Bevespi Aerosphere Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol

1. Indications and Usage
Glycopyrronium bromide and formoterol fumarate inhalation aerosol is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, to relieve symptoms. It is not indicated for the relief of acute bronchospasm.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is two inhalations twice daily. The total daily dose must not exceed four inhalations.
Administration: For oral inhalation only. The canister contains 120 inhalations and is equipped with a dose counter.
Usage Instructions: The inhaler must be primed before the first use. Patients should be instructed on proper inhalation technique.
Missed Dose: If a dose is missed, it should be taken at the next scheduled time. Doubling the dose is not recommended.
3. Mechanism of Action
Glycopyrronium Bromide: A muscarinic (M3) receptor antagonist that inhibits reflex bronchoconstriction mediated by acetylcholine, leading to bronchodilation.
Formoterol Fumarate: A selective β2-adrenergic receptor agonist that activates adenylate cyclase, increasing intracellular cyclic AMP, which relaxes bronchial smooth muscle and inhibits the release of mediators from certain inflammatory cells.
4. Safety and Warnings
Paradoxical Bronchospasm: May occur and requires immediate discontinuation and alternative therapy.
Cardiovascular Effects: May cause significant cardiovascular effects; use with caution in patients with cardiovascular disorders.
QT Prolongation: Possible QT prolongation; caution is advised in patients with risk factors.
Worsening of Narrow-Angle Glaucoma and Urinary Retention: Anticholinergic effects may exacerbate these conditions.
Hypersensitivity: Immediate hypersensitivity reactions (e.g., angioedema, anaphylaxis) have been reported.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include nasopharyngitis, headache, dry mouth, back pain, bronchitis, and urinary tract infection.
Clinical Research: Efficacy and safety were established in pivotal Phase 3 clinical trials (e.g., GLOW trials), which demonstrated significant improvements in lung function (FEV1) and reductions in COPD exacerbations compared to monotherapy or placebo.
6. Drug Interactions
Other Anticholinergics: Concomitant use with other anticholinergic drugs may increase the risk of anticholinergic adverse reactions and should be avoided.
Beta-Blockers: May interfere with the bronchodilatory effects of formoterol.
QTc-Prolonging Drugs: Concomitant use may increase the risk of arrhythmias.
Diuretics and Xanthine Derivatives: May enhance the hypokalemic effects of β2-agonists.
Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: May potentiate the cardiovascular effects of formoterol.
7. Pharmaceutical Information
Composition: The active ingredients are glycopyrronium bromide and formoterol fumarate.
Composition: The formulation contains hydrofluoroalkane-134a as a propellant.
Storage: Store at room temperature; do not puncture or expose to high temperatures.