Indacaterol
Class: Selective beta-2-Adrenergic Agonists
VA Class: RE102
Chemical Name: 5-[(1R)-2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-2(1H)-quinolinone, (2Z)-2-butenedioate (1:1)
Molecular Formula: C24H28N2O3•C4 H4O4
CAS Number: 753498-25-8
Brands: Arcapta Neohaler
Warning
Increased risk of asthma-related death with long-acting β2-adrenergic agonists. (See REMS and also see Asthma-related Death under Cautions.)
Increased risk of asthma-related death considered class effect of long-acting β2-adrenergic agonists, including indacaterol.
All long-acting β2-adrenergic agonists, including indacaterol, contraindicated in patients with asthma without concomitant use of long-term asthma controller therapy. Safety and efficacy of indacaterol in patients with asthma† not established; indacaterol not indicated for treatment of asthma.
Introduction
Bronchodilator; a relatively selective, long-acting β2-agonist.
Uses for Indacaterol
COPD
Long-term maintenance treatment of airflow obstruction associated with COPD, including chronic bronchitis and/or emphysema.
Not indicated for treatment of acute deterioration of COPD or relief of acute symptoms (i.e., as rescue therapy for treatment of acute episodes of bronchospasm). (See Deterioration of Disease and Acute Episodes under Cautions.)
Other Uses
Not indicated for treatment of asthma†; safety and efficacy in asthma not established.
Indacaterol Dosage and Administration
General
When initiating indacaterol therapy, discontinue regular use of short-acting, inhaled β2-adrenergic agonists; use such agents only for symptomatic relief of acute COPD symptoms not controlled by indacaterol.
Failure to respond to a previously effective dosage may indicate deterioration of disease that requires immediate reevaluation. Do not increase daily dosage of indacaterol beyond the recommended dosage. (See Deterioration of Disease and Acute Episodes under Cautions.)
Administration
Administer by oral inhalation only using a specific oral inhalation device (Neohaler) that delivers powdered drug from capsules.
Administer once daily at the same time every day.
Do notswallow the dry-powder capsules, as intended effects on lungs will not be obtained.
Oral Inhalation
Pull cap off and open inhaler by holding its base and tilting the mouthpiece. Expose only one capsule from blister card immediately before use. Place capsule into chamber of inhaler; do not place capsule directly into mouthpiece. After loading capsule, fully close inhaler; expect to hear a click as inhaler closes. While holding inhaler upright, fully press both piercing buttons one time only and then release; ex...
