Xeloda - (fluoropyrimidine carbamate) with anti-tumor activity Xeloda is a prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) which is changed to 5 fluoro uracil. Xeloda is generally administered orally. Xeloda is also have anti-metabolite activity




120 tablets

Xeloda indication

Colorectal cancer Adjuvant treatment in Duke’s colon cancer First line therapy in colon-rectal cancer metastasis Breast cancer In metastatic breast cancer: used in combination with docetaxel after failure of anthracycline containing chemotherapy

Mechanism of action

Capecitabine is a prodrug, it is metabolizing to 5-FU. In both non-cancer and cancer cells, 5-FU is metabolized in to 5-fluoro-2-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP) These two metabolites cause injury to the tumor cells by two major ways FdUMP and the folate cofactor (N5-10-methylenetetrahydrofolate), which binds to thymidylate synthase (TS) to form covalently bound ternary complex.

This binding prohibits the production of thymidylate from 2’-deaxyuridylate Thymidylate an important messenger of thymidylate triphosphate. It is essential for DNA synthesis; therefore, insufficiency of this compound leads to inhibit cell division Nuclear transcriptional enzymes can falsely inserted FUTP alternative to uridine triphosphate during RNA synthesis. This metabolic failure can hinder with RNA conversion and protein synthesis via assembly of counterfeit RNA


Capecitabine reaches the peak plasma level at about 1.5 hours Food decreased both the rate and duration of absorption of Xeloda with mean Cmax and AUC0-∞ reduced by 60% and 35% respectively

The human plasma protein bound to Capecitabine is occurs in less than 60%

Capecitabine is largely metabolized to 5-FU enzymatically. In liver, 60 kDa carboxylesterase hydrolyses to 5’-deoxy-5-fluorocytidine. Cytidine deaminase is an enzyme which converts 5’-DFCR to 5’-DFUR. Thymidine phosphorylase is also an enzyme which involved in the conversion of 5’-DFUR to 5-FU active drug

The route of elimination of Capecitabine is occurred through urine 95.5% The mean terminal half-life period of Capecitabine is 0.75 hour


Ingredients Capecitabine
Strength 500mg
Pack 120 tablets


First line therapy of patients with advanced colorectal cancer

The usual dose of Xeloda is 1250mg/m2 should be taken orally as twice daily (morning and evening dose 2500mg/m2); therapy continue for 2 weeks followed by 1-week rest period given as 3 weeks cycle

Adjuvant therapy for Duke’s colon cancer

The usual dose of Xeloda is 1250mg/m2 orally as twice daily (morning and evening dose 2500mg/m2); for 2 weeks followed by 1 week given as 3 weeks for total 8 cycles (24 weeks)

Breast cancer

Monotherapy: Recommended dose: 1250mg/m2 should be taken as orally for twice daily In combination with docetaxel; 1250mg/m2 of Xeloda with 75mg/m2 of docetaxel for 3 weeks Xeloda should be administered within 30 minutes after a meal

In pediatric

The safety and efficacy of the Xeloda tablets in pediatric patients has not been established


Diarrhea, nausea, anemia, Lymphopenia, head and foot syndrome, edema, fatigue, fever, headache, pain, paresthesia, alopecia, dermatitis, abdominal pain, anorexia, loss of appetite, constipation, dyspepsia, stomatitis, vomiting, neutropenia, thrombocytopenia, dyspnea, bilirubin decreased, eye irritation


Chest pain, dermatitis, Pruritus, rash, dizziness, headache, weakness, dehydration, dry mouth, dyspepsia, taste disturbance, back pain Post marketing reports: Toxic leukoencephalopathy


concomitant with warfarin, anti-coagulant response should be monitored


patients with severe diarrhea should be monitored

Cardio toxicity

while taking Xeloda , cardio toxicity occurs like; myocardial infarction, angina, dyshythmias, cardiac arrest sudden death, Cardiomyopathy Dihydropyrimidine dehydrogenase deficiency, Dehydration and renal failure, Embryo fetal toxicity, Mucocutaneous and dermatologic toxicity, Hyperbilirubinemia, Hematological problems, Care should be taken while using in geriatric patients, Hepatic insufficiency

Drug- drug interaction

  • Anticoagulant: Xeloda concomitant with warfarin and phenprocoumon, bleeding occurs. These events occurred within several days and even a month also
  • Phenytoin: combination of phenytoin and Xeloda , toxicity related to elevation of phenytoin levels
  • Leucovorin: the toxicity and concentration of 5-FU increased by Leucovorin. In elderly patients, phenytoin and Leucovorin is administered weekly which may cause; diarrhea, dehydration, enterocolitis which may causes death.
  • CYP2C9 substrate: other than warfarin, there is no drug interaction occurs while concomitant with CYP2C9 substrates
  • Drug-food interaction: In case of administering Xeloda with food, it leads to reduce the rate and duration of absorption of Xeloda. Xeloda tablets should be administered within 30 minutes after food


Xeloda is contraindicated to renal impairment patients

Xeloda is contraindicated in patients with hypersensitivity to Xeloda or other components

Pregnancy category: D Xeloda may cause harm to the fetus Generally, Xeloda should not be recommended in pregnancy or women who are become pregnant Breast feeding is not recommended

Xeloda should be stored at 20°C to 25°C (68°F to 77°F)

If patient fail to take the dose of Xeloda , must consult with medical oncologist and follow the suggestions Do not self-medicate. The missed dose must be skipped and follow the regular dosing schedule Do not double the dose

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