The recommended dose of nebulized BROVANA® (arformoterol tartrate) Inhalation Solution for COPD patients is 15 mcg administered twice a day (morning and evening) by nebulization. A total daily dose greater than 30 mcg (15 mcg twice daily) is not recommended. BROVANA should be administered by the inhaled route via a standard jet nebulizer connected to an air compressor (see the accompanying Patient Information).
BROVANA should not be swallowed. BROVANA should be stored refrigerated in foil pouches. After opening the pouch, unused ready-to-use vials should be returned to, and stored in, the pouch. An opened ready-to-use vial should be used right away.
If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered.
No dose adjustment is required for patients with renal or hepatic impairment. However, since the clearance of BROVANA is prolonged in patients with hepatic impairment, they should be monitored closely.
The drug compatibility (physical and chemical), efficacy, and safety of BROVANA when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of BROVANA have been established in clinical trials when administered using the PARI LC PLUS® nebulizers and PARI DURA-NEB® 3000 compressors.* The safety and efficacy of BROVANA when administered using other nebulizer systems has not been established.
BROVANA is supplied in a single strength (15 mcg of arformoterol, equivalent to 22 mcg of arformoterol tartrate) as 2 mL of a sterile solution in low-density polyethylene (LDPE) ready-to-use vials overwrapped in foil. BROVANA is available in a shelf-carton containing 30 or 60 ready-to-use vials.
Store BROVANA in the protective foil pouch under refrigeration at 36°-46°F (2°-8°C). Protect from light and excessive heat. After opening the pouch, unused, ready-to-use vials should be returned to, and stored in, the pouch. An unopened ready-to-use vial should be used right away. Discard any ready-to-use vial if the solution is not colorless. Unopened foil pouches of BROVANA can also be stored at room temperature 68°-77°F (20°-25°C) for up to 6 weeks. If stored at room temperature, discard if not used after 6 weeks or if past the expiration date, whichever is sooner.
*PARI LC PLUS and PARI DURA-NEB are registered trademarks of PARI GmbH.
COPD=chronic obstructive pulmonary disease.
BROVANA should only be taken with a standard jet nebulizer (also known as a compressed-air nebulizer) and matching air compressor. The nebulizer converts the liquid medication into a fine mist, which is then inhaled by breathing through a mouthpiece or mask.
BROVANA is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any of the ingredients.
Use of a LABA, including BROVANA, without an inhaled corticosteroid is contraindicated in patients with asthma.
Use of a LABA, including BROVANA, as monotherapy (without inhaled corticosteroids) for asthma increases the risk of serious asthma-related events, including hospitalization, intubation and death. No study adequate to determine whether the rate of asthma-related death is increased in patients treated with BROVANA Inhalation Solution has been conducted. Available data do not suggest an increased risk of death with use of LABAs in patients with COPD.
BROVANA should not be initiated in patients with acutely deteriorating COPD or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
BROVANA should not be used more often, at higher doses than recommended, or in conjunction with other medications containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief for acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using BROVANA should not use another medicine containing a LABA for any reason.
Immediate hypersensitivity reactions may occur with BROVANA. If signs occur, discontinue immediately and institute alternative therapy.
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, systolic or diastolic blood pressure, and/or symptoms. BROVANA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta2-adrenergic agonists may produce significant hypokalemia in some patients.
As with other beta2-agonists, BROVANA, 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.
As with other beta2-agonists, BROVANA should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.
BROVANA, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Overall efficacy of BROVANA was maintained throughout the 12-week trial duration. Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEV1 improvement remained statistically significant. This was not accompanied by other clinical manifestations of tolerance.
The five most common adverse events reported with frequency ≥2% in patients taking BROVANA, and occurring more frequently than in patients taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%).
BROVANA should not be swallowed as the intended effects on the lungs will not be obtained. BROVANA is only for oral inhalation via a standard jet nebulizer connected to an air compressor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
BROVANA® (arformoterol tartrate) Inhalation Solution is a long-acting beta2- adrenergic agonist (LABA) indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BROVANA is for use by nebulization only.
Important limitations: BROVANA is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.