XELODA- capecitabine tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

H2-Pharma, LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

XELODA is indicated for the: - adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. - perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. - treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. XELODA is indicated for the: - treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. - treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. XELODA is indicated for the: - treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. - treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. XELODA is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. XELODA 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)] , XELODA can cause fetal harm when administered to a pregnant woman. Available human data with XELODA 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 potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Oral administration of capecitabine to pregnant mice during the period of organogenesis at a dose of 198 mg/kg/day caused malformations and embryo lethality. In separate pharmacokinetic studies, this dose in mice produced 5'-DFUR AUC values that were approximately 0.2 times the AUC values in patients administered the recommended daily dose. Malformations in mice included cleft palate, anophthalmia, microphthalmia, oligodactyly, polydactyly, syndactyly, kinky tail and dilation of cerebral ventricles. Oral administration of capecitabine to pregnant monkeys during the period of organogenesis at a dose of 90 mg/kg/day, caused fetal lethality. This dose produced 5'-DFUR AUC values that were approximately 0.6 times the AUC values in patients administered the recommended daily dose. Risk Summary There is no information regarding the presence of capecitabine or its metabolites in human milk, or on its effects on milk production or the breastfed child. Capecitabine metabolites were present in the milk of lactating mice (see Data) . Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with XELODA and for 1 week after the last dose. Data Lactating mice given a single oral dose of capecitabine excreted significant amounts of capecitabine metabolites into the milk. XELODA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating XELODA. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with XELODA and for 6 months after the last dose. Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with XELODA and for 3 months after the last dose [see Nonclinical Toxicology (13.1)]. Infertility Based on animal studies, XELODA may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology (13.1)] . The safety and effectiveness of XELODA in pediatric patients have not been established. Safety and effectiveness were assessed, but not established in two single arm studies in 56 pediatric patients aged 3 months to <17 years with newly diagnosed gliomas. In both trials, pediatric patients received an investigational pediatric formulation of capecitabine concomitantly with and following completion of radiation therapy (total dose of 5580 cGy in 180 cGy fractions). The relative bioavailability of the investigational formulation to XELODA was similar. The adverse reaction profile was consistent with that of adults, with the exception of laboratory abnormalities which occurred more commonly in pediatric patients. The most frequently reported laboratory abnormalities (per-patient incidence ≥ 40%) were increased ALT (75%), lymphocytopenia (73%), hypokalemia (68%), thrombocytopenia (57%), hypoalbuminemia (55%), neutropenia (50%), low hematocrit (50%), hypocalcemia (48%), hypophosphatemia (45%) and hyponatremia (45%). Of 7938 patients with colorectal cancer who were treated with XELODA, 33% were older than 65 years. Of the 4536 patients with metastatic breast cancer who were treated with XELODA, 18% were older than 65 years. Of 1951 patients with gastric, esophageal, or gastrointestinal junction cancer who were treated with XELODA, 26% were older than 65 years. Of 364 patients with pancreatic cancer who received adjuvant treatment with XELODA, 47% were 65 years or older. No overall differences in efficacy were observed comparing older versus younger patients with colorectal cancer, gastric, esophageal or gastrointestinal junction cancer, or pancreatic cancer using the approved recommended dosages and treatment regimens. Older patients experience increased gastrointestinal toxicity due to XELODA compared to younger patients. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil [see Drug Interactions (7.1)]. The exposure of capecitabine and its inactive metabolites (5-DFUR and FBAL) increases in patients with CLcr <50 mL/min as determined by Cockcroft-Gault [see Clinical Pharmacology (12.3)] . Reduce the dosage for patients with CLcr of 30 to 50 mL/min [see Dosage and Administration (2.6)] . There is limited experience with XELODA in patients with CLcr <30 mL/min, and a dosage has not been established in those patients. If no treatment alternative exists, XELODA could be administered to such patients on an individual basis applying a reduced starting dose, close monitoring of a patient's clinical and biochemical data and dose modifications guided by observed adverse reactions. The exposure of capecitabine increases in patients with mild to moderate hepatic impairment. The effect of severe hepatic impairment on the safety and pharmacokinetics of XELODA is unknown [see Clinical Pharmacology (12.3)]. Monitor patients with hepatic impairment more frequently for adverse reactions.

製品概要:

XELODA (capecitabine) tablets are supplied as follows: 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. XELODA is a hazardous drug. Follow applicable special handling and disposal procedures.1

認証ステータス:

New Drug Application

製品の特徴

XELODA- CAPECITABINE TABLET, FILM COATED
H2-PHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XELODA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XELODA .
XELODA (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 XELODA 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
XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated
for:
COLORECTAL 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)
BREAST CANCER
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 patients with advanced or metastatic breast cancer in
combination with docetaxel after
disease progression on prior anthracycline-containing chem