Genvoya is a tablet containing a combination of cobicistat, elvitegravir, emtricitabine, and tenofovir. Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses.

Elvitegravir, emtricitabine and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body. HIV can cause acquired immunodeficiency syndrome (AIDS).

Genvoya is used to treat HIV in adults and children who are at least 12 years old and who weigh at least 55 pounds (25 kilograms).

Genvoya is not a cure for HIV or AIDS.

Genvoya can harm your liver. Call your doctor at once if you have: upper stomach pain, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Do not stop using Genvoya without your doctor's advice. Get your prescription refilled before you run out of medicine completely.

If you've ever had hepatitis B, it may become active or get worse after you stop using Genvoya. You may need frequent liver function tests for several months.

Many drugs can interact with Genvoya and some should not be used at the same time. Tell your doctor about all the medicines you use.

Before taking this medicine

Some drugs should not be used with Genvoya. Your treatment plan may change if you also use:

• alfuzosin;

• cisapride;

• oral midazolam, or triazolam;

• rifampin;

• sildenafil (Revatio, for treating pulmonary arterial hypertension);

• St. John's wort;

• antipsychotic medicine - lurasidone, pimozide;

• cholesterol medication - lomitapide, lovastatin, simvastatin;

• ergot medicine - dihydroergotamine, ergotamine, methylergonovine; or

• seizure medicine - carbamazepine, phenobarbital, phenytoin.

Genvoya is a complete combination treatment and should not be used with other antiviral medications, especially those that contain adefovir, cobicistat, elvitegravir, emtricitabine, lamivudine, ritonavir, or tenofovir: Atripla, Biktarvy, Cimduo, Combivir, Complera, Descovy, Epivir, Epzicom, Evotaz, Hepsera, Kaletra, Norvir, Odefsey, Prezcobix, Symfi, Symtuza, Technivie, Triumeq, Trizivir, Tybost, Viekira, and others.

To make sure Genvoya is safe for you, tell your doctor if you have ever had:

• hepatitis B or other liver problems; or

• kidney disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Ask your doctor about your risk.

This medicine may not work as well if you take it during pregnancy. Do not start taking the medicine if you are pregnant. Tell your doctor right away if you become pregnant.

If you plan to get pregnant, ask your doctor for another antiviral medicine to use during pregnancy. To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

If you do not plan to get pregnant, ask your doctor about using a non-hormonal birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy. Genvoya can increase certain side effects when taken with hormonal birth control (pills, injections, implants, skin patches, vaginal rings).

Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.

Take Genvoya exactly as prescribed by your doctor. This medicine is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take with food.

You will need frequent medical tests.

Use all HIV medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Skipping doses could make your virus resistant to medication. Remain under the care of a doctor.

Store in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

If you've had hepatitis B, it may come back or get worse after you stop using Genvoya. You may need liver function tests while using Genvoya and for several months after you stop.

Usual Adult Dose of Genvoya for HIV Infection:

1 tablet orally once a day with food

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (DF).

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

Usual Pediatric Dose of Genvoya for HIV Infection:

12 years or older and at least 35 kg:
-Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: 1 tablet orally once a day with food

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting cobicistat/elvitegravir/emtricitabine/tenofovir DF.

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

Some drugs should not be used with Genvoya. Your treatment plan may change if you also use:

• alfuzosin;

• cisapride;

• oral midazolam, or triazolam;

• rifampin;

• sildenafil (Revatio, for treating pulmonary arterial hypertension);

• St. John's wort;

• antipsychotic medicine - lurasidone, pimozide;

• cholesterol medication - lomitapide, lovastatin, simvastatin;

• ergot medicine - dihydroergotamine, ergotamine, methylergonovine; or

• seizure medicine - carbamazepine, phenobarbital, phenytoin.

Genvoya is a complete combination treatment and should not be used with other antiviral medications, especially those that contain adefovir, cobicistat, elvitegravir, emtricitabine, lamivudine, ritonavir, or tenofovir: Atripla, Biktarvy, Cimduo, Combivir, Complera, Descovy, Epivir, Epzicom, Evotaz, Hepsera, Kaletra, Norvir, Odefsey, Prezcobix, Symfi, Symtuza, Technivie, Triumeq, Trizivir, Tybost, Viekira, and others.

To make sure Genvoya is safe for you, tell your doctor if you have ever had:

• hepatitis B or other liver problems; or

• kidney disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Ask your doctor about your risk.

This medicine may not work as well if you take it during pregnancy. Do not start taking the medicine if you are pregnant. Tell your doctor right away if you become pregnant.

If you plan to get pregnant, ask your doctor for another antiviral medicine to use during pregnancy. To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

If you do not plan to get pregnant, ask your doctor about using a non-hormonal birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy. Genvoya can increase certain side effects when taken with hormonal birth control (pills, injections, implants, skin patches, vaginal rings).

Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking an antacid within 2 hours before or 2 hours after you take Genvoya. Some antacids can make it harder for your body to absorb cobicistat, elvitegravir, emtricitabine, and tenofovir.

Using Genvoya will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Get emergency medical help if you have signs of an allergic reaction to Genvoya: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• kidney problems - swelling, urinating less, feeling tired or short of breath;

• lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or

• liver problems - nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Antiviral medicine can affect your immune system (even weeks or months after you've used Genvoya). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Genvoya side effects may include:

• nausea; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can interact with cobicistat, elvitegravir, emtricitabine, and tenofovir, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.