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Based on postmarketing reportspatients with certain homozygous or certain compound heterozygous mutations in the DPD gene that result in complete or near complete absence of DPD activity are at increased risk for acute early-onset of toxicity and severelife-threateningor fatal adverse reactions caused by XELODAe.gmucositisdiarrheaneutropeniaand neurotoxicityPatients with partial DPD activity may also have increased risk of severelife-threateningor fatal adverse reactions caused by XELODA.

Food was shown to reduce both the rate and extent of absorption of capecitabinesee CLINICAL PHARMACOLOGYIn all clinical trialspatients were instructed to administer XELODA within 30 minutes after a mealIt is recommended that XELODA be administered with foodsee DOSAGE AND ADMINISTRATION

XELODA is contraindicated in patients with severe renal impairmentcreatinine clearance below 30 mL/minCockroft and Gaultsee Use In Specific Populations and CLINICAL PHARMACOLOGY

XELODA has been evaluated in 13 patients with mild to moderate hepatic dysfunction due to liver metastases defined by a composite score including bilirubinAST/ALT and alkaline phosphatase following a single 1255 mg/m 2 dose of XELODABoth AUC0-8 and Cmax of capecitabine increased by 60in patients with hepatic dysfunction compared to patients with normal hepatic functionn=14The AUC0-8 and Cmax of 5-FU were not affectedIn patients with mild to moderate hepatic dysfunction due to liver metastasescaution should be exercised when XELODA is administeredThe effect of severe hepatic dysfunction on XELODA is not knownsee WARNINGS AND PRECAUTIONS and Use In Specific Populations

The first trial was conducted in 22 pediatric patientsmedian age 8 yearsrange 5-17 yearswith newly diagnosed non-disseminated intrinsic diffuse brainstem gliomas and high grade gliomasIn the dosefinding portion of the trialpatients received capecitabine with concomitant radiation therapy at doses ranging from 500 mg/m 2 to 850 mg/m 2 every 12 hours for up to 9 weeksAfter a 2 week breakpatients received 1250 mg/m 2 capecitabine every 12 hours on Days 1-14 of a 21-day cycle for up to 3 cyclesThe maximum tolerated doseMTDof capecitabine administered concomitantly with radiation therapy was 650 mg/m 2 every 12 hoursThe major dose limiting toxicities were palmar-plantar erythrodysesthesia and alanine aminotransferaseALTelevation.

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