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Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide

Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide

Brand Name: Genvoya Other Names: EVG / COBI / FTC / TAF, elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide fumarate Drug Class: Combination Drugs

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What are the most important things to know about Genvoya?

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, and new or worse kidney problems, including kidney failure.

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
  • Trouble breathing
  • Stomach pain with nausea and vomiting
  • Hands or feet that feel cold or turn blue
  • Dizziness or lightheadedness
  • Fast or irregular heartbeat

Some people taking Genvoya have had liver problems. People with a history of hepatitis B virus infection (HBV) or people who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Genvoya. Liver problems have also occurred in people taking Genvoya who have no history of liver disease. Liver function tests may be done before and during treatment with Genvoya.

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
  • Nausea
  • Pain, aching, or tenderness in the right side of your stomach

Genvoya is not approved for the treatment of HBV infection. If you have both HIV and HBV infection and take Genvoya, your HBV infection may get worse (flare up) if you stop taking Genvoya.

Some people taking Genvoya have developed new or worse kidney problems, including kidney failure. Your health care provider may do blood and urine tests to check your kidneys before and during treatment with Genvoya.

If you take Genvoya, you should not take other HIV medicines.

While taking Genvoya, it is important to keep all of your appointments with your health care provider.

What is Genvoya?

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):

  • who have not taken HIV medicines before, or
  • to replace the current HIV treatment regimen of those who meet certain requirements, as determined by a health care provider.

Genvoya is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines. 

Genvoya contains the following four different medicines combined in one tablet: 

Integrase inhibitors block an HIV enzyme called integrase. NRTIs block an HIV enzyme called reverse transcriptase.

The four drugs combined in Genvoya prevent HIV from multiplying and can reduce the amount of HIV in the body. HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV treatment regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking Genvoya, don’t 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?

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 or have ever had liver problems, including hepatitis B virus infection (HBV).
  • If you have or have ever had kidney problems.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Genvoya should not be used during pregnancy. Talk to your health care provider about possible risks with taking Genvoya when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Genvoya. 
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Genvoya may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking Genvoya. For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic. 
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products 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?

How should I take Genvoya?

Genvoya comes in tablet form. Each tablet contains: 

Take Genvoya according to your health care provider’s instructions. 

Take Genvoya with food. Do not take Genvoya with other HIV medicines.

If you are on dialysis, take Genvoya after receiving dialysis.

If you need to take a medicine for indigestion (an 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 take 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?

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?

What side effects can Genvoya cause?

Genvoya may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of Genvoya can be serious. Serious side effects of Genvoya include a buildup of lactic acid in the blood (lactic acidosis), liver problems, and new or worse kidney problems, including kidney failure. (See section above: What are the most important things to know about Genvoya?) 

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?

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?

Where can I find more information about Genvoya?

More information about Genvoya is available:

Manufacturer Information

Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056

The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).

Last Reviewed: December 14, 2018