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U.S. Department of Health and Human Services

Safety

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Hepsera (adefovir dipivoxil) 10 mg tablets

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

 

Summary View

 

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.