WHAT IS GENVOYAÂŽ? GENVOYA is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older who weigh at least 77 pounds. It can either be used in people who are starting HIV-1 treatment and have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. These include having an undetectable viral load (less than 50 copies mL) for 6 months or more on their current HIV-1 treatment. GENVOYA combines 4 medicines into 1 pill taken once a day with food. GENVOYA is a complete HIV-1 treatment and should not be used with other HIV-1 medicines. GENVOYA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking GENVOYA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance QH UGZWCN EQPVCEV YKVJ DQF[ Ćƒ WKFU 0GXGT TGWUG QT UJCTG PGGFNGU QT QVJGT KVGOU VJCV JCXG DQF[ Ćƒ WKFU QP VJGO
IMPORTANT SAFETY INFORMATION What is the most important information I should know about GENVOYA? GENVOYA may cause serious side effects: • Worsening of hepatitis B (HBV) infection. GENVOYA is not approved to treat HBV. If you have both HIV-1 and HBV and stop taking GENVOYA, your HBV may suddenly get worse. Do not stop taking GENVOYA YKVJQWV Ƃ TUV VCNMKPI VQ [QWT JGCNVJECTG RTQXKFGT CU VJG[ will need to monitor your health. Who should not take GENVOYA? Do not take GENVOYA if you take: • Certain prescription medicines for other conditions. It is important to ask your healthcare provider or pharmacist about medicines that should not be taken with GENVOYA. Do not start a new medicine without telling your healthcare provider. • The herbal supplement St. John’s wort. • Any other medicines to treat HIV-1 infection. What are the other possible side effects of GENVOYA? Serious side effects of GENVOYA may also include: • Changes in your immune system. Your immune U[UVGO OC[ IGV UVTQPIGT CPF DGIKP VQ Ƃ IJV KPHGEVKQPU Tell your healthcare provider if you have any new symptoms after you start taking GENVOYA.
• Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking GENVOYA. • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-coloredâ€? urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. The most common side effect of GENVOYA is nausea. Tell your healthcare provider if you have any side effects that bother you or don’t go away. What should I tell my healthcare provider before taking GENVOYA? • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney or liver problems, including hepatitis virus infection. • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how GENVOYA works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take GENVOYA with all of your other medicines. • If you take antacids. Take antacids at least 2 hours before or after you take GENVOYA. • If you are pregnant or plan to become pregnant. It is not known if GENVOYA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking GENVOYA. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. 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. Please see Important Facts about GENVOYA, including important warnings, on the following page.
Ask your healthcare provider if GENVOYA is right for you.
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GENVOYA does not cure HIV-1 or AIDS.
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Take care of what matters most—you. GENVOYA is a 1-pill, once-a-day complete HIV-1 treatment for people who are either new to treatment or people whose healthcare provider determines they can replace their current HIV-1 medicines with GENVOYA.
IMPORTANT FACTS WHAT IS GENVOYAÂŽ? GENVOYA is a 1-pill, once-a-day prescription medicine to treat HIV-1 ( used ) in people 12 years and older who jen-VOY-uh
weigh at least 77 pounds. It can either be used in people who are starting HIV-1 treatment and have never taken MOST IMPORTANT INFORMATION ABOUT GENVOYA HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider GENVOYA may cause serious side effects, including: determines they meet certain requirements. These include •having Worsening of hepatitis B (HBV) not an undetectable viral loadinfection. (less thanGENVOYA 50 copiesismL) approved to treat HBV.on If you have both HIV-1 HBV, your for 6 months or more their current HIV-1and treatment. HBV may suddenly get4worse if you stop GENVOYA. GENVOYA combines medicines into taking 1 pill taken once a Do not stop taking GENVOYA without first talking to your day with food. GENVOYA is a complete HIV-1 treatment healthcare provider, as they will need to check your health and should be used with other HIV-1 medicines. regularly fornot several months. GENVOYA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related ABOUT GENVOYA illnesses, you must keep taking GENVOYA. Ask your if youmedicine have questions about •healthcare GENVOYA isprovider a prescription used to treat HIV-1how in topeople reduce the risk of passing to others. 12 years of age and older HIV-1 who weigh at leastAlways 77 pounds and havesafer neversex taken HIV-1 GENVOYA can practice and usemedicines condomsbefore. to lower the chance also be used to replace current HIV-1 medicines for some QH UGZWCN EQPVCEV YKVJ DQF[ ĆƒWKFU 0GXGT TGWUG QT UJCTG people who have an undetectable viral load (less than 50 PGGFNGU QT QVJGT KVGOU VJCV JCXG DQF[ ĆƒWKFU QP VJGO copies/mL of virus in their blood), and have been on the same HIV-1 medicines for at least 6 months and have never failed IMPORTANT SAFETY INFORMATION HIV-1 treatment, and whose healthcare provider determines What is the important information I should that they meetmost certain other requirements.
