Both normal and tumor cells metabolize 5-FU to 5-fluoro-2’-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP).
These metabolitesca use cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N5- 10 methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2’- deoxyuridylate.
Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division. Second, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis.
Colorectal Cancer: Zocitab (Capecitabine Tablets) is indicated as a single agent for adjuvant treatment in patients with Dukes’ C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Zocitab (Capecitabine Tablets) was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Although neither Zocitab (Capecitabine Tablets) nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to impr ove disease-free survival compared to 5-FU/LV. Physicians should consider these results when prescribing single-agent Zocitab (Capecitabine Tablets) in the adjuvant treatment of Dukes’ C colon cancer. Zocitab (Capecitabine Tablets) is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Zocitab (Capecitabine Tablets) chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with Zocitab (Capecitabine Tablets) monotherapy. Use of Zocitab (Capecitabine Tablets) instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.
Breast Cancer: Zocitab (Capecitabine Tablets) in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Zocitab (Capecitabine Tablets) monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin - 13 - equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
The recommended dose of Zocitab (Capecitabine Tablets) is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles. Zocitab (Capecitabine Tablets) should be swallowed with water within 30 minutes after a meal.
In combination with docetaxel, the recommended dose of Zocitab (Capecitabine Tablets) is 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m2 as a 1-hour intravenous infusion every 3 weeks. Pre-medication, according to the docetaxel labeling, should be started prior to docetaxel administration for patients receiving the Zocitab (Capecitabine Tablets) plus docetaxel combination. displays the total daily dose by body surface area and the number of tablets to be taken at each dose.
Adjuvant treatment in patients with Dukes’ C colon cancer is recommended for a total of 6 months, ie, Zocitab (Capecitabine Tablets) 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks).
Zocitab (Capecitabine) 500mg - Strip of 10’s tablet for the use only of a Registered Medical Practitioner or a Hospital or a Laboratory
