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BREZTRI^® AEROSPHERE^®

Important Safety Information

Indication:¹

BREZTRI AEROSPHERE is indicated for the long-term maintenance treatment to reduce exacerbations of COPD and treat airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, who are not adequately treated by a combination of an ICS/LABA or a combination of LAMA/LABA.

Clinical use:¹

BREZTRI AEROSPHERE is not indicated for:

Treatment of acute episodes of bronchospasm or asthma.
Use in pediatric patients <18 years of age.

Relevant warnings & precautions:¹

Risk of serious asthma-related events, including hospitalization, intubations, and death
Should not be initiated in patients with acutely deteriorating COPD
Excessive use with other LAMA and LABA products
Anticholinergic activity: Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention, or narrow-angle glaucoma
Cardiovascular effects, including arrhythmias, and changes in pulse and blood pressure, or QTc prolongation
Driving and operating machinery
Candidiasis
Risk of systemic effects, including Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, hypokalemia and hyperglycemia, cataract, intraocular pressure, and glaucoma
Hypercorticism, adrenal suppression
Adrenal insufficiency in patients transferred from systemic steroid
Patients with symptomatic prostatic hyperplasia, glaucoma, convulsive disorders, thyrotoxicosis, sensitivity to sympathomimetic amines, severe hepatic impairment/hepatic disease, or urinary retention
In rare cases, eosinophilic conditions
Susceptibility or decreased resistance to infections
Monitoring of hypokalemia, hyperglycemia, bone and ocular effects, and corticosteroid effects in patients with hepatic impairment
Paradoxical bronchospasm
Increased risk of pneumonia
Pregnant and nursing women
Geriatrics (≥65 years of age)

For more information:

Consult the Product Monograph for important information regarding adverse reactions, drug interactions, and dosing. The Product Monograph is also available by calling AstraZeneca Canada at 1-800-668-6000.

COPD: chronic obstructive pulmonary disease; LABA: long-acting beta₂-adrenergic agonist; LAMA: long-acting muscarinic antagonist.

Reference:

BREZTRI AEROSPHERE Product Monograph. AstraZeneca Canada Inc.