about GENVOYA? •know GENVOYA does not cure HIV-1 or AIDS. Ask your healthcare provider about how to prevent passing to others. GENVOYA may cause serious side HIV-1 effects:
• Worsening of hepatitis Do NOT take GENVOYA if you:B (HBV) infection. GENVOYA is not approved to treat HBV. If you(Uroxatral have both Ž • Take a medicine that contains: alfuzosin ), HIV-1 and HBV and (Carbatrol stop taking GENVOYA, HBV Žmay Ž Ž Ž carbamazepine , Epitol , Equetroyour , Tegretol , suddenly Žget worse. Do not stop taking GENVOYA Ž Ž Tegretol-XR , Teril ), cisapride (Propulsid , Propulsid YKVJQWV ƂTUV VCNMKPI VQ [QWT JGCNVJECTG RTQXKFGT CU VJG[ Ž Quicksolv ), dihydroergotamine (D.H.E. 45Ž, MigranalŽ), will need monitor Ž your health. ergotamine to (Cafergot , MigergotŽ, ErgostatŽ, Medihaler ErgotamineŽ, WigraineŽ, WigrettesŽ), lovastatin (AdvicorŽ, Who should not take GENVOYA? Ž Ž Altoprev , Mevacor ), lurasidone (LatudaŽ), methylergonovine Ž Ž (Ergotrate , Methergine ), midazolam (when taken by mouth), Do not take GENVOYA if you take: Ž Ž (LuminalŽ), phenytoin (Dilantin , Phenytek ), •phenobarbital Certain prescription medicines for other conditions. Ž Ž Ž Ž pimozide (Orap ), rifampin (Rifadin , Rifamate , Rifater , It is important to ask your healthcare provider or Ž Rimactane ), sildenafil when usedthat for lung problems pharmacist about medicines should not be taken Ž Ž Ž (Revatio ), simvastatin , Vytorin ZocorŽ), orwithout with GENVOYA.Ž Do(Simcor not start a new ,medicine triazolam (Halcion ). telling your healthcare provider. ••Take herbalsupplement supplement St. wort. Thethe herbal St.John’s John’s wort.
Anyany other to treat ••Take othermedicines HIV-1 medicines at theHIV-1 same infection. time. What are the other possible side effects of GENVOYA? GET MORE INFORMATION Serious side effects of GENVOYA may also include: • This is only a brief summary of important information about • Changes in your immune system. Your immune GENVOYA. Talk to your healthcare provider or pharmacist U[UVGO OC[ IGV UVTQPIGT CPF DGIKP VQ ƂIJV KPHGEVKQPU to learn more. Tell your healthcare provider if you have any new • Go to GENVOYA.com call taking 1-800-GILEAD-5 symptoms after youor start GENVOYA. • If you need help paying for your medicine, visit GENVOYA. com for program information.
