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GOLD Strategies

GOLD strategies recommend the use of long-acting beta2-agonists for COPD maintenance therapy1

  • GOLD strategies recommend using long-acting bronchodilators, including long-acting beta2-agonists, as a standard of care for COPD maintenance
  • GOLD strategies recommend using long-acting beta2-agonists in addition to bronchodilators of different pharmacological classes
  • Spirometric abnormality, severity of symptoms, history and future risk of exacerbation, and comorbidities must all be considered to provide a complete assessment of disease status

GOLD=Global Initiative for Chronic Obstructive Lung Disease. GOLD does not endorse any specific treatments. The inclusion of GOLD information is not an endorsement of Nebulized BROVANA® (arformoterol tartrate) Inhalation Solution.

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. GOLD's guidelines for COPD are 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. 

According to GOLD, COPD patients in groups A, B, C, and D may benefit from a long-acting bronchodilator1

COPD Patient Classification

COPD Patient Classification

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

GOLD=Global Initiative for Chronic Obstructive Lung Disease. GOLD does not endorse any specific treatments. The inclusion of GOLD information is not an endorsement of Nebulized BROVANA® (arformoterol tartrate) Inhalation Solution.

When assessing risk, choose the highest grade according to GOLD classification or exacerbation history

Highlighted boxes and arrows indicate preferred treatment pathways

Initial Pharmacologic Management of COPD

Initial Pharmacologic Management of COPD

In patients with a major discrepancy between the perceived level of symptoms and severity of airflow limitation, further evaluation is warranted.

For Group A, the maintenance bronchodilator can be short-acting or long-acting. A maintenance bronchodilator does not replace rescue medication. 

© 2017 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.

LAMA=long-acting muscarinic antagonist; LABA=long-acting beta2-adrenergic agonist; ICS=inhaled corticosteroid.

GOLD=Global Initiative for Chronic Obstructive Lung Disease. GOLD does not endorse any specific treatments. The inclusion of GOLD information is not an endorsement of nebulized BROVANA® (arformoterol tartrate) Inhalation Solution.

CONSIDER LABAs for COPD MAINTENANCE THERAPY 

CONSIDER LABAs for COPD
MAINTENANCE THERAPY 


Reference:
1. Global strategy for the diagnosis, management and prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2017:1-123.

 

Important Safety Information & Indication

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 LABAs, including arformoterol, the active ingredient in BROVANA.

The safety and efficacy of BROVANA in patients with asthma have not been established. BROVANA is not indicated for the treatment of asthma.


All LABAs, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication; BROVANA is also contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any of the ingredients. 

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 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 BROVANA (arformoterol tartrate) Inhalation Solution, at www.sunovionprofile.com/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.