CAPECITABINE 150MG- capecitabine tablet, film coated CAPECITABINE 500MG- capecitabine tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

CELLTRION USA, INC.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

- 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

Přehled produktů:

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 72606-554-01). 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 72606-555-01). 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. Capecitabine is 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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CAPECITABINE 150MG- CAPECITABINE TABLET, FILM COATED
CAPECITABINE 500MG- CAPECITABINE TABLET, FILM COATED
CELLTRION USA, INC.
----------
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, 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
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 recommended dose of capecitabine
tablets is 1250 mg/m twice daily for 2 weeks
f