Breyna inhaler for asthma and COPD maintenance treatment

Breyna is an inhaled combination medicine containing budesonide, a corticosteroid, and formoterol fumarate dihydrate, a long-acting beta2-adrenergic agonist. It is used for long-term maintenance treatment in asthma patients aged 6 years and older, and for maintenance of airflow obstruction and reduction of exacerbations in chronic obstructive pulmonary disease (COPD) patients.

Breyna is approved for:

• Treatment of asthma in patients 6 years of age and older. It is intended for patients whose asthma is not adequately controlled with inhaled corticosteroids alone or who require starting therapy with both an inhaled corticosteroid and a long-acting beta2-agonist (LABA).
• Maintenance treatment of airflow obstruction and reduction of exacerbations in adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The 160 mcg/4.5 mcg strength is the only one indicated for COPD.

Important limitations: Breyna is not indicated for relief of acute bronchospasm and should not be used as a rescue inhaler.

budesonide and formoterol fumarate dihydrate

Breyna combines budesonide, an inhaled corticosteroid that reduces inflammation in the airways, with formoterol fumarate dihydrate, a long-acting beta2-adrenergic agonist (LABA) that relaxes airway muscles to improve airflow and open the airways. This dual action helps control chronic symptoms of asthma and COPD and reduces the frequency of exacerbations.

Administration

For oral inhalation only. Patients should rinse their mouth with water after inhaling without swallowing to reduce the risk of mouth infections.

Asthma

• Patients 12 years and older: 2 inhalations of Breyna 80 mcg/4.5 mcg or 160 mcg/4.5 mcg twice daily (morning and evening, about 12 hours apart). Maximum 2 inhalations twice daily.
• Patients 6 to less than 12 years: 2 inhalations of Breyna 80 mcg/4.5 mcg twice daily.

Starting dose depends on asthma severity, symptom control, and prior corticosteroid use. If control is inadequate after 1-2 weeks on 80 mcg/4.5 mcg, a higher strength (160 mcg/4.5 mcg) may be used. If control worsens on a stable dose, re-evaluation and treatment adjustment are needed.

Chronic obstructive pulmonary disease (COPD)

For maintenance treatment: 2 inhalations of Breyna 160 mcg/4.5 mcg twice daily.

Important notes

• Do not exceed the prescribed dose or use more than 2 inhalations twice daily.
• Do not use Breyna for sudden breathing problems; use a short-acting beta2-agonist inhaler instead.
• If the inhaler has not been used for over 7 days or has been dropped, it should be primed by shaking and releasing two test sprays away from the face.

• Hypersensitivity to any ingredient in Breyna.
• Primary treatment of status asthmaticus or other acute asthma or COPD episodes requiring intensive measures.

• Serious asthma-related events: LABA monotherapy increases risk of asthma-related death. Breyna contains a LABA and corticosteroid; LABA alone should not be used. Use Breyna only as prescribed.
• Deterioration and acute episodes: Do not initiate Breyna in acutely worsening asthma or COPD requiring intensive measures.
• Do not use additional LABA products: Using other LABA drugs with Breyna increases overdose risk and adverse effects.
• Localized infections: Inhaled corticosteroids may cause mouth and throat yeast infections; rinse mouth after use to reduce risk.
• Pneumonia in COPD: Increased risk of pneumonia and other lung infections has been observed; monitor for respiratory infections.
• Immunosuppression: Use caution in patients with infections such as tuberculosis, fungal infections, ocular herpes simplex, measles, or chickenpox, as corticosteroids can worsen infections.
• Systemic corticosteroid transfer: Patients switching from systemic corticosteroids to Breyna require slow tapering to avoid adrenal insufficiency.
• Cardiovascular caution: Beta-agonist effects may exacerbate existing cardiovascular or central nervous system disorders; use with caution.
• Paradoxical bronchospasm: Discontinue Breyna if paradoxical bronchospasm occurs and provide alternative treatment.
• Bone effects and growth: Monitor bone mineral density in long-term use and growth in pediatric patients.
• Eye effects: Monitor for glaucoma and cataracts.

Common side effects include throat irritation and oral candidiasis (yeast infection). Serious adverse reactions may include pneumonia in COPD patients, paradoxical bronchospasm, and systemic corticosteroid effects in susceptible individuals. Patients may also experience cardiovascular effects related to beta2-agonist components.

• Concomitant use with other LABA-containing medications increases risk of overdose and adverse cardiovascular effects and is not recommended.
• Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir) may increase systemic corticosteroid exposure, requiring caution.

Pregnancy

No specific information provided.

Lactation

No specific information provided.