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Call your doctor for medical advice about side effectsYou may report side effects to FDA at 1-800FDA-1088.
XELODA tablets should be swallowed whole with water within 30 minutes after a mealDo not crush or cut XELODA tabletsXELODA dose is calculated according to body surface area.
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.
SeeWhat are the possible side effects of XELODAfor more information about side effects.
Table 12 Efficacy of XELODA vs 5-FU/LV in Adjuvant Treatment of Colon Cancer*
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table 8 percent of patients with laboratory abnormalities participating in the xeloda and docetaxel combination vs docetaxel monotherapy study.