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Hepsera (adefovir dipivoxil) package insert updated to add new safety information


On November 28, 2012, FDA approved a labeling change for the Hepsera (adefovir dipivoxil) package insert to include the following information under Section 5.5, Coadministration with Other Products, and to Section 17.1, Patient Counseling Information/Instructions for Safe Use.

  • Hepsera should not be used concurrently with Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disporoxil fumarate combination tablet).

Hepsera is nucleotide analogue for the treatment of chronic hepatitis B infection, manufactured by Gilead Sciences.

The complete, up-to-date Hepsera label may be viewed at Drugs@FDA

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration


Copyright © 2012 -FDA News, Publisher. All rights reserved to Food and Drug (FDA) Administration FDA.

Information in this article was accurate in November 30, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.