1 INDICATIONS AND USAGE Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for: â€¢ Adjuvant Colon Cancer ( 1.1 ) â€¢ Patients with Dukesâ€™ C colon cancer â€¢ Metastatic Colorectal Cancer ( 1.1 ) â€¢ First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred â€¢ Metastatic Breast Cancer ( 1.2 ) â€¢ In combination with docetaxel after failure of prior anthracycline-containing therapy â€¢ As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen 1.1 Colorectal Cancer â€¢ 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. â€¢ 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 â€¢ Capecitabine tablets in combination with docetaxel are indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. â€¢ 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 Pharmaceuticals Inc.
16 HOW SUPPLIED/STORAGE AND HANDLING Capecitabine Tablets, USP are available containing 150 mg or 500 mg of capecitabine, USP. The 150 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 511 on the other side. They are available as follows: NDC 0378-2511-91 bottles of 60 tablets 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 0378-2512-78 bottles of 120 tablets Storage and Handling: Store at 20Âº to 25ÂºC (68Âº to 77ÂºF). [See USP Controlled Room Temperature.] KEEP TIGHTLY CLOSED. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 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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