CAPECITABINE- capecitabine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAPECITABINE (UNII: 6804DJ8Z9U) (CAPECITABINE - UNII:6804DJ8Z9U)

Available from:

AvKARE, Inc.

INN (International Name):

CAPECITABINE

Composition:

CAPECITABINE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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 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 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

Product summary:

Capecitabine tablets, USP, 150 mg, are supplied as light peach, oblong, film-coated, biconvex, unscored tablets, debossed with ‘AN’ on one side and ‘843’ on the other side. They are available as follows: Bottles of 60: NDC 42291-166-60 Capecitabine tablets, USP, 500 mg, are supplied as peach, oblong, film-coated, biconvex, unscored tablets, debossed with ‘AN’ on one side and ‘844’ on the other side They are available as follows: Bottles of 120: NDC 42291-167-12 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. Capecitabine tablets, USP 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAPECITABINE- CAPECITABINE TABLET
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CAPECITABINE TABLETS
RX ONLY
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CAPECITABINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CAPECITABINE
TABLETS.
CAPECITABINE TABLETS USP, 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 (2.1) 12/2016
Warnings and Precautions (5.6, 5.7) 12/2016
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
anthracycline-containing 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 ( 2.1)
Monotherapy: 1250 mg/m
twice daily orally for 2 weeks followed by a one week rest period in
3-week cycles ( 2.2)
Adjuvant treatment is recommended for a total of 6 months (8 cycles) (
2.2)
In combination with docetaxel, the reco