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fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
Overview
What is Trelegy Ellipta?
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:
Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is CHFOS. 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:
Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is CHNO•Br (as a quaternary ammonium bromide compound). It is slightly soluble in water.
Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure:
Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is CHClNO•CHO. 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 mix of micronized fluticasone furoate (100 mcg) and lactose monohydrate (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.
Comparative in vitro data for drug delivery and aerodynamic particle size distribution of the delivered drugs fluticasone furoate, umeclidinium, and vilanterol demonstrated that there were no pharmaceutical interactions and each drug was delivered in a comparable manner whether administered via a single ELLIPTA inhaler or from separate inhalers.
Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92, 55, and 22 mcg of fluticasone furoate, umeclidinium, and vilanterol, respectively, per dose when tested at a flow rate of 60 L/min for 4 seconds.
In adult subjects with very severe COPD (FEV/FVC [forced vital capacity] <70% and FEV <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
What does Trelegy Ellipta look like?
What are the available doses of Trelegy Ellipta?
Inhalation powder: Inhaler containing 2 foil blister strips of powder formulation for oral inhalation. One strip contains fluticasone furoate 100 mcg per blister and the other contains umeclidinium/vilanterol 62.5 mcg/25 mcg per blister. ()
What should I talk to my health care provider before I take Trelegy Ellipta?
Hepatic impairment: Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects. (, )
How should I use Trelegy Ellipta?
TRELEGY ELLIPTA 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. TRELEGY ELLIPTA is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
Important Limitations of Use
TRELEGY ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
TRELEGY ELLIPTA should be administered as 1 inhalation once daily by the orally inhaled route only.
After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
TRELEGY ELLIPTA should be used at the same time every day.
Do not use TRELEGY ELLIPTA more than 1 time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment .
What interacts with Trelegy Ellipta?
Sorry No Records found
What are the warnings of Trelegy Ellipta?
Sorry No Records found
What are the precautions of Trelegy Ellipta?
Sorry No Records found
What are the side effects of Trelegy Ellipta?
Sorry No records found
What should I look out for while using Trelegy Ellipta?
The use of TRELEGY ELLIPTA is contraindicated in patients:
What might happen if I take too much Trelegy Ellipta?
No human overdosage data has been reported for TRELEGY ELLIPTA.
TRELEGY ELLIPTA contains fluticasone furoate, umeclidinium, and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply to TRELEGY ELLIPTA. Treatment of overdosage consists of discontinuation of TRELEGY ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.
How should I store and handle Trelegy Ellipta?
TALTZ is sterile and preservative-free. Discard any unused portion. TRELEGY ELLIPTA is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100 mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5 mcg and 25 mcg per blister, respectively). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:NDC 0173-0887-10 TRELEGY ELLIPTA 30 inhalations (60 blisters)NDC 0173-0887-14 TRELEGY ELLIPTA 14 inhalations (28 blisters), institutional packStore at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.TRELEGY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard TRELEGY ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.TRELEGY ELLIPTA is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100 mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5 mcg and 25 mcg per blister, respectively). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:NDC 0173-0887-10 TRELEGY ELLIPTA 30 inhalations (60 blisters)NDC 0173-0887-14 TRELEGY ELLIPTA 14 inhalations (28 blisters), institutional packStore at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.TRELEGY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard TRELEGY ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.TRELEGY ELLIPTA is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100 mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5 mcg and 25 mcg per blister, respectively). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:NDC 0173-0887-10 TRELEGY ELLIPTA 30 inhalations (60 blisters)NDC 0173-0887-14 TRELEGY ELLIPTA 14 inhalations (28 blisters), institutional packStore at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.TRELEGY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard TRELEGY ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.TRELEGY ELLIPTA is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100 mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5 mcg and 25 mcg per blister, respectively). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:NDC 0173-0887-10 TRELEGY ELLIPTA 30 inhalations (60 blisters)NDC 0173-0887-14 TRELEGY ELLIPTA 14 inhalations (28 blisters), institutional packStore at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.TRELEGY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard TRELEGY ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.TRELEGY ELLIPTA is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100 mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5 mcg and 25 mcg per blister, respectively). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:NDC 0173-0887-10 TRELEGY ELLIPTA 30 inhalations (60 blisters)NDC 0173-0887-14 TRELEGY ELLIPTA 14 inhalations (28 blisters), institutional packStore at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.TRELEGY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard TRELEGY ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
TRELEGY ELLIPTA
TRELEGY ELLIPTA contains fluticasone furoate, umeclidinium, and vilanterol. The mechanisms of action described below for the individual components apply to TRELEGY ELLIPTA. These drugs represent 3 different classes of medications (an ICS, an anticholinergic, and a LABA), each having different effects on clinical and physiological indices.
Fluticasone Furoate
Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown.
The precise mechanism through which fluticasone furoate affects COPD symptoms is not known. Inflammation is an important component in the pathogenesis of COPD. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. Specific effects of fluticasone furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB, and inhibition of antigen-induced lung eosinophilia in sensitized rats. These anti-inflammatory actions of corticosteroids may contribute to their efficacy.
Umeclidinium
Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of umeclidinium is predominantly a site-specific effect.
Vilanterol
Vilanterol is a LABA. In vitro tests have shown the functional selectivity of vilanterol was similar to salmeterol. The clinical relevance of this in vitro finding is unknown.
Although beta-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta-receptors are the predominant receptors in the heart, there are also beta-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta-agonists may have cardiac effects.
The pharmacologic effects of beta-adrenergic agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3ʹ,5ʹ-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Non-Clinical Toxicology
The use of TRELEGY ELLIPTA is contraindicated in patients:The safety and efficacy of TRELEGY ELLIPTA in patients with asthma have not been established. TRELEGY ELLIPTA is not indicated for the treatment of asthma.
Use of long-acting beta-adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroid (ICS)] for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed‑dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.
Available data from clinical trials in subjects with COPD do not suggest an increased risk of death with use of LABA in patients with COPD.
The following adverse reactions are described in greater detail in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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