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Bictegravir / Emtricitabine / Tenofovir Alafenamide

Bictegravir / Emtricitabine / Tenofovir Alafenamide

Brand Name: Biktarvy Other Names: BIC / FTC / TAF, bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate  Drug Class: Combination Drugs

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What are the most important things to know about Biktarvy?

What are the most important things to know about Biktarvy?

Biktarvy can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis) and severe liver problems.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Feeling very weak or tired
  • Unusual muscle pain
  • Trouble breathing
  • Stomach pain with nausea and vomiting
  • Feeling cold, especially in your hands and feet
  • Feeling dizzy or lightheaded
  • Fast or irregular heartbeat

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Feeling sick to your stomach (nausea)
  • Pain, aching, or tenderness in your stomach area

If you have both HIV and hepatitis B virus infection (HBV) and take Biktarvy, your HBV infection may get worse (flare up) if you stop taking Biktarvy. To help avoid this, take Biktarvy exactly as prescribed. Do not run out of Biktarvy or stop taking Biktarvy without talking to your health care provider.

If you take Biktarvy, you should not take other HIV medicines.

While taking Biktarvy, it is important to keep all of your appointments with your health care provider.

What is Biktarvy?

What is Biktarvy?

Biktarvy is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children weighing at least 55 lb (25 kg) who meet certain requirements, as determined by a health care provider.

Biktarvy is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines.

Biktarvy contains three different medicines: bictegravir, emtricitabine, and tenofovir alafenamide.

HIV medicines can’t cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, don’t cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking Biktarvy?

What should I tell my health care provider before taking Biktarvy?

Before taking Biktarvy, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) or any other medicines.
  • If you have or have ever had liver problems, including hepatitis B virus infection (HBV).
  • If you have or have ever had kidney problems.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Biktarvy contains bictegravir, which is an integrase inhibitor. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Talk to your health care provider about the risks and benefits of using Biktarvy during pregnancy or if pregnancy is being planned.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Biktarvy.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Biktarvy may affect the way other medicines or products work, and other medicines or products may affect how Biktarvy works. Taking Biktarvy together with certain medicines or products may cause serious side effects. Do not take Biktarvy if you take dofetilide or rifampin. Taking Biktarvy with dofetilide or rifampin can cause side effects that may be serious or life-threatening or could result in reduced effectiveness of Biktarvy.

How should I take Biktarvy?

How should I take Biktarvy?

Biktarvy comes in tablet form. Each tablet contains:

Take Biktarvy according to your health care provider’s instructions.

Take Biktarvy with or without food. If you are taking any other medicines or supplements, carefully follow instructions on how to take them with Biktarvy.

If you take too much Biktarvy, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take Biktarvy, see the FDA drug label.

What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of Biktarvy, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can Biktarvy cause?

What side effects can Biktarvy cause?

Biktarvy may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of Biktarvy can be serious. Serious side effects of Biktarvy include a buildup of lactic acid in the blood (lactic acidosis) and severe liver problems. (See section above: What are the most important things to know about Biktarvy?)

Other possible side effects of Biktarvy include:

  • Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
  • New or worsening kidney problems, including kidney failure.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Biktarvy. To learn more about possible side effects of Biktarvy, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should Biktarvy be stored?

How should Biktarvy be stored?

  • Store Biktarvy below 86°F (30°C).
  • Keep Biktarvy in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use Biktarvy if the original seal over the container opening is broken or missing.
  • Throw away Biktarvy that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Biktarvy and all medicines out of reach of children.

Where can I find more information about Biktarvy?

Where can I find more information about Biktarvy?

More information about Biktarvy is available:

 

Manufacturer Information

Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056

The above Patient Version drug summary is based on the following FDA label(s): Tablet.

Last Reviewed: August 6, 2019

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