Medication Guide App

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)…

 

Hide
(web2)