Label Changes for:
Atripla (Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate) Tablets
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
WARNINGS AND PRECAUTIONS
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…