Indacaterol

ATC code

R03AC18

Therapeutic class

Selective beta-2 adrenergic agonist · Long-acting beta-2 adrenergic agonist (LABA)

Forms

inhalation powder, hard capsule

Brand names

Onbrez Breezhaler (ES) · Hirobriz Breezhaler (EU) · Arcapta Neohaler (US)

Overall confidence

high

Regulatory sources consulted

Approved indications

Maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).

Contraindications

Absolute

Hypersensitivity to the active substance or to any of the excipients (contains lactose).

Clinical warnings

Major warning · Should not be used in asthma. Long-acting beta-2 adrenergic agonists (LABA) as monotherapy increase the risk of asthma-related death. — EMA
Major warning · May cause life-threatening paradoxical bronchospasm. If it occurs, discontinue treatment immediately. — EMA
Use with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, arrhythmias, hypertension) due to potential effects on heart rate and blood pressure. — EMA

Drug interactions

HighPropranololC07AA05
Mechanism: Pharmacodynamic antagonism. Beta-blockers may weaken or antagonize the effect of beta-2 agonists, potentially causing severe bronchospasm.
Recommendation: Concomitant use is generally contraindicated. If absolutely necessary, use cardioselective beta-blockers with extreme caution and under monitoring.
EMA SPC
ModerateKetoconazoleJ02AB02
Mechanism: Potent inhibition of CYP3A4 and P-gp, increasing systemic exposure to indacaterol (AUC ~2-fold).
Recommendation: Use with caution. No dose adjustment is required, but monitoring for cardiovascular adverse effects is advised.
EMA SPC

Adverse events

Common (≥1%)

nasopharyngitis · cough · headache · muscle spasms · upper respiratory tract infection

Rare but serious

paradoxical bronchospasm · atrial fibrillation · ischaemic heart disease · hypersensitivity · hyperglycaemia

Pregnancy and lactation

Not recommended during pregnancy unless the expected benefit outweighs the potential risks. It is unknown whether it is excreted in human milk; a decision must be made whether to discontinue breast-feeding or to discontinue therapy.

Recent literature (PubMed)

Effect of indacaterol/glycopyrronium on ventilation and perfusion in COPD: a randomized trial.
Singh D, et al. · Respir Res · 2022 · Relevance 4/5
Estudio de imagen por RMN con gas hiperpolarizado que demuestra que la combinación indacaterol/glicopirronio mejora el volumen pulmonar ventilado global y la relación ventilación/perfusión (V/Q) en pacientes con EPOC moderada-grave, proporcionando un soporte mecanicista para su beneficio clínico.
Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function.
Han MK, et al. · N Engl J Med · 2022 · Relevance 3/5
El ensayo RETHINC no demostró un beneficio sintomático (SGRQ) de la combinación indacaterol/glicopirronio frente a placebo en fumadores sintomáticos con espirometría preservada, a pesar de una pequeña mejora en el FEV1. Cuestiona el uso de broncodilatadores en esta población pre-EPOC.
Inhaled indacaterol/glycopyrronium/mometasone furoate fixed-dose combination in moderate-to-severe asthma.
de Llano LP, et al. · Expert Rev Respir Med · 2022 · Relevance 2/5
Revisión sobre la triple terapia fija con indacaterol/glicopirronio/mometasona para el asma no controlada. Demuestra reducción de exacerbaciones y mejora de la función pulmonar y síntomas en comparación con ICS/LABA, aunque el indacaterol en monoterapia no está indicado para el asma.