Drug ERBITUX® cetuximab Erbitux Overview This is a summary of the European public assessment report (EPAR) for Erbitux.
Xeloda is a cancer medicine that is used to treat:
Xeloda contains the active substance capecitabine.
Xeloda should only be prescribed by a doctor who is experienced in the use of cancer medicines.
Xeloda is available as tablets (150 and 500 mg). The dose depends on the patient’s height and weight and the type of cancer being treated. Xeloda tablets should be taken within 30 minutes after a meal. The tablets are given twice daily for 14 days followed by a 7-day gap before the next course.
Treatment is continued for 6 months after colon surgery. For other types of cancer, treatment is stopped if the disease gets worse or the side effects are unacceptable. Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects.
For more information about using Xeloda, see the package leaflet or contact your doctor or pharmacist.
The active substance in Xeloda, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites’. Capecitabine is a ‘prodrug’ that is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.
Fluorouracil is very similar to pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and RNA). In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it prevents the growth of tumour cells and eventually kills them.
Xeloda is taken as tablets, while fluorouracil normally needs to be injected.
In colon cancer, Xeloda on its own has been shown to be as effective as the combination of fluorouracil and folinic acid (a medicine that enhances the effects of fluorouracil) in a main study involving 1,987 patients who had had surgery for their cancer. About two-thirds of the patients taking Xeloda or the combination remained disease-free throughout the 3.8 years of the study.
Another study involving 1,886 patients who had had surgery showed that Xeloda together with oxaliplatin (another cancer medicine) was more effective than the combination of fluorouracil and folinic acid: patients taking Xeloda and oxaliplatin had 20% lower risk of getting cancer again or death compared with patients taking fluorouracil and folinic acid.
In metastatic colorectal cancer, Xeloda taken on its own was as effective as the combination of fluorouracil and folinic acid in 2 studies involving 1,207 patients. The disease responded in 19 to 25% of patients treated with Xeloda, compared with 12 to 15% with the comparator combination.
Xeloda has also been compared with the combination of fluorouracil and folinic acid, both used in combination with oxaliplatin, in 2 studies: the first involved 2,035 patients who had not been treated before, and the second involved 627 patients in whom previous treatment with irinotecan and a fluoropyrimidine (a group of cancer medicines that includes fluorouracil) had not worked. Results showed that when either Xeloda or fluorouracil and folinic acid were used with oxaliplatin, it took an average of 8 months for the disease to get worse in patients who had not been treated before, and 5 months in patients whose previous treatment had not worked.
In advanced gastric cancer, Xeloda with cisplatin was as effective as a combination of fluorouracil and cisplatin in slowing down the disease in a study involving 316 patients. It took 5.6 months for the disease to get worse in patients taking Xeloda and cisplatin, and 5.0 months in patients receiving fluorouracil and cisplatin. Also, the results of a published study involving 1,002 patients showed that patients taking combinations of medicines that included Xeloda survived for a similar period as those taking combinations that included fluorouracil.
In locally advanced or metastatic breast cancer, Xeloda with docetaxel was more effective than docetaxel on its own in a study involving 511 women. Patients taking Xeloda with docetaxel had a longer time before the disease got worse compared with patients taking docetaxel on its own (186 days compared with 128 days). Two smaller studies (238 patients) showed that Xeloda was effective after treatment with taxanes and anthracyclines did not work.
Xeloda has been shown to be effective in treating colon, colorectal, gastric and breast cancer. The safety profile of the medicine is considered acceptable. The European Medicines Agency therefore decided that Xeloda’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xeloda have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Xeloda are continuously monitored. Side effects reported with Xeloda are carefully evaluated and any necessary action taken to protect patients.
Xeloda received a marketing authorisation valid throughout the EU on 2 February 2001.
The most common side effects with Xeloda are diarrhoea, nausea (feeling sick), vomiting, abdominal (belly) pain, stomatitis (sores in the mouth), palmar-plantar erythrodysaesthesia (hand-foot syndrome, a skin reaction with rash and pain on the hands and feet), tiredness, weakness, loss of appetite, problems due to formation of blood clots in the blood vessels, heart problems and kidney problems in patients who already have reduced kidney function.
Xeloda must not be used in people who may be hypersensitive (allergic) to capecitabine, to any of the other ingredients, or to fluorouracil. Xeloda must also not be used in the following groups:
patients who have had severe and unexpected reactions to fluoropyrimidine therapy;
patients with complete absence of activity of the dihydropyrimidine dehydrogenase enzyme;
pregnant or breastfeeding women;
patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);
patients with severe liver or kidney disease;
patients taking brivudine (an antiviral medicine for treating shingles or chickenpox) or who have taken it in the last 4 weeks.
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