Breztri for Maintenance Treatment of COPD and Asthma

Breztri is a combination inhaler containing budesonide (an inhaled corticosteroid), glycopyrrolate (an anticholinergic), and formoterol fumarate (a long-acting beta2-agonist). It is designed for maintenance treatment to help manage chronic obstructive pulmonary disease (COPD) in adults and asthma in patients aged 12 years and older.

This medication is not intended for quick relief of sudden breathing problems.

• Maintenance treatment of COPD: For adult patients to improve lung function and control symptoms.
• Maintenance treatment of asthma: For adult and pediatric patients 12 years and older to maintain asthma control.

Limitations: Breztri is not indicated for relief of acute bronchospasm or sudden worsening of symptoms requiring emergency treatment.

budesonide, glycopyrrolate, formoterol fumarate

Breztri combines three active components that work together:

• Budesonide: A corticosteroid that reduces inflammation in the airways, helping to prevent asthma and COPD exacerbations.
• Glycopyrrolate: An anticholinergic that relaxes airway muscles to improve airflow.
• Formoterol fumarate: A long-acting beta2-adrenergic agonist that helps keep airways open by relaxing airway muscles over an extended period.

Together, these agents help maintain open airways and reduce inflammation to improve breathing in chronic lung conditions.

Administration

• For oral inhalation only.
• Prime the inhaler before first use by releasing 4 sprays away from the face, shaking well before each spray.
• Re-prime with 2 sprays if not used for more than 7 days, after dropping, or weekly rinsing.
• Rinse mouth with water without swallowing after each use to reduce risk of oral infections.

Dosing for COPD Maintenance in Adults

• Two inhalations of Breztri 160 mcg/9 mcg/4.8 mcg twice daily (morning and evening).

Dosing for Asthma Maintenance in Patients 12 Years and Older

• Two inhalations of Breztri 160 mcg/18 mcg/4.8 mcg twice daily (morning and evening).

Important Instructions

• Do not exceed two inhalations twice daily.
• Use the dose counter on the inhaler to track remaining doses; discard when the indicator reaches zero.

• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD that require intensive measures.
• Known hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or any excipients of the product.

Serious Warnings and Precautions

• Risk of serious asthma-related events: LABA components, when used without corticosteroids, increase risk of asthma-related death and hospitalization. Breztri contains both LABA and corticosteroid to reduce this risk.
• Not for acute symptom relief: Do not use Breztri to treat sudden breathing problems or exacerbations. Use appropriate short-acting inhalers for relief.
• Do not use multiple LABA-containing products: Using Breztri with other LABA drugs can cause overdose and serious side effects.
• Infections: Risk of pneumonia and oral candidiasis may increase. Monitor for infections and advise rinsing mouth after use.
• Adrenal insufficiency: Gradually taper systemic corticosteroids when switching to Breztri to avoid adrenal suppression.
• Paradoxical bronchospasm: If worsened breathing occurs after use, discontinue and seek medical advice.
• Cardiovascular effects: Use caution in patients with heart conditions; beta2-agonists may increase heart rate or cause arrhythmias.
• Ocular effects: Long-term corticosteroid use may cause glaucoma or cataracts; monitor eye symptoms.
• Urinary retention: Use cautiously in patients with prostate or bladder issues.
• Immunosuppression: May worsen infections such as tuberculosis, herpes simplex, chickenpox, or measles in susceptible individuals.

Common Side Effects

• Oral thrush (Candida infections in mouth/throat)
• Increased risk of respiratory infections including pneumonia
• Possible cardiovascular effects like palpitations

Serious Side Effects

• Severe allergic reactions such as angioedema, swelling of face or throat
• Paradoxical bronchospasm (worsening wheezing after inhalation)
• Adrenal insufficiency symptoms (fatigue, weakness, nausea, low blood pressure)

• Avoid concurrent use with other LABA-containing medications to prevent overdose and serious adverse effects.
• Caution with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) as they may increase systemic exposure to budesonide and risk of corticosteroid-related side effects.

The supplied evidence does not provide specific information on pregnancy, contraception, or lactation related to Breztri.

Signs of overdose may include clinically significant cardiovascular effects such as increased heart rate, blood pressure changes, and arrhythmias. Management should be supportive and symptomatic.

Store Breztri inhaler according to the instructions provided with the product; specific temperature and storage instructions were not detailed in the supplied evidence.