Maintenance COPD Treatment Options | Sunovion ProFile

Looking for an appropriate COPD treatment?


Sunovion has a range of maintenance therapies for patients with COPD, including chronic bronchitis and/or emphysema, to help you provide personalized care.

Get to know our diverse COPD portfolio

  • Our portfolio
  • Therapies by device
  • Therapies by class
  • GOLD Report Summary
  • Treating LTC residents
  • COPD in the hospital setting
  • Hospital to Home Program

Therapies by Delivery Type

Vibrating Membrane Nebulizer

  • Patients use their natural breathing to take treatment1
  • Virtually silent administration3
  • Fine, flowing mist administered in 2-3 minutes (with proper assembly and cleaning)1,2*
  • All within a small, portable, and battery-operated device1†

Nebulized

  • Used with a standard jet nebulizer
  • Twice-daily dosing
  • Five- to 10-minute administration
  • Tidal breathing
  • Allows inhalation of medicine independent of inspiratory flow rate

Handheld (NEOHALER)

  • Small and portable
  • Breath-actuated
  • Audio and visual feedback mechanisms
    • Whirring noise on inhalation confirms capsule is correctly placed
    • Clear capsule allows patient to see if there is any residual medication

Sunovion LABA & LAMA Bronchodilator Treatment Options

Each COPD patient's needs are different. Sunovion has a range of COPD maintenance options to help you select an appropriate medication and delivery device.

Patients with COPD are commonly prescribed one or both of these types of long-acting bronchodilators:

LAMA

LAMAs work by inhibiting COPD-mediated bronchoconstriction.

LABA

LABAs cause a series of physiological reactions resulting in smooth muscle relaxation.

LABA/LAMA

LABA/LAMA work by using 2 classes of bronchodilators.

These maintenance medications should not be used for the relief of acute symptoms, ie, as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.

The GOLD Report recommends bronchodilators—individually or in combination—as integral to long-term COPD maintenance therapy.1

See GOLD Report Summary

GOLD does not endorse any specific treatments.

The GOLD Report Recommends the Use of Long‑Acting Bronchodilators for COPD Maintenance Therapy

GOLD recommends prescribing a long-acting bronchodilator for maintenance treatment, with a goal to manage symptoms

  • GOLD recommends using long-acting bronchodilators as a standard of care for COPD maintenance therapy1
  • Use of short-acting bronchodilators for maintenance treatment is generally not recommended

GOLD does not endorse any specific treatments. Refer to the GOLD Report for complete recommendations.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) was launched in 1997 in collaboration with the National Heart, Lung, and Blood Institute, the National Institutes of Health, USA, and the World Health Organization. The GOLD Report is shaped by committees made up of leading experts from around the world. Working with health care professionals and public health officials, GOLD seeks to raise awareness and improve prevention and treatment of COPD.

Assess COPD symptoms, exacerbation risk, and patient response to determine initial and follow-up pharmacological treatment

Initial Pharmacological Treatment

GOLD Initial Pharmacological Treatment

GOLD Initial Pharmacological Treatment

Follow-up Pharmacological Treatment

1. IF RESPONSE TO INITIAL TREATMENT IS APPROPRIATE, MAINTAIN IT

2. IF NOT:

  Consider the predominant treatable trait to target (dyspnea or exacerbations)

  Use exacerbation pathway if both exacerbations and dyspnea need to be targeted

  Place patient in box corresponding to current treatment and follow indications

  Assess response, adjust, and review

  These recommendations do not depend on the ABCD assessment at diagnosis

GOLD Follow-up Pharmacological Treatment

GOLD Follow-up Pharmacological Treatment

Consider de-escalation of ICS or switch if pneumonia, inappropriate original indication, or lack of response to ICS.
§ Consider if eos ≥300 or eos ≥100 AND ≥2 moderate exacerbations/1 hospitalization.

GOLD does not endorse any specific treatments. Refer to the GOLD Report for complete recommendations.

LAMA=long-acting muscarinic antagonist; LABA=long-acting beta2-adrenergic agonist; ICS=inhaled corticosteroid; eos=blood eosinophil count in cells per microliter; mMRC=modified British Medical Research Council Questionnaire; CAT™=COPD Assessment Test™.

© 2019 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.

