European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - febuxostat - hyperuricemia; arthritis, gouty; gout - antigout preparations - febuxostat mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (tls).febuxostat mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).febuxostat mylan is indicated in adults.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - febuxostat - hyperuricemia; gout - antigout preparations - febuxostat krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).febuxostat krka is indicated in adults.

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

american health packaging - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)]. risk summary limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no adverse developmental effects were observed in a pre-and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the mrhd (see data) . 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 us 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 in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in a pre-and postnatal development study in pregnant female rats dosed orally from gestation day 7 through lactation day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the mrhd (on an auc basis at a maternal oral dose of 12 mg/kg/day). however, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the mrhd (on an auc basis at a maternal oral dose of 48 mg/kg/day). febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues. risk summary there are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. febuxostat is present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for febuxostat and any potential adverse effects on the breastfed child from febuxostat or from the underlying maternal condition. data animal data orally administered febuxostat was detected in the milk of lactating rats at up to approximately 7 times the plasma concentration. safety and effectiveness of febuxostat in pediatric patients have not been established. no dose adjustment is necessary in elderly patients. of the total number of patients in studies 1, 2, and 3 (clinical studies of febuxostat in the treatment of gout) [see clinical studies (14.1)], 16% were 65 and over, while 4% were 75 and over. comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out. the c max and auc 24 of febuxostat following multiple oral doses of febuxostat in geriatric patients (≥65 years) were similar to those in younger patients (18 to 40 years) [see clinical pharmacology (12.3)]. no dose adjustment is necessary in patients with mild to moderate renal impairment (cl cr 30 to 89 ml/min). for patients with severe renal impairment (cl cr 15 to 29 ml/min), the recommended dosage of febuxostat is limited to 40 mg once daily [see dosage and administration (2.2) and clinical pharmacology (12.3)]. no dose adjustment is necessary in patients with mild or moderate hepatic impairment (child-pugh class a or b). no studies have been conducted in patients with severe hepatic impairment (child-pugh class c); therefore, caution should be exercised in these patients [see clinical pharmacology (12.3)]. no studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients); febuxostat is not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, lesch-nyhan syndrome). the concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.

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

dr reddy's laboratories limited - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablet is a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. for the safe and effective use of allopurinol, see allopurinol prescribing information.   limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7) ]. risk summary limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51

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

solco healthcare us llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary limited available data with febuxostat tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no adverse developmental effects were observed in a pre-and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the mrhd (see data) . 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 us 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. animal data in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 – 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 – 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in a pre-and postnatal development study in pregnant female rats dosed orally from gestation day 7 through lactation day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the mrhd (on an auc basis at a maternal oral dose of 12 mg/kg/day). however, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the mrhd (on an auc basis at a maternal oral dose of 48 mg/kg/day). febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues. risk summary there are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. febuxostat is present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for febuxostat tablets and any potential adverse effects on the breastfed child from febuxostat tablets or from the underlying maternal condition. animal data orally administered febuxostat was detected in the milk of lactating rats at up to approximately 7 times the plasma concentration. safety and effectiveness of febuxostat in pediatric patients have not been established. no dose adjustment is necessary in elderly patients. of the total number of patients in studies 1, 2, and 3 (clinical studies of febuxostat in the treatment of gout) [see clinical studies (14.1)] , 16% were 65 and over, while 4% were 75 and over. comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out. the cmax and auc24 of febuxostat following multiple oral doses of febuxostat in geriatric patients (≥65 years) were similar to those in younger patients (18 to 40 years) [see clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate renal impairment (clcr 30 to 89 ml/min). for patients with severe renal impairment (clcr 15 to 29 ml/min), the recommended dosage of febuxostat is limited to 40 mg once daily [see dosage and administration (2.2) and clinical pharmacology (12.3)]. no dose adjustment is necessary in patients with mild or moderate hepatic impairment (child-pugh class a or b). no studies have been conducted in patients with severe hepatic impairment (child-pugh class c); therefore, caution should be exercised in these patients [see clinical pharmacology (12.3)] . no studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients); febuxostat is not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, lesch-nyhan syndrome). the concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.

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

alembic pharmaceuticals inc. - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use : febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions ( 7)] . risk summary   limited available data with febuxostat tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd

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

mylan pharmaceuticals inc. - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. for the safe and effective use of allopurinol, see allopurinol prescribing information. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . limited available data with febuxostat tablet use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times

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

sun pharmaceutical industries, inc. - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no advers

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

hikma pharmaceuticals usa inc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary: limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no adve

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

golden state medical supply, inc. - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions ( 7)] . risk summary: limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no adverse developmental effects were observed in a pre- and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the mrhd (see data). 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 us 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 : in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in a pre- and postnatal development study in pregnant female rats dosed orally from gestation day 7 through lactation day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the mrhd (on an auc basis at a maternal oral dose of 12 mg/kg/day). however, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the mrhd (on an auc basis at a maternal oral dose of 48 mg/kg/day). febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues. risk summary: there are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. febuxostat is present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for febuxostat and any potential adverse effects on the breastfed child from febuxostat or from the underlying maternal condition. data: animal data : orally administered febuxostat was detected in the milk of lactating rats at up to approximately 7 times the plasma concentration. safety and effectiveness of febuxostat in pediatric patients have not been established. no dose adjustment is necessary in elderly patients. of the total number of patients in studies 1, 2, and 3 (clinical studies of febuxostat in the treatment of gout) [see clinical studies ( 14.1)] , 16% were 65 and over, while 4% were 75 and over. comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out. the c max and auc 24 of febuxostat following multiple oral doses of febuxostat in geriatric patients (≥65 years) were similar to those in younger patients (18 to 40 years) [see clinical pharmacology ( 12.3)] . no dose adjustment is necessary in patients with mild to moderate renal impairment (cl cr 30 to 89 ml/min). for patients with severe renal impairment (clcr 15 to 29 ml/min), the recommended dosage of febuxostat is limited to 40 mg once daily [see dosage and administration ( 2.2) and clinical pharmacology ( 12.3)] . no dose adjustment is necessary in patients with mild or moderate hepatic impairment (child-pugh class a or b). no studies have been conducted in patients with severe hepatic impairment (child-pugh class c); therefore, caution should be exercised in these patients [see clinical pharmacology ( 12.3)] . no studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients); febuxostat is not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, lesch-nyhan syndrome). the concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.