Serious Adverse Reactions Or Death In Patients With Complete DPD Deficiency and Bleeding With Concomitant Use of Vitamin K Antagonists  

Serious adverse reactions or death may occur in patients with complete DPD deficiency. Test patients for genetic variants of DPYD prior to initiating capecitabine unless immediate treatment is necessary. Avoid use of capecitabine in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. (5.1)

Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine concomitantly with oral vitamin K antagonists. (5.2, 7.2) Monitor international normalized ratio (INR) more frequently and adjust the dose of the vitamin K antagonist as appropriate. (7.2)