What are the most important things to know about Genvoya?
Genvoya can cause serious, life-threatening side effects. These include a buildup ofin the blood ( ), problems, new or worsening kidney problems, including kidney failure, and .
Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:
- Weakness or tiredness
- Unusual muscle pain
- Shortness of breath or fast breathing
- Stomach pain with nausea and vomiting
- Cold or blue hands and feet
- Dizziness or lightheadedness
- Fast or abnormal heartbeat
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Yellowing of your skin or the whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite for several days or longer
- Nausea or vomiting
- Pain, aching, or tenderness on the right side of your stomach/abdominal area
If you have both HIV and(HBV) and take Genvoya, your HBV may get worse (flare-up) if you stop taking Genvoya. Do not stop taking Genvoya without first talking to your health care provider.
Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called), which may be related to tenofovir-containing drugs:
- Bone pain that does not go away or gets worse
- Pain in your arms, hands, legs, or feet
- Broken bones
- Muscle pain or weakness
Taking Genvoya with certain other medicines may cause serious, life-threatening side effects. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
While taking Genvoya, it is important to keep all of your appointments with your health care provider.
What is Genvoya?
Genvoya is a prescription medicine approved by the U.S.(FDA) for the treatment of HIV infection in adults and children who weigh at least 55 lb (25 kg) and meet certain requirements, as determined by a health care provider.
Genvoya is a complete HIVand should not be used with other HIV medicines.
For more information on the use of Genvoya in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV. If you are taking HIV medicines, do not cut down on, skip, or stop taking it unless your health care provider tells you to.
What should I tell my health care provider before taking Genvoya?
Before taking Genvoya, tell your health care provider:
- If you are allergic to any of the HIV medicines in Genvoya (elvitegravir, cobicistat, emtricitabine, or tenofovir alafenamide) or any other medicines.
- If you have liver problems, including hepatitis B virus infection (HBV).
- If you have kidney problems.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Genvoya during pregnancy. For more information on the use of Genvoya during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.
- If you are breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, implants, or vaginal rings). Your health care provider may recommend that you use additional or alternative forms of birth control while taking Genvoya. For more information about using birth control and HIV medicines at the same time, view the HIVinfo
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John’s wort) you are taking or plan to take. Genvoya may affect the way other medicines or products work, and other medicines or products may affect how Genvoya works. Taking Genvoya together with certain medicines or products may cause serious, life-threatening side effects.
How should I take Genvoya?
Genvoya comes in tablet form. Each tablet contains:
Take Genvoya according to your health care provider’s instructions. Do not miss a dose of Genvoya, and do not change your dose or stop taking Genvoya without first talking with your health care provider.
Take Genvoya by mouth with food. Do not take Genvoya with other HIV medicines.
If you are on dialysis, take your dailyof Genvoya after receiving dialysis.
If you need to take a medicine for indigestion (antacid) that contains aluminum and magnesium hydroxide or calcium carbonate during treatment with Genvoya, take it at least 2 hours before or after you take Genvoya.
If you have taken too much Genvoya, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
For more information on how to take Genvoya, see the FDA drug label.
What should I do if I forget a dose?
If you miss a dose of Genvoya, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
What side effects can Genvoya cause?
Genvoya may cause side effects. Some side effects of Genvoya can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.
Another possible side effect of Genvoya is a change in your(called immune reconstitution or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Genvoya. To learn more about possible side effects of Genvoya, read the drug label or or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How should Genvoya be stored?
- Store Genvoya below 86°F (30°C).
- Keep Genvoya in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
- Do not use Genvoya if the original seal over the container opening is broken or missing.
- Throw away Genvoya that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep Genvoya and all medicines out of reach of children.
Where can I find more information about Genvoya?
- For more information on the use of Genvoya in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
- This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated). The Patient Counseling Information section of the label includes information for people taking Genvoya.
- Genvoya-related research studies, from .
- A list of FDA-approved HIV medicines, from HIVinfo.
Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056
Last Reviewed: November 2, 2021