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.
