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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
WARNING:

WARNING:

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 (not normal) muscle pain
  • Trouble breathing
  • Stomach pain with nausea and vomiting
  • Feeling cold, especially in your arms and legs
  • Feeling dizzy or lightheaded
  • Fast or irregular heartbeat

Some people taking Biktarvy have had liver problems. People with a history of hepatitis B virus (HBV) infection or people who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Biktarvy. Liver problems have also occurred in people taking Biktarvy who have no history of liver disease. Liver function tests may be done before and during treatment with Biktarvy.

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) to treat HIV infection in adults:

  • who have never taken HIV medicines before, or
  • to replace the current HIV medicines in the HIV regimen of people who:
    • have a viral load (the amount of HIV in a sample of blood) that is less than 50 copies/mL, and
    • have been on the same HIV regimen for at least 3 months, and
    • have never had treatment failure (treatment failure is when an HIV regimen is unable to control HIV infection), and
    • have no drug resistance mutations associated with any of the HIV medicines in Biktarvy (drug resistance mutations are changes in the genetic material of HIV that cause the virus to become insensitive to certain HIV medicines).
Biktarvy is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines.

Biktarvy contains the following three different medicines combined in one pill:

Integrase inhibitors block an HIV enzyme called integrase and NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking integrase and reverse transcriptase, these three drugs work in combination to prevent HIV from multiplying and can reduce the amount of HIV in the body. 

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) 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, including Biktarvy, 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. Whether Biktarvy can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking Biktarvy when pregnant.
  • 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, 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 from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

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 the WARNING box above.)

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.
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 at https://www.accessdata.fda.gov/scripts/medwatch/.

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: February 8, 2018

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