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Patient Efficacy and Outcomes

Reduction in daily use of albuterol and ipratropium by 37% vs 2% with placebo for albuterol and vs 9% with placebo for ipratropium1*

See the data  >

Increase in symptom-free nights by 19% versus 9% for placebo from baseline2†

See the data  >

Reduction in daily use of albuterol and ipratropium by 37% vs 2% with placebo for albuterol and vs 9% with placebo for ipratropium1*

See the data  >

Increase in symptom-free nights by 19% versus 9% for placebo 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 a Sunovion daily-generated COPD questionnaire, not controlled for multiplicity. 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 Sunovion-generated COPD questionnaire upon rising in the morning to assess nighttime symptoms. Patients answered 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 said 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

As reported on a Sunovion daily-generated COPD questionnaire, not controlled for multiplicity. Data are pooled from clinical trials A and B over 12 weeks.


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 (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.