BREO ELLIPTA

Fluticasone/Vilanterol

BREO ELLIPTA

ICSLABA DPI

Fluticasone furoate / Vilanterol · GlaxoSmithKline

Clinical Reference

Active Medication & Mechanism

Fluticasone furoate ICS
50 mcg, 100 mcg, or 200 mcg per blister

Synthetic corticosteroid with enhanced glucocorticoid receptor affinity. Provides potent anti-inflammatory activity with once-daily dosing due to prolonged lung tissue retention.
Vilanterol trifenatate LABA
25 mcg per blister

Long-acting beta2-adrenergic agonist. Provides sustained bronchodilation for ≥24 hours with once-daily dosing.

FDA-Approved Dosing by Indication

// approval varies by strength + age

Asthma

2/3 approved regimens

Strength	Population	Dose & Frequency	Total Daily	Status
100/25 mcg	Adults (≥18 years)	1 inhalation once daily Maintenance treatment of asthma in adults.	100/25 mcg	FDA Approved
200/25 mcg	Adults (≥18 years)	1 inhalation once daily For adults requiring a higher inhaled corticosteroid dose. Maximum recommended adult asthma dose.	200/25 mcg	FDA Approved
Any strength	Acute bronchospasm	—	—	Not Approved Not a rescue inhaler. Use a SABA for acute symptoms.

100/25 mcg FDA Approved

Pop · Adults (≥18 years)

1 inhalation once daily

Maintenance treatment of asthma in adults.

Total · 100/25 mcg
200/25 mcg FDA Approved

Pop · Adults (≥18 years)

1 inhalation once daily

For adults requiring a higher inhaled corticosteroid dose. Maximum recommended adult asthma dose.

Total · 200/25 mcg
Any strength Not Approved

Pop · Acute bronchospasm

—

Total · — Not a rescue inhaler. Use a SABA for acute symptoms.

COPD

1/2 approved regimens

Strength	Population	Dose & Frequency	Total Daily	Status
100/25 mcg	Adults (≥18 years)	1 inhalation once daily Once-daily maintenance treatment of airflow obstruction in COPD. Also reduces COPD exacerbations in patients with a history of exacerbations.	100/25 mcg	FDA Approved
200/25 mcg	Adults (≥18 years)	—	—	Not Approved The 200/25 mcg strength is NOT indicated for COPD. Only 100/25 mcg is approved for COPD.

100/25 mcg FDA Approved

Pop · Adults (≥18 years)

1 inhalation once daily

Once-daily maintenance treatment of airflow obstruction in COPD. Also reduces COPD exacerbations in patients with a history of exacerbations.

Total · 100/25 mcg
200/25 mcg Not Approved

Pop · Adults (≥18 years)

—

Total · — The 200/25 mcg strength is NOT indicated for COPD. Only 100/25 mcg is approved for COPD.

Acute Use

0/1 approved regimens

Strength	Population	Dose & Frequency	Total Daily	Status
Any strength	Acute bronchospasm / rescue	—	—	Not Approved Not for acute bronchospasm. Use a SABA.

Any strength Not Approved

Pop · Acute bronchospasm / rescue

—

Total · — Not for acute bronchospasm. Use a SABA.