UTIBRON NEOHALER Hospital Unit Dosing

COPD patients in the hospital setting

1.8 million icon

Demand on health care resources is rising

  • Emergency department visits increased for patients with COPD from 1.5 million in 2006 to 1.8 million in 20111

Prescription icon

Hospitalized patients with COPD may require maintenance therapy

  • The Global Initiative for Chronic Lung Disease (GOLD) 2018 Report recommends SABAs, with or without short-acting anticholinergics, as the initial rescue treatment for patients hospitalized with COPD2
  • In addition, GOLD 2018 recommends starting maintenance therapy with long-acting bronchodilators as soon as possible before discharge2

GOLD does not endorse any specific treatments.

Learn more about the 2018 GOLD Report recommendations.

GET INFO 

Hospital impact

The economic impact on hospitals is substantial

  • A patient with COPD may be prescribed an inhaler that contains enough medication for 14 to 28 days of therapy. Since the average stay for COPD treatment is 4 to 5 days, that could mean discarding 9 to 24 days of unused medication3,4
  • A university-affiliated hospital study found that 87% of the total MDIs or DPIs given to 478 patients were left unused, amounting to a hospital cost of approximately $86,9735

UTIBRON NEOHALER has not been shown or indicated to impact cost in prospective, randomized, placebo-controlled trials.

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.

DPI=dry-powder inhaler.
MDI=metered-dose inhaler.
SABA=short-acting beta2-agonist.

1.8 million icon

Demand on health care resources is rising

  • Emergency department visits increased for patients with COPD from 1.5 million in 2006 to 1.8 million in 20111

Prescription icon

Hospitalized patients with COPD may require maintenance therapy

  • The Global Initiative for Chronic Lung Disease (GOLD) 2018 Report recommends SABAs, with or without short-acting anticholinergics, as the initial rescue treatment for patients hospitalized with COPD2
  • In addition, GOLD 2018 recommends starting maintenance therapy with long-acting bronchodilators as soon as possible before discharge2

GOLD does not endorse any specific treatments.

Learn more about the 2018 GOLD Report recommendations.

GET INFO 

The economic impact on hospitals is substantial

  • A patient with COPD may be prescribed an inhaler that contains enough medication for 14 to 28 days of therapy. Since the average stay for COPD treatment is 4 to 5 days, that could mean discarding 9 to 24 days of unused medication3,4
  • A university-affiliated hospital study found that 87% of the total MDIs or DPIs given to 478 patients were left unused, amounting to a hospital cost of approximately $86,9735

UTIBRON NEOHALER has not been shown or indicated to impact cost in prospective, randomized, placebo-controlled trials.

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.

DPI=dry-powder inhaler.
MDI=metered-dose inhaler.
SABA=short-acting beta2-agonist.

UTIBRON NEOHALER 3-Day Hospital Unit Dosing may help your institution save on unused medication5,6

The hospital unit dosing package is a 3-day prescription option designed for the institutional setting that may reduce the economic impact of wasted medication.

UTIBRON® NEOHALER® 3-day hospital unit dosing

For oral inhalation only. Do not swallow UTIBRON capsules, as the intended effects on the lungs will not be obtained. UTIBRON capsules should only be used with the NEOHALER device.

For inpatient and at-discharge planning

  • 3-day hospital unit doses may help decrease the potential for wasted medication4,5
  • Compact size of packaging (77 x 47 x 119 mm) allows for flexibility with storage and handling7

LEARN MORE ABOUT THE NEOHALER DEVICE 

For transition of care

As your patients prepare to return home, support their continued care with a voucher for a 30-day supply of UTIBRON NEOHALER.

SEE OFFER 

Ordering for institutional pharmacies6

Unit Dosing

Unit Dosing

Packaging Contents

Packaging Contents

NDC

NDC

Box of 60

Box of 60

10 blister cards with 6 yellow
transparent capsules each

10 blister cards with 6 yellow
transparent capsules each

63402-681-60

63402-681-60

Box of 6

Box of 6

1 blister card with 6 yellow
transparent capsules each

1 blister card with 6 yellow
transparent capsules each

63402-681-06

63402-681-06


References:
1. Ford ES. Hospital discharges, readmissions, and ED visits for COPD or bronchiectasis among US adults: findings from the nationwide inpatient sample 2001-2012 and Nationwide Emergency Department Sample 2006-2011. CHEST. 2015;147(4):989-998. 
2. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 Report. 2018:1-123.
3. Wier LM, Elixhauser A, Pfuntner A, Au DH. Overview of hospitalizations among patients with COPD, 2008. Statistical Brief #106. Healthcare Cost and Utilization Project (HCUP). February 2011. Rockville, MD: Agency for Healthcare Research and Quality. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb106.pdf. Updated May 13, 2016. Accessed June 18, 2018.
4. Larson T, Gudavalli R, Prater D, Sutton S. Critical analysis of common canister programs: a review of cross-functional considerations and health system economics. Curr Med Res Opin. 2015;31(4):853-860.
5. Sakaan S, Ulrich D, Luo J, Finch CK, Self TH. Inhaler use in hospitalized patients with chronic obstructive pulmonary disease or asthma: assessment of wasted doses. Hosp Pharm. 2015;50(5):386-390.
6. UTIBRON NEOHALER [prescribing information]. 2018.
7. Data on file. Hospital unit dosing packaging dimensions. Sunovion Pharmaceuticals Inc.

Important Safety Information & Indication

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, one of the active ingredients in UTIBRON NEOHALER.

The safety and efficacy of UTIBRON NEOHALER in patients with asthma have not been established. UTIBRON NEOHALER is 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; UTIBRON NEOHALER is also contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients.

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.

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 UTIBRON NEOHALER should not use another medicine containing a LABA for any reason.

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

As with other inhaled medicines, UTIBRON NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs following dosing with UTIBRON NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; 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. 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, UTIBRON NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

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.

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 of these signs or symptoms develop.

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%).

UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. 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 the full Prescribing Information, including BOXED WARNING and Medication Guide, for UTIBRON NEOHALER.



Indication
 

UTIBRON® NEOHALER® (indacaterol and glycopyrrolate) is a combination of indacaterol and glycopyrrolate 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: UTIBRON NEOHALER is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.