Fixed-dose combination
Dolutegravir and Rilpivirine is a fixed-dose combination of a human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor and a human immunodeficiency virus integrase strand transfer inhibitor. It is available as tablets for oral use. MedsAcross supplies Dolutegravir 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.
JULUCA 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/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA.
Source: US FDA prescribing information
JULUCA is a fixed-dose combination of the HIV-1 antiretroviral agents, dolutegravir and rilpivirine.
Source: US FDA prescribing information
• One tablet taken orally once daily with a meal. • Rifabutin coadministration: Take an additional 25-mg tablet of rilpivirine with JULUCA once daily with a meal for the duration of the rifabutin coadministration.
Source: US FDA prescribing information
JULUCA is contraindicated in patients: • with previous hypersensitivity reaction to dolutegravir or rilpivirine. • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events. • receiving other coadministered drugs in Table 1 that significantly decrease rilpivirine plasma concentrations. Table 1. Drugs That Are Contraindicated with JULUCA Drug Class Contraindicated Drugs in Class Clinical Comment Antiarrhythmic Dofetilide Potential for serious and/or life-threatening events due to the potential for increased dofetilide plasma concentrations.
Source: US FDA prescribing information
• Severe skin and hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue JULUCA immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. • Hepatotoxicity has been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen. Monitoring for hepatotoxicity is recommended. • Depressive disorders have been reported with the use of rilpivirine- or dolutegravir-containing regimens. Immediate medical evaluation is recommended for severe depressive symptoms.
Source: US FDA prescribing information
The following adverse reactions are described below and in other sections of the labeling: • Skin and hypersensitivity reactions. • Hepatotoxicity. • Depressive disorders. The most common adverse reactions (all grades) observed in at least 2% of subjects were diarrhea, headache, and nausea.
Source: US FDA prescribing information
• Because JULUCA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. • Refer to the full prescribing information for important drug interactions with JULUCA. • Drugs that induce or inhibit cytochrome P450 (CYP)3A4 or uridine diphosphate glucuronosyltransferase (UGT)1A1 may affect the plasma concentrations of the components of JULUCA. • Drugs that increase gastric pH or containing polyvalent cations may decrease plasma concentrations of the components of JULUCA. • Consider alternatives to prescribing JULUCA with drugs with a known risk of Torsade de Pointes.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Dolutegravir and Rilpivirine, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Juluca 50 mg/25 mg tabletOral | Dolutegravir 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.
Yes, on request. MedsAcross lists 1 presentations of Dolutegravir and Rilpivirine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Dolutegravir and Rilpivirine, including Juluca.
Yes. The US FDA first approved Dolutegravir and Rilpivirine on 21 November 2017, according to Drugs@FDA.
Yes. Dolutegravir and Rilpivirine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Dolutegravir and Rilpivirine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Dolutegravir and Rilpivirine is classified under ATC code J05AR21 (Dolutegravir and Rilpivirine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.