 

Following implementation of therapy, reassess patients for attainment of treatment goals

GOLD recommends reviewing symptoms, assessing inhalation device technique, and then adjusting pharmacological treatment as needed.1

Management Cycle

GOLD Management Cycle

GOLD Management Cycle

*Response to escalation should always be reviewed. De-escalation should be considered if there is a lack of clinical benefit and/or side effects.
Including pulmonary rehabilitation and self-management education.

GOLD does not endorse any specific treatments. Refer to the GOLD Report for complete recommendations.

© 2019 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.

Impact and Treatment of COPD in Long-Term Care

COPD Incidence and Impact in LTC

COPD is a top-5 cause of avoidable hospital admissions1* Readmission

Approximately 1 in 5 long-term care residents has COPD2 Long-term Care residents

No Sunovion product has been indicated or shown to reduce hospitalizations in prospective, randomized, placebo-controlled studies.

Treatment of COPD in the LTC setting often does not align with the Clinical Practice Guidelines of AMDA–The Society for Post-Acute and Long-Term Care Medicine (AMDA) or recommendations from the Global Initiative for Chronic Obstructive Lung Disease (GOLD).2,3

COPD is a major cause of hospitalizations in LTC residents

  • Approximately 1 in 5 hospitalized residents age 75 years and older discharged to a skilled nursing facility (SNF) is readmitted within 30 days4

In a study of 3,037 LTC residents with COPD5

  • 43% were admitted to the hospital at least once
  • 90% experienced at least 1 emergency department visit

COPD costs are substantial and on the rise

  • A national survey estimates that inpatient hospitalizations account for over 70% of total direct costs of COPD6
  • COPD costs are projected to increase from $32 billion in 2010 to $49 billion in 20207

Long Term Care PDF

AMDA recommends maintenance therapy in LTC.

Download the PDF

AMDA does not endorse any specific treatments.

COPD is undertreated in the LTC setting

SABA monotherapy is overused as maintenance therapy for COPD2

  • The GOLD Report recommends using long-acting bronchodilators, including long-acting beta2-agonists, as a standard of care for COPD maintenance8

GOLD does not endorse specific treatments.

More than two-thirds of patients use their inhalation devices incorrectly8

  • This can result in decreased delivery of medication and, over time, may reduce COPD symptom control9


Importance of Maintenance Therapy

Long-acting bronchodilators are underutilized in LTC settings

In a study of 27,106 LTC residents with COPD

  • 17% received no respiratory treatments for COPD2

In a study of Medicare patients with COPD

  • 69% of those with more severe COPD and multiple comorbidities did not receive a long-acting COPD maintenance medication9

In another study

  • 60% of LTC residents with COPD did not receive a long-acting COPD maintenance therapy2

LTC residents with COPD often have more advanced COPD. For these patients, AMDA recommends maintenance therapy with long-acting bronchodilators, such as a LABA or LAMA alone or in combination.8

Maintenance therapy

AMDA recommends maintenance therapy in LTC.

Read a summary about the guidelines

AMDA does not endorse any specific treatments.

If COPD symptoms persist despite appropriate treatment, first check that the patient is using the inhalation device correctly before switching or adding additional medications.8

Most residents in LTC facilities should be on long-acting bronchodilators for maintenance treatment, such as a LABA or a LAMA, either alone or in combination, with short-acting bronchodilators used as needed for rescue.8,9

The importance of choosing an appropriate inhalation device for each individual patient cannot be overemphasized.7



COPD in the hospital setting

Burden of Hospitalization

Demand on health care resources is rising

 

COPD costs are projected to reach $50 billion a year in direct and indirect costs to the US health system. Hospitalizations account for a substantial portion of that burden1

 

Emergency department visits for patients with COPD rose from ~1.5 million in 2006 to
~1.8 million in 20111

 

1 in 5 hospitalized COPD patients are readmitted within 30 days2

Hospitalizations associated with COPD place a significant demand on healthcare resources and can be expected to rise as disease progresses.3

Hospitalized patients with COPD may require maintenance therapy

 

The Global Initiative for Chronic Lung Disease (GOLD) Report recommends SABAs, with or without short-acting anticholinergics, as the initial rescue treatment for patients with acute symptoms hospitalized for COPD4

 

