Prescription medicine
Bictegravir and lenacapavir Brand names: Bixlenvo
Bictegravir and lenacapavir (Bixlenvo) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the bictegravir and lenacapavir FDA label on DailyMed (effective August 27, 2026, Gilead Sciences, Inc.); the NDA 221104 record on Drugs@FDA; every bictegravir and lenacapavir label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBIXLENVO 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 [see Clinical Studies (14) ].
Forms and strengths
- 75 mg / 50 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 27, 2026 Bixlenvo, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is bictegravir and lenacapavir used for?
From the label: indications and usageBIXLENVO 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 [see Clinical Studies (14) ]. […]
Conditions named in the indications of bictegravir and lenacapavir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus 1 Capsid Inhibitor.
Source: FDA drug label (BIXLENVO), Gilead Sciences, Inc., effective August 27, 2026 (SPL set 072a3c7e-33fb-4a87-ba21-3d8dad3f5c48), via openFDA; the full label on DailyMed
Is there a generic for bictegravir and lenacapavir (Bixlenvo)?
No generic bictegravir and lenacapavir is approved (Drugs@FDA, October 8, 2026).
- 2026 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the bictegravir and lenacapavir label say about other medicines?
The bictegravir and lenacapavir label names 33 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine | drug interactions | Initiation of BIXLENVO in patients taking buprenorphine or methadone: A dose adjustment for buprenorphine or methadone may be needed. Monitor clinical signs and symptoms. |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↓ lenacapavir ↓ bictegravir; Clinical Comment: Concomitant administration with carbamazepine or phenytoin is contraindicated. … |
| Cortisone | drug interactions | Concomitant Drug Class/Drug Name: Corticosteroids (systemic): cortisone/hydrocortisone dexamethasone; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ corticosteroids (systemic) ↓ lenacapavir (dexamethasone); … |
| Dabigatran | drug interactions | Concomitant Drug Class/Drug Name: Anticoagulants: Direct Oral Anticoagulants (DOACs) rivaroxaban dabigatran edoxaban; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ DOAC; Clinical Comment: Refer to the DOAC prescribing information for concomitant administration with moderate CYP3A inhibitors and/or P-gp … |
| Dexamethasone | drug interactions | Concomitant Drug Class/Drug Name: Corticosteroids (systemic): cortisone/hydrocortisone dexamethasone; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ corticosteroids (systemic) ↓ lenacapavir (dexamethasone); … |
| Digoxin | drug interactions | Concomitant Drug Class/Drug Name: Antiarrhythmics: digoxin dofetilide; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ digoxin ↑ dofetilide; Clinical Comment: Use digoxin with caution and monitor digoxin therapeutic concentration. … |
| Dihydroergotamine | drug interactions | Concomitant Drug Class/Drug Name: Ergot derivatives: dihydroergotamine ergotamine methylergonovine; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ dihydroergotamine ↑ ergotamine ↑ methylergonovine; … |
| Dofetilide | contraindications | CONTRAINDICATIONS Concomitant administration of BIXLENVO is contraindicated with: dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events. … |
| Edoxaban | drug interactions | Concomitant Drug Class/Drug Name: Anticoagulants: Direct Oral Anticoagulants (DOACs) rivaroxaban dabigatran edoxaban; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ DOAC; Clinical Comment: Refer to the DOAC prescribing information for concomitant administration with moderate CYP3A inhibitors and/or P-gp … |
| Ergotamine | drug interactions | Concomitant Drug Class/Drug Name: Ergot derivatives: dihydroergotamine ergotamine methylergonovine; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ dihydroergotamine ↑ ergotamine ↑ methylergonovine; … |
| Fentanyl | drug interactions | Concomitant Drug Class/Drug Name: Narcotic analgesics metabolized by CYP3A: e.g., fentanyl, oxycodone; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ fentanyl ↑ oxycodone; Clinical Comment: Careful monitoring of therapeutic effects and adverse reactions associated with CYP3A-metabolized narcotic analgesics … |
| Hydrocortisone | drug interactions | Concomitant Drug Class/Drug Name: Corticosteroids (systemic): cortisone/hydrocortisone dexamethasone; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ corticosteroids (systemic) ↓ lenacapavir (dexamethasone); … |
| Lovastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA Reductase Inhibitors: lovastatin simvastatin; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ lovastatin ↑ simvastatin; Clinical Comment: Initiate lovastatin and simvastatin with the lowest starting dose and titrate carefully while monitoring for safety (e.g., myopathy). |
