Indications for: BROVANA
Long-term maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema.
Limitations of Use:
Not indicated to treat acute deteriorations of COPD or for treatment of asthma.
Brovana Inhalation Solution was studied in 2 identical, 12-week, double-blind, placebo- and active-controlled, randomized, multicenter, parallel group trials.
Patient demographics: (N=1456)
- Age range: 34-89 years; mean age 63 years
- 860 males, 596 females
- 1383 Caucasions, 49 Blacks, 10 Asians, 10 Hispanics, and 4 patients classified as Other
- Mean FEV1: 1.3L (42% of predicted)
- 80% of patients had bronchodilator reversibility, defined as a 10% or greater increase in FEV1 after inhalation of 2 actuations (180mcg racemic albuterol from a metered dose inhaler)
Patients were randomly assigned to Brovana 15mcg twice daily (n=288), 25mcg twice daily (n=292), 50mcg twice daily (n=293), or placebo (n=293). Both trials included salmeterol inhalation aerosol, 42mcg twice daily as an active comparator (290 patients).
In both 12-week trials, treatment with Brovana 15mcg twice daily resulted in a statistically significant change of approximately 11% in mean FEV1 (as measured by percent change from study baseline FEV1 at the end of the dosing interval over the 12 weeks of treatment, the primary efficacy endpoint) compared with placebo.
Higher doses of Brovana did not provide sufficient additional benefit on a variety of endpoints, including FEV1, to support use.
Brovana 15mcg twice daily significantly improved bronchodilation compared with placebo over the 12 hours after dosing; improvement was maintained over the 12-week study period.
The median time to onset of bronchodilation (defined by an FEV1 increase of 15%) following the first dose of Brovana 15mcg was 6.7 minutes. Time to onset of bronchodilation was 20 minutes when defined as an increase in FEV1 of 12% and 200mL. Peak bronchodilator effect was generally seen within 1-3 hours of dosing.
Compared with placebo, patients treated with Brovana demonstrated improvements in peak expiratory flow rates, supplemental ipratropium and rescue albuterol use.
By nebulizer: 15mcg by inhalation twice daily (AM & PM); max 30mcg/day. Use standard jet (eg, PARI LC Plus) nebulizer with air compressor (eg, PARI DURA-NEB 3000). Reevaluate periodically.
Use of LABA without inhaled corticosteroid (ICS) in asthma.
LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in acute deteriorating COPD. Not for relief of acute symptoms. Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Discontinue if paradoxical bronchospasm or cardiovascular effects occur. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Monitor potassium and blood glucose levels. Hepatic impairment. Pregnancy. Labor & delivery. Nursing mothers.
Long-acting beta-2 agonist (LABA).
See Contraindications. Avoid other sympathomimetics (except short-acting bronchodilators). Caution with MAOIs, tricyclics, or drugs known to prolong the QTc interval; may increase risk of arrhythmias. Antagonized by β-blockers. K+-depleting diuretics, theophylline, aminophylline, steroids may potentiate hypokalemia.
Pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema, lung disorder; cardiovascular effects (eg, increased pulse rate or BP, ECG changes); rarely: paradoxical bronchospasm, hypersensitivity reactions.
Mean terminal half-life of arformoterol was 26 hours.
Generic Drug Availability:
Vials (2mL)—30, 60