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

zydus lifesciences limited - mirabegron (unii: mvr3jl3b2v) (mirabegron - unii:mvr3jl3b2v) - mirabegron monotherapy mirabegron extended-release tablets are indicated for the treatment of oab in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. pediatric use information is approved for astellas pharma global development, inc.'s myrbetriq (mirabegron extended-release tablets). however, due to astellas pharma global development, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. mirabegron extended-release tablets are contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet [see adverse reactions (6.1, 6.2)]. risk summary there are no studies with the use of mirabegron in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via auc) the maximum recommended human dose (mrhd) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the mrhd. at maternally-toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed [see data]. the estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. in the u.s. general population, the estimated background risks of major birth defects or miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data no embryo-fetal lethality or morphological fetal developmental abnormalities were produced in pregnant rats following daily oral administration of mirabegron during the period of organogenesis (days 7 to 17 of gestation) at 0, 10, 30, 100, or 300 mg/kg, doses which were associated with systemic exposures (auc) 0, 1, 6, 22, and 96-fold the mrhd. skeletal variations (wavy ribs, delayed ossification) were observed in fetuses at doses 22-fold the systemic exposure at the mrhd and were reversible during development. exposures 96-fold the mrhd were maternally-toxic (mortality, decreased body weight gain) and associated with fetal growth reduction. pregnant rabbits were treated with daily oral doses of mirabegron at 0, 3, 10, or 30 mg/kg/day during the period of organogenesis (days 6 to 20 of gestation), which resulted in plasma exposures that were 0, 1, 14, or 36-fold the mrhd based on auc. at 10 mg/kg/day (14-fold the mrhd) and higher, fetal body weights were reduced. at 30 mg/kg/day, maternal toxicity (increased heart rate, mortality, reduced body weight gain, reduced food consumption) occurred, and fetal deaths, fetal cardiomegaly and fetal dilated aortae were observed at systemic exposure levels (auc) 36-fold the mrhd. in a pre-and postnatal developmental study, rats were treated with daily oral doses of mirabegron at 0, 10, 30, or 100 mg/kg/day (0, 1, 6, or 22-fold the mrhd) from day 7 of gestation until day 20 after birth. decreased maternal body weight was observed along with decreased pup survival in the first few days after birth (92.7% survival) compared to the control group (98.8% survival), at 100 mg/kg/day (22-fold the mrhd). pup body weight gain was reduced until postnatal day 7 but not further affected throughout the remainder of the lactation period. in utero and lactational exposure did not affect developmental milestones, behavior or fertility of offspring. no effects were observed at 30 mg/kg/day. risk summary there are no data on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production. mirabegron-related material was present in rat milk and in the stomach of nursing pups following administrations of a single 10 mg/kg oral dose of 14 c-labeled mirabegron to lactating rats.  when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mirabegron and any potential adverse effects on the breastfed child from mirabegron or from the underlying maternal condition. increased mean systolic and diastolic blood pressures with use of mirabegron occurred in patients less than 12 years of age with larger increases in patients younger than 8 years of age. pediatric use information is approved for astellas pharma global development, inc.'s myrbetriq (mirabegron extended-release tablets). however, due to astellas pharma global development, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. of 5,648 patients who received mirabegron monotherapy in the phase 2 and 3 studies for oab, 2,029 (35.9%) were 65 years of age or older, and 557 (9.9%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients younger than 65 years of age and those 65 years of age or older in these studies. mirabegron have not been studied in patients with end-stage renal disease (egfr <15 ml/min/1.73 m2 ) or patients requiring hemodialysis and, therefore, is not recommended for use in these patient populations. no dose adjustment is necessary in patients with mild or moderate renal impairment (egfr 30 to 89 ml/min/1.73 m2 ). in adult patients with severe renal impairment (egfr 15 to 29 ml/min/1.73 m2 ), the daily dose of mirabegron should not exceed 25 mg. [see clinical pharmacology (12.3)] . pediatric use information is approved for astellas pharma global development, inc.'s myrbetriq (mirabegron extended-release tablets). however, due to astellas pharma global development, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. mirabegron has not been studied in patients with severe hepatic impairment (child-pugh class c) and, therefore, is not recommended for use in this patient population. in adult patients with moderate hepatic impairment (child-pugh class b), the daily dose of mirabegron should not exceed 25 mg. no dose adjustment is necessary in patients with mild hepatic impairment (child-pugh class a) [see clinical pharmacology (12.3)] . pediatric use information is approved for astellas pharma global development, inc.'s myrbetriq (mirabegron extended-release tablets). however, due to astellas pharma global development, inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

