Fixed-dose combination
Cabotegravir and Rilpivirine is a fixed-dose combination medicine indicated as a complete regimen for the treatment of HIV-1 infection in adults, among other approved uses. It is available as kits. MedsAcross supplies Cabotegravir and Rilpivirine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CABENUVA 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.
Source: US FDA prescribing information
CABENUVA contains 2 long-acting HIV-1 antiretroviral drugs, cabotegravir and rilpivirine.
Source: US FDA prescribing information
• Refer to full prescribing information for detailed information on dosage and administration recommendations. • Prior to initiating treatment with CABENUVA, oral lead-in dosing may be considered to assess the tolerability of cabotegravir and rilpivirine with the recommended dosage used for approximately 1 month. • For gluteal intramuscular injection only. • Recommended Monthly Dosing Schedule: Initiate injections of CABENUVA (600 mg of cabotegravir and 900 mg of rilpivirine) on the last day of current antiretroviral therapy or oral lead-in and continue with injections of CABENUVA (400 mg of cabotegravir and 600 mg of rilpivirine) every month thereafter.
Source: US FDA prescribing information
CABENUVA is contraindicated in patients: • with previous hypersensitivity reaction to cabotegravir or rilpivirine. • receiving the following coadministered drugs for which significant decreases in cabotegravir and/or rilpivirine plasma concentrations may occur due to uridine diphosphate glucuronosyltransferase (UGT)1A1 and/or cytochrome P450 (CYP)3A enzyme induction, which may result in loss of virologic response: o Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifabutin, rifampin, rifapentine o Glucocorticoid (systemic): Dexamethasone (more than a single-dose treatment) o Herbal product: St John’s wort ( Hypericum perforatum ) • Previous hypersensitivity reaction to cabotegravir or rilpivirine.
Source: US FDA prescribing information
• Serious or severe hypersensitivity reactions have been reported with cabotegravir- and rilpivirine-containing regimens. Reactions associated with cabotegravir include Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). Reactions associated with rilpivirine-containing regimens include cases of drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. • Serious post-injection reactions with rilpivirine were reported. Monitor and treat as clinically indicated. • Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine. Monitoring of liver chemistries is recommended. Discontinue CABENUVA if hepatotoxicity is suspected. • Depressive disorders have been reported with CABENUVA. Prompt evaluation is recommended for depressive symptoms.
Source: US FDA prescribing information
The following adverse reactions are described below and in other sections of the labeling: • Hypersensitivity reactions • Post-injection reactions • Hepatotoxicity • Depressive disorders The most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.
Source: US FDA prescribing information
• Refer to the full prescribing information for important drug interactions with CABENUVA. • Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. • Drugs that induce uridine diphosphate glucuronosyltransferase (UGT)1A1 or cytochrome P450 (CYP)3A4 may decrease the plasma concentrations of the components of CABENUVA. • CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes.
Source: US FDA prescribing information
Store CABENUVA in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton until ready to use. Do not freeze. Prior to administration, vials should be brought to room temperature (not to exceed 25°C [77°F]). Vials may remain in the carton at room temperature for up to 6 hours, do not put back into the refrigerator. The filled syringes should not be placed in the refrigerator.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Cabotegravir and Rilpivirine, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Cabenuva kit Cold chain | Cabotegravir and Rilpivirine | ViiV Healthcare | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 21 January 2021 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Cabotegravir and Rilpivirine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Cabotegravir and Rilpivirine, including Cabenuva.
Yes. The US FDA first approved Cabotegravir and Rilpivirine on 21 January 2021, according to Drugs@FDA.
At least one listed presentation of Cabotegravir and Rilpivirine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.