This is only a brief summary of important information about GENVOYAÂŽ and does not replace • Kidney problems, including kidneyabout failure.your Your talking to your healthcare provider healthcare provider should do blood and urine tests to and your treatment. condition check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking GENVOYA. •POSSIBLE Too much lactic in your blood (lactic acidosis), SIDE acid EFFECTS OF GENVOYA which is a serious but rare medical emergency that can GENVOYA can cause serious side effects, including: lead to death. Tell your healthcare provider right away if get these symptoms: weakness or being •you Those in the “Most Important Information Aboutmore tired than usual, unusual GENVOYAâ€? section.muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, • Changes in your immune system. cold or blue hands and feet, feel dizzy or lightheaded, or •aNew or worse kidney problems, including kidney failure. fast or abnormal heartbeat. Too much lactic acid in yourwhich blood (lactic which • •Severe liver problems, in rareacidosis), cases can lead to death. Tell medical your healthcare right is a serious but rare emergencyprovider that can lead to away if Tell youyour gethealthcare these symptoms: skin or the white death. provider right away if you get these part of yourweakness eyes turns dark “tea-coloredâ€? symptoms: or yellow, being more tired than usual, unusual urine, light-colored stools, loss oforappetite for several muscle pain, being short of breath fast breathing, stomach days or longer, nausea, or stomach-area pain. pain with nausea and vomiting, cold or blue hands and feet, Thefeel most side or effect is nausea. dizzycommon or lightheaded, a fastof or GENVOYA abnormal heartbeat. Tell your healthcare provider if you have any side effects • Severe liver problems, which in rare cases can lead to death. that bother you or don’t go away.
Tell your healthcare provider right away if you get these symptoms: or my the white part of your eyes turns yellow, What shouldskin I tell healthcare provider before dark “tea-coloredâ€? urine, light-colored stools, loss of appetite taking GENVOYA? for several days or longer, nausea, or stomach-area pain. • All your health problems. Be sure to tell your The most common side effect of GENVOYA is nausea. healthcare provider if you have or have had any kidney These areproblems, not all the including possible side effectsvirus of GENVOYA. or liver hepatitis infection. Tell your healthcare provider right away if you any new • All the medicines you take, including have prescription symptoms while taking GENVOYA. and over-the-counter medicines, vitamins, and herbal Your healthcareOther provider will needmay to doaffect testshow to monitor supplements. medicines your health before during with GENVOYA. GENVOYA works.and Keep a listtreatment of all your medicines and
show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take GENVOYA with all of your other medicines. BEFORE TAKING GENVOYA • If you take antacids. Take antacids at least 2 hours Tell yourorhealthcare provider if you: before after you take GENVOYA. • have had any or kidney problems, including • IfHave you or are pregnant planortoliver become pregnant. It is hepatitis not knowninfection. if GENVOYA can harm your unborn baby. •Tell your provider if you become pregnant Have anyhealthcare other medical condition. taking GENVOYA. •while Are pregnant or plan to become pregnant. • •IfAre you are breastfeeding plan to Do not breastfeeding (nursing) (nursing) or plan to or breastfeed. breastfeed. breastfeed. HIV-1ofcan be passed breastfeed ifDo younot have HIV-1 because the risk of passing toHIV-1 the baby breast milk. to yourinbaby. You encouraged reportabout negative side Tellare your healthcare to provider all the medicines effects of prescription drugs to the FDA. Visit you take: www.fda.gov/medwatch, or call 1-800-FDA-1088. • Keep a list that includes all prescription and over-the-
counter and herbal supplements, and Please seemedicines, Importantvitamins, Facts about GENVOYA, show it to your healthcare provider and pharmacist. including important warnings, on the following page. •
Ask your healthcare provider or pharmacist about medicines that should not be taken with GENVOYA.
HOW TO TAKE GENVOYA
• GENVOYA a completefor one pill, once a day HIV-1 medicine. Ask your healthcare provider if GENVOYA isis right you. •
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Take GENVOYA with food.
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