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XELODA dosage may need to be individualized to optimize patient managementPatients should be carefully monitored for toxicity and doses of XELODA should be modified as necessary to accommodate individual patient tolerance to treatmentsee Clinical StudiesToxicity due to XELODA administration may be managed by symptomatic treatmentdose interruptions and adjustment of XELODA doseOnce the dose has been reducedit should not be increased at a later timeDoses of XELODA omitted for toxicity are not replaced or restoredinstead the patient should resume the planned treatment cycles.

Enzymes convert capecitabine to 5-fluorouracil5-FUin vivoBoth normal and tumor cells metabolize 5-FU to 5-fluoro-2deoxyuridine monophosphateFdUMPand 5-fluorouridine triphosphateFUTPThese metabolites cause cell injury by two different mechanismsFirstFdUMP and the folate cofactorNmethylenetetrahydrofolatebind to thymidylate synthaseTSto form a covalently bound ternary complexThis binding inhibits the formation of thymidylate from 2deoxyuridylateThymidylate is the necessary precursor of thymidine triphosphatewhich is essential for the synthesis of DNAso that a deficiency of this compound can inhibit cell divisionSecondnuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphateUTPduring the synthesis of RNAThis metabolic error can interfere with RNA processing and protein synthesis.

No adjustment to the starting dose of XELODA is recommended in patients with mild renal impairmentcreatinine clearance51 to 80 mL/minCockroft and Gaultas shown belowIn patients with moderate renal impairmentbaseline creatinine clearance30 to 50 mL/mina dose reduction to 75of the XELODA starting dose when used as monotherapy or in combination with docetaxelfrom 1250 mg/m 2 to 950 mg/m 2 twice dailyis recommendedsee Use In Specific Populations and CLINICAL PHARMACOLOGYSubsequent dose adjustment is recommended as outlined in Table 2 and Table 3depending on the regimenif a patient develops a grade 2 to 4 adverse eventsee WARNINGS AND PRECAUTIONSThe starting dose adjustment recommendations for patients with moderate renal impairment apply to both XELODA monotherapy and XELODA in combination use with docetaxel.

Hand-and-foot syndromepalmar-plantar erythrodysesthesia or chemotherapy-induced acral erythemais a cutaneous toxicityMedian time to onset was 79 daysrange from 11 to 360 dayswith a severity range of grades 1 to 3 for patients receiving XELODA monotherapy in the metastatic settingGrade 1 is characterized by any of the followingnumbnessdysesthesia/paresthesiatinglingpainless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt normal activitiesGrade 2 hand-and-foot syndrome is defined as painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patient’s activities of daily livingGrade 3 hand-and-foot syndrome is defined as moist desquamationulcerationblistering or severe pain of the hands and/or feet and/or severe discomfort that causes the patient to be unable to work or perform activities of daily livingIf grade 2 or 3 hand-and-foot syndrome occursadministration of XELODA should be interrupted until the event resolves or decreases in intensity to grade 1Following grade 3 hand-and-foot syndromesubsequent doses of XELODA should be decreasedsee DOSAGE AND ADMINISTRATION

XELODA can induce diarrheasometimes severePatients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydratedIn 875 patients with either metastatic breast or colorectal cancer who received XELODA monotherapythe median time to first occurrence of grade 2 to 4 diarrhea was 34 daysrange from 1 to 369 daysThe median duration of grade 3 to 4 diarrhea was 5 daysNational Cancer Institute of CanadaNCICgrade 2 diarrhea is defined as an increase of 4 to 6 stools/day or nocturnal stoolsgrade 3 diarrhea as an increase of 7 to 9 stools/day or incontinence and malabsorptionand grade 4 diarrhea as an increase of10 stools/day or grossly bloody diarrhea or the need for parenteral supportIf grade 23 or 4 diarrhea occursadministration of XELODA should be immediately interrupted until the diarrhea resolves or decreases in intensity to grade 1see DOSAGE AND ADMINISTRATIONStandard antidiarrheal treatmentsegloperamideare recommended.

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