FDA label
What is Breo Ellipta used for?
Breo Ellipta contains fluticasone furoate and vilanterol trifenatate. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Breo Ellipta lists 2 uses: Maintenance Treatment of Chronic Obstructive Pulmonary Disease; Maintenance Treatment of Asthma.
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Breo Ellipta, powder
Indications and Usage, quoted from the label by GlaxoSmithKline LLC (NDA204275). Cross-references to other label sections are left out.
Maintenance Treatment of Chronic Obstructive Pulmonary Disease
BREO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Maintenance Treatment of Asthma
BREO ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 5 years and older.
Limitations of Use
BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.
Source: DailyMed label, set id 96428df1-ea05-431a-98d3-1ec2c4b63878, version 29, effective November 7, 2024. NDC 0173-0859, one of 3 listings for this product.
Questions
What is Breo Ellipta used for?
The FDA label for Breo Ellipta lists 2 uses: Maintenance Treatment of Chronic Obstructive Pulmonary Disease; Maintenance Treatment of Asthma.
What drug class is Breo Ellipta?
FDA lists fluticasone furoate and vilanterol trifenatate in the Corticosteroid and beta2-Adrenergic Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.