What is Breo Ellipta (fluticasone furoate/vilanterol) used for?

Breo Ellipta: Indications and Clinical Use

Breo Ellipta (fluticasone furoate/vilanterol) is primarily indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma in patients aged 5 years and older. 1

Indications

For COPD:

• Maintenance treatment for patients with moderate to severe COPD
• Reduces exacerbations in patients with history of exacerbations
• Improves lung function and quality of life

For Asthma:

• Maintenance treatment for patients aged 5 years and older
• Not indicated for relief of acute bronchospasm (rescue therapy)

Mechanism of Action

Breo Ellipta combines two active ingredients:

• Fluticasone furoate: An inhaled corticosteroid (ICS) that reduces airway inflammation
• Vilanterol: A long-acting beta2-adrenergic agonist (LABA) that provides bronchodilation for 24 hours

Dosing and Administration

• COPD: 1 inhalation of Breo Ellipta 100/25 mcg once daily 1
• Asthma (adults and adolescents ≥18 years): 1 inhalation of either 100/25 mcg or 200/25 mcg once daily
• Asthma (adolescents 12-17 years): 1 inhalation of 100/25 mcg once daily
• Asthma (children 5-11 years): 1 inhalation of 50/25 mcg once daily

Clinical Benefits

1. Improved Lung Function:

   • Significant improvements in FEV1 compared to placebo 2
   • Once-daily dosing provides 24-hour bronchodilation 3

2. Reduced Exacerbations:

   • Particularly beneficial for patients with frequent exacerbations and elevated eosinophil counts (≥300 cells/μL) 4
   • Number needed to treat (NNT) of 4 to prevent one moderate-severe exacerbation per year in appropriate patients 4

3. Improved Quality of Life:

   • Enhances health-related quality of life measures compared to placebo 5
   • Reduces dyspnea and improves symptom control 6

Patient Selection

Breo Ellipta is most appropriate for:

• COPD patients with moderate to severe airflow limitation (FEV1 <60% predicted) 4
• Patients with history of exacerbations despite bronchodilator therapy 4
• Asthma patients requiring both an ICS and LABA for control 7
• Patients with elevated blood eosinophil counts (≥300 cells/μL) 4

Important Precautions

1. Pneumonia Risk:

   • Increased risk of pneumonia in COPD patients using ICS-containing regimens 5, 4
   • Monitor for signs and symptoms of pneumonia

2. Not for Acute Symptoms:

   • Not indicated for relief of acute bronchospasm or status asthmaticus 1
   • Patients should maintain a rescue inhaler for acute symptoms

3. Other Potential Side Effects:

   • Oral candidiasis (thrush) - patients should rinse mouth after use 1
   • Potential for adrenal suppression with high doses or susceptible individuals 1
   • Possible effects on bone mineral density with long-term use 1

Advantages of Breo Ellipta

• Once-daily dosing: Improves adherence compared to twice-daily alternatives 3
• Ellipta device: Easy to use dry powder inhaler with high patient satisfaction 8
• Comparable efficacy: Similar effectiveness to twice-daily fluticasone propionate/salmeterol in asthma 7

Monitoring Recommendations

• Regular assessment of symptom control and exacerbation frequency
• Monitor for pneumonia, especially in COPD patients
• Consider periodic eye examinations for patients on long-term therapy due to risk of cataracts/glaucoma 1
• Assess growth in pediatric patients 1

Breo Ellipta represents an effective once-daily maintenance therapy option for both COPD and asthma patients, with the convenience of once-daily dosing potentially improving treatment adherence in appropriate patients.