An overview of the NEOHALER®: a COPD medication delivery device option

The Sunovion portfolio of handheld therapies includes:


UTIBRON®, SEEBRI®, and ARCAPTA® capsules should only be used with the NEOHALER device, provided with each prescription.

NEOHALER feedback mechanisms 

  • Audiovisual feedback—audio and visual cues each time a dose is inhaled1
  • Resistance—UTIBRON NEOHALER: 0.059 cm H2O1/2/L/min; SEEBRI NEOHALER: 0.07 cm H2O1/2/L/min
    • UTIBRON NEOHALER: Under standardized in vitro testing at a fixed flow rate of 90 L/min for 1.3 seconds, the NEOHALER inhaler delivered 20.8 mcg of indacaterol and 12.8 mcg glycopyrrolate for the 27.5 mcg/15.6 mcg dose strength (equivalent to 27.5 mcg/12.5 mcg of indacaterol/glycopyrronium) from the mouthpiece. This in vitro testing revealed that the NEOHALER device had a specific resistance of 0.059 cm H2O1/2/L/min
    • SEEBRI NEOHALER: Under standardized in vitro testing at a fixed flow rate of 90 L/min for 1.3 seconds, the NEOHALER device delivered 13.1 mcg for the 15.6 mcg dose strength (equivalent to 12.5 mcg of glycopyrronium) from the mouthpiece. This in vitro testing revealed that the NEOHALER device had a specific resistance of 0.07 cm H2O1/2/L/min

The NEOHALER device allows patients to visualize whether any powder is left in the capsule, giving them the flexibility to inhale all of the remaining dose1

HEAR - A soft whirring sound during inhalation to confirm the capsule is placed in the chamber correctly1

 

SEE - Clear capsule design allows patients to visualize whether any medication is left in the capsule. If any medication remains, simply inhale all of the remaining dose1

The 3 I’s are an easy way for patients to remember the detailed instructions

Remember the 3 I's: a summary of the full 13 steps1

Always refer to the Instructions for Use for complete steps:

  • Place the capsule into the capsule chamber1
  • Close the inhaler fully. You should hear a "click" as it fully closes1
  • Press both piercing buttons together firmly to pierce the capsule, then fully release the buttons1
  • A whirring noise during inhalation confirms the capsule is placed in the chamber correctly1
  • Capsules are for oral inhalation only and should not be swallowed1
  • Clear capsule design allows patients to visualize if medication is left in the capsule1
  • Open the NEOHALER inhaler. If any medication remains, simply inhale all of the remaining dose1

 

For representation purposes only. UTIBRON NEOHALER device and medication are shown.


 

Reference:

  1. UTIBRON NEOHALER [prescribing information]. 2018.

Important Safety Information & Indications for ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER 

Important Safety Information

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another LABA (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 all LABAs, including indacaterol, the active ingredient in ARCAPTA NEOHALER, and one of the active ingredients in UTIBRON NEOHALER.

The safety and efficacy of ARCAPTA NEOHALER or of UTIBRON NEOHALER in patients with asthma have not been established. ARCAPTA NEOHALER and UTIBRON NEOHALER are not indicated for the treatment of asthma.

 

All LABAs, including indacaterol, are contraindicated in patients with asthma without the use of a long-term asthma-control medication; ARCAPTA NEOHALER is also contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients, and UTIBRON NEOHALER is contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients. SEEBRI NEOHALER is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.

ARCAPTA NEOHALER, SEEBRI NEOHALER, or UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD, or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

ARCAPTA NEOHALER or UTIBRON NEOHALER should not be used more often, at higher doses than recommended, or in conjunction with other medicines containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief of acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using ARCAPTA NEOHALER or UTIBRON NEOHALER should not use another medicine containing a LABA for any reason.

Immediate hypersensitivity reactions have been reported with ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

As with other inhaled medicines, ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs following dosing with ARCAPTA NEOHALER, SEEBRI NEOHALER, or UTIBRON NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; ARCAPTA NEOHALER, SEEBRI  NEOHALER, or UTIBRON NEOHALER should be discontinued immediately and alternative therapy instituted.

Indacaterol, like other beta2-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. ARCAPTA NEOHALER and UTIBRON NEOHALER should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. beta2-adrenergic agonists may produce significant hypokalemia in some patients.

As with other beta2-adrenergic agonists, indacaterol should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.

As with other beta2-adrenergic agonists, ARCAPTA NEOHALER and UTIBRON NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

ARCAPTA NEOHALER and UTIBRON NEOHALER, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines. SEEBRI NEOHALER and UTIBRON NEOHALER should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any signs or symptoms develop.

In 6 clinical trials, 48% of ARCAPTA NEOHALER patients reported adverse reactions compared with 43% of placebo patients. The most common adverse events reported in ≥2% of patients taking ARCAPTA NEOHALER, and occurring more frequently than in patients taking placebo, were cough (6.5% vs 4.5%), nasopharyngitis (5.3% vs 2.7%), headache (5.1% vs 2.5%), nausea (2.4% vs 0.9%), and oropharyngeal pain (2.2% vs 0.7%). The most common serious adverse reactions of ARCAPTA NEOHALER patients were COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation, which occurred at similar rates across treatment groups.

The most common adverse events reported in ≥1% of patients taking SEEBRI NEOHALER, and occurring more frequently than in patients taking placebo, were upper respiratory tract infection (3.4% vs 2.3%), nasopharyngitis (2.1% vs 1.9%), oropharyngeal pain (1.8% vs 1.2%), urinary tract infection (1.4% vs 1.3%), and sinusitis (1.4% vs 0.7%).

The most common adverse events reported in ≥1% of patients taking UTIBRON NEOHALER, and occurring more frequently than in patients taking placebo, were nasopharyngitis (4.1% vs 1.8%), hypertension (2.0% vs 1.4%), back pain (1.8% vs 0.6%), and oropharyngeal pain (1.6% vs 1.2%).

ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules are only for oral inhalation and should only be used with the NEOHALER device.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please see full Prescribing Information, including BOXED WARNINGS and Medication Guides, for ARCAPTA NEOHALER and UTIBRON NEOHALER, and Patient Information for SEEBRI NEOHALER at www.SunovionProFile.com/ARCAPTA, www.SunovionProFile.com/UTIBRON, and www.SunovionProFile.com/SEEBRI.

Indication

ARCAPTA® NEOHALER® (indacaterol) is a long-acting beta2-adrenergic agonist (LABA), SEEBRI® NEOHALER® (glycopyrrolate) is an anticholinergic, and UTIBRON® NEOHALER® (indacaterol and glycopyrrolate) is a combination of indacaterol and glycopyrrolate; all are indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important limitations: ARCAPTA NEOHALER and UTIBRON NEOHALER are not indicated to treat acute deteriorations of COPD and are not indicated to treat asthma.