United States - English - NLM (National Library of Medicine)

h2-pharma, llc - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - 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.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - capecitabine - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - capecitabine - capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine is indicated for the treatment of metastatic colorectal cancer.capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline. capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Israel - English - Ministry of Health

abic marketing ltd, israel - capecitabine - film coated tablets - capecitabine 150 mg - capecitabine - adjuvant colon cancer: capecitabine teva® is indicated for the adjuvant treatment of patients following surgery of stage iii (dukesע stage c) colon cancer. colorectal cancer: capecitabine teva® is indicated for the treatment of patients with advanced or metastatic colorectal cancer. advanced gastric cancer: capecitabine teva® is indicated for first line treatment of advanced gastric cancer in combination with chemotherapy. breast cancer combination therapy: capecitabine teva® in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. breast cancer monotherapy: capecitabine teva® is also indicated for the treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane unless therapy with a taxane is clinically contraindicated.

Israel - English - Ministry of Health

abic marketing ltd, israel - capecitabine - film coated tablets - capecitabine 500 mg - capecitabine - adjuvant colon cancer: capecitabine teva® is indicated for the adjuvant treatment of patients following surgery of stage iii (dukes stage c) colon cancer. colorectal cancer: capecitabine teva® is indicated for the treatment of patients with advanced or metastatic colorectal cancer. advanced gastric cancer: capecitabine teva® is indicated for first line treatment of advanced gastric cancer in combination with chemotherapy. breast cancer combination therapy: capecitabine teva® in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. breast cancer monotherapy: capecitabine teva® is also indicated for the treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane unless therapy with a taxane is clinically contraindicated.

Israel - English - Ministry of Health

taro international ltd, israel - capecitabine - film coated tablets - capecitabine 500 mg - capecitabine - adjuvant colon cancer: capecitabine taro 500mg is indicated for the adjuvant treatment of patients following surgery of stage iii (dukes stage c) colon cancer. colorectal cancer: capecitabine taro 500mg is indicated for the treatment of patients with advanced or metastatic colorectal cancer. advanced gastric cancer: capecitabine taro 500mg is indicated for first line treatment of advanced gastric cancer in combination with chemotherapy. breast cancer combination therapy: capecitabine taro 500mg in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. breast cancer monotherapy: capecitabine taro 500mg is also indicated for the treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane unless therapy with a taxane is clinically contraindicated.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastic agents - capecitabine accord is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine accord is indicated for the treatment of metastatic colorectal cancer.capecitabine accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine accord in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.capecitabine accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - capecitabine - colorectal neoplasms - antineoplastic agents - capecitabine medac is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine medac is indicated for the treatment of metastatic colorectal cancer.capecitabine medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.capecitabine medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastic agents - capecitabine teva is indicated for the adjuvant treatment of patients following surgery of stage iii (dukes’ stage c) colon cancer.capecitabine teva is indicated for the treatment of metastatic colorectal cancer.capecitabine teva is indicated for first‑line treatment of advanced gastric cancer in combination with a platinum‑based regimen.capecitabine teva in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline. capecitabine teva is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - capecitabine 150mg - film coated tablet - 150 mg - active: capecitabine 150mg excipient: colloidal silicon dioxide croscarmellose sodium hypromellose   iron oxide red iron oxide yellow macrogol 400 magnesium stearate microcrystalline cellulose purified talc purified water   titanium dioxide - capecitabine winthrop is indicated for the treatment of patients with locally advanced or / metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated. capecitabine winthrop in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - capecitabine 500mg - film coated tablet - 500 mg - active: capecitabine 500mg excipient: colloidal silicon dioxide croscarmellose sodium hypromellose   iron oxide red iron oxide yellow macrogol 400 magnesium stearate microcrystalline cellulose purified talc purified water   titanium dioxide - capecitabine winthrop is indicated for the treatment of patients with locally advanced or / metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated. capecitabine winthrop in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.