Biktarvy is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Biktarvy is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). bictegravir, emtricitabine, and tenofovir is not a cure for HIV or AIDS.

Biktarvy is for use in adults and children who weigh at least 31 pounds (14 kilograms) who have not received HIV-1 medicines, or to replace their current HIV-1 medicines for those who meet certain requirements.

Biktarvy may also be used for purposes not listed in this medication guide.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Biktarvy is a complete regimen and is not for use with other antiviral medications.

You may take Biktarvy with or without food. If you take a multivitamin or mineral supplement that contains iron or calcium, take it with food at the same time you take Biktarvy.

The tablet can be split and each part taken separately as long as all parts are swallowed within 10 minutes.

You will need frequent medical tests.

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 ever had hepatitis B, this virus may become active or get worse in the months after you stop using Biktarvy. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Usual Adult Dose for HIV Infection:

Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg orally once a day

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 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:

At least 14 to less than 25 kg: Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg orally once a day
At least 25 kg: Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg orally once a day

Comments:
-For children at least 14 to less than 25 kg who are unable to swallow a whole tablet, the tablet can be split and each part can be taken separately as long as all parts are ingested within about 10 minutes.

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 with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

Some medicines can cause unwanted or dangerous effects when used with Biktarvy. Your doctor may need to change your treatment plan if you also use:

• dofetilide; or

• rifampin.

Tell your doctor if you have ever had:

• liver disease (especially cirrhosis or hepatitis B); or

• kidney disease.

Tell your doctor if you are pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines to control your infection. Your name may be listed on a pregnancy registry to track the effects of Biktarvy on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use 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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Bictegravir, emtricitabine, and tenofovir may cause serious side effects. Call your doctor at once if you have:

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

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

• liver problems--swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Biktarvy affects your immune system, which may cause certain side effects (even weeks or months after you've taken 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 bictegravir, emtricitabine, and tenofovir may include:

• nausea, diarrhea; or

• headache.

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 medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Certain antacids, laxatives, or buffered medicines can make Biktarvy much less effective when taken at the same time. Take your Biktarvy dose on an empty stomach, 2 hours before you take any of these other medicines.

Many drugs can affect Biktarvy. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.