Indacaterol

Indacaterol can cause serious side effects, including:

• serious allergic reactions including rash, hives, swelling of the tongue, lips and face, difficulties in breathing or swallowing. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
• sudden shortness of breath that may be life-threatening
• fast or irregular heartbeat (palpitations)
• increased blood pressure
• chest pain
• low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
• high blood sugar

People with asthma who take long-acting beta2 adrenergic-agonist (LABA) medicines, such as indacaterol, have an increased risk of death from asthma problems.

It is not known if LABA medicines, such as indacaterol, increase the risk of death in people with chronic obstructive pulmonary disease (COPD).

• Get emergency medical care if:
  • breathing problems worsen quickly
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems.

Do not use indacaterol if you:

• have asthma
• have had an allergic reaction to indacaterol 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of indacaterol there are no specific foods that you must exclude from your diet when receiving this medication.

The recommended indacaterol dose for the treatment of chronic obstructive pulmonary disease (COPD) is one 75 mcg capsule inhaled into the lungs using the Neohaler device once daily.

• Store indacaterol (inhaler and blister-packaged capsules) in a dry place 59° F to 86° F (15°C to 30°C).  Protect indacaterol (inhaler and blister-packaged capsules) from moisture. 
• Do not remove indacaterol capsules from their foil package until just before use.
• Keep indacaterol capsules out of the light.
• Do not store indacaterol capsules in the Neohaler inhaler.
• Keep indacaterol and all medicines out of the reach of children.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• To gain the most benefit, do not miss doses.
• Keep using indacaterol as you have been told by your doctor or other health care provider, even if you feel well.
• Use this medicine at the same time of day.
• Do not use more than 1 time a day.
• Do not swallow capsule. The contents of the capsule will be breathed into the lungs.
• Use with the Neohaler™ puffer (inhaler) only.
• Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
• Take the capsule out of the foil right before use.
• If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
• Do not use a spacer with the puffer (inhaler).
• Put the cap back on after you are done using your dose.
• Use new puffer (inhaler) with each refill.
• Do not wash the device. Always keep mouthpiece dry.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

• Indacaterol Maleate
• QAB149

5 minutes; Peak effect: 1-4 hours

Time to Peak

Serum: ~15 minutes

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture. Remove capsule from blister pack immediately before use; discard if not used immediately.

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy

Caffeine and Caffeine Containing Products: May enhance the adverse/toxic effect of Indacaterol. Caffeine and Caffeine Containing Products may enhance the hypokalemic effect of Indacaterol. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Corticosteroids (Systemic): Indacaterol may enhance the hypokalemic effect of Corticosteroids (Systemic). Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Long-Acting Beta2-Agonists: May enhance the adverse/toxic effect of other Long-Acting Beta2-Agonists. Avoid combination

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification

Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Theophylline Derivatives: May enhance the adverse/toxic effect of Indacaterol. Theophylline Derivatives may enhance the hypokalemic effect of Indacaterol. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

>10%: Respiratory: Cough (post-inhalation 7% to 24%)

1% to 10%:

Central nervous system: Headache (5%)

Gastrointestinal: Nausea (2%)

Respiratory: Nasopharyngitis (5%), oropharyngeal pain (2%)

<1% (Limited to important or life-threatening): Dizziness, hypersensitivity reaction, palpitations, paradoxical bronchospasm, pruritus, skin rash, tachycardia