Show your Power

GENVOYA® is a prescription medicine used to treat HIV-1 in people 12 years and older. It can be used in people who are either:

Starting HIV-1 treatment and have never taken HIV-1 medicines before OR

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 does not cure HIV-1 or AIDS.

Ask your healthcare provider if 1-pill, once-a-day GENVOYA is right for you.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about GENVOYA?

GENVOYA may cause serious side effects:

  • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold (especially in your arms and legs), feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.
  • Serious liver problems. The liver may become large and fatty. Symptoms of liver problems include your skin or the white part of your eyes turning yellow (jaundice), dark "tea-colored" urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain.
  • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking GENVOYA for a long time. In some cases, lactic acidosis and serious liver problems have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
  • 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 without first talking to your healthcare provider, as they 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 body fat, which can happen in people taking HIV-1 medicines.
  • Changes in your immune system. Your immune system may get stronger and begin to fight infections. 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.
  • Bone problems, such as bone pain, softening, or thinning, which may lead to fractures. Your healthcare provider may do tests to check your bones.

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, bone, 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 .

What is GENVOYA?

GENVOYA is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older. 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 of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

Please see Important Facts about GENVOYA, including important warnings.