Dosing & Uses
Dosage Forms & Strengths
capsule, powder for inhalation
- 75mcg/capsule
COPD
Long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
75 mcg inhaled orally qDay; not to exceed once daily
Limitations of use
- Not indicated for acute deteriorations of COPD
- Not indicated for asthma
Administration
For oral inhalation only
Do not swallow the capsules for inhalation; if swallowed, intended effects on the lungs will not be obtained
For use with Neohaler inhaler device only
Administer qDay at the same time of the day by the oral inhalation route only
If a dose is missed, the next dose should be taken as soon as it is remembered
Not to exceed once daily administration
Store capsule in the blister pack it comes in until immediately before use
Safety and efficacy not established
No dosage adjustment is required for geriatric patients, patients with mild-to-moderate hepatic impairment, or patients with renal impairment
Data are not available for severe hepatic impairment
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- umeclidinium bromide/vilanterol inhaled
indacaterol, inhaled, umeclidinium bromide/vilanterol inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated.
- vilanterol/fluticasone furoate inhaled
indacaterol, inhaled, vilanterol/fluticasone furoate inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated.
Serious - Use Alternative (18)
- adagrasib
adagrasib, indacaterol, inhaled. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients.
- amisulpride
amisulpride and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- arformoterol
arformoterol and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.
- crizotinib
crizotinib and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.
- entrectinib
indacaterol, inhaled and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
- glasdegib
indacaterol, inhaled and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.
- inotuzumab
inotuzumab and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.
- itraconazole
itraconazole and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.
- lefamulin
lefamulin and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.
- macimorelin
macimorelin and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.
- mobocertinib
mobocertinib and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.
- ondansetron
indacaterol, inhaled, ondansetron. QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.
- panobinostat
indacaterol, inhaled and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.
- pitolisant
indacaterol, inhaled and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.
- ribociclib
ribociclib increases toxicity of indacaterol, inhaled by QTc interval. Avoid or Use Alternate Drug.
Monitor Closely (162)
- abiraterone
indacaterol, inhaled, abiraterone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- acebutolol
indacaterol, inhaled, acebutolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- alfuzosin
indacaterol, inhaled and alfuzosin both increase QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
alfuzosin and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor. - amiodarone
indacaterol, inhaled, amiodarone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- amitriptyline
indacaterol, inhaled, amitriptyline. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- amoxapine
indacaterol, inhaled, amoxapine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- apomorphine
indacaterol, inhaled, apomorphine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- aripiprazole
aripiprazole and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- arsenic trioxide
indacaterol, inhaled, arsenic trioxide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- artemether
artemether and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- artemether/lumefantrine
indacaterol, inhaled, artemether/lumefantrine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- asenapine
indacaterol, inhaled, asenapine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- asenapine transdermal
asenapine transdermal and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- atenolol
indacaterol, inhaled, atenolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- atomoxetine
atomoxetine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- azithromycin
indacaterol, inhaled, azithromycin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- betamethasone
betamethasone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- betaxolol
indacaterol, inhaled, betaxolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- bisoprolol
indacaterol, inhaled, bisoprolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- bumetanide
bumetanide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, bumetanide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - ceritinib
ceritinib and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- chlorothiazide
chlorothiazide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, chlorothiazide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - chlorpromazine
indacaterol, inhaled, chlorpromazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- chlorthalidone
chlorthalidone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, chlorthalidone. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - ciprofloxacin
indacaterol, inhaled, ciprofloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- citalopram
indacaterol, inhaled, citalopram. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- clarithromycin
clarithromycin increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
indacaterol, inhaled, clarithromycin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - clomipramine
indacaterol, inhaled, clomipramine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- clozapine
clozapine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- cortisone
cortisone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- cyclobenzaprine
indacaterol, inhaled, cyclobenzaprine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- dasatinib
indacaterol, inhaled, dasatinib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- degarelix
indacaterol, inhaled, degarelix. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- desipramine
indacaterol, inhaled, desipramine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- deutetrabenazine
deutetrabenazine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- dexamethasone
dexamethasone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- dichlorphenamide
dichlorphenamide and indacaterol, inhaled both decrease serum potassium. Use Caution/Monitor.
- disopyramide
indacaterol, inhaled, disopyramide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- dobutamine
dobutamine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.
- dofetilide
dofetilide increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor.
