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Roche Xeloda

Executive Summary

"Dear Doctor" letter issued warning of potential interaction of capecitabine with coumarin derivatives. "The time of occurrence of these events (altered coagulation parameters and/or bleeding) ranged from several days to several months after starting Xeloda therapy and, in isolated cases, occurred within one month after the last dose," the March letter states. "Patients taking Xeloda with concomitant coumarin derivatives should be monitored regularly for alterations in their coagulation parameters (PT or INR)." Language describing the coagulopathy has been added to the "Warnings" section of labeling, and a description of the drug-drug interactions has been added to the "Precautions" section
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