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 Medication Guide).
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.
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 not indicated for the treatment of acute episodes of bronchospasm, ie, rescue therapy, and does not replace fast-acting rescue inhalers. 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. 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.
All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication.
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.
BROVANA 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.
BROVANA, as with other beta2-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 the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.
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%).
For additional information, please see the full Prescribing Information including Boxed Warning, and Medication Guide for BROVANA (arformoterol tartrate) Inhalation Solution, at www.sunovionprofile.com/brovana.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
BROVANA® (arformoterol tartrate) Inhalation Solution is 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 emphysema. BROVANA is for use by nebulization only.