Indicated for:

Maintenance Treatment of COPD:

• The 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 Inhalation Solution is for use by nebulization only.

BROVANA Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease.

BROVANA Inhalation Solution is not indicated to treat asthma.The safety and efficacy of Brovana Inhalation Solution in patients with asthma have not been established.

Long-acting beta₂-adrenergic agonists (LABA) increase the risk of asthma-related death. 

All LABA, including BROVANA Inhalation Solution, are contraindicated in patients with asthma without use of a long-term asthma control medication.

As with other inhaled beta₂-agonists, BROVANA Inhalation Solution can produce paradoxical bronchospasm that may be life-threatening.

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

BROVANA Inhalation Solution, like 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.

Beta-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.

Beta-agonist medications may produce transient hyperglycemia in some patients.

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. As with other inhaled beta₂-adrenergic drugs, BROVANA Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other medications containing long-acting beta₂-agonists.

Concomitant treatment with methylxanthine (aminophylline, theophylline), steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists including BROVANA Inhalation Solution.

The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta-agonists, including BROVANA Inhalation Solution, with non-potassium sparing diuretics.

BROVANA Inhalation Solution, as with other beta-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 of the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.

Beta-adrenergic receptor antagonists (beta-blockers) and BROVANA Inhalation Solution may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

There are no adequate and well-controlled studies of BROVANA Inhalation Solution in pregnant women. Animal studies: Arformoterol has been shown to be teratogenic including neonatal mortality and developmental delays.

In reproductive studies in rats, arformoterol was excreted in the milk. It is not known whether arformoterol is excreted in human milk.

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• Use in patients under the age of 18. GoToSource

• Total daily dosage greater than 30 mcg. GoToSource

• Exercise induced bronchospasm. GoToSource

• Mitigate chlorine induced lung injury. GoToSource

• Acute episodes of bronchospasm. GoToSource

• Asthma. GoToSource

COPD exacerbation, respiratory death and urinary tract infection. GoToSource

Atrial tachycardia (fast abnormal heart rhythm). GoToSource

Anxiety, nervousness and palpitations. GoToSource

Tremors, hypotension (low blood pressure), hypokalemia (low blood potassium level) and hyperglycemia (high blood sugar). GoToSource

Lawsuits filed for asthma-related deaths.