Bevespi Aerosphere for maintenance treatment of chronic obstructive pulmonary disease (COPD)

Bevespi Aerosphere is a combination inhaler containing glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist. It is used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) to help improve breathing. It is not for use in asthma or for relief of sudden breathing problems.

Bevespi Aerosphere is approved for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) to help control symptoms and prevent flare-ups. It is intended for adults requiring regular inhaled therapy for COPD management. It is not indicated for treating asthma or providing immediate relief of acute bronchospasm.

glycopyrrolate and formoterol fumarate

Bevespi Aerosphere combines two active ingredients with complementary effects to improve lung function in COPD. Glycopyrrolate works by blocking muscarinic receptors in the airways, reducing bronchoconstriction caused by acetylcholine. Formoterol fumarate is a long-acting beta2-adrenergic agonist that relaxes airway smooth muscle, leading to bronchodilation. Together, these effects help open airways and ease breathing over time when used regularly.

Adults with COPD: The recommended dose is two inhalations of Bevespi Aerosphere twice daily (morning and evening) by oral inhalation. Each inhalation delivers 9 mcg glycopyrrolate and 4.8 mcg formoterol fumarate (total 18 mcg glycopyrrolate and 9.6 mcg formoterol fumarate per dose). Do not exceed two inhalations twice daily.

Administration instructions:

• Only for oral inhalation.
• Prime before first use by shaking the inhaler and releasing 4 sprays into the air away from the face.
• If the inhaler has not been used for more than 7 days, re-prime by releasing 2 sprays away from the face.
• The device includes a dose counter that moves every 10 actuations and shows red near the end of doses; discard when it shows zero.

Bevespi Aerosphere is contraindicated in:

• Patients with asthma who do not use inhaled corticosteroids due to increased risk of serious asthma-related events.
• Known hypersensitivity to glycopyrrolate, formoterol fumarate, or any components of the product.

Not for asthma or acute bronchospasm: Bevespi Aerosphere is not indicated for asthma treatment or for relief of sudden breathing difficulties (acute bronchospasm). It must not be used as rescue therapy.

LABA monotherapy risk in asthma: Use of long-acting beta2-agonists (LABAs) alone without inhaled corticosteroids increases serious asthma-related risks. Bevespi Aerosphere contains a LABA and should not be used by patients with asthma.

Do not initiate in acutely deteriorating COPD: Treatment should not start during an acute worsening as the safety and efficacy in this setting are not established.

Avoid overdose and combination with other LABAs: Do not use more than recommended or combine with other LABA-containing medicines due to risk of overdose and serious cardiovascular effects.

Paradoxical bronchospasm: May occur and can be life-threatening; discontinue immediately if it happens and treat with a short-acting bronchodilator.

Hypersensitivity reactions: May cause immediate allergic reactions including angioedema; stop use and seek medical attention if symptoms occur.

Cardiovascular caution: Use cautiously in patients with coronary insufficiency, arrhythmias, or hypertension. Monitor for increased pulse, blood pressure, or electrocardiographic changes.

Glaucoma and urinary retention: Use with caution in narrow-angle glaucoma or urinary retention; patients should promptly report symptoms such as eye pain or difficulty urinating.

Other conditions: Exercise caution in those with convulsive disorders, thyrotoxicosis, diabetes mellitus, or ketoacidosis.

Electrolyte and glucose effects: Beta2-agonists may cause low potassium or high blood sugar; usually transient and not requiring treatment.

Common adverse reactions (≥2% and more frequent than placebo):

• Cough (4.0%)
• Urinary tract infection (2.6%)

Other adverse reactions occurring >1% but

Additional reported adverse effects include: hypersensitivity reactions, hyperglycemia, sleep disturbance, agitation, restlessness, tremor, nausea, tachycardia, palpitations, and cardiac arrhythmias such as atrial fibrillation and supraventricular tachycardia.

Postmarketing reports have identified hypersensitivity and urinary retention cases.

Do not use Bevespi Aerosphere with other long-acting beta2-agonists containing medications due to risk of overdose and serious cardiovascular effects.