The time to peak plasma concentrations T max in hours were 1. Capecitabine and its metabolites are predominantly excreted in urine; Caution must be exercised in patients with central or peripheral nervous system disease, e. Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product s.
Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product s.
Respiratory, thoracic and mediastinal system disorders. Of these, patients were evaluable for response or tolerability for response and for tolerability. Gender The results of a meta-analysis of 14 clinical trials with data from over 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.
The evolving role of capecitabine in breast cancer.
Xeloda Drug Imprint
Once the dose has been reduced, it should not be increased at a later time. It is known that certain chemotherapeutic drugs, such as taxanes and cyclophosphamide, as well as radiotherapy, upregulate this enzyme [ 23 — 25 ].
Renal and urinary disorders.
Dose limiting toxicities Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome hand-foot skin reaction, palmar-plantar erythrodysesthesia. Xeloda Rating 17 User Reviews 7. Colon and colorectal cancer: Table 1 displays the total daily dose of XELODA by body surface area and the number of tablets to be taken at each dose.
ADRs are added to the appropriate frequency grouping Very common or Common according to the highest incidence seen in any of the major clinical trials and are only added when they were seen in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy see table 4. Caution must be exercised in patients with history of significant cardiac disease, arrhythmias and angina pectoris see section 4.
Thus, capecitabine has relatively selective cytotoxicity for tumor tissue. Diarrhoea, Vomiting, Nausea, Stomatitis, Abdominal pain. Careful monitoring during the first cycle of treatment is recommended for all patients. Cutaneous lupus erythematosus rareSevere skin reactions such as Stevens-Johnson Syndrome and toxic Epidermal Necrolysis very rare see section 4. Our three groups, stratified by dose level, are uneven in size and, prognostically, not comparable.
Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be withheld or reduced.
If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.
Dose per administration mg. Standard antidiarrheal treatments eg, loperamide are recommended. Caution must be exercised in patients with pre-existing hypo- or hypercalcaemia see section 4. PPE, palmar—plantar erythrodysesthesia hand—foot syndrome ; NF, neutropenic fever.