FDA label
What is Juluca used for?
Juluca contains dolutegravir and 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 says: “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...”
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Juluca, tablet, film coated
Indications and Usage, quoted from the label by ViiV Healthcare Company (NDA210192). Cross-references to other label sections are left out.
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: DailyMed label, set id 806653d1-bf35-4924-b999-ad5d21821cc1, version 16, effective October 29, 2025. NDC 49702-242, one of 1 listing for this product.
Questions
What is Juluca used for?
The FDA label says: “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...”
What drug class is Juluca?
FDA lists dolutegravir and rilpivirine in the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Integrase Strand Transfer 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.
More on Juluca
- Is Juluca a controlled substance?Federal schedule
- Generic for JulucaFDA Orange Book
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Integrase Strand Transfer Inhibitors listFDA drug class
- Juluca Medicare Part D coverageBy plan and state
- NDC 49702-242Juluca NDC record