What are the most important things to know about Biktarvy?
Biktarvy can cause serious, life-threatening side effects. These include a buildup ofin the blood ( ), problems, new or worsening problems, including kidney failure, and .
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 ( )
- 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/abdominal area
If you have both HIV and(HBV) and take Biktarvy, your HBV may get worse (flare up) if you stop taking Biktarvy. Do not stop taking Biktarvy without first talking with your health care provider.
Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called), which may be related to tenofovir-containing drugs:
- Bone pain that does not go away or gets worse
- Pain in your arms, hands, legs, or feet
- Broken bones
- Muscle pain or weakness
Taking Biktarvy with certain other medicines may cause 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?
Biktarvy is a prescription medicine approved by the U.S.(FDA) for the treatment of HIV infection in adults and children weighing at least 31 lb (14 kg) and who meet certain requirements, as determined by a health care provider.
Biktarvy is a complete HIVand should not be used with other HIV medicines.
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 with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
HIV medicines cannot 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. If you are taking HIV medicines, do not 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?
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 problems, including
- If you have 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 During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
- If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, , or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo
- 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?
Biktarvy comes in tablet form in two different strengths:
- 50 mg bictegravir, 200 mg emtricitabine, 25 mg tenofovir alafenamide
- 30 mg bictegravir, 120 mg emtricitabine, 15 g tenofovir alafenamide
Take Biktarvy according to your health care provider’s instructions. Do not miss a
Take Biktarvy by mouth with or without food. If you are taking any other medicines or supplements, including ; laxatives; other products containing aluminum or magnesium; buffered medicines; iron; or calcium, carefully follow instructions on how to take them with Biktarvy.
If you are receiving dialysis, take your daily dose of Biktarvy after dialysis.
For children who cannot swallow a whole tablet, the tablet can be split and each part should be swallowed separately within approximately 10 minutes.
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?
If you miss aof 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?
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 (called 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 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?
- 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 ), 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?
- 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 with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
- This Patient Version drug summary is based on the following FDA label(s): Tablet. The Patient Package Insert includes information for people taking Biktarvy.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for bictegravir, emtricitabine, and tenofovir alafenamide available from MedlinePlus.
- Biktarvy-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
- A list of FDA-approved HIV medicines, from HIVinfo.
Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056
Last Reviewed: March 20, 2023