indacaterol

indacaterol

(in-da-kat-e-role) ,

Arcapta Neohaler

(trade name),

Onbrez Breezhaler

(trade name)

Classification

Therapeutic: bronchodilators
Pharmacologic: adrenergics
Pregnancy Category: C

Indications

Long-term maintenance treatment of airflow obstruction associated with chronic obstructive pulmonary disease (COPD).

Action

Produces accumulation of cyclic adenosine monophosphate (cAMP) at beta2-adrenergic receptors. Relatively specific for pulmonary receptors.
Acts as a long-acting beta-agonist (LABA).

Therapeutic effects

Bronchodilation, with improvement in symptoms of COPD.

Pharmacokinetics

Absorption: Some systemic absorption from lungs and GI tract (43–45%).
Distribution: Extensively distributed.
Metabolism and Excretion: 54% excreted unchanged in feces; absorbed drug is mostly metabolized; 23% excreted in feces as metabolites.
Half-life: 45.5–126 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
Inhalnunknown15 min24 hr†
† Bronchodilation.

Contraindications/Precautions

Contraindicated in: HypersensitivityAcutely deteriorating COPD or acute respiratory symptoms;Asthma.
Use Cautiously in: Obstetric: Use during pregnancy only if potential benefit justifies potential fetal risks; may interfere with uterine contractility during labor; Pediatric: Safety and effectiveness not established.
Exercise Extreme Caution in: Concurrent use of MAO inhibitors, tricyclic antidepressants or drugs that prolong the QTc interval (↑ risk of adverse cardiovascular reactions).

Adverse Reactions/Side Effects

Central nervous system

  • headache

Ear, Eye, Nose, Throat

  • nasopharyngitis
  • oropharyngeal pain

Respiratory

  • paradoxical bronchospasm (life-threatening)
  • cough

Gastrointestinal

  • nausea

Miscellaneous

  • allergic reactions (life-threatening)

Interactions

Drug-Drug interaction

↑ risk of serious adverse cardiovascular effects with MAO inhibitors, tricyclic antidepressants, drugs that prolong the QTc interval ; use with extreme caution.Effectiveness may be ↓ by beta-blockers; use cautiously and only when necessary.Concurrent use with other adrenergics may ↑ adrenergic adverse reactions (↑ heart rate, BP, jitteriness).↑ risk of hypokalemia or ECG changes with xanthine derivatives, corticosteroids, diuretics, or non-potassium sparing diuretics.Use with caffeine-containing herbs (cola nut, guarana, mate, tea, coffee) ↑ stimulant effect.

Route/Dosage

Inhalation (Adults) 75 mcg once daily.

Availability

Capsules for inhalation: 75 mcg

Nursing implications

Nursing assessment

  • Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) before administration and at peak of medication. Consult health care professional about alternative medication if severe bronchospasm is present; onset of action is too slow for patients in acute distress. If paradoxical bronchospasm (wheezing) occurs, withhold medication and notify health care professional immediately.
  • Monitor for signs and symptoms of allergic reactions (difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash). Discontinue therapy if symptoms occur.
  • Lab Test Considerations: May cause transient hypokalemia and hyperglycemia.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Risk for activity intolerance (Indications)

Implementation

  • Inhalation: Pull cap off Neohaler. Open inhaler by holding the base and tilting the mouthpiece. Tear perforation to separate one blister from blister card; peal away protective back to expose foil. With dry hands, push capsule through foil to remove. Insert capsule into capsule chamber; do not swallow capsule or place directly into mouthpiece. Close inhaler until it clicks. Press both buttons fully 1 time; click is heard as capsule is pierced; do not press piercing buttons more than 1 time. Release buttons fully. Breathe out; do not blow into mouthpiece. Close lips around mouthpiece; hold inhaler with buttons left and right (not up and down). Breathe in rapidly and steadily, as deep as possible, a whirring noise is heard. Continue to hold breath as long as possible while removing inhaler from mouth. Open inhaler, if powder remains in capsule, close inhaler and inhale again. Usually requires 1–2 breaths. Remove capsule.

Patient/Family Teaching

  • Instruct patient in the correct use of capsules and Neohaler. Advise patient not to discontinue without consulting health care professional; symptoms may recur.
  • Inform patient that indacaterol is not a bronchodilator and should not be used for treating sudden breathing problems.
  • Advise patient to notify health care professional if signs and symptoms of allergic reaction, worsening symptoms; decreasing effectiveness of inhaled, short-acting beta2-agonists; need for more inhalations than usual of inhaled, short-acting beta2-agonists; or significant decrease in lung function occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products without consulting health care professional.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in the number of flare-ups or the worsening of COPD symptoms (exacerbations).
References in periodicals archive ?
The Beta-2-adrenoreceptor agonists, formoterol and indacaterol, but not salbutamol, effectively suppress the reactivity of human neutrophils in vitro.
QVM149 combines comprehensive bronchodilation of indacaterol acetate (a LABA [long-acting beta agonist]) and glycopyrronium bromide (a LAMA [long-acting muscarinic receptor antagonists) with mometasone furoate (an inhaled corticosteroid) in a precise once-daily formulation delivered in a dry-powder inhaler device.
Switzerland-based Novartis has revealed the first study results from the phase III PLATINUM clinical development program evaluating the safety and efficacy of QMF149, an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate (IND - a long acting beta agonist [LABA]) and mometasone furoate (MF - an anti-inflammatory (ICS), it was reported yesterday.
Novartis announced the first study results from the phase III PLATINUM clinical development program assessing the safety and efficacy of QMF149, an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate and mometasone furoate.
Vectura and its co-development partner Sosei Co Ltd licenced QVM149, which combines the drugs indacaterol acetate and glycopyrronium bromide, to Novartis in 2005.
According to the company, QVM149 is an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF), delivered with the dose-confirming Breezhaler inhalation device.
Bronchodilators, which improve lung function, decrease hyperinflation, and improve exercise performance by decreasing airway smooth muscle tone, are the cornerstone of COPD treatment and include short- and long-acting [[beta].sub.2]-agonists (SABAs [eg, albuterol/salbutamol and levalbuterol] and LABAs [eg, formoterol, indacaterol, olodaterol, and salmeterol]), and shortand long-acting muscarinic antagonists (SAMAs [eg, ipratropium bromide] and LAMAs [eg, aclidinium, glycopyrronium bromide, umeclidinium, and tiotropium]).
Suppose one would like to perform a randomized trial on the effectiveness of indacaterol versus tiotropium, among subjects suffering from chronic obstructive pulmonary disease, similar to Donohue et al.
J: Jadad score; FP: fluticasone propionate; SAL: salmeterol xinafoate; SFC: combination of salmeterol xinafoate and fluticasone propionate; BDP: beclomethasone dipropionate; FOR: formoterol; TIO: tiotropium; UMEC: umeclidinium; QVA149: combination of indacaterol (a long-acting agonist) with glycopyrronium (a long-acting muscarinic antagonist) as a dual bronchodilator; FF: fluticasone furoate; VI: vilanterol; NA: not applicable.
tested the effect of three [beta]2-agonists (formoterol, indacaterol, and salbutamol) on the inhibition to the proinflammatory activity.
* Arcapta (indacaterol; Novartis): Is lack of experience with Arcapta preventing doctors from recommending it?