BEVESPI AEROSPHERE

GLYCOPYRROLATE AND FORMOTEROL FUMARATE

Manufacturer: AstraZeneca Pharmaceuticals LP

Score: 141.0

Quick Summary

BEVESPI AEROSPHERE is a combination of glycopyrrolate and formoterol fumarate used for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The recommended dosage is 2 inhalations of BEVESPI AEROSPHERE twice daily by oral inhalation. Key clinical findings include improvement in lung function and reduction in exacerbations. Important safety information includes warnings about paradoxical bronchospasm, hypersensitivity reactions, and cardiovascular effects. Contraindications include use of a long-acting beta2-adrenergic agonist without an inhaled corticosteroid in patients with asthma and hypersensitivity to glycopyrrolate or formoterol fumarate.

Key Clinical Findings and Indications

Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Improvement in lung function
Reduction in exacerbations

Important Safety Information

Warning

Paradoxical bronchospasm, hypersensitivity reactions, and cardiovascular effects

Contraindications

Use of a long-acting beta2-adrenergic agonist without an inhaled corticosteroid in patients with asthma
Hypersensitivity to glycopyrrolate or formoterol fumarate

Adverse Reactions

Urinary tract infection
Cough
Hypersensitivity reactions
Cardiovascular effects

Dosing Recommendations

General Guidance

No dose adjustments are recommended based on age, sex, or body weight

COPD

Adult Dose

2 inhalations of BEVESPI AEROSPHERE twice daily by oral inhalation

Pediatric Dose

Not indicated for use in children

Special Population Considerations

Pregnancy

There are no adequate and well-controlled trials of BEVESPI AEROSPHERE in pregnant women
Use during labor only if the potential benefit justifies the potential risk

Nursing Mothers

It is not known whether BEVESPI AEROSPHERE is excreted in human milk

Pediatric Use

BEVESPI AEROSPHERE is not indicated for use in children
The safety and effectiveness of BEVESPI AEROSPHERE in the pediatric population have not been established

Geriatric Use

No overall differences in safety or effectiveness were observed between geriatric subjects and younger subjects
Greater sensitivity in some older individuals cannot be ruled out

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