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Label Changes for:

Atripla (Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate) Tablets

April 2013

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013



Coadministration with Related Products
  • Related drugs not for coadministration with Atripla include Complera (emtricitabine/rilpivirine/tenofovir DF), Emtriva (emtricitabine), Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir DF), Truvada (emtricitabine/tenofovir DF), and Viread (tenofovir DF), which contain the same active components as Atripla…
  • For patients who have had a life-threatening cutaneous reaction (eg, Stevens-Johnson syndrome), alternative therapy should be considered…