTA SV ™ to other people, even if they have • Are pregnant or become pregnant. If you taking certain growth hormone. Actual patient • Share adviceREDUCTION for starting IN and staying on living with HIV. become pregnant, stop using EGRIFTA SV ™ The most common side effects of A different kind of fat therapyHARD BELLY FAT the same symptoms you have. It may harm them. and talk with your healthcare provider. EGRIFTA SV ™ include: IMPORTANT SAFETY INFORMATION • Are less than 18 years of age. • Pain in legs and arms • Muscle pain may need a different • Answer common therapy-related Do not share your syringe or needles with other people, even You should not take EGRIFTA SV ™ if you: Before using EGRIFTA SV™, tell your These are not all of the possible side effects of kind of treatment questions throughout your treatment if the needle has been changed. You may give other people a healthcare provider if you: EGRIFTA SV ™. For more information, ask your • Have a pituitary gland tumor, surgery, or other problems related to your pituitary Average of Trial 2 • Have or have had cancer. healthcare provider or pharmacist. Call your seriousgland, or infectionhave had radiation or get treatment a serious to your infection head or head from injury. them. • Have problems with blood sugar or diabetes. doctor for medical advice about side effects. • Have active cancer. • Have scheduled heart or stomach surgery. You may report side effects to FDA at FIND A SPECIALIST •IMPORTANT Are allergic SAFETY to tesamorelin INFORMATION or any of the ingredients in EGRIFTA SV ™. • Have breathing problems. 1-800-FDA-1088 or to THERA patient support® AT EGRIFTASV.COM Expert14% assistance – just a phone call away •The Are most pregnant common or become side effects pregnant. of EGRIFTA If you become SV ™ include: pregnant, stop using EGRIFTA SV ™ • Are breastfeeding or plan to breastfeed. toll-free at 1-833-23THERA (1-833-238-4372). • andPain talk in legs with and your arms healthcare • Muscle provider. pain • Are taking any other prescription and This information is not intended to replace REDUCTION IN non-prescription medicines, vitamins, and ® • Are less than 18 years of age. discussions with your doctor. For additional CallHARD THERA BELLY patient FAT support toll-free at These are not all of the possible side effects of EGRIFTA SV™. For more information, ask your herbal supplements. information about EGRIFTA SV ™, go to: IF YOU ARE LIVING WITH Beforehealthcare using provider EGRIFTA or pharmacist. SV ™, tell your Call healthcareyour doctor forprovider medical if adviceyou: about side effects. EGRIFTA SV ™ may cause serious side effects http://egriftasv.com for the full Prescribing HIV AND LIPODYSTROPHY 1-833-23THERA (1-833-238-4372) •You Have may or report have sidehad cancer.effects to FDA at 1-800-FDA-1088 or to THERA patient support® including: Information, Patient Information and Patient * This 2 mg/vial strength of tesamorelin has the same toll-free• Have problems at 1-833-23THERA with blood (1-833-238-4372). sugar or diabetes. • Increased risk of new cancer in HIV positive Instructions for Use, and talk to your doctor. For ASK YOUR HEALTHCARE PROVIDER Monday-Friday, 8:30 a.m. - 8 p.m. ET TM efficacy and safety of tesamorelin 1 mg/vial. The • Have scheduled heart or stomach surgery. patients or your cancer coming back more information about EGRIFTA SV ™ contact ABOUT EGRIFTA SV . 2 mg/vial is more concentrated than the 1 mg/vial, This information is not intended to replace discussions with your doctor. For additional ® Voicemail messages will be returned within the next • Have breathing problems. (reactivation). Stop using EGRIFTA SV™ if any THERA patient support toll-free at and the recommended daily dose is 1.4 mg. information about EGRIFTA SV™, go to: http://egriftasv.com for the full Prescribing business day. • Are breastfeeding or plan to breastfeed. cancer symptoms come back. 1-833-23THERA (1-833-238-4372). Information, Patient Information and Patient Instructions for Use, and talk to your Please see Important Safety Information throughout, and the enclosed full • Are taking any other prescription and non-prescription medicines, vitamins, and Actual patient living with HIV. doctor. For more information about EGRIFTA SV ™ contact THERA patient support® Prescribing Information, Patient Information, and Patient Instructions for Use. herbal supplements. toll-free at 1-833-23THERA (1-833-238-4372). These documents are also available at http://egriftasv.com.

