Prescription medicine
Cabotegravir and rilpivirine Brand names: Cabenuva
Cabotegravir and rilpivirine (Cabenuva) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cabotegravir and rilpivirine FDA label on DailyMed (effective November 26, 2025, ViiV Healthcare Company); the NDA 212888 record on Drugs@FDA; every cabotegravir and rilpivirine label on DailyMed.
Highlights of the record
FDA label of November 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpi
Forms and strengths
Kit.
On the market
- Earliest approval on file
- January 21, 2021 Cabenuva Kit, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- Last listed patent
- October 1, 2040 Cabenuva Kit injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,104 through July 30, 2026
What is cabotegravir and rilpivirine used for?
From the label: indications and usageCABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine [see Microbiology ( 12.4 ), Clinical Studies ( 14.1 )]. […]
Conditions named in the indications of cabotegravir and rilpivirine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Cabenuva), ViiV Healthcare Company, effective November 26, 2025 (SPL set 1698baf3-f895-4c42-a1b1-e9ee3f20da36), via openFDA; the full label on DailyMed
Is there a generic for cabotegravir and rilpivirine (Cabenuva)?
No generic cabotegravir and rilpivirine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 10 patents for Cabenuva Kit injection: the compound patent runs to February 4, 2031, and the last listed entry to October 1, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cabotegravir and rilpivirine label say about other medicines?
The cabotegravir and rilpivirine label names 28 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name cabotegravir and rilpivirine. 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 |
|---|---|---|
| Acetaminophen | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Atazanavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Atorvastatin | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Azithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: Azithromycin Clarithromycin Erythromycin; Effect on Concentration: ↔Cabotegravir ↑Rilpivirine; Clinical Comment: Macrolides are expected to increase concentrations of rilpivirine and are associated with a risk of Torsade de Pointes [see Warnings and … |
| Carbamazepine | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifabutin, rifampin, rifapentine o Glucocorticoid (systemic): |
| Chlorzoxazone | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Clarithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: Azithromycin Clarithromycin Erythromycin; Effect on Concentration: ↔Cabotegravir ↑Rilpivirine; Clinical Comment: Macrolides are expected to increase concentrations of rilpivirine and are associated with a risk of Torsade de Pointes [see Warnings and … |
| Darunavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Dexamethasone | contraindications | Dexamethasone (more than a single-dose treatment) o Herbal product: St John’s wort ( Hypericum perforatum ) |
| Digoxin | drug interactions | Rilpivirine did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin. |
| Dolutegravir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Erythromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: Azithromycin Clarithromycin Erythromycin; Effect on Concentration: ↔Cabotegravir ↑Rilpivirine; Clinical Comment: Macrolides are expected to increase concentrations of rilpivirine and are associated with a risk of Torsade de Pointes [see Warnings and … |
| Etravirine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Levonorgestrel | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
Every other medicine the cabotegravir and rilpivirine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Metformin | drug interactions | Rilpivirine did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin. |
| Methadone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic analgesic: Methadone a; Effect on Concentration: ↔Cabotegravir ↓Methadone ↔Rilpivirine; … |
| Midazolam | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Norethindrone | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Oxcarbazepine | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifabutin, rifampin, rifapentine o Glucocorticoid (systemic): |
| Phenobarbital | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifabutin, rifampin, rifapentine o Glucocorticoid (systemic): |
| Phenytoin | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifabutin, rifampin, rifapentine o Glucocorticoid (systemic): |
| Raltegravir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Rifabutin | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifabutin, rifampin, rifapentine o Glucocorticoid (systemic): |
| Rifampin | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifabutin, rifampin, rifapentine o Glucocorticoid (systemic): |
| Rifapentine | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifabutin, rifampin, rifapentine o Glucocorticoid (systemic): |
| Sildenafil | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Tenofovir alafenamide | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Tenofovir disoproxil | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
Source: FDA drug label (Cabenuva), ViiV Healthcare Company, effective November 26, 2025 (SPL set 1698baf3-f895-4c42-a1b1-e9ee3f20da36), via openFDA; the full label on DailyMed
What do FAERS reports show for cabotegravir and rilpivirine?
The FDA Adverse Event Reporting System holds 6,104 reports that list cabotegravir and rilpivirine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 113 are coded as a death and 252 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,510, against a median of 2 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Cabotegravir and rilpivirine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other