Label Changes for:
Hepsera (adefovir dipivoxil) Tablets
November 2012
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2012
WARNINGS AND PRECAUTIONS
Coadministration with Other Products
- HEPSERA should not be used concurrently with ...STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate combination tablet)
PATIENT INFORMATION
Patients should be advised that:
- HEPSERA should not be administered concurrently with ... or STRIBILD
February 2012
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 Truva(emtricitabine/tenofovir disoproxil fumarate combination tablet), Atripla(efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablet) and Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate).
ADVERSE REACTIONS
Post-Marketing Experience
- Musculoskeletal System and Connective Tissue Disorders: myopathy, osteomalacia (manifested as bone pain and may contribute to fractures), both associated with proximal renal tubulopathy
PATIENT INFORMATION
What is the most important information I should know about Hepsera?
- You may be more likely to get lactic acidosis or serious liver problems if you are very overweight (obese) or have been taking nucleoside analog medicines [Atripla (efavirenz plus emtricitabine plus tenofovir disoproxil fumarate), Complera (emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate)…
