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). This medicine 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.

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 Bictegravir, Emtricitabine, And Tenofovir (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

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 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.

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