Label Changes for:
Incivek (telaprevir) film-coated tablets
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
WARNINGS and PRECAUTIONS
- Hemoglobin should be monitored prior to and at least at weeks 2, 4, 8 and 12 during Incivek combination treatment and as clinically appropriate