Instructions for Use

How your patients should use BROVANA

It is important that patients understand how to use BROVANA Inhalation Solution with a nebulizer appropriately, and how it should be used in relation to other medications they are taking to treat COPD. Patients should be instructed not to mix other medications with BROVANA Inhalation Solution and not to inject or swallow BROVANA Inhalation Solution. Patients should throw the plastic dispensing vials away immediately after use. Due to their small size, the vials pose a danger of choking to young children.

Women should be advised to contact their physician if they become pregnant or if they are nursing.

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.

It takes about 5 to 10 minutes for each BROVANA treatment—twice a day
Additional time and multiple steps are needed to set up and clean the device after each use
Each unit dose vial of BROVANA is 1 dose (15 mcg)
The usual dose of BROVANA for the treatment of COPD symptoms is 1 vial twice a day (morning and evening) breathed in through a nebulizer
Each dose of nebulized BROVANA is taken about 12 hours apart; COPD patients should not use more than 2 vials a day
If a COPD patient misses a dose of BROVANA, they should skip that dose and take the next one at their usual time
BROVANA should be used exactly as prescribed

How to Use BROVANA

Do not mix BROVANA with other medicines in your nebulizer machine.

BROVANA comes sealed in a foil pouch. Do not open a sealed pouch until you are ready to use a dose of BROVANA. 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.

1. Open the foil pouch by tearing on the rough edge along the seam of the pouch. Remove a ready-to-use vial of BROVANA.

2. Carefully twist open the top of the ready-to-use vial and use it right away.

3. Squeeze all of the medicine from the ready-to-use vial into the nebulizer medicine cup (reservoir).

4. Connect the nebulizer reservoir to the mouthpiece or face mask.

5. Connect the nebulizer to the compressor.

6. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the compressor.

7. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer reservoir. It takes about 5 to 10 minutes for each treatment.

8. Clean the nebulizer (see manufacturer’s instructions).

A Guide to Taking BROVANA

This animated guide shows your patients how to take BROVANA step by step.

Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide.

Important Safety Information & Indication

Important Safety Information

WARNING: ASTHMA-RELATED DEATH

Long-acting beta₂-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABAs, including arformoterol, the active ingredient in BROVANA.

The safety and efficacy of BROVANA in patients with asthma have not been established. BROVANA is not indicated for the treatment of asthma.

All LABAs, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication; BROVANA is also contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any of the ingredients.

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 www.fda.gov/medwatch or call 1-800-FDA-1088.

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.

Indication

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.