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Based on postmarketing reports, patients 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 severe, life-threatening, or fatal adverse reactions caused by xeloda e.

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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.

XELODA in combination with docetaxel resulted in statistically significant improvement in time to disease progressionoverall survival and objective response rate compared to monotherapy with docetaxel as shown in Table 17Figure 4and Figure 5.

These are not all the possible side effects of XELODAFor more informationask your doctor or pharmacist.

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

Diarrhea nausea vomiting mouth and throat sores loss of appetite or decreased appetite excessive water loss from the bodydehydrationhand-foot syndrome irregular periods this can include temporary cessationusually resume after medication is completedor permanent cessation of menstrual periods depending on your age and other factors.

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no adjustment to the starting dose of xeloda is recommended in patients with mild renal impairment creatinine clearance 51 to 80 ml min cockroft and gault, as shown below .

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