BROVANA® (arformoterol tartrate) Inhalation
Solution Safety/Adverse Events

Not an actual COPD patient.

BROVANA® (arformoterol tartrate):
A proven safety profile

  • BROVANA® (arformoterol tartrate), 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 symptoms.

* 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 flutter, AV block, AV block first or supraventricular extrasystoles, tachycardia, ventricular or supraventricular tachycardia, or ventricular arrhythmia.

|| Includes deaths: One patient arformoterol aortic aneurysm.

  • Percentage of patients reporting adverse events with BROVANA® (arformoterol tartrate) Inhalation Solution was comparable to placebo.1

As with other inhaled beta2-agonists, BROVANA® (arformoterol tartrate) 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® (arformoterol tartrate), 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® (arformoterol tartrate) 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.


References:

1. BROVANA [prescribing information]. Sunovion Pharmaceuticals Inc; 2012.  2. 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.