In addition, GOLD 2019 recommends starting maintenance therapy with long-acting bronchodilators as soon as possible before discharge5

The accompanying impact of medication waste is substantial3,5-7

 

Length of hospitalization vs provided supply of medication:

  • The average length of a COPD hospitalization is 4.7 days; however, patients may be prescribed an inhaler containing enough medication for 14 to 28 days of therapy. This means that depending on packaging, as many as 24 days of medication may be left unused by each patient.5,6 See Sunovion's available unit doses for COPD

  • A university-affiliated hospital study found that 87% of the total MDIs of DPIs given to 478 patients were left unused, amounting to a hospital cost of approximately $86,9737

 

Errors of use and patient-to-device mismatch:

  • According to the GOLD Report, more than two-thirds of patients make at least one error in using an inhalational device, which may affect symptom control over time4

  • GOLD states the choice of inhalation device should be tailored to the patient, and will depend on access, cost, prescriber, and importantly, the patient's ability and preference4

  • Inhalation device education and technique training are essential to symptom management4

No Sunovion product has been shown or indicated to impact hospitalizations, readmissions, or cost in prospective, randomized, placebo-controlled trials.

GOLD does not endorse any specific treatments.

DPI=dry-powder inhaler.

MDI=metered-dose inhaler.

SABA=short-acting beta2-agonist.

References:

  1. Ford ES. Hospital discharges, readmissions, and ED visits for COPD or bronchiectasis among US adults. CHEST. 2015;147(4):989-998.
  2. Krishnan JA, Gussin HA, Prieto-Centurion V, Sullivan JL, Zaidi F, Thomashow BM. Integrating COPD into patient-centered hospital reasmission reduction programs. Chronic Obstr Pulm Dis. 2015;2(1):70-80.
  3. Jinjuvadia C, Jinjivadia R, Mandapakala C, Durairajan N, Liangpunsakul S, Soubani AO. Trends in outcomes, financial burden, and mortality for acute exacerbation of chronic obstructive pulmonary disease (COPD) in the United States from 2002 to 2010. COPD. 2016;14(1):72-79.
  4. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2019 report. Global Initiate for Chronic Obstructive Lung Disease (GOLD). 2019:1-139.
  5. 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.
  6. 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):853-390.
  7. 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.

Available Unit-Doses

Sunovion COPD maintenance treatments are available in packaging that may help reduce unused medication1-4

Packaging that aids prescribing flexibility and may help your organization reduce waste

Brovana

  • 30-pack shelf-carton for twice-daily dosing:
    NDC 63402-911-302

  • Bar-coded foil pouches2

  • Individual, ready-to-use unit-dose vials may help decrease the potential for wasted medication1,5

BROVANA is a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BROVANA is for use by nebulization only.

Important limitations: BROVANA is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.

BROVANA is for use by nebulization only and should not be swallowed.

For additional information, please see the full Prescribing Information and Patient Information for BROVANA.

Utibron Neohaler

  • 3-day hospital unit doses may help decrease the potential for wasted medication1,3,5

  • Compact packaging (77 x 47 x 119 mm) allows for flexibility with storage and handling6

UTIBRON NEOHALER is a combination of indacterol 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.

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

For additional information, please see the full Prescribing Information and Patient Information for UTIBRON NEOHALER.

SEEBRI NEOHALER

  • 3-day hospital unit doses may help decrease the potential for wasted medication1,4,5

  • Compact packaging (77 x 47 x 119 mm) allows for flexibility with storage and handling7

SEEBRI NEOHALER (glycopyrrolate) is an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

SEEBRI NEOHALER is not a rescue inhaler and is not indicated to treat episodes of acute bronchospasm.

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

For additional information, please see the full Prescribing Information and Patient Information for
SEEBRI NEOHALER.

Learn More about Access for Recently Discharged COPD Patients

References:

  1. 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.
  2. BROVANA (prescribing information). Sunovion Pharmaceuticals Inc.; 2019.
  3. UTIBRON NEOHALER (prescribing information). 2019.
  4. SEEBRI NEOHALER (prescribing information). 2019.
  5. 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):853-390.
  6. Data on file. Hospital unit dosing packaging dimensions. Sunovion Pharmaceuticals Inc.
  7. Data on file. Hospital unit dosing packaging dimensions. Sunovion Pharmaceuticals Inc.

