Brovana is a selective beta2-adrenergic bronchodilator. Beta2-receptors are the predominant adrenergic receptors in bronchial
smooth muscle. They cause stimulation of intracellular adenyl cyclase
which in turn causes relaxation of bronchial smooth muscle.
Arformoterol tartrateBrovana is specifically indicated for the long term, twice daily maintenance treatment of bronchoconstriction in patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis and
emphysema.
Brovana is supplied as 2 mL of a sterile solution in unit-dose, low-density polyethylene vials individually overwrapped in foil. It is
designed for use as an inhalation solution. The recommended initial dose
of the drug is 15 mcg administered twice a day (morning and evening) by
nebulization.
FDA approval of Brovana was based on the results of two clinical trials. These were identical, 12-week, double-blind, placebo- and
active-controlled, randomized, multi-center, parallel group trials. A
total of 1,456 subjects were enrolled. Subjects received 15 or 25 mcg of
Brovana twice daily, 50 mcg of Brovana once daily or placebo. Both
trials included salmeterol inhalation aerosol, 42 mcg twice daily as an
active comparator. In both trials Brovana administered at 15 mcg twice
daily resulted in significantly greater post-dose bronchodilation (as
measured by percent change from study baseline FEV1 at the end of the
dosing interval over the 12 weeks of treatment) compared to placebo. At
the 25 and 50 mcg doses, Brovana did not demonstrate sufficient enough
benefit on a number of endpoints to support the use of higher doses. In
addition, when compared to placebo, the subjects treated with Brovana
demonstrated improvements in peak expiratory flow rates, supplemental
ipratropium and rescue albuterol use.
In addition, Brovana has been seen to cause infrequent yet clinically significant changes in systolic
and/or diastolic blood pressure, pulse rate and electrocardiograms.
Treatment 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 also produce significant hypokalemia in
some patients. Brovana is contraindicated in patients with a history of
hypersensitivity to arformoterol, racemic formoterol or to any other
components of this product.
Brovana is a selective beta2-adrenergic bronchodilator. Beta2-receptors are the predominant adrenergic receptors in bronchial
smooth muscle. They cause stimulation of intracellular adenyl cyclase,
the enzyme that catalyzes the conversion of adenosine triphosphate (ATP)
to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased
intracellular cyclic AMP levels cause relaxation of bronchial smooth
muscle and inhibition of release of mediators of immediate
hypersensitivity from cells, especially from mast cells.
