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

glaxosmithkline australia pty ltd - vilanterol trifenatate, quantity: 40 microgram (equivalent: vilanterol, qty 25 microgram); fluticasone furoate, quantity: 100 microgram - inhalation, powder for - excipient ingredients: magnesium stearate; lactose monohydrate - copd,breo ellipta is indicated for symptomatic treatment of patients with copd with a fev1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite regular bronchodilator therapy.,breo ellipta is not indicated for the initiation of bronchodilator therapy in copd.,asthma,breo ellipta is indicated in the regular treatment of moderate to severe asthma in patients who require a medium to high dose inhaled corticosteroid combined with a long-acting beta-2-agonist.,vilanterol, an active ingredient in breo ellipta, is a long-acting beta-2-agonist (laba). a class effect of all labas can be an increased risk of asthma death (see precautions).

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

glaxosmithkline australia pty ltd - fluticasone furoate, quantity: 200 microgram; vilanterol trifenatate, quantity: 40 microgram (equivalent: vilanterol, qty 25 microgram) - inhalation, powder for - excipient ingredients: magnesium stearate; lactose monohydrate - asthma,breo ellipta is indicated in the regular treatment of moderate to severe asthma in patients who require a medium to high dose inhaled corticosteroid combined with a long-acting beta-2-agonist.,vilanterol, an active ingredient in breo ellipta, is a long-acting beta-2-agonist (laba). a class effect of all labas can be an increased risk of asthma death (see precautions).

