GOLD Recommendations

GOLD recommends the use of long-acting beta2-agonists for COPD maintenance therapy1

  • GOLD recommends using long-acting bronchodilators, including long-acting beta2-agonists, as a standard of care for COPD maintenance
  • GOLD recommends using long-acting beta2-agonists in addition to bronchodilators of different pharmacological classes
  • Spirometry, symptoms, and exacerbation history provide a more complete assessment and picture of disease status

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® (arformoterol tartrate) Inhalation Solution.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) was launched in 1997 in collaboration with the National Heart, Lung, and Blood Institute, the National Institutes of Health, USA, and the World Health Organization. GOLD’s guidelines for COPD are shaped by committees made up of leading experts from around the world. Working with health care professionals and public health officials, GOLD seeks to raise awareness and improve prevention and treatment of COPD.

COPD patients in groups B, C, and D may benefit from a long-acting bronchodilator1

Patient classification1

COPD Patient Classification

*CAT is the intellectual property of GlaxoSmithKline. Not validated for US-based physicians.

When assessing risk, choose the highest grade according to GOLD classification or exacerbation history

Initial pharmacologic management of COPD1

Initial Pharmacologic Management of COPD

*Medications in each box are mentioned in alphabetical order, and therefore not necessarily in order of preference.
†Medications in this column can be used alone or in combination with other options in the Recommended First Choice and Alternative Choice columns.

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® (arformoterol tartrate) Inhalation Solution.

CONSIDER LABAs for COPD MAINTENANCE THERAPY 

CONSIDER LABAs for COPD
MAINTENANCE THERAPY 


References:
1. Global strategy for the diagnosis, management and prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2016:1-80.

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.