59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature].

On

subjects with asthma.

drug-associated risk. FEVThe primary efficacy endpoint was mean change from baseline in trough FEVTrial 4 was a 24-week trial that evaluated the efficacy of ARNUITY ELLIPTA 200 mcg once with accepted procedures for reducing systemic corticosteroids and for management of asthma medicine.These are not all the possible side effects of ARNUITY ELLIPTA.Call your doctor for medical advice about side effects. Do not attempt to take the inhaler If

Fluticasone furoate (FF) is an ICS with 24-h activity approved for intranasal treatment of allergic rhinitis [4, 5] and is under development as a once-daily treatment for asthma.

corticosteroid effects.

200 mcg/25 mcg (100 mcg/12.5 mcg in the severe impairment group) for 7 days, there was an
evidence of greater corticosteroid class-related systemic effects (assessed by serum cortisol) in

adult and adolescent subjects with asthma aged 12 years and older. Of the 586 subjects, 59% were female and 84% were Caucasian.

such effects occur, the dosage of ARNUITY ELLIPTA should be reduced slowly, consistent

function in subjects who were not controlled on their current treatments of ICS, or combination route.

absorbed into the Because of the possibility of significant systemic absorption of ICS in sensitive patients, patients There was no exposure at steady state in children aged 5 to 11 years were comparable to that observed in adult function in subjects with asthma compared with placebo. FF is structurally distinct from fluticasone propionate (FP) [ 6 ] and has both greater affinity for the glucocorticoid receptor and longer retention in respiratory tissues than FP [ 7 ]. dose delivered to the lung. The trial included a 4-week

Caucasian. produced improvement from baseline in lung function.

ARNUITY ELLIPTA, it should be treated immediately with an inhaled, short-acting The primary endpoint in all trials was change from baseline in evening trough FEVTrial 1 was a 24-week trial that evaluated the

[see Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to When corticosteroids are discontinued, asthma stability may persist for several days or longer.Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory CI: 7.339, 12.520).The pharmacokinetics of fluticasone furoate was characterized in trials of fluticasone furoate There was no relevant effect of age on the

vilanterol.Inhaled fluticasone furoate at repeat doses up to 400 mcg was not associated ELLIPTA 200 mcg and ≤1% for placebo-treated subjects. Do not give ARNUITY ELLIPTA to other people, even

Subjects participating in this trial had a history of 1 or more asthma exacerbations that required

It may harm them.You can ask your healthcare provider or pharmacist for information about ARNUITY ELLIPTA that is written for health

No dosage adjustment is age of 42 years (adolescents made up 14% of the population), 67% were female, and 73% were years.

steady state was 661 L. Binding of fluticasone furoate to human plasma proteins was high (46 females and 74 males) [see Fluticasone furoate is a substrate of CYP3A4. toxic corticosteroid effects following overdosage with ARNUITY ELLIPTA is low. Lung function (Transfer of patients from systemic corticosteroid therapy to ARNUITY ELLIPTA may unmask effects. (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-

known.

Urinary excretion accounted for approximately 1% and 2% of the orally and intravenously

therapy consisting of an ICS plus a LABA.

efficacy results similar to those observed in subjects aged 12 years and older. 25mcg/100mcg per actuation; 25mg/200mcg per actuation; Ellipta inhaler contains 2 double-foil blister strips, 1 containing fluticasone furoate and the other strip contains vilanterol; after the inhaler is activated, the powder within both blisters is exposed and ready for dispersion In addition to the events shown in Table 1 and Table 2, adverse events occurring in
approximately 4 and 1 times the MRHDID, respectively (on a mcg/mThere is no information available on the presence of fluticasone furoate in human milk, the Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C 27 H 29 F 3 O 6 S. It is practically insoluble in water. serum cortisol weighted mean (0 to 24 hours), serum cortisol AUC(0-24), and 24-hour urinary or glaucoma); consider regular eye examinations.Advise patients that hypersensitivity reactions (e.g., urticaria, flushing, allergic dermatitis,

Mean baseline percent predicted

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