Bevespi Aerosphere Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol

1. Indications and Usage
Chronic Obstructive Pulmonary Disease (COPD):
Maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Important Safety Limitation: Not indicated for the relief of acute bronchospasm (rescue inhaler).
2. Dosage and Administration
Route of Administration:
For Oral Inhalation ONLY.
Recommended Dosage:
Standard Dose: 2 actuations (puffs) twice daily (morning and evening).
Dose Strength: Each actuation typically contains Glycopyrronium 7.2 mcg and Formoterol 5 mcg.
Critical Administration Instructions:
Prime the Inhaler: Before using for the first time, or if the inhaler has not been used for more than 7 days, shake well and spray into the air 4 times.
Rinse Mouth: Although it does not contain steroids, rinsing the mouth after inhalation is recommended to reduce the risk of oral candidiasis and throat irritation.
3. Mechanism of Action
The drug combines two distinct pharmacological classes of bronchodilators:
Glycopyrronium Bromide (LAMA):
A long-acting muscarinic antagonist. It blocks the action of acetylcholine on M3 receptors in the airways, preventing bronchoconstriction.
Formoterol Fumarate (LABA):
A long-acting selective β2-adrenergic receptor agonist. It relaxes bronchial smooth muscle by increasing intracellular cAMP, providing bronchodilation for up to 12 hours.
Synergistic Effect:
The combination provides greater bronchodilation than either agent alone.
4. Safety and Warnings
Not for Acute Episodes:
Not indicated for the initial treatment of acute episodes of bronchospasm.
Increased Risk of Asthma-Related Events:
Contraindicated as monotherapy for asthma. Using LABAs without ICS in asthma patients increases the risk of asthma-related death. This drug is not approved for asthma treatment.
Cardiovascular Effects:
LABA components may cause transient cardiovascular effects (e.g., increased heart rate, palpitations, QTc prolongation).
Glaucoma and Urinary Retention:
Anticholinergic components may cause or worsen narrow-angle glaucoma or urinary retention.
Hypokalemia:
Beta-agonists may produce significant hypokalemia in some patients.
5.Adverse Reactions
Most Common:
Nasopharyngitis, upper respiratory tract infection, headache, diarrhea, dizziness, and nasalsinusitis.
6.Drug Interactions
Beta-Blockers:
May block the pulmonary effects of Formoterol. Generally contraindicated unless there are compelling reasons for their use.
QTc-Prolonging Drugs:
Concomitant use with other drugs that prolong the QTc interval may increase the risk of arrhythmias.
Anticholinergics:
Avoid concomitant use with other inhaled anticholinergic drugs (e.g., tiotropium) to avoid additive side effects.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredients: Glycopyrronium Bromide, Formoterol Fumarate.
Propellant: Hydrofluoroalkane (HFA-134a).
Appearance: Pressurized Metered-Dose Inhaler (pMDI).
Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).