Drug Database: Bictegravir / Lenacapavir

What is Bixlenvo?What is Bixlenvo?

What is Bixlenvo?

Bixlenvo is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV in adults who meet certain requirements, as determined by a health care provider.

Bixlenvo is a complete HIV treatment regimen. Do not take Bixlenvo with other HIV medicines unless your health care provider has prescribed it for use with other HIV medicines.

Bixlenvo contains two different medicines: bictegravir and lenacapavir.

For more information on the use of Bixlenvo in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. (The Adult and Adolescent ARV Guidelines may not yet be updated with information on Bixlenvo at the time this drug record is published. Please refer to the Guidelines as new updates become available.)

HIV medicines cannot cure HIV, but using HIV medicines as directed by a health care provider helps people with HIV live long, healthy lives. HIV medicines also reduce the risk of HIV transmission. If you are using HIV medicines, do not cut down on, skip, or stop using them unless your health care provider tells you to. For more information about using your HIV medicines as prescribed and ways to overcome barriers to medication adherence, please read the HIVinfo fact sheet on HIV Treatment Adherence.

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

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

Before taking Bixlenvo, tell your health care provider:

• If you are allergic to any of the HIV medicines in Bixlenvo (bictegravir or lenacapavir) or any other medicines.
• If you have ever had liver problems, including hepatitis B virus infection (HBV).
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the benefits and risks of taking Bixlenvo during pregnancy. For more information on the use of Bixlenvo 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. (The Perinatal Guidelines may not yet be updated with information on Bixlenvo at the time this drug record is published. Please refer to the Guidelines as new updates become available.)
• If you are breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breastfeeding.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John’s wort) you are taking or plan to take.

How should I take Bixlenvo?How should I take Bixlenvo?

How should I take Bixlenvo?

Bixlenvo comes in tablet form. Each tablet contains:

• 75 mg bictegravir
• 50 mg lenacapavir

Take Bixlenvo according to your health care provider’s instructions. Do not miss a dose of Bixlenvo, and do not change your dose or stop taking Bixlenvo without first talking with your health care provider. While taking Bixlenvo, it is important to keep all your appointments with your health care provider.

On Day 1 and Day 2 of treatment with Bixlenvo, you must take Bixlenvo tablets with lenacapavir (brand name: Sunlenca) tablets. Take Bixlenvo and lenacapavir tablets by mouth, with or without food. It is important that you take Bixlenvo tablets with lenacapavir tablets on the first 2 days, exactly as instructed by your health care provider.

On Day 3 and each day after, you will take 1 Bixlenvo tablet by mouth daily.

If you are taking any other medicines, supplements, antacids, or laxatives that contain magnesium, aluminum, calcium, iron, or zinc, carefully follow your health care provider’s instructions on how to take them with Bixlenvo.

Do not take Bixlenvo with other HIV medicines unless your health care provider has prescribed it for use with other HIV medicines.

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

For more information on how to take Bixlenvo, 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 Bixlenvo or lenacapavir on Day 1 or Day 2, take the missed dose as soon as possible. Do not take Day 1 and Day 2 doses of lenacapavir on the same day.

If you miss a dose of Bixlenvo on Day 3 or after, 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. If you miss a dose of Bixlenvo by more than 7 days, contact your health care provider right away to discuss how to continue your treatment.

What side effects can Bixlenvo cause?What side effects can Bixlenvo cause?

What side effects can Bixlenvo cause?

Bixlenvo may cause side effects. Many side effects from HIV medicines, such as Bixlenvo, are temporary or manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information. The most common side effects of Bixlenvo are headache, nausea, and diarrhea.

Tell your health care provider if you have any side effects that bother you or that do not go away.

These are not all the possible side effects of Bixlenvo. To learn more about possible side effects of Bixlenvo, 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.

What medicines can interact with Bixlenvo?What medicines can interact with Bixlenvo?

What medicines can interact with Bixlenvo?

HIV medicines may interact with other medicines and supplements. Before starting Bixlenvo, tell your health care provider about all the prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Taking Bixlenvo together with certain medicines or products may cause serious side effects.

For a list of medicines that may interact with Bixlenvo, see the drug label or ask your health care provider or pharmacist. You can also look up potential interactions between your HIV medicines and other drugs using the HIV Drug Interaction Checker online.

How should Bixlenvo be stored?How should Bixlenvo be stored?

How should Bixlenvo be stored?

• Store Bixlenvo at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep Bixlenvo 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. Do not eat the desiccant. The desiccant protects the medicine from moisture.
• Do not use Bixlenvo if the original seal over the container opening is broken or missing.
• Throw away Bixlenvo that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep Bixlenvo and all medicines out of reach of children.

Where can I find more information about Bixlenvo?Where can I find more information about Bixlenvo?

Where can I find more information about Bixlenvo?

• For more information on the use of Bixlenvo in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. (The Adult and Adolescent ARV Guidelines may not yet be updated with information on Bixlenvo at the time this drug record is published. Please refer to the Guidelines as new updates become available.)
• This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated). The Patient Package Insert includes information for people taking Bixlenvo.
• Bixlenvo-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.