indacaterol

(redirected from Arcapta Neohaler)

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 ?
Arcapta Neohaler is approved with data demonstrating improvements in health-related quality of life
Arcapta Neohaler is an inhaled, steroid-free COPD treatment.
The primary endpoint results at week 12 showed that Arcapta Neohaler significantly improved lung function (FEV1) at 24 hours compared to placebo.
The launch of Arcapta Neohaler is a significant milestone as we continue to establish a strong respiratory presence in the US market.
Arcapta Neohaler has not been shown to impact mortality or long-term disability caused by COPD.
Once-daily Arcapta Neohaler also reduced the need for patients to use short-acting beta2-agonists (albuterol) as rescue therapy, measured as a secondary endpoint.
The safety and tolerability of Arcapta Neohaler was assessed in a clinical program of more than 5,400 COPD patients, with more than 2,500 who received Arcapta Neohaler for at least 12 weeks at doses of 75 mcg or higher.
The safety and efficacy of Arcapta Neohaler in patients with asthma have not been established.
Please see full prescribing information about Arcapta Neohaler, including BOXED WARNING at http://www.
1 US Launch Under Brand Name Arcapta Neohaler Expected in 2011 8.
The FDA has approved the Arcapta Neohaler for chronic obstructive pulmonary disease, albeit at a single and much lower dose than the two doses originally sought.
We also note that other than QVA149, Novartis' COPD portfolio includes Onbrez Breezhaler (indacaterol maleate) which was launched in the US under the brand name Arcapta Neohaler and in Japan under the name Onbrez Inhalation Capsules where it is being co-promoted by Eisai and Co.