Label Changes for:

Incivek (telaprevir) film-coated tablets

June 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) – March and June 2012

 

June 2012

WARNINGS and PRECAUTIONS

Anemia
  • Hemoglobin should be monitored prior to and at least at weeks 2, 4, 8 and 12 during Incivek combination treatment and as clinically appropriate
Laboratory Tests
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