LABA/LAMA: An Update in the Management of COPD

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 Join your colleagues to:

• Receive an update on the 2017 Global Initiative for Chronic

Obstructive Lung Disease (GOLD) report for the treatment of chronic

obstructive pulmonary disease (COPD)

• Review a hypothetical COPD patient case and the clinical

considerations for determining appropriate treatment

• Receive a clinical and safety overview of UTIBRON™ NEOHALER®

(indacaterol/glycopyrrolate) inhalation powder, a treatment option

for the long-term, maintenance treatment of airflow obstruction in

patients with COPD, including chronic bronchitis and/or emphysema

This promotional, non-CME program is intended only for health care

professionals involved in the treatment of patients with COPD in the US.

LABA/LAMA: An Update

in the Management of COPD

Clinical Overview of UTIBRON™ NEOHALER®

EVENT DETAILS

Sunovion Representative

Ruthie Holland

ruthie.holland@sunovion.com

832-816-8425

Presented by:

Nanette Wrobel, RPh

Director of Education/Clinical Director

Department of Pharmacy

Pharmacy Alternatives

Oak Park, IL

Thursday, June 29, 2017

6:30 PM

Bob’s Steak & Chop House

Omni Fort Worth Hotel

1300 Houston St

Fort Worth, TX 76102

817-350-4100

Meeting Code: 50160

This promotional non-CME

program is sponsored by

Indication

 

Seating is limited, so register now.

Registration is preferred.

reference the provided meeting code  50160 at www. Sunovionresp.com.

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© 2010 Sunovion Pharmaceuticals Inc.

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Indication

UTIBRONTM 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.

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-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-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-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. 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

at www.sunovionprofile.com/utibron.

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