Toxicity was similar between treatments with the exception of neutropenia reported more commonly in patients treated with FOLFIRI.Montagnani et al used the results from the above three studies to provide an overall analysis of randomised studies comparing FOLFIRI and XELIRI treatment regimens in the treatment of mCRC. In the absence of serious toxicity, subsequent doses may be increased with careful monitoring. In this trial, 255 patients were randomised to treatment with capecitabine (1250 mg/mData from two multicentre phase II clinical trials support the use of capecitabine monotherapy for treatment of patients after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. combinations of the four variants with at least one allele of c.1905+1G>A or c.1679T>G) are known to cause complete or near complete absence of DPD enzymatic activity.Patients with certain heterozygous DPYD variants (including c.1905+1G>A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants) have increased risk of severe toxicity when treated with fluoropyrimidines. In monkeys, abortion and embryolethality were observed at high doses, but there was no evidence of teratogenicity.Do not store above 30°C, store in the original package in order to protect from moisture.Pack size of 60 film-coated tablets (6 blisters of 10 tablets)Pack size of 120 film-coated tablets (12 blisters of 10 tablets)Procedures for safe handling of cytotoxic drugs should be followed. Data from one multicentre, randomised, controlled phase III clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine for the adjuvant treatment of patients with colon cancer (XACT Study; M66001). Table 9 Key efficacy results for the non-inferiority analysis of Study NO16967 *PPP=per-protocol population; **ITT=intent-to-treat populationData from a multicentre, randomised, controlled phase III clinical trial in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (ML17032). There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Xeloda.DPD activity is rate limiting in the catabolism of 5-fluorouracil (see Section 5.2). Cardiovascular toxicity (e.g. It is not known whether capecitabine is excreted in human breast milk. Administration with food decreases the rate of capecitabine absorption, but only results in a minor effect on the AUC of 5'-DFUR, and on the AUC of the subsequent metabolite 5-FU. The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/mAfter oral administration, capecitabine is rapidly and extensively absorbed, followed by extensive conversion to the metabolites, 5'-DFCR and 5'-DFUR. Never disregard the medical advice of your physician or health professional, or delay in seeking such advice, because of something you read on this Site. 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).. The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, female gender was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia. Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1250 mg/m 2. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. Common Questions and Answers about Xeloda dosing calculator. PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/kg) but not after repeated oral dosing (1379 mg/mA two-year mouse carcinogenicity study produced no evidence of carcinogenicity by capecitabine. If the patient becomes pregnant while receiving capecitabine, the potential hazard to the foetus must be explained. The median follow up at the time of the primary analyses in the intent-to-treat population was 2.1 years; data from analyses following an additional 6 months of follow up are also included in table 9. The effects of DNA and RNA deprivation are most marked on those cells which proliferate more rapidly and which metabolise 5-FU at a more rapid rate. The median follow up at the time of the primary analyses in the intent-to-treat population was 1.5 years; data from analyses following an additional 1 year of follow up are also included in table 7. 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