Generic Name

Breo Ellipta

Mechanism

• Fluticasone furoate
• High‑potency glucocorticoid → binds mineralocorticoid‑free glucocorticoid receptors in airway smooth‑muscle and alveolar macrophages.
• Suppresses transcription of pro‑inflammatory cytokines (IL‑4/5/13, IL‑8), reduces eosinophil recruitment, and diminishes airway hyperresponsiveness.
• Vilanterol
• Ultra‑selective β₂‑adrenergic agonist → activates Gs protein, increases cAMP, and induces bronchodilation of airway smooth‑muscle.
• Prolonged action (≈27 h) sustains bronchodilation and improves symptom control.
• Synergistic effect → the anti‑inflammatory action of fluticasone furoate enhances the bronchodilator efficacy of vilanterol, allowing lower steroid doses compared with monotherapy.

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Pharmacokinetics

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Indications

• Asthma – Maintenance treatment ≥ 2 years, prevent exacerbations, improve lung function.
• Adult and child ≥ 6 yrs (dose 100/25 µg once daily).
• COPD – Maintenance treatment of COPD with bronchospastic disease and chronic inflammation.
• Adult ≥ 40 yrs, FEV₁ < 50% predicted, or frequent exacerbations (dose 200/25 µg once daily).

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Contraindications

• Contraindicated
• Immediate use for acute bronchospasm, exacerbation, or asthma attack (emergency inhaler required).
• Known hypersensitivity to fluticasone furoate, vilanterol, or any excipients.
• Warnings
• Systemic corticosteroid effects: adrenal suppression (especially with > 6 months use), bone loss, cataracts, glucose intolerance.
• Infection risk: pneumonia, tuberculosis, viral infections (e.g., cold, flu).
• Drug interactions: potent CYP3A4 or CYP2B6 inhibitors may raise systemic exposure.
• Use with caution in patients with uncontrolled infections, severe asthma attack, pregnancy (Category C), lactation (limited data but excretion in milk is minimal).

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Dosing

• Inhalation Technique
• Anchor hand on the inhaler; perform a slow, deep inhalation; hold breath 5 s; exhale slowly.
• No need for spacer or breath hold device.

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Monitoring

• Pulmonary Function (FEV₁, peak expiratory flow) every 3–6 months or at exacerbation.
• Lung Symptoms – diary or online tool to record rescue inhaler use.
• Bone Mineral Density – baseline and 2 yr for ≥ 2 yr therapy in elderly/osteoporotic patients.
• Blood Glucose – baseline and periodically for diabetics or at risk.
• Adrenal Function – cortisol level if systemic symptoms or prolonged use > 6 mo.
• Oral Health – oral hygiene instructions and check for candidiasis.

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Clinical Pearls

1. Minimal Technique Errors – Ellipta’s breath‑actuated design results in fewer inhalation technique failures versus metered‑dose inhalers, improving adherence.
2. Switch‑over Protocols – When transitioning a patient from a high‑dose oral corticosteroid to Breo Ellipta, taper the systemic steroid over 4–6 weeks to avoid adrenal crisis.
3. Dose‑Response in COPD – In COPD patients > 50 % predicted FEV₁, the higher 200 µg F / 25 µg V dose provides greater exacerbation reduction; consider stepping down if well‑controlled.
4. Drug Interaction Check – Review concurrent medications for potent CYP3A4 or CYP2B6 inhibitors (e.g., ketoconazole, ritonavir) and counsel patients to monitor for symptoms of adrenal suppression.
5. Oral Candidiasis Prevention – Encourage rinsing mouth with water or a non‑irritant mouthwash after inhalation; consider prophylactic clotrimazole inhalation in patients with a history of thrush.
6. Contra‑Indication in Acute Exacerbations – Do not use Breo Ellipta as a rescue inhaler; prescribe short‑acting β₂‑agonists for acute episodes.
7. Pregnancy and Lactation – Limited data; consider alternative inhaled corticosteroids if the patient is pregnant or breastfeeding, weighing risks vs. benefits.

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