Capecitabine (CABITA TABLET)

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Capecitabine USP

 

COMPOSITION: Each film coated tablet contains Capecitabine USP 500 mg.

INDICATIONS: Colorectal Cancer: Capecitabine 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. Capecitabine was non-inferior to 5- flourouracil and Calcium folinate for disease-free survival (DFS). Although neither Capecitabine nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-fluorouracil or Calcium folinate. Capecitabine is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-fluorouracil or Calcium folinate alone. A survival benefit over 5 fluorouracil or Calcium folinate has not been demonstrated with Capecitabine monotherapy.Use of Capecitabine instead of 5-fluorouracil or Calcium folinate in combinations has not been adequately studied to assure safety or preservation of the survival advantage.

Breast Cancer: Capecitabine in combination with Docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Capecitabine 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 400mg/m2 of Doxorubicin or Doxorubicin 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

DOSAGE AND ADMINISTRATION: The recommended dose of Cabita 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. Cabita tablets should be swallowed with water within 30 minutes after a meal. In combination with Docetaxel, the recommended dose of Cabita is 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with Docetaxel at 75mg/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 Cabita plus Docetaxel combination. Adjuvant treatment in patients with Dukes’ C colon cancer is recommended for a total of 6 months, ie, Cabita 1250 mg/m2 orally twice daily for 2 week followed by a 1-week rest period, given as 3- week cycles for a total of 8 cycles (24 weeks). Or, as directed by the registered physicians.

Use in Pregnancy & Lactation: This medicine should not be used during pregnancy as it may be harmful to the unborn baby. Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least a few months after treatment is finished. Lactation: It is not known if this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed.

Packing: Each box contains 28 tablets in Alu-Alu blister pack.

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Capecitabine (CABITA TABLET)

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