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Indacaterol

Pronunciation

(in da KA ter ol)

Index Terms

  • Indacaterol Maleate
  • QAB149

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Inhalation:

Arcapta Neohaler: 75 mcg [contains lactose monohydrate, milk protein]

Brand Names: U.S.

  • Arcapta Neohaler

Pharmacologic Category

  • Beta2 Agonist
  • Beta2-Adrenergic Agonist, Long-Acting

Pharmacology

Relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate; acts locally in the lung.

Absorption

Systemic: Inhalation: 43% to 45% bioavailable

Metabolism

Hepatic; hydroxylated via CYP3A4, CYP2D6, and CYP1A1

Excretion

Feces (>90%; 54% as unchanged drug [after oral administration]); urine (<2% as unchanged drug)

Onset of Action

5 minutes; Peak effect: 1-4 hours

Time to Peak

Serum: ~15 minutes

Duration of Action

24 hours

Half-Life Elimination

40-56 hours

Protein Binding

~95%

Use: Labeled Indications

Chronic obstructive pulmonary disease (maintenance): Long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema

Limitations of use: Not indicated for treatment of acute deterioration of COPD or for treatment of asthma.

Contraindications

Hypersensitivity to indacaterol or any component of the formulation; monotherapy in the treatment of asthma (ie, use without a concomitant long-term asthma control medication, such as an inhaled corticosteroid).

Dosing: Adult

COPD (maintenance): Inhalation: Contents of 1 capsule (75 mcg) inhaled once daily using Neohaler inhaler (US labeling) or Onbrez Breezhaler inhalation device (Canadian labeling). Maximum dose: 1 capsule (75 mcg)/day.

Note: A dose of 75 to 300 mcg once daily is recommended by the 2015 Updated GOLD Guidelines.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

Mild-to-moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Administration

Inhalation: Administer via oral inhalation using Neohaler inhaler (US labeling) or Onbrez Breezhaler (Canadian labeling) only. Do not swallow capsules. Use the new inhaler included with each prescription. Do not remove capsule from blister until immediately before use. Use at the same time each day. Not to be used for the relief of acute attacks. Not for use with a spacer device. Do not wash mouthpiece; inhalation device should be kept dry. Discard any capsules that are exposed to air and not used immediately.

Storage

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.

Drug Interactions

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

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

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

Adverse Reactions

>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

ALERT: U.S. Boxed Warning

Asthma-related death:

Long-acting beta-2 adrenergic agonists increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of another long-acting beta-2 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 long-acting beta-2 adrenergic agonists, 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.

Warnings/Precautions

Concerns related to adverse effects:

• Asthma-related deaths: [US Boxed Warning]: Long-acting beta2-agonists (LABAs) increase the risk of asthma-related deaths. Indacaterol is not indicated for the treatment of asthma; the safety and efficacy of indacaterol in the treatment of asthma have not been established. In a large, randomized, placebo-controlled U.S. clinical trial (SMART, 2006), salmeterol was associated with an increase in asthma-related deaths (when added to usual asthma therapy); risk is considered a class effect among all LABAs. It is unknown if indacaterol increases asthma-related deaths. No data exist associating LABA use with an increased risk of death in patients with COPD.

• Bronchospasm: Rarely, paradoxical, life-threatening bronchospasm may occur with use of inhaled beta2-agonists; distinguish from inadequate response, discontinue medication immediately, institute alternative therapy.

• Hypersensitivity: Hypersensitivity reactions may occur; discontinue therapy if patient develops an allergic reaction.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, hypertension, or HF); beta-agonists may cause elevation in blood pressure and heart rate. Beta2-agonists may also produce changes in the ECG (eg, T-wave flattening, QTc prolongation, ST segment depression).

• COPD: Appropriate use: Do not use for acute bronchospastic episodes of COPD; always prescribe indacaterol with an inhaled short-acting beta2-agonist and educate patient on appropriate use. Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Do not increase the indacaterol dose or frequency beyond what is recommended.

• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose.

• Hyperthyroidism: Use with caution in patients with hyperthyroidism; may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium.

• Seizure disorders: Use with caution in patients with seizure disorders; beta2-agonists may result in CNS stimulation/excitation.

Concurrent drug therapy issues:

• LABA: Do not use with other long-acting beta2-agonists; deaths and significant cardiovascular effects have been reported with excessive sympathomimetic use.

Dosage form specific issues:

• Lactose: Product contains lactose; allergic reactions possible in patients with severe milk protein allergy.

Monitoring Parameters

FEV1, FVC, and/or other pulmonary function tests; serum potassium, serum glucose; blood pressure, heart rate; CNS stimulation. Monitor for increased use of short-acting beta2-agonist inhalers; may be marker of a deteriorating condition. Monitor for changes in risk factors (eg, environmental exposure, smoking status).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Beta agonists may interfere with uterine contractility if administered during labor.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience cough or rhinorrhea. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), angina, tachycardia, severe anxiety, severe headache, severe dizziness, swelling of arms or legs, tremors, or signs of a severe pulmonary disorder (lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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