AstraZeneca’s latest approval BEVESPI AEROSPHERE™ (glycopyrrolate and formoterol fumarate) inhalation aerosol, is the first long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA) delivered in a pressurized metered dose inhaler (pMDI). It is the first approved product to use the novel Co-Suspension™ Technology. BEVESPI AEROSPHERE was recently approved by the U.S. Food and Drug Administration for long-term maintenance treatment of people with chronic obstructive pulmonary disease (COPD). BEVESPI AEROSPHERE is not for the relief of acute symptoms of COPD or for the treatment of asthma. More information about the approval can be found in our press release.
This progress demonstrates AstraZeneca’s continued commitment to deliver new treatment options for the millions of people affected by chronic respiratory conditions. But, what exactly is Co-Suspension Technology? Below are facts about Co-Suspension Technology to answer this question.
- Utilizes a specially formulated phospholipid particle designed for distribution throughout the lungs: Co-Suspension Technology uses a novel, specially engineered particle to assist with drug crystal delivery. The particles are designed to release drug crystals at their site of deposition, and dissolve in the lung fluid
- Designed to prevent separation and sedimentation of drug crystals over time: Co-Suspension Technology uses low-density particles that are intended to prevent settling (sedimentation) and remain in a stable homogeneous suspension
- Designed for dose consistency: AstraZeneca’s Co-Suspension Technology allows for consistent dosing of one or more different drugs from a single pMDI, the most commonly used inhaler in the US.
We remain focused on developing innovative technology for respiratory patients, and look forward to Co-Suspension Technology as the platform for future combination products within AstraZeneca’s robust respiratory pipeline. Click here for more information about Co-Suspension Technology.
BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
Important Safety Information about BEVESPI AEROSPHERE, including Boxed WARNING
WARNING: Long-acting beta2-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including formoterol fumarate. The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma.
All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication. BEVESPI is contraindicated in patients with a hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of the product.
BEVESPI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.
BEVESPI should not be used for the relief of acute symptoms, i.e., as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
BEVESPI should not be used more often or at higher doses than recommended, or with other LABAs, as an overdose may result.
If paradoxical bronchospasm occurs, discontinue BEVESPI immediately and institute alternative therapy.
If immediate hypersensitivity reactions, including angioedema, urticaria, or skin rash, occur, discontinue BEVESPI at once and consider alternative treatment.
BEVESPI can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure, or symptoms. If such effects occur, BEVESPI may need to be discontinued.
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Be alert to hypokalemia and hyperglycemia.
Worsening of narrow-angle glaucoma or urinary retention may occur. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur.
The most common adverse reactions with BEVESPI (≥2% and more common than placebo) were: cough, 4.0% (2.7%), and urinary tract infection, 2.6% (2.3%).
Use caution if administering adrenergic drugs because the sympathetic effects of formoterol may be potentiated.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of formoterol.
Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta2-agonists.
The action of adrenergic agonists on the cardiovascular system may be potentiated by monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval. Therefore BEVESPI should be used with extreme caution in patients being treated with these agents.
Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.
Avoid co-administration of BEVESPI with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
Please see full Prescribing Information including Boxed WARNING, and Medication Guide.