What is the recommended adult dosing and administration instructions for Breo Ellipta (fluticasone propionate 100 µg/vilanterol 25 µg) inhalation powder?

Breo Ellipta Dosing and Administration

For COPD, administer Breo Ellipta 100/25 mcg (fluticasone furoate 100 mcg/vilanterol 25 mcg) as one inhalation once daily by oral inhalation. 1

COPD Dosing

• The only approved dose for COPD is Breo Ellipta 100/25 mcg: one inhalation once daily. 1
• Do not exceed one inhalation per 24-hour period, as higher doses increase adverse effects without additional benefit. 1
• Use at the same time each day to maintain consistent therapeutic levels. 1
• For breakthrough shortness of breath between doses, use a short-acting beta2-agonist (e.g., albuterol) as rescue medication. 1

Asthma Dosing (If Applicable)

Adults (≥18 years)

• Starting dose: Breo Ellipta 100/25 mcg once daily. 1
• If inadequate response: May increase to Breo Ellipta 200/25 mcg once daily. 1
• Maximum dose: Breo Ellipta 200/25 mcg once daily—do not exceed this. 1

Adolescents (12-17 years)

• Recommended dose: Breo Ellipta 100/25 mcg once daily. 1

Children (5-11 years)

• Recommended dose: Breo Ellipta 50/25 mcg once daily. 1

Administration Technique

• Rinse mouth thoroughly with water and spit after each inhalation to reduce the risk of oral candidiasis (thrush). 1
• Administer via the Ellipta dry powder inhaler using a single-step activation. 2, 3
• Do not use a spacer with the Ellipta device—it is a dry powder inhaler designed for direct inhalation. 2
• Ensure proper inhaler technique at every visit, as incorrect use is a common cause of treatment failure. 4

Onset of Action

• Median time to onset (defined as 100 mL increase in FEV1) is approximately 15 minutes after administration. 1
• Individual response varies; some patients experience faster or slower symptom relief. 1

Key Safety Considerations

Pneumonia Risk (COPD Patients)

• Fluticasone furoate/vilanterol increases pneumonia risk compared to vilanterol alone, particularly in patients who benefit most from the combination. 2, 3
• Monitor for signs of pneumonia (fever, increased sputum production, new infiltrates on imaging). 3

Cardiovascular Effects

• Vilanterol is a long-acting beta2-agonist (LABA) and may cause tachycardia, palpitations, or arrhythmias. 1
• Use caution in patients with cardiovascular disease; a trend toward increased cardiac events has been observed at higher doses. 5

Systemic Corticosteroid Effects

• At the 100 mcg fluticasone furoate dose, systemic effects are minimal. 6
• Higher doses (200 mcg) may increase risk of adrenal suppression, bone loss, and growth suppression in children. 7, 4

Oral Candidiasis

• Occurs in approximately 9-10% of patients. 4
• Mitigate by rinsing mouth and spitting after each use. 1

Critical Contraindications and Warnings

• Never use as monotherapy for asthma—LABAs without inhaled corticosteroids increase risk of asthma-related death. 1
• Not indicated for acute bronchospasm or status asthmaticus—use short-acting bronchodilators instead. 1
• Contraindicated in severe hypersensitivity to milk proteins (the powder contains lactose). 1

Common Pitfalls to Avoid

• Do not use more than once daily—increased frequency raises adverse effects without improving efficacy. 1
• Do not abruptly discontinue in asthma patients, as this may precipitate exacerbations. 4
• Do not prescribe LABA monotherapy—always combine with an inhaled corticosteroid in asthma. 4, 1
• Verify inhaler technique at every visit—improper use is the most common cause of apparent treatment failure. 4

Monitoring

• Reassess COPD or asthma control 2-6 weeks after initiating therapy. 4
• Monitor for signs of pneumonia in COPD patients on long-term therapy. 3
• In children, monitor growth velocity if using higher doses or prolonged therapy. 7, 4