Capecitabine

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

The FDA recommends, but does not require, genetic testing prior to initiating treatment with capecitabine.

Capecitabine is a pro-drug of 5-fluorouracil used for the treatment of various types of neoplasms including colorectal and breast neoplasms. Variants in the DPYD gene (also known as dihydropyrimidine dehydrogenase and DPD) are associated with increased risk for adverse events. See the Fluroropyrimidine Pathway and DPYD VIP for more information.

Excerpts from the capecitabine (Xeloda) drug label:

Capecitabine "is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency."

"Rarely, unexpected, severe toxicity (eg, stomatitis, diarrhea, neutropenia and neurotoxicity) associated with 5-fluorouracil has been attributed to a deficiency of dihydropyrimidine dehydrogenase (DPD) activity. A link between decreased levels of DPD and increased, potentially fatal toxic effects of 5-fluorouracil therefore cannot be excluded."

The label also notes drug-drug interactions with warfarin and phenytoin and cautions that "care should be exercised when XELODA is coadministered with CYP2C9 substrates."

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Capecitabine drug label PDF.

*Disclaimer: The contents of this page have not been endorsed by the FDA and are the sole responsibility of PharmGKB.