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

zydus pharmaceuticals (usa) inc. - mirabegron (unii: mvr3jl3b2v) (mirabegron - unii:mvr3jl3b2v) - mirabegron monotherapy mirabegron extended-release tablets are indicated for the treatment of oab in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. pediatric use information is approved for astellas pharma global development, inc.'s myrbetriq (mirabegron extended-release tablets). however, due to astellas pharma global development, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. mirabegron extended-release tablets are contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet [see adverse reactions (6.1, 6.2)]. risk summary there are no studies with the use of mirabegron in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via auc) the maximum recommended human dose (mrhd) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the mrhd. at maternally-toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed [see data]. the estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. in the u.s. general population, the estimated background risks of major birth defects or miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data no embryo-fetal lethality or morphological fetal developmental abnormalities were produced in pregnant rats following daily oral administration of mirabegron during the period of organogenesis (days 7 to 17 of gestation) at 0, 10, 30, 100, or 300 mg/kg, doses which were associated with systemic exposures (auc) 0, 1, 6, 22, and 96-fold the mrhd. skeletal variations (wavy ribs, delayed ossification) were observed in fetuses at doses 22-fold the systemic exposure at the mrhd and were reversible during development. exposures 96-fold the mrhd were maternally-toxic (mortality, decreased body weight gain) and associated with fetal growth reduction. pregnant rabbits were treated with daily oral doses of mirabegron at 0, 3, 10, or 30 mg/kg/day during the period of organogenesis (days 6 to 20 of gestation), which resulted in plasma exposures that were 0, 1, 14, or 36-fold the mrhd based on auc. at 10 mg/kg/day (14-fold the mrhd) and higher, fetal body weights were reduced. at 30 mg/kg/day, maternal toxicity (increased heart rate, mortality, reduced body weight gain, reduced food consumption) occurred, and fetal deaths, fetal cardiomegaly and fetal dilated aortae were observed at systemic exposure levels (auc) 36-fold the mrhd. in a pre-and postnatal developmental study, rats were treated with daily oral doses of mirabegron at 0, 10, 30, or 100 mg/kg/day (0, 1, 6, or 22-fold the mrhd) from day 7 of gestation until day 20 after birth. decreased maternal body weight was observed along with decreased pup survival in the first few days after birth (92.7% survival) compared to the control group (98.8% survival), at 100 mg/kg/day (22-fold the mrhd). pup body weight gain was reduced until postnatal day 7 but not further affected throughout the remainder of the lactation period. in utero and lactational exposure did not affect developmental milestones, behavior or fertility of offspring. no effects were observed at 30 mg/kg/day. risk summary there are no data on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production. mirabegron-related material was present in rat milk and in the stomach of nursing pups following administrations of a single 10 mg/kg oral dose of 14 c-labeled mirabegron to lactating rats.  when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mirabegron and any potential adverse effects on the breastfed child from mirabegron or from the underlying maternal condition. increased mean systolic and diastolic blood pressures with use of mirabegron occurred in patients less than 12 years of age with larger increases in patients younger than 8 years of age. pediatric use information is approved for astellas pharma global development, inc.'s myrbetriq (mirabegron extended-release tablets). however, due to astellas pharma global development, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. of 5,648 patients who received mirabegron monotherapy in the phase 2 and 3 studies for oab, 2,029 (35.9%) were 65 years of age or older, and 557 (9.9%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients younger than 65 years of age and those 65 years of age or older in these studies. mirabegron have not been studied in patients with end-stage renal disease (egfr <15 ml/min/1.73 m2 ) or patients requiring hemodialysis and, therefore, is not recommended for use in these patient populations. no dose adjustment is necessary in patients with mild or moderate renal impairment (egfr 30 to 89 ml/min/1.73 m2 ). in adult patients with severe renal impairment (egfr 15 to 29 ml/min/1.73 m2 ), the daily dose of mirabegron should not exceed 25 mg. [see clinical pharmacology (12.3)] . pediatric use information is approved for astellas pharma global development, inc.'s myrbetriq (mirabegron extended-release tablets). however, due to astellas pharma global development, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. mirabegron has not been studied in patients with severe hepatic impairment (child-pugh class c) and, therefore, is not recommended for use in this patient population. in adult patients with moderate hepatic impairment (child-pugh class b), the daily dose of mirabegron should not exceed 25 mg. no dose adjustment is necessary in patients with mild hepatic impairment (child-pugh class a) [see clinical pharmacology (12.3)] . pediatric use information is approved for astellas pharma global development, inc.'s myrbetriq (mirabegron extended-release tablets). however, due to astellas pharma global development, inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

