(in da KA ter ol)
- Indacaterol Maleate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Arcapta Neohaler: 75 mcg [contains lactose monohydrate, milk protein]
Brand Names: U.S.
- Arcapta Neohaler
- Beta2 Agonist
- Beta2-Adrenergic Agonist, Long-Acting
Relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate; acts locally in the lung.
Systemic: Inhalation: 43% to 45% bioavailable
Hepatic; hydroxylated via CYP3A4, CYP2D6, and CYP1A1
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
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.
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).
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.
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).
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.
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
Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Avoid combination
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
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
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
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
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
QTc-Prolonging Agents (Highest Risk): QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). 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
QTc-Prolonging Agents (Moderate Risk): QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). 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
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 US 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. Data are not available to determine if the addition of an inhaled corticosteroid lessens this increased risk of death associated with LABA use; however, current guidelines recommend the use of an inhaled corticosteroid before adding a LABA (GINA 2015; NIH/NHLBI 2007). In a more recent multicenter, randomized, double-blinded trial, the use of salmeterol and an inhaled corticosteroid (ie, fluticasone) combined in a single inhaler in a large number of children, adolescent, and adult patients with persistent asthma (non-life threatening and stable) did not increase the risk of serious asthma-related events compared with fluticasone alone; in addition, patients receiving fluticasone/salmeterol had fewer severe asthma exacerbations compared with patients receiving fluticasone alone (Peters 2016; Stempel 2016a; Stempel 2016b). 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.
• 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.
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
Adverse events were not observed in animal reproduction studies. Beta agonists may interfere with uterine contractility if administered during labor.
• 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 pharyngitis, nausea, cough, or rhinorrhea. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, 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, difficulty swallowing, passing out, vision changes, severe headache, severe dizziness, swelling of arms or legs, tremors, or signs of a severe pulmonary disorder (lung or breathing problems like difficulty 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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- Drug class: adrenergic bronchodilators
Other brands: Arcapta