"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
You may also be interested in...
Roche is preparing a letter to physicians highlighting a black box warning about interactions between Xeloda (capecitabine) and warfarin following FDA's Sept. 7 approval of the labeling change.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011