Please see Important Safety Information throughout, and the enclosed full Prescribing Information, Patient Information, and Instructions for Use. These documents are also available at http://egriftasv.com. Access and assistance throughout Helping to reduce HARD BELLY How do I store EGRIFTA SV ™? Don’t delay. Talk to your healthcare treatment (and maintain your results) provider today. • You will be given two boxes from the pharmacy when you get your prescription of EGRIFTA SV ™: Expert Patient Care Coordinators are standing by to help you: EGRIFTA SV ™ ™ (tesamorelinmay help reduce for injection) HARD BELLY is an by FDA changing approved Ask your healthcare provider about EGRIFTA SV ™. – Store the 2 mg EGRIFTA SV ™ vials in the Medication Box they come in, * To learn more, go to http://egriftasv.com. • Enroll in the EGRIFTA SV ™ howtreatment certain used hormones to reduce (chemicals excess visceral that your abdominal body produces fat in adult at room temperature between 68°F to 77°F (20°C to 25°C). Co-Pay Assistance Program naturally)patients living are released.with HIV andTo maintain lipodystrophy. any reduction EGRIFTA SV™in HARD is a – Store the Sterile Water for Injection, syringes and needles that come in BELLYprescription, your healthcaretreatment thatprovider you injectmay recommenddaily subcutaneously that you the Injection Box at room temperature between 68°F to 77°F (20°C to 25°C). • Identify the best insurance Important Information for Patients about EGRIFTA SV™ (tesamorelin for injection) and coverage options continually(under the skin)use EGRIFTAaround yourSV ™. abdominal (belly) area. • Keep EGRIFTA SV ™ vials out of the light. What is EGRIFTA SV™ (tesamorelin for • Increased levels of your insulin-like growth • After mixing, use EGRIFTA SV ™ right away. Throw away any injection)? factor-1 (IGF-1). Your healthcare provider will • Follow up about your insurance benefits Tesamorelin for injection was studied in two clinical trials in adult • EGRIFTA SV ™ is an injectable prescription do blood tests to check your IGF-1 levels • Find specialty pharmacies in your unused EGRIFTA SV ™ after mixing. medicine used to reduce excess abdominal while you are taking EGRIFTA SV ™. patientsTesamorelin living with for HIV injection who developed reduced HARD HARD BELLY BELLY. • Do not store, freeze, or refrigerate EGRIFTA SV ™ after it has fat in adult patients living with HIV and • Serious allergic reaction such as rash or insurance network, so you can quickly lipodystrophy. hives anywhere over the body or on the skin, • Each trial lasted 6 months,People with an who additional used tesamorelin 6-month been mixed with the Sterile Water. EGRIFTA SV ™ is a growth hormone-releasing swelling of the face or throat, shortness of receive your medication factor (GHRF) analog. breath or trouble breathing, fast heartbeat extension phase. • Prepare for therapy for injection continually for • Throw away any Sterile Water for Injection left in the bottle • EGRIFTA SV™ is not for weight loss feeling of faintness or fainting, itching and after use. management. reddening or flushing of the skin. If you have • Verify eligibility to enroll in the EGRIFTA SV ™ Financial • Patients receiving tesamorelin1 year for maintained injection saw their significant • The long-term safety of EGRIFTA SV ™ on the any of these symptoms, stop using Assistance Program, which may help with the cost of therapy reductions in HARD BELLY.results over this time period • Do not use EGRIFTA SV ™ after the expiration date (EXP) heart and blood vessels (cardiovascular) is EGRIFTA SV™ and get emergency medical printed on the carton and vial labels. not known. help right away. EGRIFTA SV ™ is not indicated for weight loss management. • It is not known whether taking EGRIFTA SV ™ • Swelling or fluid retention. Call your helps improve how well you take your healthcare provider if you have swelling, an Keep EGRIFTA SV ™ and all medicines out of the reach antiretroviral medications. increase in joint pain, or pain or numbness WHEN IT’S of children. • It is not known if EGRIFTA SV ™ is safe and in your hands or wrist. Without tesamorelin for injection, effective in children, do not use in children. • Increase in blood sugar (glucose) or HARD BELLY HARD BELLY came back General information about the safe and effective use You should not take EGRIFTA SV™ if you: diabetes. (EXCESS VISCERAL • Have a pituitary gland tumor, surgery, or • Injection site reactions. Injection site HARD BELLY returned when of EGRIFTA SV ™ other problems related to your pituitary reactions are a common side effect of ABDOMINAL FAT)� ® Average of Trial 1 Our THERA patient support Staff Nurses are ready to help: tesamorelin for injection was Medicines are sometimes prescribed for purposes other than gland, or have had radiation treatment to EGRIFTA SV™, but may sometimes be serious. your head or head injury. • Increased risk of death in people who have those listed in a Patient Information