What is the recommended dosage of Breo Ellipta (fluticasone furoate/vilanterol) for patients with Chronic Obstructive Pulmonary Disease (COPD) or asthma?

From the Guidelines

The recommended dosage of Breo Ellipta for patients with Chronic Obstructive Pulmonary Disease (COPD) or asthma is one inhalation of the 100/25 mcg strength once daily, with the option of 200/25 mcg for asthma patients with more severe conditions. When considering the management of COPD and asthma, it's crucial to prioritize treatments that improve lung function, reduce exacerbations, and enhance health-related quality of life. The combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA), such as fluticasone furoate and vilanterol in Breo Ellipta, is a recommended approach for patients with COPD and asthma, especially those with a history of exacerbations 1.

Key points to consider in the management of these conditions include:

• The importance of regular, once-daily dosing to maintain consistent therapeutic levels and improve adherence.
• The potential for oral thrush with inhaled corticosteroids, which can be mitigated by rinsing the mouth with water after use.
• Monitoring for systemic effects of corticosteroids, although less common with inhaled forms.
• The role of patient education in proper inhaler technique and the importance of not exceeding the recommended dose.

Given the evidence from recent guidelines and studies, the use of Breo Ellipta at the recommended dosages is supported for the management of COPD and asthma, with adjustments based on individual patient response and disease severity 1. It's also important to consider the overall treatment strategy, including the potential addition of other agents like long-acting muscarinic antagonists (LAMAs) for triple therapy in more severe cases, as suggested by guidelines and consensus documents 1.

From the FDA Drug Label

2.1 Recommended Dosage for Maintenance Treatment of Chronic Obstructive Pulmonary Disease The recommended dosage of BREO ELLIPTA 100/25 mcg (containing fluticasone furoate 100 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation. 2.2 Recommended Dosage for Maintenance Treatment of Asthma Adult Patients Aged 18 Years and Older The recommended dosage of BREO ELLIPTA 100/25 mcg (containing fluticasone furoate 100 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation or BREO ELLIPTA 200/25 mcg (containing fluticasone furoate 200 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation.

The recommended dosage of Breo Ellipta for patients with Chronic Obstructive Pulmonary Disease (COPD) is 1 actuation of 100/25 mcg once daily by oral inhalation. For patients with asthma, the recommended dosage is 1 actuation of 100/25 mcg or 200/25 mcg once daily by oral inhalation, depending on the patient's disease severity and previous asthma therapy 2.

• The maximum recommended dosage is 1 inhalation of BREO ELLIPTA 200/25 mcg once daily.
• For patients who do not respond adequately to the initial dosage, the dose may be increased to the next higher strength, but the patient should be re-evaluated and considered for other therapeutic options if the higher dose is not effective 2.
• Pediatric patients aged 12 to 17 years should receive 1 actuation of 100/25 mcg once daily, while those aged 5 to 11 years should receive 1 actuation of 50/25 mcg once daily 3.

From the Research

Recommended Dosage of Breo Ellipta

The recommended dosage of Breo Ellipta (fluticasone furoate/vilanterol) for patients with Chronic Obstructive Pulmonary Disease (COPD) or asthma is as follows:

• For COPD patients, the recommended dosage is 100/25 mcg once daily, administered in the morning 4.
• The dosage of 100/25 mcg was shown to be effective in reducing the rate of moderate or severe exacerbations in COPD patients, with a lower rate of exacerbations compared to usual care 5.
• In terms of pulmonary function, the 100/25 mcg dosage was associated with significant increases in trough FEV1 compared to vilanterol and fluticasone furoate alone 6.

Key Findings

Some key findings related to the dosage of Breo Ellipta include:

• The 100/25 mcg dosage was shown to be well-tolerated, with a similar safety profile to twice-daily fluticasone propionate/salmeterol 250/50 mcg 4.
• The use of Breo Ellipta was associated with a decreased rate of COPD exacerbations, without affecting mortality or cardiovascular outcomes in patients with moderate to severe stable COPD 6.
• However, the use of fluticasone furoate was associated with an increased risk of pneumonia, although this risk was not significantly different when compared to vilanterol alone 6.

Dosage Considerations

When considering the dosage of Breo Ellipta, the following points should be taken into account:

• The dosage of 100/25 mcg is recommended for COPD patients, and should be administered once daily in the morning 4.
• Patients should be individualized based on their unique phenotypes, with those having asthma-COPD overlap, sputum and/or blood eosinophilia, or frequent exacerbations being more likely to show a therapeutic response to Breo Ellipta 7.