- dolasetron
indacaterol, inhaled, dolasetron. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- donepezil
donepezil and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- dopamine
dopamine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.
- doxepin
indacaterol, inhaled, doxepin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- dronedarone
indacaterol, inhaled, dronedarone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- droperidol
indacaterol, inhaled, droperidol. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- efavirenz
efavirenz and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- encorafenib
encorafenib and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- ephedrine
ephedrine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.
- epinephrine
epinephrine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.
- eribulin
eribulin and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- erythromycin base
indacaterol, inhaled, erythromycin base. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
erythromycin base increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose. - erythromycin ethylsuccinate
erythromycin ethylsuccinate increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
indacaterol, inhaled, erythromycin ethylsuccinate. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - erythromycin lactobionate
erythromycin lactobionate increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
indacaterol, inhaled, erythromycin lactobionate. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - erythromycin stearate
erythromycin stearate increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
indacaterol, inhaled, erythromycin stearate. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - escitalopram
indacaterol, inhaled, escitalopram. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
escitalopram increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. - esmolol
indacaterol, inhaled, esmolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- ethacrynic acid
ethacrynic acid, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, ethacrynic acid. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - fingolimod
fingolimod and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- flecainide
indacaterol, inhaled, flecainide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- fluconazole
indacaterol, inhaled, fluconazole. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- fluoxetine
indacaterol, inhaled and fluoxetine both increase QTc interval. Modify Therapy/Monitor Closely. Fluoxetine prolongs the QT interval; the prescribing information for fluoxetine recommends avoiding concurrent use of other drugs that may prolong the QT interval; risk may be increased with higher doses and/or when associated with hypokalemia; drugs that prolong the QTc interval may potentiate the effects of beta2 agonists on the cardiovascular system
- fluphenazine
indacaterol, inhaled, fluphenazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- foscarnet
indacaterol, inhaled, foscarnet. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- fostemsavir
indacaterol, inhaled and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- furosemide
furosemide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, furosemide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - gemifloxacin
indacaterol, inhaled, gemifloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- gemtuzumab
indacaterol, inhaled and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- gepirone
gepirone and indacaterol, inhaled both increase QTc interval. Modify Therapy/Monitor Closely.
- gilteritinib
gilteritinib and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- goserelin
goserelin increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- haloperidol
indacaterol, inhaled, haloperidol. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- hawthorn
indacaterol, inhaled, hawthorn. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- histrelin
histrelin increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- hydrochlorothiazide
hydrochlorothiazide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, hydrochlorothiazide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - hydrocortisone
hydrocortisone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- ibutilide
indacaterol, inhaled, ibutilide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- iloperidone
indacaterol, inhaled, iloperidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- imipramine
indacaterol, inhaled, imipramine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- indapamide
indapamide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, indapamide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.
indacaterol, inhaled, indapamide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - isocarboxazid
indacaterol, inhaled, isocarboxazid. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with MAO inhibitors. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- isoproterenol
isoproterenol increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.
- ketoconazole
ketoconazole increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
- lapatinib
lapatinib increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
indacaterol, inhaled, lapatinib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - lenvatinib
indacaterol, inhaled and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- leuprolide
leuprolide increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- levofloxacin
indacaterol, inhaled, levofloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- levoketoconazole
levoketoconazole increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
- lopinavir
indacaterol, inhaled, lopinavir. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- lumefantrine
indacaterol, inhaled, lumefantrine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- maprotiline
indacaterol, inhaled, maprotiline. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- mefloquine
indacaterol, inhaled, mefloquine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- methadone
indacaterol, inhaled, methadone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- methyclothiazide
methyclothiazide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, methyclothiazide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - methylprednisolone
methylprednisolone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- metolazone
metolazone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, metolazone. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - metoprolol
indacaterol, inhaled, metoprolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- moxifloxacin
indacaterol, inhaled, moxifloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- nadolol
indacaterol, inhaled, nadolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- nebivolol
indacaterol, inhaled, nebivolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- nelfinavir
nelfinavir increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
- nilotinib
indacaterol, inhaled, nilotinib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- norepinephrine
norepinephrine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.
- nortriptyline
indacaterol, inhaled, nortriptyline. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- octreotide
indacaterol, inhaled, octreotide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- ofloxacin
indacaterol, inhaled, ofloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- olodaterol inhaled
indacaterol, inhaled and olodaterol inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Caution with coadministration of adrenergic drugs by any route because of additive sympathetic effects
- osilodrostat
osilodrostat and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- osimertinib
osimertinib and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.
