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U.S. Department of Health and Human Services

For Consumers

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Changes to the Complera (emtricitabine/rilpivirine/tenofovir dispoproxil fumarate) labeling

On June 5, 2014, FDA approved changes to the  Complera (emtricitabine/rilpivirine/tenofovir dispoproxil fumarate) fixed-dose combination tablet labeling to include rilpivirine dose adjustment information when Complera is coadministered with rifabutin.

If Complera is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant) once per day is recommended to be taken concomitantly with Complera and with a meal for the duration of the rifabutin coadministration.

With these new dosing recommendations, rifabutin was removed from the CONTRAINDICATIONS section.

The revised labeling will be posted soon on the Drugs@FDA web page.

Complera is a product of Gilead Sciences, Inc.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration