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U.S. Department of Health and Human Services

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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 Drug Products
Food and Drug Administration