* BROVANA has not been demonstrated to have an impact on these outcomes.
In the next decade, the economic impact of COPD is projected to increase more than 50%1
The average annual number of hospital discharges for COPD was 100,000 higher from 2008 to 2012 than from 2001 to 20072
COPD is one of the top 5 causes of hospital readmissions among Medicare patients3,4†
The all-cause 30-day readmission rate for COPD is approximately 21%5
†According to the Centers for Medicare & Medicaid Services (CMS) Hospital Readmissions Reduction Program.
of Medicare patients with COPD are discharged on long-acting bronchodilators9
1. Ford ES, Murphy LB, Khavjou O, Giles WH, Holt JB, Croft JB. Total and state-specific medical and absenteeism costs of COPD among adults aged ≥ 18 years in the United States for 2010 and projections through 2020. Chest. 2015;147(1):31-45.
2. 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.
3. Centers for Medicare & Medicaid Services. Readmissions reduction program. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html. Accessed February 10, 2016.
4. The Advisory Board Company. AHRQ: the conditions that cause the most readmissions. https://www.advisory.com/daily-briefing/2014/04/22/most-common-readmissions. Accessed February 10, 2016.
5. US Department of Health and Human Services. Agency for Healthcare Research and Quality. Welcome to HCUPnet. http://hcupnet.ahrq.gov. Accessed February 10, 2016.
6. National Committee for Quality Assurance. Insights for Improvement: Advancing COPD Care Through Quality Measurement. 2009. http://www.ncqa.org/portals/0/publications/NCQA_Insights_Improvement_FINAL.pdf. Accessed February 10, 2016.
7. National Quality Forum. MAP Pre-rulemaking Report: 2013 Recommendations on Measures Under Consideration by HHS. February 2013. https://www.qualityforum.org/publications/2013/02/map_pre-rulemaking_report_-_february_2013.aspx.
8. Global strategy for the diagnosis, management and prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2017:1-123.
9. Yip NH, Yuen G, Lazar EJ, et al. Analysis of hospitalizations for COPD exacerbation: opportunities for improving care. COPD. 2010;7:85-92.
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.
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.