Drug information

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Brand Name:
Biktarvy
Other Names:
BIC / FTC / TAF, bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate
Drug Class:
Combination Drugs
Integrase Strand Transfer Inhibitor (bictegravir)
Nucleoside Reverse Transcriptase Inhibitor (emtricitabine, tenofovir alafenamide)
Drug Image(s): (Click to enlarge)
 
What are the most important things to know about Biktarvy? 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), liver problems, new or worsening kidney problems, including kidney failure, and drug interactions. 

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

  • Weakness or tiredness
  • Unusual muscle pain
  • Shortness of breath or fast breathing
  • Stomach pain with nausea and vomiting
  • Cold or blue hands and feet
  • Dizziness or lightheadedness
  • Fast or abnormal 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
  • Nausea or vomiting
  • Pain, aching, or tenderness on the right side of your stomach area
  • Itching

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. Do not run out of Biktarvy or stop taking Biktarvy without talking to your health care provider.

Some people taking Biktarvy have developed new or worsening kidney problems, including kidney failure. Blood and urine tests are used to check the kidneys before and during treatment with Biktarvy.

Taking Biktarvy with certain medicines may result in serious, life-threatening side effects. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

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

What is Biktarvy?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) and who meet certain requirements, as determined by a health care provider.

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

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

For more information on the use of Biktarvy in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric Patients with HIV Infection

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?

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, or tenofovir alafenamide) or any other medicines.
  • If you have liver problems, including hepatitis B virus infection (HBV).
  • If you have kidney problems.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Biktarvy during pregnancy. For more information on the use of Biktarvy during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States
  • If you are breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
  • 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 HIVinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) 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, life-threatening side effects. 
How should I take 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 by mouth with or without food. If you are taking any other medicines or supplements, including antacids, carefully follow instructions on how to take them with Biktarvy.

Do not take Biktarvy with other HIV medicines.

If you have taken 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?

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?

What side effects can Biktarvy cause?

 

Biktarvy may cause side effects. Some side effects of Biktarvy can be serious, as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

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.
  • Diarrhea and headache.


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?

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?

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

 

Last Reviewed: March 1, 2021