Monograph Details

Neoplasms > Antimetabolites
XELODA
Manufacturer
Roche Laboratories
Legal Classification
Rx
Pharmacological Class
Fluoropyrimidine.
Generic Name
Capecitabine (prodrug of 5-fluorouracil) 150mg, 500mg; tabs.
Indications
Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel when further anthracycline therapy is not indicated (eg, prior cumulative doses of 400mg/m2 of doxorubicin or its equivalents). With docetaxel for metastatic breast cancer after failure of prior anthracycline-containing regimen. First-line treatment of metastatic colorectal carcinoma when fluoropyrimidine therapy alone is preferred. Adjuvant treatment of Dukes' C colon cancer after complete resection of the primary tumor when fluoropyrimidine therapy alone is preferred.
Children
<18yrs: not recommended.
Adults
See literature. Give cyclically (2 weeks on, 1 week off). Take with water within 30 minutes after AM & PM meals. ≥18yrs: 1250mg/m2 twice daily. Dukes' C colon cancer: continue for a total of 8 cycles. Combination therapy: give with docetaxel 75mg/m2 IV infused over 1 hour every 3 weeks. Interrupt, adjust dose, and/or treat symptoms if toxicity occurs (eg, hyperbilirubinemia, diarrhea, nausea, vomiting, hand-and-foot syndrome, stomatitis) (see literature); do not increase dose afterwards. Renal impairment (CrCl 51–80mL/min): monitor carefully; (CrCl 30–50mL/min): reduce capecitabine dose to 75% of starting dose (ie, 950mg/m2 twice daily).
Contraindications
Severe renal impairment (CrCl <30mL/min). Dihydropyrimidine dehydrogenase deficiency. Pregnancy (Cat.D), nursing mothers: not recommended.
Precautions
Hepatic or renal dysfunction. Coronary artery disease. Elderly (≥80years).
Interactions
Potentiated by leucovorin. Monitor warfarin, other CYP2C9 substrates, phenytoin.
Adverse Reactions
Diarrhea, lymphopenia, necrotizing enterocolitis, hand-and-foot syndrome, GI upset, stomatitis, fatigue, dermatitis, anorexia, cardiotoxicity, bone marrow suppression, blood dyscrasias, hyperbilirubinemia, paresthesias, eye irritation, fever, headache, edema, dizziness, insomnia, myalgia, dehydration, nail disorder, limb pain, skin discoloration, alopecia.
How Supplied
Tabs 150mg—60
500mg—120
Additional Resources
Related Prescribing Note