These highlights do not include all the information needed to use XELODA ® safely and effectively. See full prescribing information for XELODA ®.
XELODA ® (capecitabine) tablets, for oral use
Initial U.S. Approval: 1998
WARNING: XELODA-WARFARIN INTERACTION
See full prescribing information for complete boxed warning.
Patients receiving concomitant XELODA and oral coumarin-derivative anticoagulants such as warfarin and phenprocoumon should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. Altered coagulation parameters and/or bleeding, including death, have been reported during concomitant use.
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Occurrence: Within several days and up to several months after initiating XELODA therapy; may also be seen within 1 month after stopping XELODA
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Predisposing factors: age>60 and diagnosis of cancer
RECENT MAJOR CHANGES
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Dosage and Administration (2.0) |
10/2014 |
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Contraindications (4.1) |
02/2015 |
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Warnings and Precautions (5.1, 5.2, 5.5, and 5.7) |
10/2014 |
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Warnings and Precautions (5.4) |
02/2015 |
INDICATIONS AND USAGE
XELODA (capecitabine) is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
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Adjuvant Colon Cancer (1.1)
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Patients with Dukes' C colon cancer
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Metastatic Colorectal Cancer (1.1)
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First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred
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Metastatic Breast Cancer (1.2)
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In combination with docetaxel after failure of prior anthracycline-containing therapy
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As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen
DOSAGE AND ADMINISTRATION
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Take XELODA with water within 30 min after a meal (2)
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Monotherapy: 1250 mg/m2 twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles (2.1)
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Adjuvant treatment is recommended for a total of 6 months (8 cycles) (2.1)
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In combination with docetaxel, the recommended dose of XELODA is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1-hour IV infusion every 3 weeks (2.1)
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XELODA dosage may need to be individualized to optimize patient management (2.2)
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Reduce the dose of XELODA by 25% in patients with moderate renal impairment (2.3)
DOSAGE FORMS AND STRENGTHS
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Tablets: 150 mg and 500 mg (3)
CONTRAINDICATIONS
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Severe Renal Impairment (4.1)
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Hypersensitivity (4.2)
WARNINGS AND PRECAUTIONS
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Coagulopathy: May result in bleeding, death. Monitor anticoagulant response (e.g., INR) and adjust anticoagulant dose accordingly. (5.1)
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Diarrhea: May be severe. Interrupt XELODA treatment immediately until diarrhea resolves or decreases to grade 1. Recommend standard antidiarrheal treatments. (5.2)
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Cardiotoxicity: Common in patients with a prior history of coronary artery disease. (5.3)
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Increased Risk of Severe or Fatal Adverse Reactions in Patients with Low or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity: Withhold or permanently discontinue XELODA in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity. No XELODA dose has been proven safe in patients with absent DPD activity. (5.4)
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Dehydration and Renal Failure: Interrupt XELODA treatment until dehydration is corrected. Potential risk of acute renal failure secondary to dehyd
