In April 2007, Sepracor commercially launched BROVANA® brand arformoterol tartrate Inhalation Solution in the U.S. BROVANA Inhalation Solution 15 mcg (micrograms) is a long-acting beta2-agonist used as a long-term, twice-daily (morning and evening), maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only.
For more information about BROVANA, including complete prescribing information and the Boxed Warning, please see the BROVANA product web site at www.brovana.com.
COPD
According to the National Center for Health Statistics, an estimated 12 million adults in the U.S. have COPD. Approximately 24 million adults have evidence of impaired lung function, which may indicate that COPD is underdiagnosed, according to the National Heart, Lung and Blood Institute (NHLBI). COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function. COPD includes chronic bronchitis, chronic obstructive bronchitis and emphysema, as well as combinations of these conditions.
BROVANA has not been demonstrated to have an impact on the progression of the disease or the survival of patients with COPD.
Important Safety Information
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data from a large placebo-controlled
U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma
therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to
arformoterol (a long-acting beta2-adrenergic agonist), the active ingredient in BROVANA.
Data are not available to determine whether the rate of death in patients with COPD is increased by long-acting beta2-adrenergic agonists. BROVANA is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only. BROVANA is not indicated for the treatment of acute episodes of bronchospasm, i.e. rescue therapy. 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. BROVANA should not be used with other medications containing long-acting beta2-agonists. 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, blood pressure, and/or symptoms. Although such effects are uncommon after administration of BROVANA at the recommended dose, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTC interval and ST segment depression. The clinical significance of these findings is unknown. BROVANA, as with other sympathomimetic amines, 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.
In clinical studies, the numbers and percent of patients who reported adverse events were comparable in the BROVANA 15 mcg twice daily and placebo groups. The most frequent adverse events reported in patients taking BROVANA were pain (8%), chest pain (7%), back pain (6%), diarrhea (6%) and sinusitis (5%). BROVANA, as with other long-acting beta2-adrenergic 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 these agents may potentiate the action of adrenergic agonists on the cardiovascular system. Please refer to the product's full prescribing information for additional information at: http://www.sepracor.com/BrovanaApprovedLabelingText.pdf.