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JULUCA (dolutegravir and rilpivirine)FDA Prescribing Information
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--------------------------- INDICATIONS AND USAGE ----------------------------
JULUCA, a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per 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. (1)
----------------------- DOSAGE AND ADMINISTRATION -----------------------
⋅One tablet taken orally once daily with a meal. (2.1)
⋅Rifabutin coadministration: Take an additional 25-mg tablet of rilpivirine with JULUCA once daily
Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for themaintenance treatment of virologically suppressed HIV-1 infection - PRESS RELEASE - (11/28/17)
FDA approves first two-drug regimen for certain patients with HIV - Fixed Dose dolutegravir and rilpivirine - FDA News Release - (11/28/17)

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