leaflet. Do not use critical illness because of heart or stomach IT MAY BE TIME FOR • Train on proper injection and reconstitution stopped after 6 months of • Have active cancer. TM • Are allergic to tesamorelin or any of the surgery, trauma or serious breathing 18% EGRIFTA SV ™ for a condition for which it was not prescribed. techniques, either on the phone or at home therapy ingredients in EGRIFTA SV™. (respiratory) problems has happened when EGRIFTA SV Do not give EGRIFTA SV ™ to other people, even if they have • Are pregnant or become pregnant. If you taking certain growth hormone. Actual patient • Share advice for starting and staying on REDUCTION IN living with HIV. become pregnant, stop using EGRIFTA SV ™ The most common side effects of A different kind of fat therapy HARD BELLY FAT the same symptoms you have. It may harm them. and talk with your healthcare provider. EGRIFTA SV ™ include: IMPORTANT SAFETY INFORMATION • Are less than 18 years of age. • Pain in legs and arms • Muscle pain may need a different • Answer common therapy-related Do not share your syringe or needles with other people, even You should not take EGRIFTA SV ™ if you: Before using EGRIFTA SV™, tell your These are not all of the possible side effects of kind of treatment questions throughout your treatment if the needle has been changed. You may give other people a healthcare provider if you: EGRIFTA SV ™. For more information, ask your • Have a pituitary gland tumor, surgery, or other problems related to your pituitary Average of Trial 2 • Have or have had cancer. healthcare provider or pharmacist. Call your gland, or have had radiation treatment to your head or head injury. serious infection or get a serious infection from them. • Have problems with blood sugar or diabetes. doctor for medical advice about side effects. • Have active cancer. • Have scheduled heart or stomach surgery. You may report side effects to FDA at FIND A SPECIALIST • Are allergic to tesamorelin or any of the ingredients in EGRIFTA SV ™. IMPORTANT SAFETY INFORMATION • Have breathing problems. 1-800-FDA-1088 or to THERA patient support® AT EGRIFTASV.COM Expert assistance – just a phone call away • Are pregnant or14% become pregnant. If you become pregnant, stop using EGRIFTA SV ™ The most common side effects of EGRIFTA SV ™ include: • Are breastfeeding or plan to breastfeed. toll-free at 1-833-23THERA (1-833-238-4372). and talk with your healthcare provider. • Pain in legs and arms • Muscle pain • Are taking any other prescription and This information is not intended to replace REDUCTION IN non-prescription medicines, vitamins, and ® • Are less than 18 years of age. discussions with your doctor. For additional Call THERA patient support toll-free at HARD BELLY FAT These are not all of the possible side effects of EGRIFTA SV™. For more information, ask your herbal supplements. information about EGRIFTA SV ™, go to: IF YOU ARE LIVING WITH Before using EGRIFTA SV ™, tell your healthcare provider if you: healthcare provider or pharmacist. Call your doctor for medical advice about side effects. EGRIFTA SV ™ may cause serious side effects http://egriftasv.com for the full Prescribing HIV AND LIPODYSTROPHY 1-833-23THERA (1-833-238-4372) • Have or have had cancer. You may report side effects to FDA at 1-800-FDA-1088 or to THERA patient support® including: Information, Patient Information and Patient •* This Have 2 mg/vial problems strength with of bloodtesamorelin sugar has or the diabetes. same toll-free at 1-833-23THERA (1-833-238-4372). • Increased risk of new cancer in HIV positive Instructions for Use, and talk to your doctor. For ASK YOUR HEALTHCARE PROVIDER Monday-Friday, 8:30 a.m. - 8 p.m. ET TM •efficacy Have scheduledand safety of heart tesamorelin or stomach 1 mg/vial. surgery. The patients or your cancer coming back more information about EGRIFTA SV ™ contact ABOUT EGRIFTA SV . 2 mg/vial is more concentrated than the 1 mg/vial, This information is not intended to replace discussions with your doctor. For additional ® Voicemail messages will be returned within the next • Have breathing problems. (reactivation). Stop using EGRIFTA SV™ if any THERA patient support toll-free at and the recommended daily dose is 1.4 mg. information about EGRIFTA SV™, go to: http://egriftasv.com for the full Prescribing business day. • Are breastfeeding or plan to breastfeed. cancer symptoms come back. 1-833-23THERA (1-833-238-4372). Information, Patient Information and Patient Instructions for Use, and talk to your Please see Important Safety Information throughout, and the enclosed full • Are taking any other prescription and non-prescription medicines, vitamins, and Actual patient living with HIV. doctor. For more information about EGRIFTA SV ™ contact THERA patient support® Prescribing Information, Patient Information, and Patient Instructions for Use. herbal supplements. toll-free at 1-833-23THERA (1-833-238-4372). These documents are also available at http://egriftasv.com.

