HIV/AIDS Update - Hepsera (adefovir dipivoxil) package insert updated to add new safety information

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: HIV/AIDS Update - Hepsera (adefovir dipivoxil) package insert updated to add new safety information

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

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

 

.

 

If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDA Patient Network News, a twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420