Combination Therapy Data

Nebulized BROVANA® (arformoterol tartrate) Inhalation Solution as an additional bronchodilator for COPD

GOLD recommends adding 1 or more classes of long-acting bronchodilators when necessary1

GOLD=Global Initiative for Chronic Obstructive Lung Disease. GOLD does not endorse any specific treatments.
The inclusion of GOLD information is not an endorsement of Nebulized BROVANA.


BROVANA improved FEV1 over 24 hours when added to tiotropium2

Improved FEV over 24 hours when added to tiotropium

Mean change in FEV1 from study baseline at Week 2 in a 2-week, prospective, multicenter, randomized, modified-blind, double-dummy, parallel-group study designed to evaluate the efficacy and safety of the combination of BROVANA 15 mcg twice daily and tiotropium 18 mcg once daily in the morning vs the individual monotherapies in the treatment of patients with COPD (N=234).

*Dosed sequentially. Patients instructed to use nebulizer first, followed immediately (within 5 minutes) by the dry powder inhaler (DPI).


  • Adding BROVANA to tiotropium was more effective in improving lung function than either monotherapy alone2
  • Occurrence of headache was greater in the BROVANA/tiotropium group (5.1%) than in the BROVANA (1.3%) or tiotropium (3.8%) monotherapy groups3
  • Percentage of patients with change from baseline in heart rate of ≥25 bpm was greater in the BROVANA/tiotropium group (14.1%) than in the BROVANA (7.9%) or tiotropium (6.3%) monotherapy groups. Systolic blood pressure (SBP) >180 mm Hg and diastolic blood pressure (DBP) >105 mm Hg were greater with BROVANA/tiotropium therapy than with either monotherapy. SBP >180 mm Hg occurred in 3.9%, 2.5%, and 6.4% of patients in the BROVANA, tiotropium, and BROVANA/tiotropium groups, respectively. DBP >105 mm Hg occurred in 2.6%, 3.8%, and 5.1% of patients, respectively3
  • Treatment-emergent adverse events (AEs) occurred in 25.0%, 27.5%, and 30.8% of patients in the BROVANA, tiotropium, and BROVANA/tiotropium therapy groups, respectively3
  • The most frequently reported AEs were diarrhea, nausea, chest pain, bronchitis, dizziness, headache, cough, nasal congestion, pharyngolaryngeal pain, and hypertension3

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.



References:
1. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Global Initiative for Chronic Obstructive Lung Disease (GOLD); 2016:1-80. http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015_Apr2.pdf. Accessed February 10, 2016.
2. Tashkin DP, Donohue JF, Mahler DA, et al. Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. Respir Med. 2009;103(4):516-524.
3. Data on file. CSR 091–902. 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.