- oxaliplatin
oxaliplatin will increase the level or effect of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.
- ozanimod
ozanimod and indacaterol, inhaled both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.
- paliperidone
indacaterol, inhaled, paliperidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- pazopanib
indacaterol, inhaled, pazopanib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- penbutolol
indacaterol, inhaled, penbutolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- pentamidine
indacaterol, inhaled, pentamidine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- perphenazine
indacaterol, inhaled, perphenazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- phenelzine
indacaterol, inhaled, phenelzine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with MAO inhibitors. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- phenylephrine
phenylephrine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.
- pimozide
indacaterol, inhaled, pimozide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- pindolol
indacaterol, inhaled, pindolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- posaconazole
indacaterol, inhaled, posaconazole. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- prednisolone
prednisolone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- prednisone
prednisone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- procainamide
indacaterol, inhaled, procainamide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- propafenone
indacaterol, inhaled, propafenone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- propranolol
indacaterol, inhaled, propranolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- protriptyline
indacaterol, inhaled, protriptyline. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- quetiapine
indacaterol, inhaled, quetiapine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- quinidine
indacaterol, inhaled, quinidine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- quinine
indacaterol, inhaled, quinine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- quizartinib
quizartinib, indacaterol, inhaled. Either increases effects of the other by QTc interval. Modify Therapy/Monitor Closely. Monitor patients more frequently with ECG if coadministered with QT prolonging drugs.
- ranolazine
indacaterol, inhaled, ranolazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- risperidone
indacaterol, inhaled, risperidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- ritonavir
ritonavir increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
indacaterol, inhaled, ritonavir. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - romidepsin
indacaterol, inhaled, romidepsin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- saquinavir
saquinavir increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
indacaterol, inhaled, saquinavir. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - selpercatinib
selpercatinib increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor.
- solriamfetol
indacaterol, inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.
- sotalol
indacaterol, inhaled, sotalol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
indacaterol, inhaled, sotalol. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias. - sunitinib
indacaterol, inhaled, sunitinib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- tacrolimus
indacaterol, inhaled, tacrolimus. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- telavancin
indacaterol, inhaled, telavancin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- theophylline
theophylline, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- thioridazine
indacaterol, inhaled, thioridazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- thiothixene
indacaterol, inhaled, thiothixene. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- timolol
indacaterol, inhaled, timolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- toremifene
indacaterol, inhaled, toremifene. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- torsemide
torsemide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
indacaterol, inhaled, torsemide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics. - tranylcypromine
indacaterol, inhaled, tranylcypromine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with MAO inhibitors. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.
- triclabendazole
triclabendazole and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- trifluoperazine
indacaterol, inhaled, trifluoperazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- trimipramine
indacaterol, inhaled, trimipramine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- triptorelin
triptorelin increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- valbenazine
valbenazine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- vandetanib
indacaterol, inhaled, vandetanib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- vardenafil
indacaterol, inhaled, vardenafil. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- verapamil
verapamil increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
- voclosporin
voclosporin, indacaterol, inhaled. Either increases effects of the other by QTc interval. Use Caution/Monitor.
- voriconazole
indacaterol, inhaled, voriconazole. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- vorinostat
indacaterol, inhaled, vorinostat. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- ziprasidone
indacaterol, inhaled, ziprasidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
Minor (2)
- chloroquine
chloroquine increases toxicity of indacaterol, inhaled by QTc interval. Minor/Significance Unknown.
- itraconazole
itraconazole increases levels of indacaterol, inhaled by Other (see comment). Minor/Significance Unknown. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.
