What are the usage guidelines for Breo Ellipta (fluticasone furoate/vilanterol)

Breo Ellipta Usage Guidelines

Primary Indications and Approved Populations

Breo Ellipta (fluticasone furoate/vilanterol) is FDA-approved for once-daily maintenance treatment of COPD in adults and for maintenance treatment of asthma in patients aged 5 years and older. 1

• Critical limitation: Breo Ellipta is NOT indicated for relief of acute bronchospasm or acute exacerbations—it is maintenance therapy only 1
• Never use as monotherapy for asthma without the inhaled corticosteroid component, as LABA monotherapy increases the risk of serious asthma-related events and death 1

Dosing by Indication

For COPD (Adults)

• Standard dose: 1 actuation of Breo Ellipta 100/25 mcg once daily 1
• This is the only approved strength for COPD 1
• Timing: Administer at the same time each day for optimal adherence 2

For Asthma (Age-Stratified Dosing)

• Ages 5-11 years: 1 actuation of 50/25 mcg once daily 1
• Ages 12-17 years: 1 actuation of 100/25 mcg once daily 1
• Ages 18 years and older: 1 actuation of 100/25 mcg OR 200/25 mcg once daily, depending on asthma severity 1

The higher 200/25 mcg strength should be reserved for patients with more severe asthma requiring higher-dose inhaled corticosteroids 1.

Administration Technique

Proper inhaler technique is critical—studies show only 5-14% of COPD patients make critical errors with Ellipta after reading instructions, compared to 44-60% with other devices. 3

Step-by-Step Administration:

1. Open the cover by sliding it down until you hear a "click"—this prepares one dose 1
2. Breathe out fully away from the mouthpiece (never exhale into the device) 1
3. Place mouthpiece between lips and take one long, steady, deep breath through your mouth (not nose) 1
4. Do not block the air vent with your fingers during inhalation 1
5. Hold breath for 3-4 seconds after removing the inhaler 1
6. Close the cover by sliding it back up 1
7. Rinse mouth with water and spit (do not swallow) to reduce risk of oral candidiasis 1

Critical Pitfalls to Avoid:

• Never open and close the cover without inhaling—this wastes a dose that cannot be recovered 1
• Do not shake the inhaler—it is a dry powder device, not a metered-dose inhaler 1
• Do not take a second dose even if you didn't taste or feel the medicine—the dose was delivered correctly 1
• Write the "discard" date (6 weeks after opening the foil tray) on the inhaler label 1

Contraindications

Absolute contraindications include: 1

• Primary treatment of status asthmaticus or acute COPD/asthma episodes requiring intensive measures
• Severe hypersensitivity to milk proteins (the device contains lactose monohydrate)
• Any known hypersensitivity to fluticasone furoate, vilanterol, or other ingredients

Safety Monitoring and Adverse Effects

Common Adverse Effects (≥3% incidence in COPD): 1

• Nasopharyngitis, upper respiratory tract infection
• Oral candidiasis (thrush)—mitigated by mouth rinsing after each use 1
• Headache, back pain, arthralgia
• Pneumonia risk in COPD patients—monitor for signs/symptoms of pneumonia 1
• Bronchitis, sinusitis, cough, oropharyngeal pain

Serious Safety Concerns Requiring Monitoring:

• Cardiovascular effects: Monitor for increased blood pressure, tachycardia, chest pain due to beta-adrenergic stimulation 1
• Bone mineral density: Assess BMD initially and periodically, especially with long-term use 1
• Growth velocity in children: Monitor height regularly in pediatric patients 1
• Ocular effects: Screen for glaucoma and cataracts with long-term use; consider ophthalmology referral if symptoms develop 1
• Metabolic effects: Monitor for hyperglycemia and hypokalemia 1
• Adrenal suppression: Risk increases with high doses or in susceptible individuals; wean slowly if transferring from systemic corticosteroids 1

Infection Risk:

• Use with caution in patients with active or quiescent tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex 1
• More serious or fatal courses of chickenpox or measles can occur in susceptible patients 1

Drug Interactions and Combination Therapy

Never use Breo Ellipta with additional LABA-containing medications—this creates risk of LABA overdose with cardiovascular effects 1.

• Avoid concurrent use with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) as they increase fluticasone furoate systemic exposure 1
• Use with caution in patients on beta-blockers, as they may diminish bronchodilator effects 1

Evidence Base for Efficacy

Fluticasone furoate/vilanterol improves lung function and reduces exacerbations more effectively than either monocomponent alone in COPD. 4

• In head-to-head trials, once-daily FF/VI 100/25 mcg was more effective than twice-daily fluticasone propionate/salmeterol 250/50 mcg for pulmonary function in COPD 2
• For asthma, once-daily FF/VI showed similar efficacy to twice-daily FP/SAL in improving lung function with no difference in exacerbation rates 5
• The once-daily regimen offers adherence advantages over twice-daily combination inhalers 6, 2

Storage and Disposal

• Store at room temperature (68-77°F/20-25°C) in a dry place away from heat and sunlight 1
• Keep in unopened foil tray until ready for use 1
• Discard 6 weeks after opening the tray OR when the dose counter reads "0," whichever comes first 1
• The desiccant packet in the tray should be discarded and not eaten or inhaled 1

Device Characteristics

The Ellipta device is a novel blister-strip dry powder inhaler with medium resistance that delivers a consistent dose across a range of inspiratory flow rates 6. Patient preference studies show 57-70% of patients make no errors using Ellipta without instruction, compared to requiring instruction for 56-85% of patients using other devices 3. This ease of use makes it particularly suitable for patients who struggle with complex inhaler techniques 6.