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

glaxosmithkline llc - umeclidinium bromide (unii: 7an603v4jv) (umeclidinium - unii:ge2t1418sv), vilanterol trifenatate (unii: 40aho2c6dg) (vilanterol - unii:028lzy775b) - umeclidinium 62.5 ug - anoro ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). limitations of use anoro ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. the safety and effectiveness of anoro ellipta in asthma have not been established. anoro ellipta is contraindicated in: risk summary there are insufficient data on the use of anoro ellipta or its individual components, umeclidinium and vilanterol, in pregnant women to inform a drug-associated risk. (see clinical considerations.) in animal reproduction studies, umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effects on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (mrhdid). vilanterol administered via inhalation to pregnant rats and rabbits produced no fetal structural abnormalities at exposures approximately 70 times the mrhdid. (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 labor or delivery: anoro 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 umeclidinium and vilanterol has not been studied in pregnant animals. studies in pregnant animals have been conducted with umeclidinium and vilanterol individually. umeclidinium: in separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the mrhdid, respectively (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 with no evidence of effects on offspring development at doses up to approximately 26 times the mrhdid (on an auc basis at maternal subcutaneous doses up to 60 mcg/kg/day). vilanterol: in separate embryofetal developmental studies, pregnant rats and rabbits received vilanterol during the period of organogenesis at doses up to approximately 13,000 and 450 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 70 times the mrhdid (on an auc basis at maternal doses up to 591 mcg/kg/day in rabbits). however, fetal skeletal variations were observed in rabbits at approximately 450 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 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 anoro ellipta and any potential adverse effects on the breastfed child from 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 anoro ellipta have not been established in pediatric patients. anoro ellipta is not indicated for use in pediatric patients. based on available data, no adjustment of the dosage of anoro ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. clinical trials of anoro ellipta for copd included 2,143 subjects aged 65 years and older and 478 subjects aged 75 years and older. 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. 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)] . there were no significant increases in either umeclidinium 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)] .

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

glaxosmithkline llc - umeclidinium bromide (unii: 7an603v4jv) (umeclidinium - unii:ge2t1418sv) - umeclidinium 62.5 ug - incruse ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). incruse ellipta is contraindicated in the following conditions: risk summary there are insufficient data on the use of umeclidinium in pregnant women to inform a drug‑associated risk. umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (mrhdid). (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. data animal data: in separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the mrhdid, respectively (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 with no evidence of effects on offspring development at doses up to approximately 26 times the mrhdid (on an auc basis at maternal subcutaneous doses up to 60 mcg/kg/day). risk summary there is no information available on the presence of umeclidinium 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 incruse ellipta and any potential adverse effects on the breastfed child from umeclidinium 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 milk. the safety and effectiveness of incruse ellipta have not been established in pediatric patients. incruse ellipta is not indicated for use in pediatric patients. based on available data, no adjustment of the dosage of incruse ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. clinical trials of incruse ellipta included 810 subjects aged 65 years and older, and, of those, 183 subjects were aged 75 years and older. 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. 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)] . 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)] . instructions for use incruse ellipta (in-cruise e-lip-ta) (umeclidinium inhalation powder) for oral inhalation use read this before you start: your incruse ellipta inhaler how to use your inhaler figure a figure b important notes: check the counter. see figure c. figure c prepare your dose: wait to open the cover until you are ready to take your dose. figure d step 1. open the cover of the inhaler. see figure d. figure e step 2. breathe out. see figure e. figure f step 3. inhale your medicine. see figure f. figure g figure h figure i step 4. breathe out slowly and gently. see figure i. figure j step 5. close the inhaler. see figure j. important note: when should you get a refill? figure k for more information about incruse ellipta or how to use your inhaler, call 1-888-825-5249. trademarks are owned by or licensed to the gsk group of companies. glaxosmithkline, durham, nc 27701 ©2023 gsk group of companies or its licensor. inc:3ifu this instructions for use has been approved by the u.s. food and drug administration               revised: december 2023

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg;  ; vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg;   - powder for inhalation - 62.5mcg/25mcg - active: umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg   vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg   excipient: lactose monohydrate magnesium stearate - long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg;   - powder for inhalation - 62.5 mcg - active: umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg   excipient: lactose monohydrate magnesium stearate - incruse ellipta is indicated as a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - umeclidinium as bromide - powder for inhalation - umeclidinium as bromide 55 mcg - umeclidinium bromide - incruse is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Canada - English - Health Canada

glaxosmithkline inc - umeclidinium (umeclidinium bromide) - powder - 62.5mcg - umeclidinium (umeclidinium bromide) 62.5mcg - antimuscarinics antispasmodics

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide, vilanterol trifenatate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - anoro ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - umeclidinium as bromide; vilanterol as trifenatate - powder for inhalation - vilanterol as trifenatate 22 mcg; umeclidinium as bromide 55 mcg - vilanterol and umeclidinium bromide - anoro is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).anoro ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

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.

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.