DIQTA 1.0: Drug-Induced QT Prolongation Atlas

INDACATEROL MALEATE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIQT concern

Severity Score:3.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

WARNINGS AND PRECAUTIONS
Cardiovascular Effects
ARCAPTA NEOHALER, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. If such effects occur, ARCAPTA NEOHALER may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression, although the clinical significance of these findings is unknown. Therefore, ARCAPTA NEOHALER, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
DRUG INTERACTIONS
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs
Indacaterol, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval may have an increased risk of ventricular arrhythmias.
OVERDOSAGE
Human Experience
In COPD patients single doses of 40 times the 75 mcg dose were associated with moderate increases in pulse rate, systolic blood pressure and QTc interval.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Electrophysiology
The effect of ARCAPTA NEOHALER on the QT interval was evaluated in a double-blind, placebo- and active (moxifloxacin)-controlled study following multiple doses of indacaterol 150 mcg, 300 mcg or 600 mcg once-daily for 2 weeks in 404 healthy volunteers. Fridericia's method for heart rate correction was employed to derive the corrected QT interval (QTcF). Maximum mean prolongation of QTcF intervals were <5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time-matched comparisons versus placebo. During these studies, there were no clinically meaningful QT-interval prolongations. There was no evidence of a clinically relevant concentration-delta QTc relationship in the range of doses evaluated.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24085

Other ADRs

15128

38366459

Odds Ratio = 0.738

Drug Property Information

ATC Code(s):

R03AC18 - indacaterol maleate

R03AC - Selective beta-2-adrenoreceptor agonists
R03A - "ADRENERGICS, INHALANTS"
R03 - DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R - RESPIRATORY SYSTEM

Active Ingredient:INDACATEROL MALEATE

Active Ingredient UNII:2JEC1ITX7R

Drugbank ID:DB05039

PubChem Compound:6918554

CTD ID:C510790

PharmGKB:PA165958348

CAS Number:312753-06-3

Dosage Form(s):capsule

Route(s) Of Administrator:oral; respiratory (inhalation)

Daily Dose:

0.15 mg/day R03AC18

Chemical Structure:

SMILE Code:
CCC1=C(CC)C=C2CC(CC2=C1)NC[C@H](O)C1=C2C=CC(=O)NC2=C(O)C=C1

Reference

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