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XELODA may cause fetal harm when given to a pregnant womanCapecitabine caused embryolethality and teratogenicity in mice and embryolethality in monkeys when administered during organogenesisIf this drug is used during pregnancyor if a patient becomes pregnant while receiving XELODAthe patient should be apprised of the potential hazard to the fetussee Use In Specific Populations
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
Inactive ingredientsanhydrous lactosecroscarmellose sodiumhydroxypropyl methylcellulosemicrocrystalline cellulosemagnesium stearate and purified waterThe peach or light peach film coating contains hydroxypropyl methylcellulosetalctitanium dioxideand synthetic yellow and red iron oxides.
The chemical name for capecitabine is 5deoxy-5-fluoro-Npentyloxycarbonylcytidine and has a molecular weight of 359.35Capecitabine has the following structural formula:
First-line treatment of metastatic colorectal carcinoma when fluoropyrimidine therapy alone is preferredAdjuvant treatment of DukesC colon cancer after complete resection of the primary tumor when fluoropyrimidine therapy alone is preferred.
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