the QTc interval may have an increased the risk of ventricular arrhythmias.pindololMonitor Closely (1)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.pitolisantSerious - Use Alternative (1)indacaterol, inhaled and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.posaconazoleMonitor Closely (1)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.prednisoloneMonitor Closely (1)prednisolone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.prednisoneMonitor Closely (1)prednisone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.procainamideMonitor Closely (1)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.propafenoneMonitor Closely (1)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.propranololMonitor Closely (1)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.protriptylineMonitor Closely (1)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.quetiapineMonitor Closely (1)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.quinidineMonitor Closely (1)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.quinineMonitor Closely (1)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.ranolazineMonitor Closely (1)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.ribociclibSerious - Use Alternative (1)ribociclib increases toxicity of indacaterol, inhaled by QTc interval. Avoid or Use Alternate Drug.risperidoneMonitor Closely (1)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.ritonavirMonitor Closely (2)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. 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.romidepsinMonitor Closely (1)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.saquinavirMonitor Closely (2)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. 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.selpercatinibMonitor Closely (1)selpercatinib increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor.solriamfetolMonitor Closely (1)indacaterol, inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.sotalolMonitor Closely (2)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.sunitinibMonitor Closely (1)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.tacrolimusMonitor Closely (1)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.telavancinMonitor Closely (1)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.theophyllineMonitor Closely (1)theophylline, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.thioridazineMonitor Closely (1)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.thiothixeneMonitor Closely (1)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.timololMonitor Closely (1)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.toremifeneMonitor Closely (1)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.torsemideMonitor Closely (2)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.tranylcypromineMonitor Closely (1)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 suspensionMonitor Closely (1)triamcinolone acetonide injectable suspension, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.triclabendazoleMonitor Closely (1)triclabendazole and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.trifluoperazineMonitor Closely (1)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.trimipramineMonitor Closely (1)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.triptorelinMonitor Closely (1)triptorelin increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.umeclidinium bromide/vilanterol inhaledContraindicated (1)indacaterol, inhaled, umeclidinium bromide/vilanterol inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated.valbenazineMonitor Closely (1)valbenazine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.vandetanibMonitor Closely (1)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.vardenafilMonitor Closely (1)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.verapamilMonitor Closely (1)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.vilanterol/fluticasone furoate inhaledContraindicated (1)indacaterol, inhaled, vilanterol/fluticasone furoate inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated.voclosporinMonitor Closely (1)voclosporin, indacaterol, inhaled. Either increases effects of the other by QTc interval. Use Caution/Monitor.voriconazoleMonitor Closely (1)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.vorinostatMonitor Closely (1)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.ziprasidoneMonitor Closely (1)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. >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 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 asthmaContraindications 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 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