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

cardinal health 107, llc - mirabegron (unii: mvr3jl3b2v) (mirabegron - unii:mvr3jl3b2v) - mirabegron 25 mg - myrbetriq® is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. myrbetriq in combination with the muscarinic antagonist solifenacin succinate is indicated for the treatment of oab with symptoms of urge urinary incontinence, urgency, and urinary frequency. do not use myrbetriq in patients who have known hypersensitivity reactions to mirabegron or any component of the tablet [see adverse reactions (6.1, 6.2)] . risk summary there are no studies with the use of myrbetriq in pregnant women to inform drug-associated risk for birth defects or miscarriage. mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via auc) the maximum recommended human dose (mrhd) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the mrhd. at maternally toxic exposures in rats (96-fold), decreased fetal weight and increased fetal m

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

astellas pharma us, inc. - mirabegron (unii: mvr3jl3b2v) (mirabegron - unii:mvr3jl3b2v) - mirabegron 25 mg - myrbetriq monotherapy myrbetriq® is indicated for the treatment of oab in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. myrbetriq combination therapy with solifenacin succinate myrbetriq, in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of oab in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. myrbetriq granules myrbetriq® granules is indicated for the treatment of ndo in pediatric patients aged 3 years and older. myrbetriq myrbetriq is indicated for the treatment of ndo in pediatric patients aged 3 years and older and weighing 35 kg or more. myrbetriq/myrbetriq granules is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet or oral suspension [see adverse reactions (6.1, 6.2)] . risk summary there are no studies with the use of myrbetriq/myrbetriq granules in pregnant women or adolescents to inform a

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

avera mckennan hospital - mirabegron (unii: mvr3jl3b2v) (mirabegron - unii:mvr3jl3b2v) - mirabegron 25 mg

Australia - English - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - mirabegron, quantity: 50 mg - tablet, modified release - excipient ingredients: macrogol 2000000; macrogol 8000; purified water; butylated hydroxytoluene; hyprolose; magnesium stearate; hypromellose; iron oxide yellow - symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence in patients with overactive bladder (oab) syndrome.

Australia - English - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - mirabegron, quantity: 25 mg - tablet, modified release - excipient ingredients: butylated hydroxytoluene; magnesium stearate; hyprolose; purified water; macrogol 2000000; macrogol 8000; hypromellose; iron oxide yellow; iron oxide red - symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence in patients with overactive bladder (oab) syndrome.

Israel - English - Ministry of Health

astellas pharma international b.v., israel - mirabegron - tablets prolonged release - mirabegron 25 mg - mirabegron - symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (oab) syndrome

Israel - English - Ministry of Health

astellas pharma international b.v., israel - mirabegron - tablets prolonged release - mirabegron 25 mg - mirabegron - symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (oab) syndrome

Israel - English - Ministry of Health

astellas pharma international b.v., israel - mirabegron - tablets prolonged release - mirabegron 50 mg - mirabegron - symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (oab) syndrome