Breo ellipta for Maintenance Treatment of COPD and Asthma

Breo Ellipta is an inhalation powder combining fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist. It is used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma in patients aged 5 years and older. It is not intended for relief of acute bronchospasm.

• Maintenance treatment of COPD: for adults requiring daily inhaled therapy to manage this chronic lung disease.
• Maintenance treatment of asthma: for patients aged 5 years and older to control persistent asthma symptoms.

Important: Breo Ellipta is not indicated for the relief of sudden breathing problems or acute asthma attacks; a separate rescue inhaler should be used.

fluticasone furoate; vilanterol trifenatate

Breo Ellipta delivers two medications by inhalation: fluticasone furoate, which reduces inflammation in the airways as a corticosteroid, and vilanterol, which relaxes airway muscles as a long-acting beta2-adrenergic agonist (LABA). Together, they help open airways and reduce symptoms of COPD and asthma over time.

General administration: Breo Ellipta is taken once daily by oral inhalation at about the same time each day. After use, rinse the mouth with water without swallowing to reduce the risk of oral fungal infections.

Maintenance treatment of COPD (adults)

• Recommended dose: 1 actuation of 100/25 mcg once daily.
• If symptoms worsen, use a separate short-acting inhaled beta2-agonist as rescue therapy.

Maintenance treatment of asthma

• Adults (18 years and older): 1 actuation once daily of either 100/25 mcg or 200/25 mcg, chosen based on disease severity and previous therapy.
• Adolescents (12-17 years): 1 actuation once daily of 100/25 mcg.
• Children (5-11 years): 1 actuation once daily of 50/25 mcg.
• Do not use more than 1 inhalation daily; increasing dose or frequency is not recommended due to risk of adverse effects.
• If asthma symptoms occur between doses, use an inhaled short-acting beta2-agonist for immediate relief.

• Primary treatment of status asthmaticus or other acute COPD or asthma episodes requiring intensive interventions.
• Severe hypersensitivity to milk proteins, fluticasone furoate, vilanterol, or any excipients (such as lactose monohydrate, magnesium stearate).

• Do not use for acute bronchospasm or rapidly worsening asthma or COPD. Breo Ellipta is not effective for sudden symptom relief.
• Concurrent LABA therapy: Avoid using other LABA-containing medicines alongside Breo Ellipta to prevent overdose.
• Monitor for pneumonia in COPD patients: Treatment with Breo Ellipta increases pneumonia risk; watch for symptoms and distinguish from COPD exacerbations.
• Oral candidiasis: Patients should rinse their mouth after inhalation to lower the chance of fungal infections in the mouth and throat.
• Adrenal insufficiency: Patients switching from systemic corticosteroids need gradual withdrawal and monitoring for adrenal suppression symptoms.
• Paradoxical bronchospasm: Discontinue immediately if breathing worsens after use.
• Hypersensitivity reactions: Severe allergic reactions including anaphylaxis can occur; avoid in patients with severe milk protein allergy due to lactose content.
• Use with caution: in patients with active infections (tuberculosis, herpes simplex, fungal, bacterial, viral, parasitic), cardiovascular disorders, glaucoma, cataracts, convulsive disorders, thyrotoxicosis, diabetes, and ketoacidosis.
• Do not initiate treatment during acutely deteriorating disease or life-threatening episodes.

LABA monotherapy raises the risk of serious asthma-related events; Breo Ellipta combines LABA with an inhaled corticosteroid, which clinical trials have shown does not significantly increase this risk compared to corticosteroids alone.

• Common: Oral thrush (Candida infections), pneumonia in COPD patients, upper respiratory tract infections.
• Serious: Pneumonia leading to hospitalization or death in rare cases, paradoxical bronchospasm, hypersensitivity reactions including anaphylaxis, adrenal suppression symptoms (fatigue, weakness, nausea).

• Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) can increase systemic corticosteroid exposure, raising the risk of adrenal suppression and cardiovascular side effects.
• Avoid using other LABAs simultaneously to prevent overdose and serious cardiovascular events.