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

Medical guidelines

Package inserts

Updated: January 2018