The FDA has approved bevespi aerosphere inhalation aerosol for the long-term maintenance treatment of airflow obstruction in patients with COPD.
The FDA has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate; AstraZeneca) inhalation aerosol for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The indication includes patients with chronic bronchitis and/or emphysema, but carries the limitation that the product should not be used for treating acute bronchospasm or asthma.1 Approximately 329 million individuals worldwide are affected by COPD, and it is expected to be the third leading cause of death by 2030.2
PHARMACOLOGY AND PHARMACOKINETICS
Glycopyrrolate is a long-acting anticholinergic agent that inhibits the muscarinic M3 receptor at the smooth muscle to cause site-specific bronchodilation. Formoterol fumarate is a long-acting selective beta2-adrenergic agonist (LABA). It increases levels of cyclic adenosine monophosphate to relax bronchial smooth muscles and inhibit the release of mediators of immediate hypersensitivity from cells, especially mast cells.
Both medications exhibit linear pharmacokinetics and reach steady state within 2 to 3 days of beginning treatment. Age, gender, race, ethnicity, and body weight do not affect the pharmacokinetics of either glycopyrrolate or formoterol fumarate.1
DOSAGE AND ADMINISTRATION
Each inhalation of Bevespi Aerosphere delivers 9 mcg of glycopyrrolate and 4.8 mcg of formoterol fumarate. Patients should use 2 inhalations twice daily.1
The safety and efficacy of Bevespi Aerosphere was studied in 8 dose-ranging trials and 2 placebo-controlled lung function trials. The findings from the dose-ranging trials established a dose of 18/9.6 mcg of glycopyrrolate/formoterol fumarate to be administered in the lung function trials.
The lung function trials consisted of two 24-week, randomized, double-blind, placebo-controlled, parallel- group trials in 3699 patients with moderate to very severe COPD. Patients were randomized to use Bevespi Aerosphere, glycopyrrolate 18 mcg, formoterol fumarate 9.6 mcg, or placebo. All medications were administered twice daily. Patients using Bevespi Aerosphere were found to have a statistically significant improvement in morning predose trough FEV1 compared with glycopyrrolate, formoterol fumarate, or placebo. The Bevespi Aerosphere group also demonstrated a significant improvement, compared with placebo, in peak FEV1 within 2 hours after medication administration and rescue medication use.1,2
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
Bevespi Aerosphere carries a boxed warning stating that the use of LABAs in asthma can increase the risk of asthma-related death and that the safety and efficacy of Bevespi Aerosphere in patients with asthma has not been established. The warning also states that Bevespi Aerosphere is not indicated for the treatment of asthma.
Bevespi Aerosphere is contraindicated in patients with a hypersensitivity to any of its components. Treatment with Bevespi Aerosphere also should not be started in patients with acutely deteriorating COPD or to treat acute COPD symptoms, and it should not be used in combination with another LABA. Bevespi Aerosphere should be discontinued immediately if paradoxical bronchospasm occurs. In addition, it should be used cautiously in patients with cardiovascular disorders, convulsive disorders, thyrotoxicosis, diabetes, and ketoacidosis. Hypokalemia or hyperglycemia may occur, as well as worsening of narrow-angle glaucoma and urinary retention.
The concomitant use of other adrenergic medications with Bevespi Aerosphere may potentiate the effect of Bevespi Aerosphere. Xanthine derivatives, steroids, diuretics or non—potassium-sparing diuretics may potentiate hypokalemia or electrocardiographic changes. Extreme caution should be used when administering Bevespi Aerosphere in combination with a monoamine oxidase inhibitor or tricyclic antidepressant. Concurrent use with a beta-blocker should only occur if medically necessary. Bevespi Aerosphere should not be administered in combination with other anticholinergic medications.
The most common adverse reactions (≥2%, and more common than with placebo) include urinary tract infection and cough.1
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.
- Bevespi Aerosphere [prescribing information]. Wilmington, DE: AstraZeneca; 2016. azpicentral.com/bevespi/bevespi_pi.pdf. Accessed June 2016.
- Bevespi Aerosphere approved by the US FDA for patients with COPD [news release]. AstraZeneca; April 25, 2016. astrazeneca.com/media-centre/press-releases/2016/bevespi-aerosphere-approved-by-the-us-fda-for-patients-with-copd-25042016.html. Accessed June 2016.