Patient-Reported Outcomes

Reduction of 37% in daily rescue medication use1

See the data  >

Increase in symptom-free nights by 19% from baseline2

See the data  >

Reduction of 37% in daily rescue medication use1

See the data  >

Increase in symptom-free nights by 19% from baseline2

See the data  >


Patients reported a 37% reduction in daily use of albuterol and ipratropium with Nebulized BROVANA (arformoterol tartrate) Inhalation Solution1*

Reduction in daily use of albuterol1

Reduction in daily use of albuterol and ipratropium

Reduction in daily use of ipratropium1

Reduction in daily use of albuterol and ipratropium

Data from 2 identical, 12-week, double-blind, double-dummy, placebo-controlled, randomized, multicenter trials assessing the efficacy and tolerability of BROVANA 15 mcg twice daily (n=285) vs placebo (n=289) in patients with COPD.

BROVANA® reduced daily use of both albuterol and ipratropium by 37% (vs 2% and 9% for placebo, respectively) from baseline.1

*As reported on patient diary cards. Data are pooled from clinical trials A and B over 12 weeks.


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, 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 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 i nstructed to discontinue their regular use and to use them only for symptomatic relief for acute respiratory symptoms.


Patients taking BROVANA® reported an increase in symptom-free nights2

Increase in number of symptom-free nights from baseline2

Increase in number of symptom-free nights from baseline

Data from 2 identical 12-week, double-blind, double-dummy, placebo-controlled, randomized, multicenter trials (trials A & B) assessing the efficacy and tolerability of BROVANA 15 mcg twice daily (n=288) vs placebo (n=293) in patients with COPD.

  • Patients completed a COPD questionnaire upon rising in the morning to assess nighttime symptoms. Patients reported the number of times they woke during the night due to lung disease symptoms2
  • A symptom-free night was defined as a night in which a COPD patient reported he/she did not awaken due to lung disease symptoms (such as coughing, wheezing, chest tightness, bringing up mucus, shortness of breath)2
  • 19% increase in mean number of symptom-free nights per week over the 12-week study period (vs 9% for placebo) compared to baseline2

References:
1. Data on file. From a pooled analysis of trials 091-050 and 091-051. Sunovion Pharmaceuticals Inc.
2. Data on file. Integrated Summary of Efficacy, Table 35.3. Sunovion Pharmaceuticals Inc.

Important Safety Information & Indication

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (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 LABA, including arformoterol, the active ingredient in BROVANA (see WARNINGS). The safety and efficacy of BROVANA in patients with asthma have not been established. All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication (see CONTRAINDICATIONS).

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.

Indication
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.