CAPECITABINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

CAPECITABINE

Composition:

CAPECITABINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Capecitabine is indicated for the: Capecitabine is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. Capecitabine is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine [see Adverse Reactions ( 6.1)] . Risk Summary: Based on findings in animal reproduction studies and its mechanism of action [see Clinical Pharmacology (12.1)] , capecitabine can cause fetal harm when administered to a pregnant woman. Available human data with capecitabine use in pregnant women is not sufficient to inform the drug-associated risk. In animal reproduction studies, administration of capecitabine to pregnant animals during the period of organogenesis caused embryolethality and teratogenicity in mice and embryolethality in monkeys at 0.2 and 0.6 times the exposure (AUC) in patients receiving the recommended dose of 1,250 mg/m2 twice daily, respectively (see Data) . Advise pregnant women of the

Product summary:

Capecitabine Tablets, USP are supplied as follows: NDC 0054-0272-23: Bottle of 120 Tablets Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] KEEP TIGHTLY CLOSED. Capecitabine is a hazardous drug. Follow applicable special handling and disposal procedures.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAPECITABINE- CAPECITABINE TABLET, FILM COATED
HIKMA PHARMACEUTICALS USA INC.
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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: INCREASED RISK OF BLEEDING WITH
CONCOMITANT USE OF VITAMIN K ANTAGONISTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ALTERED COAGULATION PARAMETERS AND/OR BLEEDING, INCLUDING DEATH, HAVE
BEEN REPORTED
IN PATIENTS TAKING CAPECITABINE CONCOMITANTLY WITH ORAL VITAMIN K
ANTAGONISTS. (5.1,
7.2)
MONITOR INTERNATIONAL NORMALIZED RATIO (INR) MORE FREQUENTLY AND
ADJUST THE DOSE OF THE
VITAMIN K ANTAGONIST AS APPROPRIATE. (7.2)
RECENT MAJOR CHANGES
Boxed Warning (12/2022)
Indications and Usage, Colorectal Cancer (1.1) (12/2022)
Indications and Usage, Breast Cancer (1.2) (12/2022)
Indications and Usage, Gastric, Esophageal, or
Gastroesophageal Junction Cancer (1.3) (12/2022)
Indications and Usage, Pancreatic Cancer (1.4) (12/2022)
Dosage and Administration (2.1-2.7) (12/2022)
Contraindications (4) (12/2022)
Warnings and Precautions (5.1-5.12) (12/2022)
INDICATIONS AND USAGE
Capecitabine is a nucleoside metabolic inhibitor indicated for:
COLORECTAL CANCER
•
•
•
BREAST CANCER
•
•
GASTRIC, ESOPHAGEAL, OR GASTROESOPHAGEAL JUNCTION CANCER
•
•
PANCREATIC CANCER
•
adjuvant treatment of patients with Stage III colon cancer as a single
agent or as a component of a
combination chemotherapy regimen. (1.1)
perioperative treatment of adults with locally advanced rectal cancer
as a component of
chemoradiotherapy. (1.1)
treatment of patients with unresectable or metastatic colorectal
cancer as a single agent or as a
component of a combination chemotherapy regimen. (1.1)
treatment of patients with advanced or metastatic breast cancer as a
single agent if an
anthracycline- or taxane-containing chemotherapy is not indicated.
(1.2)
treatment of p