* This 2 mg/vial strength of tesamorelin has EGRIFTA SV is a trademark of Theratechnologies Inc. the same efficacy and safety of tesamorelin THERA patient support is a registered trademark 1 mg/vial. The 2 mg/vial is more concentrated of Theratechnologies Inc. than the 1 mg/vial, and the recommended daily © 2020 Theratechnologies Inc. All rights reserved. Please see Important Safety Information throughout, and the enclosed Please see Important Safety Information throughout, and the enclosed dose is 1.4 mg. full Prescribing Information, Patient Information, and Instructions for Use. full Prescribing Information, Patient Information, and Instructions for Use. These documents are also available at http://egriftasv.com. These documents are also available at http://egriftasv.com. 598-04-06/20 Helping to reduce HARD BELLY How do I store EGRIFTA SV ™? Don’t delay. Talk to your healthcare (and maintain your results) provider today. • You will be given two boxes from the pharmacy when you get your prescription of EGRIFTA SV ™: EGRIFTA SV ™ (tesamorelin for injection) is an FDA approved Ask your healthcare provider about EGRIFTA SV ™. – Store the 2 mg EGRIFTA SV ™ vials in the Medication Box they come in, * To learn more, go to http://egriftasv.com. treatment used to reduce excess visceral abdominal fat in adult at room temperature between 68°F to 77°F (20°C to 25°C). patients living with HIV and lipodystrophy. EGRIFTA SV™ is a – Store the Sterile Water for Injection, syringes and needles that come in the Injection Box at room temperature between 68°F to 77°F (20°C to 25°C). prescription treatment that you inject daily subcutaneously Important Information for Patients about EGRIFTA SV™ (tesamorelin for injection) (under the skin) around your abdominal (belly) area. • Keep EGRIFTA SV ™ vials out of the light. What is EGRIFTA SV™ (tesamorelin for • Increased levels of your insulin-like growth • After mixing, use EGRIFTA SV ™ right away. Throw away any injection)? factor-1 (IGF-1). Your healthcare provider will Tesamorelin for injection was studied in two clinical trials in adult • EGRIFTA SV ™ is an injectable prescription do blood tests to check your IGF-1 levels unused EGRIFTA SV ™ after mixing. medicine used to reduce excess abdominal while you are taking EGRIFTA SV ™. patients living with HIV who developed HARD BELLY. • Do not store, freeze, or refrigerate EGRIFTA SV ™ after it has fat in adult patients living with HIV and • Serious allergic reaction such as rash or lipodystrophy. hives anywhere over the body or on the skin, • Each trial lasted 6 months, with an additional 6-month been mixed with the Sterile Water. EGRIFTA SV ™ is a growth hormone-releasing swelling of the face or throat, shortness of factor (GHRF) analog. breath or trouble breathing, fast heartbeat extension phase. • Throw away any Sterile Water for Injection left in the bottle • EGRIFTA SV ™ is not for weight loss feeling of faintness or fainting, itching and after use. management. reddening or flushing of the skin. If you have • Patients receiving tesamorelin for injection saw significant • The long-term safety of EGRIFTA SV ™ on the any of these symptoms, stop using reductions in HARD BELLY. • Do not use EGRIFTA SV ™ after the expiration date (EXP) heart and blood vessels (cardiovascular) is EGRIFTA SV™ and get emergency medical printed on the carton and vial labels. not known. help right away. EGRIFTA SV ™ is not indicated for weight loss management. • It is not known whether taking EGRIFTA SV ™ • Swelling or fluid retention. Call your helps improve how well you take your healthcare provider if you have swelling, an Keep EGRIFTA SV ™ and all medicines out of the reach antiretroviral medications. increase in joint pain, or pain or numbness WHEN IT’S of children. • It is not known if EGRIFTA SV ™ is safe and in your hands or wrist. effective in children, do not use in children. • Increase in blood sugar (glucose) or HARD BELLY General information about the safe and effective use You should not take EGRIFTA SV™ if you: diabetes. (EXCESS VISCERAL • Have a pituitary gland tumor, surgery, or • Injection