Hospital to Home Program

Program Overview

Ensuring medication access for recently discharged COPD patients

The Hospital to Home Program is designed to support continuity of care for patients by helping to ensure access to UTIBRON NEOHALER, SEEBRI NEHOHALER, or BROVANA following hospital discharge.*

The program helps mitigate potential roadblocks to same-day access to these long-acting COPD maintenance medications, which helps support continuity-of-care goals.

GOLD recommendations should be considered when preparing your discharge plans. GOLD recommends initiating maintenance therapy with long-acting bronchodilators as soon as possible before discharge.1

GOLD does not endorse any specific treatments.

Step-by-step discharge process*†

1

Confirm
need for treatment

Clarify with the in-hospital health care provider that the patient is appropriate for treatment at discharge with UTIBRON NEOHALER, SEEBRI NEOHALER, or BROVANA.

BROVANA® is a LABA; SEEBRI® NEOHALER® is a LAMA; UTIBRON® NEOHALER® is a LAMA + LABA combination product

2

Write
prescription

If it has been determined that UTIBRON NEOHALER or SEEBRI NEOHALER is needed at discharge, provide the patient with:

  • A 30-day prescription for UTIBRON NEOHALER or SEEBRI NEOHALER
  • 30-day prescription UTIBRON® NEOHALER 30-day prescription SEEBRI NEOHALER
  • A voucher for a free 30-day supply of UTIBRON NEOHALER or SEEBRI NEOHALER

    See Details and Print Voucher

If it has been determined that BROVANA is needed at discharge, provide the patient with:

  • A 15-day prescription and consider a separate 30-day prescription for BROVANA to help smooth the transition after the 15-day supply runs out
  • 15-day prescription BROVANA® 30-day prescription BROVANA®
  • A voucher for a free 15-day supply of BROVANA

    See Details and Print Voucher
  • Implement the appropriate discharge process to provide a nebulizer to patients who don't already have one

3

Reinforce
patient understanding

Confirm that patients understand they should make an appointment with their health care provider following discharge to discuss continuing a COPD maintenance treatment with a medicine such as UTIBRON NEOHALER, SEEBRI NEOHALER, or BROVANA.

UTIBRON NEOHALER, SEEBRI NEOHALER, or BROVANA 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.

*For eligible patients only. Restrictions may apply. Subject to terms and conditions. See terms and conditions on claim form.
No guarantee of coverage.

Medicare coverage

UTIBRON® NEOHALER® and SEEBRI® NEOHALER® covered under Medicare Part D and BROVANA® covered under Medicare Part B

Patients taking BROVANA move from Part A coverage in the hospital to Part B coverage at home.2

Hospital to Home Program

Click HERE to learn more about prescribing BROVANA for Medicare patients new to nebulized therapy.

Institutional Cost Management

Get UTIBRON NEOHALER, SEEBRI NEOHALER, or BROVANA for your COPD patients as they prepare to return home

UTIBRON NEOHALER and SEEBRI NEOHALER vouchers

Vouchers for a 30-day supply of UTIBRON NEOHALER and SEEBRI NEOHALER*


PRINT voucher for UTIBRON NEOHALER and SEEBRI NEOHALER

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

*For eligible patients only. Restrictions may apply. Subject to terms and conditions. See terms and conditions on claim form.

BROVANA vouchers

Brovana Franchise Page Image

Vouchers for a 15-day supply for BROVANA


PRINT voucher for BROVANA

BROVANA should not be swallowed as the intended effects on the lungs will not be obtained. BROVANA is only for oral inhalation via a standard jet nebulizer connected to an air compressor.

15 days is a 2-week supply.

For eligible patients only. Restrictions may apply. Subject to terms and conditions. See terms and conditions on claim form.

For fast, convenient access to resources for the brands you prescribe most, Sunovion ProFile is ready to assist you—on any device, at any time.

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and other resources for your patients and practice.

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IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR ARCAPTA NEOHALER,
SEEBRI NEOHALER, UTIBRON NEOHALER, LONHALA MAGNAIR AND BROVANA

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR ARCAPTA NEOHALER, SEEBRI NEOHALER, AND UTIBRON NEOHALER

IMPORTANT SAFETY INFORMATION

ARCAPTA NEOHALER is 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.

