Edurant Label Update to Include Long-Term Use and Hepatotoxicity Data

Edurant Label Update to Include Long-Term Use and Hepatotoxicity Data
Edurant Label Update to Include Long-Term Use and Hepatotoxicity Data

Janssen announced that the FDA has approved a prescribing information update for Edurant (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies. The ECHO and THRIVE studies evaluated the efficacy and safety of Edurant for the treatment of HIV-1 in antiretroviral treatment-naïve adults.

In addition to the clinical trials update, the Indications and Usage section was revised to: EDURANT®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. This indication is based on safety and efficacy analyses through 96 weeks from two randomized, double-blind, active-controlled Phase 3 trials in treatment-naive subjects.

The Warnings and Precautions section was also updated with information on hepatotoxicity. It now states that patients with underlying hepatic disease, including hepatitis B or C, or marked elevations in transaminases before treatment may be at increased risk for worsening or development of liver enzyme elevations.

Edurant is a non-nucleoside reverse transcriptase inhibitor indicated for HIV-1 infection in antiretroviral treatment-naïve adult patients, in combination with other antiretroviral agents.

For more information call (800) 526-7736 or visit www.edurant.com.