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XELODA(capecitabine) tablet, film coated
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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use XELODA® safely and effectively. See full prescribing information for XELODA®.XELODA® (capecitabine) Tablets, Film Coated for Oral useInitial U.S. Approval: 1998
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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
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INDICATIONS AND USAGE
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XELODA (capecitabine) is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
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Adjuvant Colon Cancer (1.1)–Patients with Dukes' C colon cancer
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Metastatic Colorectal Cancer (1.1) –First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred
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Metastatic Breast Cancer (1.2) –In combination with docetaxel after failure of prior anthracycline-containing therapy–As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen
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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)
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DOSAGE FORMS AND STRENGTHS
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Tablets: 150 mg and 500 mg (3)
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CONTRAINDICATIONS
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Dihydropyrimidine dehydrogenase (DPD) deficiency (4.1)
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Severe Renal Impairment (4.2)
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Hypersensitivity (4.3)
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WARNINGS AND PRECAUTIONS
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Diarrhea: May be severe. Interrupt XELODA treatment immediately until diarrhea resolves or decreases to grade 1. Recommend standard antidiarrheal treatments. (5.1)
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Coagulopathy: May result in bleeding, death. Monitor anticoagulant response (e.g., INR) and adjust anticoagulant dose accordingly. (5.2)
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Cardiotoxicity: Common in patients with a prior history of coronary artery disease. (5.3)
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Pregnancy: Can cause fetal harm. Advise women of the potential risk to the fetus. (5.6, 8.1)
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Hand-and-Foot Syndrome (Grade 2 or 3): Interrupt XELODA treatment until the event resolves or decreases in intensity. (5.7)
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Hyperbilirubinemia (Grade 2 to 4): Interrupt XELODA treatment immediately until the hyperbilirubinemia resolves or decreases in intensity. (5.8)
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Hematologic: Do not treat patients with neutrophil counts <1.5 × 10
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