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

glaxosmithkline llc - fluticasone furoate (unii: js86977wnv) (fluticasone - unii:cut2w21n7u), umeclidinium bromide (unii: 7an603v4jv) (umeclidinium - unii:ge2t1418sv), vilanterol trifenatate (unii: 40aho2c6dg) (vilanterol - unii:028lzy775b) - fluticasone furoate 100 ug - trelegy ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). trelegy ellipta is indicated for the maintenance treatment of asthma in patients aged 18 years and older. trelegy ellipta is not indicated for the relief of acute bronchospasm. trelegy ellipta is contraindicated in the following conditions: risk summary there are insufficient data on the use of trelegy ellipta or its individual components, fluticasone furoate, umeclidinium, and vilanterol, in pregnant women to inform a drug‑associated risk. (see clinical considerations.) in an animal reproduction study, fluticasone furoate and vilanterol administered by inhalation alone or in combination to pregnant rats during the period of organogenesis produced no fetal structural abnormalities. the highest fluticasone furoate and vilanterol doses in this study were approximately 4.5 and 40 times the maximum recommended human daily inhalation doses (mrhdid) of 200 and 25 mcg, respectively in adults. (see data.) umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 40 and 150 times, respectively, the human exposure at the mrhdid of 62.5 mcg. (see data.) the estimated risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk: in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. labor or delivery: trelegy ellipta should be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility. data animal data: the combination of fluticasone furoate, umeclidinium, and vilanterol has not been studied in pregnant animals. studies in pregnant animals have been conducted with fluticasone furoate and vilanterol in combination and individually with fluticasone furoate, umeclidinium, or vilanterol. fluticasone furoate and vilanterol: in an embryofetal developmental study, pregnant rats received fluticasone furoate and vilanterol during the period of organogenesis at doses up to approximately 4.5 and 40 times the mrhdid of 200 and 25 mcg, respectively, alone or in combination (on a mcg/m2 basis at inhalation doses up to approximately 95 mcg/kg/day). no evidence of structural abnormalities was observed. fluticasone furoate: in 2 separate embryofetal developmental studies, pregnant rats and rabbits received fluticasone furoate during the period of organogenesis at doses up to approximately 4.5 times and equal to, respectively, the mrhdid of 200 mcg (on a mcg/m2 basis at maternal inhalation doses up to 91 and 8 mcg/kg/day, respectively). no evidence of structural abnormalities in fetuses was observed in either species. in a perinatal and postnatal developmental study in rats, dams received fluticasone furoate during late gestation and lactation periods at doses up to approximately 1.5 times the mrhdid of 200 mcg (on a mcg/m2 basis at maternal inhalation doses up to 27 mcg/kg/day). no evidence of effects on offspring development was observed. umeclidinium: in 2 separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 40 and 150 times, respectively the mrhdid of 62.5 mcg (on an auc basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits). no evidence of teratogenic effects was observed in either species. in a perinatal and postnatal developmental study in rats, dams received umeclidinium during late gestation and lactation periods at doses up to approximately 20 times the mrhdid (on an auc basis at maternal subcutaneous doses up to 60 mcg/kg/day). no evidence of effects on offspring development was observed. vilanterol: in 2 separate embryofetal developmental studies, pregnant rats and rabbits received vilanterol during the period of organogenesis at doses up to approximately 13,000 and 760 times, respectively, the mrhdid (on a mcg/m2 basis at maternal inhalation doses up to 33,700 mcg/kg/day in rats and on an auc basis at maternal inhaled doses up to 5,740 mcg/kg/day in rabbits). no evidence of structural abnormalities was observed at any dose in rats or in rabbits up to approximately 120 times the mrhdid (on an auc basis at maternal doses up to 591 mcg/kg/day). however, fetal skeletal variations were observed in rabbits at approximately 760 or 840 times the mrhdid (on an auc basis at maternal inhaled or subcutaneous doses of 5,740 or 300 mcg/kg/day, respectively). the skeletal variations included decreased or absent ossification in cervical vertebral centrum and metacarpals. in a perinatal and postnatal developmental study in rats, dams received vilanterol during late gestation and the lactation periods at doses up to approximately 3,900 times the mrhdid (on a mcg/m2 basis at maternal oral doses up to 10,000 mcg/kg/day). no evidence of effects in offspring development was observed. risk summary there is no information available on the presence of fluticasone furoate, umeclidinium, or vilanterol in human milk; the effects on the breastfed child; or the effects on milk production. umeclidinium was detected in the plasma of offspring of lactating rats treated with umeclidinium, suggesting its presence in maternal milk. (see data.) the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trelegy ellipta and any potential adverse effects on the breastfed child from fluticasone furoate, umeclidinium, or vilanterol or from the underlying maternal condition. data subcutaneous administration of umeclidinium to lactating rats at greater than or equal to 60 mcg/kg/day resulted in a quantifiable level of umeclidinium in 2 of 54 pups, which may indicate transfer of umeclidinium in rat milk. the safety and effectiveness of trelegy ellipta have not been established in pediatric patients (aged 17 years and younger). trelegy ellipta is not indicated for use in pediatric patients. effects on growth orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. controlled clinical trials have shown that ics may cause a reduction in growth in children. in these trials, the mean reduction in growth velocity was approximately 1 cm/year (range: 0.3 to 1.8 cm/year) and appears to be related to dose and duration of exposure. this effect has been observed in the absence of laboratory evidence of hpa axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in children than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. a randomized, double-blind, parallel-group, multicenter, 1-year, placebo-controlled trial evaluated the effect of once-daily treatment with 110 mcg of fluticasone furoate in the nasal spray formulation on growth velocity assessed by stadiometry. the subjects were 474 prepubescent children (girls aged 5 to 7.5 years and boys aged 5 to 8.5 years). mean growth velocity over the 52-week treatment period was lower in the subjects receiving fluticasone furoate nasal spray (5.19 cm/year) compared with placebo (5.46 cm/year). the mean reduction in growth velocity was 0.27 cm/year (95% ci: 0.06, 0.48) [see warnings and precautions (5.18)] . based on available data, no adjustment of the dosage of trelegy ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. in copd trials 1 and 2 (coadministration trials), 189 subjects aged 65 years and older, of which 39 subjects were aged 75 years and older, were administered umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg. in copd trial 3, 2,265 subjects aged 65 years and older, of which 565 subjects were aged 75 years and older, were administered trelegy ellipta. in an asthma clinical trial (trial 4), 159 subjects aged 65 years and older, of which 27 subjects were aged 75 years and older, were administered trelegy ellipta 100/62.5/25 mcg or trelegy ellipta 200/62.5/25 mcg. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects. trelegy ellipta has not been studied in subjects with hepatic impairment. information on the individual components is provided below. fluticasone furoate/vilanterol fluticasone furoate systemic exposure increased by up to 3-fold in subjects with hepatic impairment compared with healthy subjects. hepatic impairment had no effect on vilanterol systemic exposure. use trelegy ellipta with caution in patients with moderate or severe hepatic impairment. monitor patients for corticosteroid-related side effects [see clinical pharmacology (12.3)] . umeclidinium patients with moderate hepatic impairment (child-pugh score of 7-9) showed no relevant increases in cmax or auc, nor did protein binding differ between subjects with moderate hepatic impairment and their healthy controls. studies in subjects with severe hepatic impairment have not been performed [see clinical pharmacology (12.3)] . trelegy ellipta has not been studied in subjects with renal impairment. information on the individual components is provided below. fluticasone furoate/vilanterol there were no significant increases in either fluticasone furoate or vilanterol exposure in subjects with severe renal impairment (crcl <30 ml/min) compared with healthy subjects. no dosage adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] . umeclidinium patients with severe renal impairment (crcl <30 ml/min) showed no relevant increases in cmax or auc, nor did protein binding differ between subjects with severe renal impairment and their healthy controls. no dosage adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] .

