Label Changes for:

Hepsera (adefovir dipivoxil) 10 mg tablets

October 2009

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009

WARNINGS and PRECAUTIONS

Coadministration with Other Products
  • Hepsera should not be used concurrently with Viread (tenofovir disoproxil fumarate) or tenofovir disoproxil fumarate-containing products including Truvada (emtricitabine/tenofovir disoproxil fumarate combination tablet) and Atripla (efavirenz/emtricitabine/tenofivir disoproxil fumarate combination tablet)

ADVERSE REACTIONS

Post-Marketing Experience
  • Gastrointestinal Disorders: pancreatitis

PATIENT PACKAGE INSERT

  • To add information regarding co-administration of Hepsera with other products containing tenofovir disoproxil fumarate
  • To add side effects associated with Hepsera to the “What are the possible side effects of Hepsera?” section.
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