Use of a LABA, including ARCAPTA NEOHALER or UTIBRON NEOHALER, without an inhaled corticosteroid is contraindicated in patients with asthma.

Use of a LABA, including ARCAPTA NEOHALER or UTIBRON NEOHALER, as monotherapy (without inhaled corticosteroids) for asthma, increases the risk of serious asthma-related events, including hospitalization, intubation and death. No study adequate to determine whether the rate of asthma-related death is increased in patients treated with ARCAPTA NEOHALER or UTIBRON NEOHALER has been conducted. Available data do not suggest an increased risk of death with use of LABAs in patients with COPD.

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 and Patient Information for ARCAPTA NEOHALER, UTIBRON NEOHALER, and SEEBRI NEOHALER at www.sunovionprofile.com/arcapta, www.sunovionprofile.com/utibron, and www.sunovionprofile.com/seebri.
 

INDICATIONS

ARCAPTA® NEOHALER® (indacaterol) Inhalation Powder is a long-acting beta2-adrenergic agonist (LABA), SEEBRI® NEOHALER® (glycopyrrolate) Inhalation Powder is an anticholinergic, and UTIBRON® NEOHALER® (indacaterol and glycopyrrolate) Inhalation Powder 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.

 

IMPORTANT SAFETY INFORMATION AND INDICATION FOR LONHALA MAGNAIR

IMPORTANT SAFETY INFORMATION

LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.

LONHALA MAGNAIR 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.

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

Immediate hypersensitivity reactions have been reported with LONHALA MAGNAIR. If signs occur, discontinue LONHALA MAGNAIR immediately and institute alternative therapy.

LONHALA MAGNAIR 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 ≥2% of patients taking LONHALA MAGNAIR, and occurring more frequently than in patients taking placebo, were dyspnea (4.9% vs 3.0%) and urinary tract infection (2.1% vs 1.4%).

LONHALA solution is for oral inhalation only and should not be injected or swallowed. LONHALA vials should only be administered with MAGNAIR.

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 and Patient Information for LONHALA MAGNAIR at www.sunovionprofile.com/lonhala-magnair.

INDICATION

LONHALA® MAGNAIR® (glycopyrrolate) is an anticholinergic 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 SAFETY INFORMATION AND INDICATION FOR BROVANA

IMPORTANT SAFETY INFORMATION

BROVANA is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any of the ingredients.

Use of a LABA, including BROVANA, without an inhaled corticosteroid is contraindicated in patients with asthma. 

Use of a LABA, including BROVANA, as monotherapy (without inhaled corticosteroids) for asthma increases the risk of serious asthma-related events, including hospitalization, intubation and death. No study adequate to determine whether the rate of asthma-related death is increased in patients treated with BROVANA Inhalation Solution has been conducted. Available data do not suggest an increased risk of death with use of LABAs in patients with COPD.

BROVANA should not be initiated in patients with acutely deteriorating COPD 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.

BROVANA should not be used more often, at higher doses than recommended, or in conjunction with other medications 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 for acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using BROVANA should not use another medicine containing a LABA for any reason.

Immediate hypersensitivity reactions may occur with BROVANA. If signs occur, discontinue immediately and institute alternative therapy.

As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, BROVANA should be discontinued immediately and alternative therapy instituted.

BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. BROVANA 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-agonists, BROVANA, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or 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-agonists, BROVANA should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

BROVANA, 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.

Overall efficacy of BROVANA was maintained throughout the 12-week trial duration. Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEV1 improvement remained statistically significant. This was not accompanied by other clinical manifestations of tolerance.

The five most common adverse events reported with frequency ≥2% in patients taking BROVANA, and occurring more frequently than in patients taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%).

BROVANA should not be swallowed as the intended effects on the lungs will not be obtained.  BROVANA is only for oral inhalation via a standard jet nebulizer connected to an air compressor.

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

For additional information, please see full Prescribing Information and Patient Information for BROVANA at www.sunovionprofile.com/sp/brovana.

INDICATION
BROVANA® (arformoterol tartrate) Inhalation Solution is a long-acting beta2- adrenergic agonist (LABA) indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BROVANA is for use by nebulization only.

Important limitations: BROVANA is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.