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

prasco laboratories - fluticasone furoate (unii: js86977wnv) (fluticasone - unii:cut2w21n7u), vilanterol trifenatate (unii: 40aho2c6dg) (vilanterol - unii:028lzy775b) - fluticasone furoate/vilanterol ellipta 100/25 mcg is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. fluticasone furoate/vilanterol ellipta 100/25 mcg is also indicated to reduce exacerbations of copd in patients with a history of exacerbations. fluticasone furoate/vilanterol ellipta 100/25 mcg once daily is the only strength indicated for the treatment of copd. important limitation of use fluticasone furoate/vilanterol ellipta is not indicated for the relief of acute bronchospasm fluticasone furoate/vilanterol ellipta is indicated for the once-daily treatment of asthma in patients aged 18 years and older. fluticasone furoate/vilanterol ellipta should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - fluticasone furoate; umeclidinium as bromide; vilanterol as trifenatate - powder for inhalation pre-dispensed - vilanterol as trifenatate 22 mcg/inh; umeclidinium as bromide 55 mcg/inh; fluticasone furoate 184 mcg/inh - vilanterol, umeclidinium bromide and fluticasone furoate - asthmatrelegy ellipta 184/55/22 mcg is indicated for the maintenance treatment of asthma in patients aged 18 years and older. trelegy ellipta 184/55/22 mcg should be prescribed for patients who are not adequately controlled on maintenance asthma medication, such as an ics/laba.important limitations of usetrelegy ellipta 184/55/22 mcg is not indicated for the relief of acute asthma.trelegy ellipta 184/55/22 mcg is not indicated for patients with copd.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - fluticasone furoate; vilanterol as trifenatate - powder for inhalation - vilanterol as trifenatate 22 mcg; fluticasone furoate 184 mcg - fluticasone furoate - asthmarelvar ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonists.• patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - fluticasone furoate; vilanterol as trifenatate - powder for inhalation - vilanterol as trifenatate 22 mcg; fluticasone furoate 92 mcg - fluticasone furoate - asthmarelvar ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate:• patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonists.• patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.copd (chronic obstructive pulmonary disease)relvar ellipta is indicated for the symptomatic treatment of adults with copd with a fev1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.

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

glaxosmithkline llc - fluticasone furoate (unii: js86977wnv) (fluticasone - unii:cut2w21n7u), vilanterol trifenatate (unii: 40aho2c6dg) (vilanterol - unii:028lzy775b) - fluticasone furoate 100 ug - breo ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). breo ellipta is indicated for the maintenance treatment of asthma in patients aged 5 years and older. breo ellipta is not indicated for the relief of acute bronchospasm. breo ellipta is contraindicated in the following conditions: risk summary there are insufficient data on the use of breo ellipta or its individual components, fluticasone furoate and vilanterol, in pregnant women to inform a drug-associated risk. (see clinical considerations.) in an animal reproduction study, fluticasone furoate and vilanterol administered by inhalation alone or in combination to pregnant rats during the period of organogenesis produced no fetal structural abnormalities. the highest fluticasone furoate and vilanterol doses in this study were approximately 5 and 40 times the maximum recommended human daily inhalation doses (mrhdid) of 200 and 25 mcg, respectively. (see data.) the estimated risk of major birth

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

glaxosmithkline llc - fluticasone furoate (unii: js86977wnv) (fluticasone - unii:cut2w21n7u) - fluticasone furoate 27.5 ug - veramyst® (fluticasone furoate) nasal spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older. veramyst nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3)] . teratogenic effects pregnancy category c. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. there were no teratogenic effects in rats and rabbits at inhaled fluticasone furoate dosages of up to 91 and 8 mcg/kg/day, respectively (approximately 7 and 1 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). there was also no effect on pre- or post-natal development in rats treated with up to 27 mcg/kg/day by inhalation during gestation and lactation (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). there are no adequate and well-co

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - fluticasone furoate; umeclidinium as bromide; vilanterol as trifenatate - powder for inhalation pre-dispensed - vilanterol as trifenatate 22 mcg/inh; umeclidinium as bromide 55 mcg/inh; fluticasone furoate 92 mcg/inh - vilanterol, umeclidinium bromide and fluticasone furoate - asthmatrelegy ellipta 92/55/22 mcg is indicated for the maintenance treatment of asthma in patients aged 18 years and older.trelegy ellipta 92/55/22 mcg should be prescribed for patients who are not adequately controlled on maintenance asthma medication, such as an ics/laba.important limitations of use:trelegy ellipta 92/55/22 mcg is not indicated for the relief of acute asthma.copd (chronic obstructive pulmonary disease)trelegy ellipta 92/55/22 mcg is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.