Quick answers
- What is Bictegravir/lenacapavir used for?
- The FDA-approved label (Bixlenvo, Gilead Sciences, Inc., August 27, 2026) says: “BIXLENVO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bictegravir/lenacapavir have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bictegravir/lenacapavir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bictegravir/lenacapavir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Bictegravir/lenacapavir?
- 1 company lists prescription products of Bictegravir/lenacapavir in the FDA NDC Directory, including Gilead Sciences, Inc..
What Bictegravir/lenacapavir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BIXLENVO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO […]. …
— FDA label: Bixlenvo, Gilead Sciences, Inc., effective August 27, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Bixlenvo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Gilead Sciences, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA221104 BIXLENVO | Gilead Sciences Inc | August 27, 2026 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2750177, 2750183 |
|---|---|
| SPL set ID of the quoted label | 072a3c7e-33fb-4a87-ba21-3d8dad3f5c48 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA221104 |
| Active ingredients (FDA) | BICTEGRAVIR / LENACAPAVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bixlenvo, Gilead Sciences, Inc., effective August 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →