Important Safety Information1

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.

Click here for additional safety information and for a link to the product monograph discussing:

  • Relevant warnings and precautions regarding risk of serious asthma-related events, deterioration of disease, excessive use with other LAMA and LABA products, anticholinergic activity, cardiovascular effects, driving and operating machinery, candidiasis, risk of systemic effects, 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, systemic eosinophilic conditions (in rare cases), susceptibility or decreased resistance to infections, monitoring, paradoxical bronchospasm, increased risk of pneumonia, pregnant and nursing women, and geriatrics.
  • Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions.

The Product Monograph is also available by calling AstraZeneca Canada at 1-800-668-6000.

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

Reference:

  1. BREZTRI AEROSPHERE Product Monograph. AstraZeneca Canada Inc.
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BREZTRI® AEROSPHERE®

Safety Profile

Safety profile established in pivotal trials encompassing 10,405 patients1

The overall safety profile of BREZTRI AEROSPHERE was generally consistent with the known pharmacologic class effects of ICSs, LAMAs and/or LABAs.

Adverse drug reactions in the ETHOS 52-week trial occurring in ≥2% of patients, any treatment group (BREZTRI AEROSPHERE, n=2,144; GFF MDI, n=2,125; BFF MDI; n=2,136)

Headache  (BREZTRI AEROSPHERE, 2.7%; GFF MDI, 2.8%; BFF MDI, 3.2%), cough (BREZTRI AEROSPHERE, 2.7%; GFF MDI, 2.4%; BFF MDI, 2.4%), muscle spasms (BREZTRI AEROSPHERE, 2.8%; GFF MDI, 0.9%; BFF MDI, 2.5%), oral candidiasis (BREZTRI AEROSPHERE, 3.0%; GFF MDI, 1.1%; BFF MDI, 2.7%), pneumonia (BREZTRI AEROSPHERE, 4.6%; GFF MDI, 2.9%.; BFF MDI, 5.0%), urinary tract infection (BREZTRI AEROSPHERE, 2.7%; GFF MDI, 2.8%; BFF MDI, 1.9%)

Pneumonia

In the 52-week ETHOS trial, the incidence of confirmed pneumonia was:1

BREZTRI AEROSPHERE

GFF MDI

BFF MDI

4.2%

2.3%

4.5%

In the 24-week KRONOS trial, the incidence of confirmed pneumonia was low and similar across treatment groups1

BREZTRI AEROSPHERE

GFF MDI

BFF MDI

1.9%

1.6%

1.9%

BFF: budesonide/formoterol fumarate dihydrate; GFF: glycopyrronium/formoterol fumarate dihydrate; ICS: inhaled corticosteroid; LABA: long-acting beta2-adrenergic agonist; LAMA: long-acting muscarinic antagonist; MDI: metered-dose inhaler.

Reference:

  1. BREZTRI AEROSPHERE Product Monograph. AstraZeneca Canada Inc.
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