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Safety

Nebulized BROVANA® (arformoterol tartrate) Inhalation Solution offers a proven safety profile1,2

BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some COPD patients as measured by increases in pulse rate, blood pressure, and/or symptoms2

Low incidence of cardiovascular adverse events (AEs) was comparable to placebo in two 12-week pivotal trials1

Low incidence of cardiovascular AEs was comparable to placebo in two 12-week pivotal trials

*Patients were allowed to use rescue albuterol and supplemental ipratropium as needed. More patients in the placebo group used rescue albuterol than in the BROVANA group.
Serious adverse events included any fatal or life-threatening, or permanently disabling, experience; or events that required or prolonged hospitalization, were a congenital anomaly, or necessitated intervention to prevent permanent damage.
Includes coded adverse event terms: angina pectoris, bundle branch block, coronary artery disorder, myocardial infarct, myocardial ischemia, ST depressed, ST elevated, or T wave inverted.
§Includes coded adverse event terms: arrhythmia, atrial or ventricular fibrillation, atrial flutter, AV block, AV block first or second degree, extrasystoles, ventricular or supraventricular extrasystoles, heart block, heart arrest, syncope, tachycardia, ventricular or supraventricular tachycardia, or ventricular arrhythmia.
|Includes deaths: 1 patient (arformoterol 15 mcg twice daily) from abdominal aortic aneurysm.


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

BROVANA, as with other beta2-agonists, 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 the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

BROVANA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.


Five most common adverse events (AEs) with BROVANA and occurring more frequently than with placebo in two 12-week pivotal trials2

Five most common AEs with BROVANA are occurring more frequently than with placebo in two 12-week pivotal trials


Adults with COPD long-term (52-week) safety trial2

In this 52-week double-blind, randomized, placebo-controlled safety trial of patients with moderate to severe COPD, the primary endpoint was time to either respiratory death or first COPD exacerbation-related hospitalization, whichever occurred first2

  • The event had to be a death or hospitalization for which the patient’s respiratory status was predominant and/or inciting contributor, as determined by the clinical investigator
  • The objective of the trial was to demonstrate that the risk of respiratory death or COPD exacerbation-related hospitalization for patients treated with BROVANA was not greater than 40% more than the risk for patients treated with placebo

A total of 841 patients with COPD were randomized: 420 to BROVANA and 421 to placebo2

  • Of the randomized patients, 255 (61%) in the BROVANA group and 211 (50%) in the placebo group completed one year of treatment

The trial objective was met demonstrating that COPD patients treated with BROVANA are not at an increased risk of respiratory death or COPD exacerbation-related hospitalization compared to placebo2

BROVANA is not indicated for the treatment of acute episodes of bronchospasm, ie, rescue therapy, and does not replace fast-acting rescue inhalers.

BROVANA should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.

BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists.



References:
1. Hanrahan JP, Grogan DR, Baumgartner RA, et al. Arrhythmias in patients with chronic obstructive pulmonary disease (COPD): occurrence frequency and the effect of treatment with the inhaled long-acting beta2-agonists arformoterol and salmeterol. Medicine. 2008;87(6):319-328.
2. BROVANA [prescribing information]. Sunovion Pharmaceuticals Inc.; 2014.

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.