Is fluticasone furoate vilanterol used for asthma and Chronic Obstructive Pulmonary Disease (COPD)?

Fluticasone Furoate/Vilanterol: Approved Uses

Fluticasone furoate/vilanterol is FDA-approved for both maintenance treatment of COPD and asthma in patients aged 5 years and older, administered as a once-daily inhalation. 1

FDA-Approved Indications

COPD Treatment

• Fluticasone furoate/vilanterol 100/25 mcg once daily is indicated for maintenance treatment of COPD. 1
• The combination improves pulmonary function more than placebo or fluticasone furoate alone, and reduces exacerbation rates more effectively than vilanterol monotherapy. 2
• This ICS/LABA combination provides bronchodilation and decreases the frequency of COPD exacerbations, particularly in patients with asthma-COPD overlap, eosinophilia, brisk bronchodilator response, or frequent exacerbations. 3

Asthma Treatment

• For adults aged 18 years and older with asthma: fluticasone furoate/vilanterol 100/25 mcg or 200/25 mcg once daily. 1
• For adolescents aged 12-17 years: fluticasone furoate/vilanterol 100/25 mcg once daily. 1
• For children aged 5-11 years: fluticasone furoate/vilanterol 50/25 mcg once daily. 1
• The combination significantly improves lung function, reduces rescue medication use, and increases symptom-free periods compared to inhaled corticosteroid monotherapy. 4

When to Use Triple Therapy vs. Dual Therapy

Triple Therapy Indications (for COPD)

• The American Thoracic Society recommends triple therapy for patients with persistent moderate to severe dyspnea despite dual therapy. 5
• Triple therapy is indicated for patients at high risk of COPD exacerbations (≥2 exacerbations per year or ≥1 hospitalization). 5, 6
• Single inhaler triple therapy may reduce mortality in individuals with moderate-severe disease compared to dual therapy options. 5, 6

Dual Therapy Positioning

• Fluticasone furoate/vilanterol represents dual therapy (ICS/LABA combination) and is appropriate before escalating to triple therapy. 1, 3
• Once-daily fluticasone furoate/vilanterol 100/25 mcg demonstrated similar efficacy to twice-daily fluticasone propionate/salmeterol 250/50 mcg and comparable effectiveness to fluticasone propionate/salmeterol 500/50 mcg. 2

Critical Limitations and Contraindications

What This Medication Is NOT For

• Not indicated for relief of acute bronchospasm or status asthmaticus. 1
• Contraindicated in patients with severe hypersensitivity to milk proteins or any ingredients. 1
• Do not use in combination with additional LABA-containing therapy due to overdose risk. 1

Important Safety Warnings

• LABA monotherapy increases the risk of serious asthma-related events—always use with an ICS component as in this fixed combination. 1
• Increased risk of pneumonia in COPD patients (number needed to harm of 33 patients treated for one year). 7, 1
• Monitor for Candida albicans infection of the mouth and pharynx; advise patients to rinse mouth with water without swallowing after inhalation. 1
• Risk of hypercorticism and adrenal suppression may occur with very high dosages or in susceptible individuals. 1

Common Clinical Pitfalls to Avoid

• Never add additional ICS therapy (like Pulmicort) to fluticasone furoate/vilanterol—this represents irrational polypharmacy and doubles ICS exposure without guideline support. 7
• When transitioning from dual ICS/LABA therapy to fluticasone furoate/vilanterol, discontinue the previous ICS-containing regimen rather than continuing both. 7
• If patients remain symptomatic on fluticasone furoate/vilanterol with chronic bronchitis phenotype and FEV₁ <50% predicted, add roflumilast rather than additional ICS. 7