Cholinergic Antagonists

Anticholinergic

Pulmonary Emphysema

Bronchitis, Chronic

<section class="Section" data-sectioncode="34089-3"><a name="ID_f8172527-776b-4758-8f49-999f18516c2d"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">INCRUSE ELLIPTA is an inhalation powder drug product for delivery of umeclidinium (an anticholinergic) to patients by oral inhalation.</p><p>Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure:</p><div class="Figure"><a name="id8598620"></a><img alt="incruse-ellipta-spl-graphic-01.jpg" src="incruse-ellipta-spl-graphic-01.jpg"/></div><p>Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C<span class="Sub">29</span>H<span class="Sub">34</span>NO<span class="Sub">2</span>•Br (as a quaternary ammonium bromide compound). It is slightly soluble in water.</p><p>INCRUSE ELLIPTA is a light grey and light green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), magnesium stearate (75 mcg), and lactose monohydrate (to 12.5 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.</p><p>Under standardized in vitro test conditions, INCRUSE ELLIPTA delivers 55 mcg of umeclidinium per dose when tested at a flow rate of 60 L/min for 4 seconds.</p><p>In adult subjects with obstructive lung disease and severely compromised lung function (COPD with forced expiratory volume in 1 second/forced vital capacity [FEV<span class="Sub">1</span>/FVC] &lt;70% and FEV<span class="Sub">1</span> &lt;30% predicted or FEV<span class="Sub">1</span> &lt;50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 67.5 L/min (range: 41.6 to 83.3 L/min).</p><p>The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</p></section>

Incruse Ellipta

umeclidinium

30 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler

Incruse

30 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler [Incruse]

7 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler

7 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler [Incruse]

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

INCRUSE ELLIPTA is an anticholinergic indicated for the maintenance
treatment of patients with chronic obstructive pulmonary disease (COPD)