In addition to the ADRs described in tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of capecitabine monotherapy with an incidence of less than 0.1%.In the instance of exposure to crushed or cut capecitabine tablets, the following adverse drug reactions have been reported: eye irritation, eye swelling, skin rash, headache, paresthesia, diarrhoea, nausea, gastric irritation, and vomiting.An analysis of safety data in patients ≥60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients <60 years of age. In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus ≥1).Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50% of patients. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine or the other medicinal product(s), then administration of all therapy should be delayed until the requirements for restarting all medicinal products are met. By using this Site you agree to the following Available for Android and iOS devices. This site uses cookies. XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of progression-free survival in the per-protocol population and intent-to-treat population (see table 9). Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer) The recommended dose of XELODA is 1250 mg/m 2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m 2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles (see Table 1).. Drug information provided by: IBM Micromedex Along with its needed effects, a medicine may cause some unwanted effects. Since current safety and efficacy data are based upon administration with food, it is recommended that capecitabine be administered with food. Weight is the patients weight, expressed in kg or lb. Careful monitoring during the first cycle of treatment is recommended for all patients. Subscribe to MedHelp's free newsletter for Community Support, Experience, and Guidance. In the absence of serious toxicity, subsequent doses may be increased with careful monitoring.
Applies to the following strengths: hydrochloride 25 mg/mL; hydrochloride 50 mg/mL; hydrochloride 10 mg/5 mL; hydrochloride 10 mg; hydrochloride 25 mg; hydrochloride 50 mg; hydrochloride 100 mg; pamoate 25 mg; pamoate 50 mg; pamoate 100 mg; pamoate 25 mg/5 mL; hydrochloride; pamoateAlways consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In this trial, 1002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:The primary efficacy analyses in the per protocol population demonstrated non-inferiority in overall survival for capecitabine- vs 5-FU-based regimens (hazard ratio 0.86; 95% CI 0.8 - 0.99) and for oxaliplatin- vs cisplatin-based regimens (hazard ratio 0.92; 95% CI 0.80 - 1.1).
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