- Interaction with oral coumarin derivative anticoagulants. Altered coagulation parameters, bleeding and death have been reported with this combination.
- Increases in INR have occurred several days up to several months after initiating capecitabine, and in some cases, within one month after stopping the capecitabin.
- These events have occurred in patients with and without liver metastases.
- Age greater than 60 years and a diagnosis of cancer are independent risk factors for risk of coagulopathy.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- INRs or prothrombin time monitoring required with great frequency and appropriate adjustment of anticoagulant dose
Patient Counseling Information
Updated January 2018