| Metformin | drug interactions | Concomitant Drug Class/Drug Name: Metformin; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ metformin; Clinical Comment: Refer to the prescribing information of metformin for assessing the benefit and risk of concomitant use of BIXLENVO and metformin. |
Every other medicine the bictegravir and lenacapavir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Methadone | drug interactions | Initiation of BIXLENVO in patients taking buprenorphine or methadone: A dose adjustment for buprenorphine or methadone may be needed. Monitor clinical signs and symptoms. |
| Methylergonovine | drug interactions | Concomitant Drug Class/Drug Name: Ergot derivatives: dihydroergotamine ergotamine methylergonovine; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ dihydroergotamine ↑ ergotamine ↑ … |
| Midazolam | drug interactions | Concomitant Drug Class/Drug Name: Sedatives/Hypnotics: midazolam (oral) triazolam; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ midazolam (oral) ↑ triazolam; … |
| Naloxegol | drug interactions | Concomitant Drug Class/Drug Name: Opioid Antagonist: Naloxegol; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ naloxegol; Clinical Comment: Avoid use with BIXLENVO; … |
| Oxcarbazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↓ lenacapavir ↓ bictegravir; … |
| Oxycodone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic analgesics metabolized by CYP3A: e.g., fentanyl, oxycodone; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ fentanyl ↑ oxycodone; … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↓ lenacapavir ↓ bictegravir; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↓ lenacapavir ↓ bictegravir; … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin Drug-drug interaction study was conducted for components of BIXLENVO dosed as individual agents (BIC or LEN). rifampin rifapentine; … |
| Rifampin | drug interactions | … for components of BIXLENVO dosed as individual agents (BIC or LEN). rifampin rifapentine; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↓ lenacapavir ↓ bictegravir; … |
| Rifapentine | drug interactions | … components of BIXLENVO dosed as individual agents (BIC or LEN). rifampin rifapentine; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↓ lenacapavir ↓ bictegravir; … |
| Rivaroxaban | drug interactions | Concomitant Drug Class/Drug Name: Anticoagulants: Direct Oral Anticoagulants (DOACs) rivaroxaban dabigatran edoxaban; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ DOAC; … |
| Sildenafil | drug interactions | Concomitant Drug Class/Drug Name: Phosphodiesterase-5 (PDE-5) Inhibitors: sildenafil tadalafil vardenafil; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ PDE-5 inhibitors; … |
| Simvastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA Reductase Inhibitors: lovastatin simvastatin; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ lovastatin ↑ simvastatin; … |
| Sucralfate | drug interactions | … Calcium or iron supplements Cation-containing antacids or laxatives Sucralfate Buffered medications; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↓ bictegravir; … |
| Tadalafil | drug interactions | Concomitant Drug Class/Drug Name: Phosphodiesterase-5 (PDE-5) Inhibitors: sildenafil tadalafil vardenafil; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ PDE-5 inhibitors; … |
| Tramadol | drug interactions | Concomitant Drug Class/Drug Name: Tramadol; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ tramadol; Clinical Comment: A decrease in dose may be needed for tramadol with concomitant use. |
| Triazolam | drug interactions | Concomitant Drug Class/Drug Name: Sedatives/Hypnotics: midazolam (oral) triazolam; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ midazolam (oral) ↑ triazolam; … |
| Vardenafil | drug interactions | Concomitant Drug Class/Drug Name: Phosphodiesterase-5 (PDE-5) Inhibitors: sildenafil tadalafil vardenafil; Effect on Concentration ↑ = Increase, ↓ = Decrease: ↑ PDE-5 inhibitors; … |
Source: FDA drug label (BIXLENVO), Gilead Sciences, Inc., effective August 27, 2026 (SPL set 072a3c7e-33fb-4a87-ba21-3d8dad3f5c48), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as bictegravir and lenacapavir?
42 other medicines are given the same way (oral) and in the same FDA class as bictegravir and lenacapavir or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
| Darunavir | HIV | 13 labelers | $1.16 per tablet 600 mg tablet | No current entry |
| Lamivudine | HIV | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Maraviroc | HIV | 8 labelers | $9.15 per tablet 150 mg tablet | A presentation being discontinued |
| Atazanavir | HIV | 4 labelers | $2.23 per capsule 300 mg capsule | No current entry |
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
Every medicine labeled for the same conditions as bictegravir and lenacapavir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to bictegravir and lenacapavir
- 42 medicines for the same use
- Other human immunodeficiency virus 1 capsid inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other