LYCOS RETRIEVER 
Xeloda
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Xeloda is an oral medication for treating advanced breast cancers that are resistant to combination therapy with the drugs of choice, paclitaxel (Taxol) as well as a drug from the anthracycline family of drugs, for example, doxorubicin (Adriamycin). Xeloda is converted by the body to 5-fluorouracil (5-FU), a drug which has been given intravenously for many years to treat various types of cancer. It is not surprising, therefore, that xeloda as well as is effective in the treatment of colorectal cancer, a type of cancer which is treated frequently with 5-FU. 5-FU inhibits the production of both DNA as well as protein by the cancerous cells that are essential for the cells to divide as well as the cancer to grow in size. Xeloda was approved by the FDA in 1998 for the treatment of breast cancer as well as in 2005 for the treatment of colorectal cancer.
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A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.
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The "smart tablet" Xeloda has a unique mechanism of activation. It is activated by an enzyme, found at higher levels in cancer than in healthy tissue. This leads to more of the cancer-killing agent 5-FU being produced in the tumor, where it is needed. Taxotere further increases the levels of this enzyme, potentially leading to even more Xeloda being converted into cancer-killing 5-FU.
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Xeloda can induce diarrhoea, which can sometimes be severe. In patients receiving Xeloda monotherapy the median time to first occurrence of Grade 2 - 4 diarrhoea was 31 days, and median duration of Grade 3 or 4 diarrhoea was 4.5 days. Patients with severe diarrhoea should be carefully monitored and, if they become dehydrated, should be given fluid and electrolyte replacement. If Grade 2, 3 or 4 diarrhoea occurs, administration of Xeloda should be immediately interrupted until the diarrhoea resolves or decreases in intensity to Grade 1. Following Grade 3 or 4 diarrhoea, subsequent doses of Xeloda should be decreased (see Dosage and Method of Administration). Standard anti-diarrhoea treatments (e.g.
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Xeloda was superior to 5-FU/LV for objective response rate in Study 1 and Study 2. The similarity of Xeloda and 5-FU/LV in these studies was assessed by examining the potential difference between the two treatments. In order to assure that Xeloda has a clinically meaningful survival effect, statistical analyses were performed to determine the percent of the survival effect of 5-FU/LV that was retained by Xeloda. The estimate of the survival effect of 5-FU/LV was derived from a meta-analysis of ten randomized studies from the published literature comparing 5-FU to regimens of 5-FU/LV that were similar to the control arms used in these Studies 1 and 2. The method for comparing the treatments was to examine the worst case (95% confidence upper bound) for the difference between 5-FU/LV and Xeloda, and to show that loss of more than 50% of the 5-FU/LV survival effect was ruled out. It was demonstrated that the percent of the survival effect of 5-FU/LV maintained was at least 61% for Study 2 and 10% for Study 1.
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There are no studies in pregnant women using Xeloda; ... based on the pharmacological and toxicological properties of Xeloda, it can be assumed that Xeloda may cause foetal harm if administered to pregnant women. In reproductive toxicity studies in animals, capecitabine administration caused embryolethality and teratogenicity. These findings are expected effects of fluoropyrimidine derivatives. Capecitabine should be considered a potential human teratogen. Xeloda should not be used during pregnancy. If Xeloda is used during pregnancy, or if the patient becomes pregnant while receiving this medicine, the patient must be apprised of the potential hazard to the foetus.
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