Xeloda is a preparation, approved for application in more than 90 countries of the world, including the EU countries, the USA, Japan, Australia, and Canada. The preparation has proved as an effective, rather safe, simple and convenient medical product for the application. For today Xeloda is used for treating more than 1 million oncological patients.
In 2001 the company “Roche” has received the sanction to use Xeloda as monotherapy of the first line at the treatment of patients with metastatic colorectal cancer (colorectal cancer with metastasizes in other parts of a body) in many countries, including the EU countries and the USA. In March 2005 the European Commission, and in June of the same year and the FDA of the USA has approved Xeloda as means of adjuvant (after surgical treatment) therapies of cancer of the large intestine.
The sanction to the application of Xeloda in a combination with Taxotere (docetaxel) for treatment of women with locally spread and metastatic cancer of a mammary gland, at the inefficiency of the chemotherapy including an anthracycline preparation, is received.
The monotherapy with Xeloda is shown also for the treatment of patients with locally spread and metastatic cancer of a mammary gland, resistant to treatment by such chemo preparation, as taxons and anthracyclines, and also for those patients to whom treatment by anthracyclines is not prescribed.
Xeloda is already approved for application as the first line therapy of a cancer of a stomach in South Korea, the preparation has got the approval of the European committee of the Control over the medical products, used at the people, and now “Roche” expects for approval of indications for application of the given preparation in other countries of the world.
The first and the unique peroral tumour-activated cytostatic for effective treatment of a colorectal cancer and a cancer of the mammary gland, allowing to follow a full policy of chemotherapy in the home or outpatient conditions.
Xeloda has a unique tumour-activated mechanism of action, owing to which, a the most part of the preparation destroying cancer cells (5- fluorouracil), gets directly in a tumour, in comparison with intravenous chemotherapy by 5- fluorouracil/leucovorin.
At the patients receiving Xeloda for treatment of a colorectal cancer, greater reduction of the sizes of a tumour and smaller quantity of by-effects (such as a diarrhea, ulcerations of a mucous membranes of mouth, loss of hair) is observed, in comparison with the patients receiving intravenously 5- fluorouracil/leucovorin.
The patients prefer freedom of peroral Xeloda, that allows them to spend less time in conditions of a hospital and to give more attention to family and friends.
Treatment of patients with locally spread or a metastasing cancer of a mammary gland after inefficient chemotherapy which includes paclitaxel and the antracycline preparations. A preparation of the first line for treatment colocteral cancer with metastasises.
Hypersensitivity to capecitabyn. Heavy and unexpected reactions to treatment with fluorpyrimidin or hypersensitivity to fluorouracil (metabolites of capecitabyn) in the anamnesis.
Application of fluoropyrimidines can be accompanied by the phenomena of cardiotoxicity, including the changes on an electrocardiogram, a heart attack of the myocardium, stenocardia, arrhythmias, cardiogenic shock, sudden death. These undesirable phenomena are more characteristic for the patients suffering from CHD.
In rare cases at treatment by 5-fluorouracil unexpectedly heavy phenomena of toxicity in the form of a stomatitis, diarrheas, granulocytopenia and neurotoxicity, caused by insufficient activity of dihydropyrimidinedehydrogenase are marked.
It is necessary carefully to observe the patients accepting Xeloda for attributes of toxicity. Frequency of the toxic phenomena from a gastroenteric path at patients the age of 60-79 years was the same, as in the general population of patients. At patients of 80 years also and more senior the reversible gastroenteric frustration of 3 and 4 degrees, such as diarrhea, nausea, and stomatitis, developed more often.
The treatment with Xeloda can cause diarrhea, sometimes complicated. The median of time before occurrence of first attributes of diarrhea of 2-4 degrees has made 31 days. Patients with complicated diarrhea should be observed carefully, providing compensation of a liquid and electrolytes in case of dehydration to them. A diarrhea of the 2nd degree is defined as an increase of a stool up to 4–6 times day or a night-stool, a diarrhea of 3 degrees — as an increase of a stool up to 7–9 times day or fecal incontinence and a syndrome of malabsorption, a diarrhea of 4 degrees — as increase of a stool up to 10 and more times a day, or occurrence in the stool of a macro impurity of blood, or necessity of parenteral supporting therapy. At occurrence of diarrhea 2, 3 and 4 degrees therapy with Xeloda are necessary to be interrupted before the disappearance of diarrhea or reduction of its intensity up to a degree 1. At diarrhea of 3rd and 4th degrees treatment with Xeloda should be renewed with reduction of a doze. It is recommended to appoint standard antidiarrhea preparations (for example, loperamyde).
Xeloda can cause the development of a palmoplantar syndrome, which is characterized by numbnesses, paresthesias, pricking, hypostases, reddening, a peeling, formation of blisters and a sharp painful syndrome. A palmoplantar syndrome of the 2nd degree is shown by painful reddening and hypostases of hands and/or feet, and the discomfort caused by these symptoms breaks the daily activity of the patient. A palmoplantar syndrome of the 3rd degree is defined as damp desquamation, ulceration, the formation of bubbles and sharp pains in hands and/or feet, and also the strong discomfort, making any kinds of daily activity impossible for the patient. At occurrence of the 2nd or 3rd degrees a palmoplantar syndrome it is necessary to interrupt the application of Xeloda before the disappearance of symptoms or their reduction up to the 1st degree; at a syndrome of the 3rd degree the subsequent doses of Xeloda should be reduced.
At an increase of the level of bilirubin in the serum of 2-4 degrees the reception of Xeloda should be stopped immediately before the disappearance of hyperbilirubinemia or its reduction up to the 1st degree. According to criteria of the National oncological institute of Canada, hyperbilirubinemia of the 2nd degree is defined as an increase of concentration up to a level, in 1.5 times higher than the top border of norm, 3rd degree — in 1.5–3 times above the top border of norm, 4th degree — more, than 3 times above the top border of norm. Patients with the easy and moderate infringement of function of a liver owing to metastasize need to be observed carefully. At renal insufficiency the experience of application of preparation is not enough; at the prescription of Xeloda such patients should be careful.