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Indacaterol Maleate

Asthma Related Death

  • Long acting beta2-adrenergic agonists (LABA) increase the risk of asthma related death.
  • Data from a large placebo-controlled US study that compared the safety of another long acting beta2-adrenergic agonist (salemterol) 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 LABA, including indacaterol, the active ingredient in Arcapta Neohaler.
  • The safety and efficacy of Arcapta Neohaler in patients with asthma have not been established.
  • Indacaterol is not indicated for the treatment of asthma. [See contraindications, Warninigs and Precautions]

Patient Counseling Information

Medication Guides

Medication Guide

Package Inserts

Arcapta Neohaler

Updated January 2018