What are the most important things to know about Genvoya?
Genvoya can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, new or worsening kidney problems, including kidney failure, and drug interactions.
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 (jaundice)
- 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 hepatitis B virus infection (HBV) and take Genvoya, your HBV infection 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 Fanconi Syndrome), 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. Food and Drug Administration (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 HIV treatment regimen and should not be used with other HIV medicines.
Genvoya contains four different medicines: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide.
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 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 transmission. 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 During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
- If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
- If you are using hormone-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 HIV and Birth Control infographic.
- 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:
- 150 mg elvitegravir
- 150 mg cobicistat
- 200 mg emtricitabine
- 10 mg tenofovir alafenamide
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 daily dose of 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 immune system (called immune reconstitution syndrome 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 package insert 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 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 Package Insert includes information for people taking Genvoya.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for elvitegravir, cobicistat, emtricitabine, and tenofovir available from MedlinePlus.
- Genvoya-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
- 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 21, 2022