Umeclidinium + Vilanterol

1 INDICATIONS AND USAGE BREO ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta 2 ‑adrenergic agonist (LABA), indicated for: • Long-term, once-daily, maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.1) • Once-daily treatment of asthma in patients aged 18 years and older. ( 1.2 ) Important limitation: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 , 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BREO ® ELLIPTA ® 100/25 is a combination inhaled corticosteroid/long-acting beta 2 -adrenergic agonist (ICS/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BREO ELLIPTA 100/25 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA 100/25 once daily is the only strength indicated for the treatment of COPD. Important Limitation of Use BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm. 1.2 Treatment of Asthma BREO ELLIPTA is a combination ICS/LABA indicated for the once-daily treatment of asthma in patients aged 18 years and older. LABA, such as vilanterol, one of the active ingredients in BREO ELLIPTA, increase the risk of asthma-related death. Available data from controlled cl