FDA label
What is Edurant used for?
Edurant contains rilpivirine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Edurant lists 2 uses: Treatment of HIV-1 in Treatment-Naïve Patients; Treatment of HIV-1 in Combination with Cabotegravir.
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Edurant, tablet, film coated
Indications and Usage, quoted from the label by Janssen Products, LP (NDA202022). Cross-references to other label sections are left out.
Treatment of HIV-1 in Treatment-Naïve Patients
EDURANT and EDURANT PED, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 2 years of age and older and weighing at least 14 kg with plasma HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
Limitations of Use
- More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies].
Treatment of HIV-1 in Combination with Cabotegravir
EDURANT is indicated in combination with VOCABRIA (cabotegravir) for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 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, for use as [see Dosage and Administration]:
- oral lead-in to assess the tolerability of rilpivirine prior to administration of rilpivirine extended-release injectable suspension, a component of CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension).
- oral therapy for patients who will miss planned injection dosing with CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension).
Source: DailyMed label, set id 03880372-2c68-45c6-a53a-f420c49541d6, version 28, effective August 28, 2025. NDC 59676-278, one of 1 listing for this product.
Questions
What is Edurant used for?
The FDA label for Edurant lists 2 uses: Treatment of HIV-1 in Treatment-Naïve Patients; Treatment of HIV-1 in Combination with Cabotegravir.
What drug class is Edurant?
FDA lists rilpivirine in the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.