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Indacaterol/Glycopyrrolate

Asthma-Related Death

  • Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including indacaterol, one of the active ingredients in UTIBRON NEOHALER

  • The safety and efficacy of UTIBRON NEOHALER in patients with asthma have not been established. UTIBRON NEOHALER is not indicated for the treatment of asthma[see Warnings and Precautions (5.1)].


Patient Counseling Information

Package Inserts

Indacaterol maleate/Glycopyrrolate

Updated January 2018