translation agency

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

<p>Richard Klein and Kimberly Struble</p>

November 30, 2012

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