Adrenergic beta2-Agonists

beta2-Adrenergic Agonist

Cholinergic Antagonists

Anticholinergic

Corticosteroid Hormone Receptor Agonists

Corticosteroid

Pulmonary Emphysema

Rhinitis, Allergic, Perennial

Sleep Apnea, Obstructive

Bronchitis, Chronic

<section class="Section" data-sectioncode="34089-3"><a name="ID_a0683369-43b9-4e1c-bd8b-96545f2c0d06"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation.Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure:<div class="Figure"><a name="id-1614583184"></a><img alt="Fluticasone furoate chemical structure" src="trelegy-ellipta-spl-graphic-01.jpg"/></div>Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water.Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure:<div class="Figure"><a name="id1520584"></a><img alt="Umeclidinium chemical structure" src="trelegy-ellipta-spl-graphic-02.jpg"/></div>Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2•Br (as a quaternary ammonium bromide compound). It is slightly soluble in water.Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure:<div class="Figure"><a name="id-1828963571"></a><img alt="Vilanterol chemical structure" src="trelegy-ellipta-spl-graphic-03.jpg"/></div>Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5•C20H16O2. It is practically insoluble in water.TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component.In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] &lt;70% and FEV1 &lt;30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min).In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min).The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</section>

Trelegy Ellipta

vilanterol

umeclidinium

fluticasone / umeclidinium / vilanterol

14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler

Trelegy

14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]

30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler

30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]

14 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler

14 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]

30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler

30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]

fluticasone

fluticasone furoate

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled
corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a
long-acting beta2-adrenergic agonist (LABA), indicated for:
• the maintenance treatment of patients with chronic obstructive pulmonary
disease (COPD).
• the maintenance treatment of asthma in patients aged 18 years and older. 