Clinical Guidelines Highlights

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AMDA recommends that most LTC residents with COPD should be treated with long-acting maintenance bronchodilators1*

AMDA recommendation table

Used by permission. Further reproduction and/or distribution not permitted without written permission from AMDA. Sunovion has derived this information, with permission from AMDA, from the AMDA Clinical Practice Guideline (CPG) on COPD. Sunovion had no involvement in the preparation of the CPG.


Bronchodilators, especially the long-acting forms, are underutilized in PA/LTC. —AMDA, 2016



*AMDA–The Society for Post-Acute Care and Long-Term Medicine does not endorse any specific treatments.
From a retrospective analysis of more than 126,000 nursing home residents.

AMDA guidelines summary

AMDA recommends maintenance therapy in LTC.

Read a summary of the AMDA guidelines
 
 

AMDA does not endorse any specific treatments.
 

AMDA recommendation table

Used by permission. Further reproduction and/or distribution not permitted without written permission from AMDA. Sunovion has derived this information, with permission from AMDA, from the AMDA Clinical Practice Guideline (CPG) on COPD. Sunovion had no involvement in the preparation of the CPG.


Bronchodilators, especially the long-acting forms, are underutilized in PA/LTC. —AMDA, 2016



*AMDA–The Society for Post-Acute Care and Long-Term Medicine does not endorse any specific treatments.
From a retrospective analysis of more than 126,000 nursing home residents.

AMDA guidelines summary

AMDA recommends maintenance therapy in LTC.

Read a summary of the AMDA guidelines
 
 

AMDA does not endorse any specific treatments.
 

GOLD report icon

The GOLD 2018 report recommends the use of long-acting bronchodilators for COPD maintenance therapy2

COPD patients in all groups may benefit from a long-acting bronchodilator

  • Inhaled therapy is preferred
  • Prescribe a long-acting bronchodilator for maintenance treatment, with a goal to manage symptoms
  • Use of short-acting bronchodilators for maintenance treatment is generally not recommended

ABCD assessment tool

*CAT is the intellectual property of GlaxoSmithKline. Not validated for US-based physicians.

© 2018 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.


Inhalation-device education and technique training are essential to symptom management.2

On average more than two-thirds of patients make at least one error in using an inhalational device. —GOLD, 2018


GOLD does not endorse any specific treatments. The inclusion of GOLD information is not an endorsement of UTIBRON® NEOHALER® (indacaterol/glycopyrrolate) Inhalation Powder.

COPD=chronic obstructive pulmonary disease.
GOLD=Global Initiative for Chronic Obstructive Lung Disease.
LTC=long-term care.
PA=post-acute.

USING UTIBRON NEOHALER IN LONG-TERM CARE 

COPD patients in all groups may benefit from a long-acting bronchodilator

  • Inhaled therapy is preferred
  • Prescribe a long-acting bronchodilator for maintenance treatment, with a goal to manage symptoms
  • Use of short-acting bronchodilators for maintenance treatment is generally not recommended

ABCD assessment tool

*CAT is the intellectual property of GlaxoSmithKline. Not validated for US-based physicians.

© 2018 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.


Inhalation-device education and technique training are essential to symptom management.2

On average more than two-thirds of patients make at least one error in using an inhalational device. —GOLD, 2018


GOLD does not endorse any specific treatments. The inclusion of GOLD information is not an endorsement of nebulized UTIBRON® NEOHALER® (indacaterol/glycopyrrolate) Inhalation Powder.

COPD=chronic obstructive pulmonary disease.
GOLD=Global Initiative for Chronic Obstructive Lung Disease.
LTC=long-term care.
PA=post-acute.

USING UTIBRON NEOHALER IN LONG-TERM CARE 


References:
1. AMDA—The Society for Post-Acute and Long-Term Care Medicine. COPD Management in the Post-Acute and Long-Term Care Setting Clinical Practice Guideline. Columbia, MD: AMDA; 2016.
2. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2018 report. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2018:1-123. 

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.