Avoid other sympathomimetics (except short-acting bronchodilators)

Avoid use during or within 2 weeks of MAOIs, tricylics,

Other that prolong QTc interval.

Antagonized by beta-blockers, potassium depleting diuretics, theophylline, aminophylline,

steroids may potentiate hypokalemia

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use

BROVANA® safely and effectively. See full prescribing information for BROVANA. BROVANA® (arformoterol tartrate) Inhalation Solution

Initial U.S. Approval: 2006 

WARNING: ASTHMA-RELATED DEATH See full prescribing information for complete boxed warning.

• Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. 

• A placebo-controlled study with another long-acting beta2­ adrenergic agonist (salmeterol) showed an increase in asthma related deaths in patients receiving salmeterol. 

• The finding of an increase in the risk of asthma-related deaths with salmeterol is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA Inhalation Solution. The safety and efficacy of BROVANA Inhalation Solution in patients with asthma have not been established. All LABA, including BROVANA Inhalation Solution, are contraindicated in patients with asthma without use of a long-term asthma control medication. 

INDICATIONS AND USAGE

­ BROVANA Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:

• Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 

Important limitations of use:

• BROVANA Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. 

• BROVANA Inhalation Solution is not indicated to treat asthma.

DOSAGE AND ADMINISTRATION

­ For oral inhalation only.

• A total daily dose of greater than 30 mcg is not recommended.

• One 15 mcg/2 mL vial every 12 hours. 

• For use with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. 

DOSAGE FORMS AND STRENGTHS

-­ Inhalation Solution (unit-dose vial for nebulization): 15 mcg/2 mL solution 

Asthenia, ferver, bronchitis, headache,

GI upset, serum potassium changes,

leucocytosis, nervousness,

pain, tremor, fly syndrome,

cardiovascular effects (e.g increased pulse rate, or BP, consider discontinuing if this occurs)

Rarely paradoxical bronchospasm,

hypersensitivity reactions- Increased risk of asthma -related death

Not for treatment of acute attacks

Do not initiate in significantly or acutely deterioating COPD

 Concomittantly other long acting beta-agonists

Special precautions-

Do not exceed recommended dose.

Cardiovascular disease ( esp. coronary insufficiency, arrhythmias, hypertension ) Convulsive disorders,

Hepatic impairment

Hyperthyroidism, Diabetes

Ketoacidosis

Hyperresponsiveness to sympathomimetics.

Monitor Potassium

Prescribe a short -acting beta agonist for acute symptoms, monitor for increased need.

Pregnancy ,Lactation

INDICATIONS AND USAGE

BROVANA Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:

• Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 

Important limitations of use:

• BROVANA Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. 

• BROVANA Inhalation Solution is not indicated to treat asthma.

DOSAGE AND ADMINISTRATION

For oral inhalation only.

• A total daily dose of greater than 30 mcg is not recommended.

• One 15 mcg/2 mL vial every 12 hours. 

• For use with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. 

DOSAGE FORMS AND STRENGTHS

-­ Inhalation Solution (unit-dose vial for nebulization): 15 mcg/2 mL solution 

I

PATIENT COUNSELING INFORMATION

Patients should be instructed to read the accompanying Medication Guide with each new prescription and refill.

The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be given the following information:

Asthma-Related Deaths, Acute Exacerbations or Deteriorations Patients should be informed that long-acting beta2-adrenergic agonists, such as BROVANA Inhalation Solution, increase risk of asthma-related death in patients with asthma.

BROVANA Inhalation Solution is not indicated to relieve acute respiratory symptoms and extra doses should not be used for that purpose.

Acute symptoms should be treated with an inhaled, short-acting, beta2-agonist (the health-care provider should prescribe the patient with such medication and instruct the patient in how it should be used).

Patients should be instructed to seek medical attention if their symptoms worsen despite recommended doses of BROVANA Inhalation Solution, if BROVANA Inhalation Solution treatment becomes less effective, or if they need more inhalations of a short-acting beta2-agonist than usual.

Appropriate Dosing Patients should not stop using BROVANA Inhalation Solution unless told to do so by a healthcare provider because symptoms may get worse.

Patients should not inhale more than one dose at any one time. The daily dosage of BROVANA Inhalation Solution should not exceed one unit-dose vial (15 mcg) by inhalation twice daily (30 mcg total daily dose).

Excessive use of sympathomimetics may cause significant cardiovascular effects, and may be fatal. Concomitant Therapy Patients who have been taking inhaled, short-acting beta2-agonists (e.g., levalbuterol) on a regular basis should be instructed to discontinue the regular use of these products and use them only for the symptomatic relief of acute symptoms.

BROVANA Inhalation Solution should not be used in conjunction with other inhaled medications containing long-acting beta2-agonists.

Patients should be warned not to stop or change the dose of other concomitant COPD therapy without medical advice, even if symptoms improve after initiating treatment with BROVANA Inhalation Solution.

Common Adverse Reactions with Beta2-agonists-                                               Patients should be informed that treatment with beta2-agonists may lead to adverse reactions that include palpitations, chest pain, rapid heart rate, increased or decreased blood pressure, headache, tremor, nervousness, dry mouth, muscle cramps, nausea, dizziness, fatigue, malaise, low blood potassium, high blood sugar, high blood acid, or trouble sleeping 

Instructions for Administration                                                                                           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 to treat COPD they are taking 

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.  

Manufactured for:

Sunovion Pharmaceuticals Inc. Marlborough, MA 01752 USA For customer service, call 1-888-394-7377. To report adverse events, call 1-877-737-7226. For medical information, call 1-800-739-0565. 

Use with caution during pregnancy and lactation