Adverse Effects
>10%
Post-inhalation cough (24% compared with 7% on placebo)
1-10%
Cough (6.5%)
Nasopharyngitis (5.3%)
Headache (5.1%)
Nausea (2.4%)
Oropharyngeal pain (2.2%)
Postmarketing Reports
Hypersensitivity reactions
Paradoxical bronchospasm
Tachycardia/heart rate increase/palpitations
Pruritus/rash
Dizziness
Pruritus
Warnings
Black Box Warnings
Long-acting beta2-adrenergic agonists (LABAs) 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 (salmeterol) 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 safety and efficacy of indacaterol in patients with asthma have not been established
Indacaterol is NOT indicated for the treatment of asthma
Contraindications
Hypersensitivity
Use of a long-acting beta2-adrenergic agonists (LABAs) without an inhaled corticosteroid in patients with asthma
Cautions
Do not initiate in acutely deteriorating COPD patients
Do not use for relief of acute symptoms; prescribe concomitant short-acting beta2-agonists for acute exacerbations
Do not exceed recommended daily dose; excessive doses may result in cardiovascular effects and may be fatal
Life-threatening paradoxical bronchospasm can occur; discontinue use immediately
Immediate hypersensitivity reactions may occur after administration of therapy; if signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash, anaphylaxis) occur, discontinue therapy and institute alternative therapy
Safety and efficacy in patients with asthma not established; not indicated for asthma
Data from a large placebo-controlled study in asthma patients showed that long-acting beta2-adrenergic agonists may increase the risk of asthma-related death (see Black Box Warnings)
Caution with CV disease, epilepsy, thyrotoxicosis, or sensitivity to sympathomimetics
Contains trace levels of milk protein
Tolerance to the effects of inhaled beta-agonists can occur with regularly-scheduled, chronic use
Increased sympathomimetic effects may occur if coadministered with other adrenergic drugs
May cause hypokalemia; this effect may be potentiated if coadministered with xanthine derivatives, corticosteroids, or diuretics
ECG changes or hypokalemia that may result from non-potassium sparing diuretics (eg, thiazides or loop diuretics) can be acutely worsened by beta-agonists, especially with high doses; use caution
Caution with coadministration of MOAIs, TCAs, and drugs that prolong QTc interval
Beta blockers may antagonize the effect of indacaterol
Strong dual inhibitors of CYP3A4 and P-gp (ie, ketoconazole, erythromycin, verapamil, ritonavir) may delay systemic clearance of indacaterol (AUC increased 1.9-fold); no dose adjustment is warranted with 75 mcg/day
Beta2 agonists may increase serum glucose; use caution in patients with diabetes mellitus
Use caution in patients with seizure disorders
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; women should be advised to contact their physician if they become pregnant while receiving therapy
There are no adequate and well-controlled human studies that have investigated effects during labor and delivery; because beta-agonist may potentially interfere with uterine contractility, drug should be used during labor only if potential benefit justifies potential risk
Animal data
- In animal reproduction studies, there was no evidence of fetal harm or structural abnormalities following subcutaneous administration of indacaterol maleate to pregnant Wistar rats and New Zealand White rabbits during the period of organogenesis at exposures approximately 180 and 410 times the maximum recommended human dose (MRHD of 75 mcg), respectively, on an exposure area under the curve (AUC) basis
Lactation
There is no data on presence of indacaterol in human milk, effect on breastfed infant, or on milk production; drug is present in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Long-acting beta2-adrenergic agonist; when inhaled, acts locally in the lung as a bronchodilator
Stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle
In vitro studies have shown that indacaterol has more than 24-fold greater agonist activity at beta2-receptors compared to beta1-receptors (selectivity profile is similar to formoterol)
Absorption
Bioavailability: 43-45% following inhalation (composite of pulmonary and intestinal absorption)
Peak Plasma Time: 15 min
Distribution
Protein Bound: 95% (after IV administration)
Vd: 2361-2557 L (after IV administration)
Metabolism
Metabolized by UGT1A1, CYP3A4 (predominant for hydroxylation), CYP1A1, CYP2D6
Low affinity for efflux pump P-gp
In vitro investigations indicated that indacaterol has negligible potential to cause metabolic interactions with medications (by inhibition or induction of cytochrome P450 enzymes, or induction of UGT1A1)
Elimination
Half-life (terminal): 45.5-126 hr, multiphasic half-life
Half-life (effective): 40-56 hr, calculated from accumulation after repeated dosing
Renal clearance: 0.46-1.2 L/hr
Total body clearance: 18.8-23.3 L/hr
Excretion: feces (54% unchanged, 23% hydroxylated metabolites), urine (<2%)
Pharmacogenomics
Pharmacokinetics were prospectively investigated in individuals with the UGT1A1 (TA)7/(TA)7 genotype (low UGT1A1 expression; also referred to as *28) and the (TA)6, (TA)6 genotype
Steady-state AUC and Cmax were 1.2-fold higher in the [(TA)7, (TA)7] genotype, suggesting no relevant effect of UGT1A1 genotype of indacaterol exposure
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Formulary
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