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
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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
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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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