Version July 2025
Chronic obstructive pulmonary disease, maintenance: Note: Use long-acting bronchodilator combination therapy (long-acting beta agonist and long-acting muscarinic antagonist) in patients with more symptoms (eg, Group B). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Metered-dose inhaler (glycopyrrolate 9 mcg/formoterol 4.8 mcg per actuation): Oral inhalation: 2 inhalations twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl >30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
CrCl ≤30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.
ESRD on dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); formoterol exposure may be increased with hepatic impairment; use with caution and monitor closely.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. See individual agents.
1% to 10%:
Cardiovascular: Chest pain (1% to <2%)
Central nervous system: Anxiety (1% to <2%), dizziness (1% to <2%), falling (1% to <2%), fatigue (1% to <2%), headache (1% to <2%)
Gastrointestinal: Vomiting (1% to <2%), xerostomia (1% to <2%)
Genitourinary: Urinary tract infection (3%)
Hematologic & oncologic: Bruise (1% to <2%)
Infection: Influenza (1% to <2%), tooth abscess (1% to <2%)
Neuromuscular & skeletal: Arthralgia (1% to <2%), limb pain (1% to <2%), muscle spasm (1% to <2%)
Respiratory: Cough (4%), acute sinusitis (1% to <2%), oropharyngeal pain (1% to <2%)
Frequency not defined: Respiratory: Paradoxical bronchospasm
<1%, postmarketing, and/or case reports: Hypersensitivity reaction, urinary retention
Hypersensitivity to glycopyrrolate, formoterol, or any component of the formulation; monotherapy (without use of a concomitant inhaled corticosteroid) in the treatment of asthma.
Concerns related to adverse effects:
• Asthma-related deaths: Monotherapy with a long-acting beta-2 agonist (LABA) is contraindicated in the treatment of asthma. Glycopyrrolate/formoterol is not indicated for the treatment of asthma. Available data do not suggest an increased risk of death with use of LABA in patients with chronic obstructive pulmonary disease (COPD).
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue use and institute alternative therapy.
• CNS effects: May cause drowsiness, dizziness, and/or blurred vision; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Hypersensitivity: Immediate hypersensitivity reactions, including anaphylaxis, angioedema, rash, or urticaria may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur.
• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (eg, arrhythmia, coronary insufficiency, hypertension); beta agonists may cause elevation in blood pressure and heart rate. Beta-2 agonists may also produce changes in the ECG (eg, T-wave flattening, QTc prolongation, ST segment depression).
• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may aggravate preexisting diabetes and ketoacidosis and increase serum glucose.
• Glaucoma: Use with caution in patients with narrow angle glaucoma; may increase intraocular pressure.
• Hepatic impairment: Use with caution; beta-2 agonists exposure may be increased with hepatic impairment; monitor closely.
• Hyperthyroidism: Use with caution in patients with hyperthyroidism; beta-2 agonists may stimulate thyroid activity.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient).
• Renal impairment: Use with caution in patients with severe renal impairment (CrCl ≤30 mL/minute/1.73 m2) or ESRD on dialysis.
• Seizures: Use with caution in patients with seizure disorders; beta-2 agonists may result in CNS stimulation/excitation.
• Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction.
Special populations:
• Pediatric: LABAs, when used as monotherapy, may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials in adolescents do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone.
Other warnings/precautions:
• Appropriate use: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm or with acutely deteriorating or potentially life-threatening COPD; after initiation of therapy, patients should use short-acting bronchodilators only on an as needed basis for acute symptoms.
Bevespi Aerosphere 10.7 g canisters contain 120 inhalations; 5.9 g canisters contain 28 inhalations
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol, Inhalation:
Bevespi Aerosphere: Glycopyrrolate 9 mcg and formoterol fumarate dihydrate 4.8 mcg per actuation (10.7 g)
No
Aerosol (Bevespi Aerosphere Inhalation)
9-4.8 mcg/ACT (per gram): $49.87
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral inhalation: Metered-dose inhaler: For oral inhalation using the Bevespi Aerosphere only. Prior to use, inhaler must be primed by releasing 4 test sprays into the air (away from face and eyes), shake well before each spray. Inhaler must be reprimed if not used >7 days by releasing 2 sprays into the air. Shake well before each use. Clean inhaler (remove canister out of actuator) one time each week by running warm water through the actuator and allow to air dry. Reprime the inhaler after each cleaning by releasing 2 sprays into the air. The dose indicator moves after every tenth actuation and the color in the dose indicator display window changes to red when nearing the end of usable inhalations; discard device when dose counter reads “0”.
Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Clinically Relevant Anticholinergic Effects: May increase anticholinergic effects of Glycopyrrolate (Oral Inhalation). Risk X: Avoid
Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Atomoxetine: May increase tachycardic effects of Beta2-Agonists. Atomoxetine may increase hypertensive effects of Beta2-Agonists. Risk C: Monitor
Atosiban: Beta2-Agonists may increase adverse/toxic effects of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor
Beta-Blockers (Beta1 Selective): May decrease bronchodilatory effects of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor
Beta-Blockers (Nonselective): May decrease bronchodilatory effects of Beta2-Agonists. Risk X: Avoid
Beta2-Agonists (Long-Acting): May increase adverse/toxic effects of Beta2-Agonists (Long-Acting). Risk X: Avoid
Caffeine and Caffeine Containing Products: May increase adverse/toxic effects of Formoterol. Caffeine and Caffeine Containing Products may increase hypokalemic effects of Formoterol. Risk C: Monitor
Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification
Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor
Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor
Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor
Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Inhaled Anticholinergic Agents: May increase anticholinergic effects of Inhaled Anticholinergic Agents. Risk C: Monitor
Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid
Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor
Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification
Loop Diuretics: Beta2-Agonists may increase hypokalemic effects of Loop Diuretics. Risk C: Monitor
Loxapine: Agents to Treat Airway Disease may increase adverse/toxic effects of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid
Methacholine: Beta2-Agonists (Long-Acting) may decrease therapeutic effects of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider Therapy Modification
Methacholine: Long-acting muscarinic antagonists (LAMAs) may decrease therapeutic effects of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Risk D: Consider Therapy Modification
Monoamine Oxidase Inhibitors: May increase adverse/toxic effects of Beta2-Agonists. Risk C: Monitor
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor
Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor
Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor
Theophylline Derivatives: May increase hypokalemic effects of Beta2-Agonists. Beta2-Agonists may increase adverse/toxic effects of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Risk C: Monitor
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Beta-agonists have the potential to affect uterine contractility if administered during labor. Refer to individual monographs for additional information.
It is not known if formoterol or glycopyrrolate are present in breast milk following oral inhalation.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Refer to individual monographs for additional information.
FEV1, peak flow, and/or other pulmonary function tests; serum potassium, serum glucose; blood pressure, heart rate; CNS stimulation; signs/symptoms of glaucoma; hypersensitivity reactions; urinary retention.
Glycopyrrolate: In COPD, competitively and reversibly inhibits the action of acetylcholine at muscarinic receptor subtypes 1-3 (greater affinity for subtypes 1 and 3) in bronchial smooth muscle thereby causing bronchodilation.
Formoterol: Relaxes bronchial smooth muscle by selective action on beta2 receptors with little effect on heart rate. Formoterol has a long-acting effect.
See individual agents.
Altered kidney function: Formoterol systemic exposure (AUC0-12) in subjects with moderate renal impairment (CrCl 45 mL/minute) is expected to be approximately 45% higher.
