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Genvoya: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
150 mg, 150 mg, 200 mg, 10 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Genvoya

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

GENVOYA can cause serious side effects, including:

  • Worsening of hepatitis B virus (HBV) infection. Your healthcare provider will test you for HBV infection before or when you start treatment with GENVOYA. If you have HBV infection and take GENVOYA, your HBV may get worse (flare-up) if you stop taking GENVOYA. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.

    • Do not run out of GENVOYA. Refill your prescription or talk to your healthcare provider before your GENVOYA is all gone.
    • Do not stop taking GENVOYA without first talking to your healthcare provider.
    • If you stop taking GENVOYA, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver, and may give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking GENVOYA.

For more information about side effects, see "What are the possible side effects of GENVOYA?"

What is GENVOYA?

GENVOYA is a prescription medicine that is used without other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 infection in adults and children who weigh at least 55 pounds (25 kg):

  • who have not received HIV-1 medicines in the past, or
  • to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

GENVOYA contains the prescription medicines elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

It is not known if GENVOYA is safe and effective in children who weigh less than 55 pounds (25 kg).

Do not take GENVOYA if you also take a medicine that contains:

  • alfuzosin hydrochloride
  • carbamazepine

  • ergot-containing medicines, including:

    • dihydroergotamine mesylate
    • ergotamine tartrate
    • methylergonovine maleate
  • lomitapide
  • lovastatin
  • lurasidone
  • midazolam, when taken by mouth
  • phenobarbital
  • phenytoin
  • pimozide
  • rifampin
  • sildenafil, when used for treating the lung problem, pulmonary arterial hypertension
  • simvastatin
  • triazolam
  • St. John's wort (Hypericum perforatum) or a product that contains St. John's wort.

What should I tell my healthcare provider before taking GENVOYA?

Before taking GENVOYA, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems, including HBV infection
  • have kidney problems

  • are pregnant or plan to become pregnant.

    • It is not known if GENVOYA can harm your unborn baby.
    • GENVOYA should not be used during pregnancy because you may not have enough GENVOYA in your body during pregnancy.
    • Tell your healthcare provider if you become pregnant during treatment with GENVOYA. Your healthcare provider may prescribe different medicines if you become pregnant while taking GENVOYA.

    Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take GENVOYA.

    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • At least one of the medicines in GENVOYA can pass to your baby in your breast milk. It is not known if the other medicines in GENVOYA can pass into your breast milk.

    Talk with your healthcare provider about the best way to feed your baby during treatment with GENVOYA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines may interact with GENVOYA. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with GENVOYA.
  • Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take GENVOYA with other medicines.

How should I take GENVOYA?

  • Take GENVOYA exactly as your healthcare provider tells you to take it. GENVOYA is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection.
  • Take GENVOYA 1 time each day with food.
  • If you are on dialysis, take your daily dose of GENVOYA following dialysis.
  • Do not change your dose or stop taking GENVOYA without first talking with your healthcare provider. Stay under a healthcare provider's care during treatment with GENVOYA.
  • If you need to take a medicine for indigestion (antacid) that contains aluminum hydroxide, magnesium hydroxide, or calcium carbonate during treatment with GENVOYA, take it at least 2 hours before or after you take GENVOYA.
  • Do not miss a dose of GENVOYA.
  • When your GENVOYA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to GENVOYA and become harder to treat.
  • If you take too much GENVOYA, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of GENVOYA?

GENVOYA may cause serious side effects, including:

  • See "What is the most important information I should know about GENVOYA?"
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
  • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys when starting and during treatment with GENVOYA. Your healthcare provider may tell you to stop taking GENVOYA if you develop new or worse kidney problems.
  • Too much lactic acid in your blood (lactic acidosis). Too much lactic acid 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. In rare cases, severe liver problems can happen that 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-colored" 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.

These are not all the possible side effects of GENVOYA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store GENVOYA?

  • Store GENVOYA below 86°F (30°C).
  • Keep GENVOYA in its original container.
  • Keep the container tightly closed.

Keep GENVOYA and all medicines out of reach of children.

General information about the safe and effective use of GENVOYA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GENVOYA for a condition for which it was not prescribed. Do not give GENVOYA to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about GENVOYA that is written for health professionals.

What are the ingredients in GENVOYA?

Active ingredients: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, and sodium lauryl sulfate. The tablets are film-coated with a coating material containing FD&C Blue No. 2/indigo carmine aluminum lake, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404

GENVOYA is a trademark of Gilead Sciences, Inc., or its related companies.

© 2022 Gilead Sciences, Inc. All rights reserved.

207561-GS--017

For more information, call 1-800-445-3235 or go to www.GENVOYA.com.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 207561 · View the label on DailyMed

Revision date stated in the text: January 2022

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Genvoya

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Cytochrome P450 3A Inhibitor, Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Active ingredients Elvitegravir 150 mg, Cobicistat 150 mg, Emtricitabine 200 mg, Tenofovir alafenamide fumarate 10 mg
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) GILEAD SCIENCES INC
FDA approval NDA 207561New Drug Application (NDA) Approved November 5, 2015
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
150 mg, 150 mg, 200 mg, 10 mg – 30 in 1 bottle, plastic NDC 61958-1901-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.