HIGHLIGHTS OF PRESCRIBING INFORMATION • Increased risk of pneumonia in patients with COPD taking BREO These highlights do not include all the information needed to use the ELLIPTA. Monitor patients for signs and symptoms of pneumonia. () BREO ELLIPTA inhaler safely and effectively. See full prescribing • Potential worsening of infections (., existing tuberculosis; fungal, information for BREO ELLIPTA. bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course BREO ELLIPTA (fluticasone furoate and vilanterol inhalation powder) of chickenpox or measles can occur in susceptible patients. () FOR ORAL INHALATION USE • Risk of impaired adrenal function when transferring from systemic Initial . Approval: 2013 corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to BREO ELLIPTA. () WARNING: ASTHMA-RELATED DEATH • Hypercorticism and adrenal suppression may occur with very high See full prescribing information for complete boxed warning. dosages or at the regular dosage in susceptible individuals. If such • Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, changes occur, discontinue BREO ELLIPTA slowly. () one of the active ingredients in BREO ELLIPTA, increase the risk of • If paradoxical bronchospasm occurs, discontinue B
