Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAPECITABINE (UNII: 6804DJ8Z9U) (CAPECITABINE - UNII:6804DJ8Z9U)
Rising Pharmaceuticals, Inc.
CAPECITABINE
CAPECITABINE 150 mg
ORAL
PRESCRIPTION DRUG
- Capecitabine tablets are 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 tablets are 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 Dukes' 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
150 mg: Light pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 150. 150 mg tablets are packaged in bottles of 60 (NDC 64980-276-06). 500 mg: Dark pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 500. 500 mg tablets are packaged in bottles of 120 (NDC 64980-277-12). Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. Care should be exercised in the handling of capecitabine tablets, USP. Capecitabine tablets, USP should not be cut or crushed. Procedures for the proper handling and disposal of anticancer drugs should be considered. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Several guidelines on the subject have been published.1-4
Abbreviated New Drug Application
CAPECITABINE- CAPECITABINE TABLET, FILM COATED RISING PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CAPECITABINE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CAPECITABINE TABLETS USP. CAPECITABINE TABLETS USP, FILM COATED FOR ORAL USE INITIAL U.S. APPROVAL: 1998 WARNING: CAPECITABINE -WARFARIN INTERACTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ PATIENTS RECEIVING CONCOMITANT CAPECITABINE AND ORAL COUMARIN-DERIVATIVE ANTICOAGULANTS SUCH AS WARFARIN AND PHENPROCOUMON SHOULD HAVE THEIR ANTICOAGULANT RESPONSE (INR OR PROTHROMBIN TIME) MONITORED FREQUENTLY IN ORDER TO ADJUST THE ANTICOAGULANT DOSE ACCORDINGLY. ALTERED COAGULATION PARAMETERS AND/OR BLEEDING, INCLUDING DEATH, HAVE BEEN REPORTED DURING CONCOMITANT USE. OCCURRENCE: WITHIN SEVERAL DAYS AND UP TO SEVERAL MONTHS AFTER INITIATING CAPECITABINE THERAPY; MAY ALSO BE SEEN WITHIN 1 MONTH AFTER STOPPING CAPECITABINE PREDISPOSING FACTORS: AGE>60 AND DIAGNOSIS OF CANCER RECENT MAJOR CHANGES Dosage and Administration (2.0) 10/2014 Contraindications (4.1) 02/2015 Warnings and Precautions (5.1, 5.2, 5.5, and 5.7) 10/2014 Warnings and Precautions (5.4) 02/2015 INDICATIONS AND USAGE Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for: • ADJUVANT COLON CANCER (1.1) – Patients with Dukes' 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 anthracyclinecontaining therapy – As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen DOSAGE AND ADMINISTRATION Take capecitabine tablets with water within 30 min after a meal (2) Monotherapy: 1250 mg/m twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles (2.1) Adjuvant treatment is recom Read the complete document