HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BEVESPI AEROSPHERE safely and effectively. See full prescribing information for BEVESPI AEROSPHERE.
     
BEVESPI AEROSPHERE™ (glycopyrrolate and formoterol fumarate) inhalation aerosol, for oral inhalation use
Initial U.S. Approval: 2016
WARNING: ASTHMA-RELATED DEATH SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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Long-acting beta2-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including formoterol fumarate. (5.1)
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The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma. (5.1)
INDICATIONS AND USAGE
BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). (1)
Limitation of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1, 5.1, 5.2)
DOSAGE AND ADMINISTRATION
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For oral inhalation only.
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Maintenance treatment of COPD: 2 inhalations of BEVESPI AEROSPHERE twice daily. ( 2)
DOSAGE FORMS AND STRENGTHS

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Inhalation aerosol: Pressurized metered dose inhaler containing a combination of glycopyrrolate (9 mcg) and formoterol fumarate (4.8 mcg) as an inhalation aerosol.
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Two inhalations equal one dose. ( 3)
CONTRAINDICATIONS

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All LABAs are contraindicated in patients with asthma without use of a long-term asthma controller medication. ( 4) BEVESPI AEROSPHERE is not indicated for the treatment of asthma. ( 1)
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Hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of this product. ( 4, 5.5)
WARNINGS AND PRECAUTIONS

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Do not initiate in acutely deteriorating COPD or to treat acute symptoms. ( 5.2)
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Do not use in combination with an additional medicine containing a LABA because of risk of overdose. ( 5.3, 7.1)
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If paradoxical bronchospasm occurs, discontinue BEVESPI AEROSPHERE and institute alternative therapy. ( 5.4)
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Use with caution in patients with cardiovascular disorders. ( 5.6)
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Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. ( 5.7)
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Be alert to hypokalemia and hyperglycemia. ( 5.8)
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Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur. ( 5.9)
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Worsening urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur. ( 5.10)
ADVERSE REACTIONS

Most common adverse reactions (incidence ≥2% and more common than with placebo