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Table 5 Percent Incidence of Grade 3/4 Laboratory Abnormalities Reported in1of Patients Receiving XELODA Monotherapy for Adjuvant Treatment of Colon CancerSafety Population)

Dehydration has been observed and may cause acute renal failure which can be fatalPatients with preexisting compromised renal function or who are receiving concomitant XELODA with known nephrotoxic agents are at higher riskPatients with anorexiaasthenianauseavomiting or diarrhea may rapidly become dehydratedMonitor patients when XELODA is administered to prevent and correct dehydration at the onsetIf grade 2or higherdehydration occursXELODA treatment should be immediately interrupted and the dehydration correctedTreatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlledDose modifications should be applied for the precipitating adverse event as necessarysee DOSAGE AND ADMINISTRATION

It is administered orally in the form of tabletswhich are usually taken twice a day with plenty of waterThe dosage is defined according the characteristics of both tumor and patientbut the treatment usually consist of several cyclesAfter being ingestedthe body transforms capecitabine tablets into the common chemotherapy drug fluorouracil.

XELODA is contraindicated in patients with known hypersensitivity to capecitabine or to any of its componentsXELODA is contraindicated in patients who have a known hypersensitivity to 5fluorouracil.

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