BROVANA: A proven safety profile

BROVANA: Frequency of cardiovascular events with long-acting BROVANA
was low and comparable to placebo^1,2

	BROVANA 15 mcg (n=288)	Placebo (n=293)
All cardiovascular adverse events	6.9%	13.3%
Serious cardiovascular adverse events*	1.4%	1.4%
Ischemic events†	0.7%	1.4%
Arrhythmic events‡	3.1%	4.4%
Discontinuation due to cardiovascular events§ Ischemic events† Arrhythmic events‡	3.8% 0.7% 1.4%	1.7% 0.0% 1.4%

* 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.

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

The five most common adverse events with BROVANA,
and occurring more frequently than with placebo¹

Adverse Events	BROVANA 15 mcg	Placebo
Pain	8%	5%
Chest pain	7%	6%
Back pain	6%	2%
Diarrhea	6%	4%
Sinusitis	5%	4%

• Percentage of patients reporting adverse events with BROVANA was comparable to placebo.¹

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, 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.