Cobicistat, elvitegravir, emtricitabine and tenofovir is a combination medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). cobicistat, elvitegravir, emtricitabine, and tenofovir is not a cure for HIV or AIDS.

Cobicistat, elvitegravir, emtricitabine, and tenofovir is for use in adults and children weighing at least 55 pounds (25 kilograms).

Cobicistat, elvitegravir, emtricitabine, and tenofovir may also be used for purposes not listed in this medication guide.

Tell your doctor about all your other medicines. Some drugs should not be used together.

This medicine 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.

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

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

This medicine is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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 this medicine. You may need liver function tests while using this medicine and for several months after you stop.

Usual Adult Dose for HIV Infection:

1 tablet orally once a day with food

Comments:
-This drug is not recommended during pregnancy due to considerably lower exposures of cobicistat and elvitegravir during the second and third trimesters.
-This drug should not be started in pregnant women; patients who become pregnant during therapy with this drug should be switched to an alternative regimen.

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 for HIV Infection:

Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide:
At least 25 kg: 1 tablet orally once a day with food

Cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (DF):
12 years or older and at least 35 kg: 1 tablet orally once a day with food

Comments:
-This drug is not recommended during pregnancy due to considerably lower exposures of cobicistat and elvitegravir during the second and third trimesters.
-This drug should not be started in pregnant women; patients who become pregnant during therapy with this drug should be switched to an alternative regimen.

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 cobicistat, elvitegravir, emtricitabine, and tenofovir. 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.

Cobicistat, elvitegravir, emtricitabine, and tenofovir 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.

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. Cobicistat, elvitegravir, emtricitabine, and tenofovir 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 cobicistat, elvitegravir, emtricitabine, and tenofovir. Some antacids can make it harder for your body to absorb this medicine.

Using this medicine 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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cobicistat, elvitegravir, emtricitabine, and tenofovir may cause serious side effects. 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 this medicine). 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 side effects of cobicistat, elvitegravir, emtricitabine, and tenofovir 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 affect 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.