1 INDICATIONS AND USAGE Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for: Adjuvant Colon Cancer ( 1.1 ) Patients with Dukesâ€™ C colon cancer Metastatic Colorectal Cancer ( 1.1 ) First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred Metastatic Breast Cancer ( 1.2 ) In combination with docetaxel after failure of prior anthracycline-containing therapy As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen 1.1 Colorectal Cancer Capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with Dukesâ€™ C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Capecitabine tablets were non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent capecitabine tablets in the adjuvant treatment of Dukesâ€™ C colon cancer. Capecitabine tablets are 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-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with capecitabine tablets monotherapy. Use of capecitabine tablets instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage. 1.2 Breast Cancer Capecitabine tablets in combination with docetaxel are indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. 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 (e.g., patients who have received cumulative doses of 400 mg/m 2 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.
Mylan Institutional Inc.
16 HOW SUPPLIED/STORAGE AND HANDLING Capecitabine Tablets, USP are available containing 500 mg of capecitabine, USP. The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M512 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-510-05 â€“ Unit dose blister packages of 20 (2 cards of 10 tablets each). Storage and Handling: Store at 20Âº to 25ÂºC (68Âº to 77ÂºF). [See USP Controlled Room Temperature.] Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Any unused product should be disposed of in accordance with local requirements, or drug take back programs.
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