What is the recommended use and dosage of Breztri (budesonide, glycopyrrolate, and formoterol) for chronic obstructive pulmonary disease (COPD) management?

Breztri for COPD Management

Recommended Use and Dosage

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) is indicated for maintenance treatment of moderate-to-severe COPD at a dose of 160/9/4.8 mcg (2 inhalations) twice daily, delivering 320/18/9.6 mcg total daily dose. 1, 2

Clinical Indications

Breztri should be prescribed for patients with:

• Moderate-to-severe COPD inadequately controlled on dual therapy (either ICS/LABA or LAMA/LABA combinations) 1, 3
• Patients experiencing exacerbations despite current therapy, as real-world data shows 57.9% of Breztri initiators had evidence of COPD exacerbation or related events in the prior 12 months 4
• Symptomatic patients with dyspnea (50.8% of initiators had documented dyspnea) 4

Important: No Exacerbation History Required

Breztri reduces exacerbation rates by 48% even in patients WITHOUT a recent exacerbation history, demonstrating benefit across the COPD spectrum 5. The 24-week KRONOS trial specifically did not require exacerbation history for enrollment, and 74% of patients had no moderate/severe exacerbations in the prior 12 months 5.

Key Clinical Benefits

Exacerbation Reduction

• Reduces moderate/severe exacerbation rates versus dual bronchodilator therapy (glycopyrrolate/formoterol) by 48-58% depending on exacerbation history 5
• Greater benefit with higher blood eosinophil counts - the magnitude of exacerbation reduction increases with eosinophil levels 5, 2

Mortality Benefit

• Reduces all-cause mortality compared to dual bronchodilator therapy, with benefit increasing with blood eosinophil count 1, 2

Symptom Improvement

• Improves forced expiratory volume (FEV1) 1, 2
• Reduces dyspnea and rescue medication requirements 1
• Improves health-related quality of life 1, 2

Dosing Algorithm

Standard dose: 2 inhalations of 160/9/4.8 mcg twice daily (morning and evening) 2

• Do NOT exceed recommended dose 6
• Do NOT use for acute symptom relief or rescue therapy 6
• Patients should have a separate short-acting beta2-agonist prescribed for acute symptoms 6

Critical Safety Considerations

What Breztri Is NOT For

• NOT for acute deteriorations or rescue therapy - formoterol component is long-acting and inappropriate for acute bronchospasm 6
• NOT indicated for asthma treatment 6
• Patients must discontinue regular use of short-acting beta2-agonists and reserve them only for symptomatic relief 6

Common Adverse Effects

• Dysphonia and oral candidiasis more common than with dual bronchodilators (due to ICS component) 3
• Pneumonia risk increased compared to dual bronchodilators - this is a class effect of inhaled corticosteroids 3

Cardiovascular Precautions

• Use with caution in patients with cardiovascular disorders, coronary insufficiency, cardiac arrhythmias, and hypertension 6
• Can cause clinically significant cardiovascular effects including increased pulse rate and blood pressure 6
• May cause ECG changes (T wave flattening, QTc prolongation, ST segment depression) 6

Metabolic Effects

• May cause hypokalemia through intracellular potassium shunting 6
• May cause transient hyperglycemia, particularly relevant in diabetic patients 6

Patient Population Characteristics

Real-world data shows Breztri initiators typically have:

• Mean age 68.2 years, 57.1% female 4
• High prevalence of comorbidities: hypertension (58.8%), dyslipidemia (43.9%), cardiovascular disease (41.4%), heart failure (19.9%) 4
• 21% had prior triple therapy use 4
• 54.3% had prior oral corticosteroid use, with 29.9% having cumulative exposures >1000 mg 4

Common Pitfalls to Avoid

• Do NOT increase dosing beyond twice-daily when symptoms worsen - this signals disease deterioration requiring re-evaluation, not dose escalation 6
• Do NOT combine with other long-acting beta2-agonists - risk of overdose and cardiovascular effects 6
• Do NOT use in patients taking beta-blockers (including eye drops) - beta-blockers should be avoided in COPD 7, 8
• Ensure proper inhaler technique - the co-suspension delivery technology via MDI requires correct technique for optimal drug delivery 1, 3

When to Reassess Treatment

Increasing use of rescue short-acting beta2-agonist or worsening symptoms despite Breztri indicates disease deterioration requiring immediate re-evaluation of the entire COPD treatment regimen 6.