site reactions. Injection site of EGRIFTA SV ™ other problems related to your pituitary reactions are a common side effect of ABDOMINAL FAT)� Average of Trial 1 Medicines are sometimes prescribed for purposes other than gland, or have had radiation treatment to EGRIFTA SV™, but may sometimes be serious. your head or head injury. • Increased risk of death in people who have those listed in a Patient Information leaflet. Do not use critical illness because of heart or stomach IT MAY BE TIME FOR • Have active cancer. TM • Are allergic to tesamorelin or any of the surgery, trauma or serious breathing 18% EGRIFTA SV ™ for a condition for which it was not prescribed. ingredients in EGRIFTA SV™. (respiratory) problems has happened when EGRIFTA SV Do not give EGRIFTA SV ™ to other people, even if they have • Are pregnant or become pregnant. If you taking certain growth hormone. Actual patient REDUCTION IN living with HIV. become pregnant, stop using EGRIFTA SV ™ The most common side effects of A different kind of fat HARD BELLY FAT the same symptoms you have. It may harm them. and talk with your healthcare provider. EGRIFTA SV ™ include: • Are less than 18 years of age. • Pain in legs and arms • Muscle pain may need a different Do not share your syringe or needles with other people, even Before using EGRIFTA SV™, tell your These are not all of the possible side effects of kind of treatment if the needle has been changed. You may give other people a healthcare provider if you: EGRIFTA SV ™. For more information, ask your Average of Trial 2 • Have or have had cancer. healthcare provider or pharmacist. Call your serious infection or get a serious infection from them. • Have problems with blood sugar or diabetes. doctor for medical advice about side effects. • Have scheduled heart or stomach surgery. You may report side effects to FDA at FIND A SPECIALIST IMPORTANT SAFETY INFORMATION • Have breathing problems. 1-800-FDA-1088 or to THERA patient support® AT EGRIFTASV.COM 14% • Are breastfeeding or plan to breastfeed. toll-free at 1-833-23THERA (1-833-238-4372). The most common side effects of EGRIFTA SV ™ include: • Pain in legs and arms • Muscle pain • Are taking any other prescription and This information is not intended to replace REDUCTION IN non-prescription medicines, vitamins, and discussions with your doctor. For additional HARD BELLY FAT These are not all of the possible side effects of EGRIFTA SV™. For more information, ask your herbal supplements. information about EGRIFTA SV ™, go to: IF YOU ARE LIVING WITH healthcare provider or pharmacist. Call your doctor for medical advice about side effects. EGRIFTA SV ™ may cause serious side effects http://egriftasv.com for the full Prescribing HIV AND LIPODYSTROPHY You may report side effects to FDA at 1-800-FDA-1088 or to THERA patient support® including: Information, Patient Information and Patient * This 2 mg/vial strength of tesamorelin has the same toll-free at 1-833-23THERA (1-833-238-4372). • Increased risk of new cancer in HIV positive Instructions for Use, and talk to your doctor. For ASK YOUR HEALTHCARE PROVIDER TM efficacy and safety of tesamorelin 1 mg/vial. The patients or your cancer coming back more information about EGRIFTA SV ™ contact ABOUT EGRIFTA SV . 2 mg/vial is more concentrated than the 1 mg/vial, This information is not intended to replace discussions with your doctor. For additional ® and the recommended daily dose is 1.4 mg. (reactivation). Stop using EGRIFTA SV™ if any THERA patient support toll-free at information about EGRIFTA SV™, go to: http://egriftasv.com for the full Prescribing cancer symptoms come back. 1-833-23THERA (1-833-238-4372). Information, Patient Information and Patient Instructions for Use, and talk to your Please see Important Safety Information throughout, and the enclosed full Actual patient living with HIV. doctor. For more information about EGRIFTA SV ™ contact THERA patient support® Prescribing Information, Patient Information, and Patient Instructions for Use. toll-free at 1-833-23THERA (1-833-238-4372). These documents are also available at http://egriftasv.com.