Label Changes for:

Epzicom (abacavir sulfate and lamivudine) tablets

March 2009

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

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

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

Sections Modified

 

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

  • Myocardial Infarction
    • In a published...the use of abacavir within the previous 6 months was correlated with an increased risk of myocardial infarction (MI)...

MEDICATION GUIDE

  • revised to include information related to myocardial infarction

BOXED WARNING

  • Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitvity reaction to abacavir. Prior to initiating therapy .....
  • Regardless of HLA-B*5701 status permanently discontinue Epzicom if hypersensitivity cannot be ruled out...
  • Following a hypersensitivity reaction to abacavir, NEVER restart Epzicom... severe symptoms can occur within hours .....
  • Reintroduction of Epzicom or any other abacavir-containing product...can result in serious or fatal .....

CONTRAINDICATIONS

  • Never restart Epzicom or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status....

WARNINGS

  • ...Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir...
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