Breo Ellipta

What it is

BREO ELLIPTA is a powder for inhalation containing fluticasone furoate and vilanterol trifenatate. The medicine is presented as white powder in a light grey inhaler with a pale blue mouthpiece cover and a dose counter. Two strengths are available: the 100/25 microgram strength delivers 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol per dose, and the 200/25 microgram strength delivers 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol per dose. Vilanterol is a selective long-acting beta 2-adrenergic agonist (LABA). Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. BREO ELLIPTA contains lactose monohydrate, which contains milk protein.

Approved indications

— Symptomatic treatment of patients with COPD with a FEV₁ <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite regular bronchodilator therapy. — Regular treatment of moderate to severe asthma in patients who require a medium to high dose inhaled corticosteroid combined with a long-acting beta 2-agonist.

Dosing overview

BREO ELLIPTA should be administered once daily either morning or evening but at the same time every day. After inhalation, the patient should rinse their mouth with water without swallowing. BREO ELLIPTA should not be used in children younger than 12 years of age.

Key safety warnings

Limited post-marketing data are available for vilanterol; however, post-marketing data for other LABAs show that LABAs can be associated with an increased risk of asthma death, which is considered a class effect of all LABAs. BREO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA. Patients using BREO ELLIPTA should not use another medicine containing a LABA for any reason. An increase in pneumonia has been observed in patients with COPD receiving fluticasone furoate/vilanterol, with an increased incidence of pneumonias resulting in hospitalisation, and in some incidences these pneumonia events were fatal. Risk factors for pneumonia in patients with COPD receiving fluticasone furoate/vilanterol include current smokers, patients with a history of prior pneumonia, patients with a body mass index <25 kg/m² and patients with a FEV₁ <50% predicted. Medium to high doses of inhaled corticosteroids may cause systemic effects, including growth retardation in adolescents. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). BREO ELLIPTA should not be used to treat acute asthma symptoms or an acute exacerbation in COPD, for which a short-acting bronchodilator is required.

Contraindications

BREO ELLIPTA is contraindicated in patients with severe milk-protein allergy or who have demonstrated hypersensitivity to either fluticasone furoate, vilanterol or any of the excipients.

PBS listing

BREO ELLIPTA 50 micrograms per dose is listed on the PBS on an unrestricted basis as a cost-minimisation listing to fluticasone propionate 100 micrograms twice daily (July 2019 PBAC recommendation).

Regulatory history

BREO ELLIPTA fluticasone furoate 100 microgram/vilanterol 25 microgram and BREO ELLIPTA fluticasone furoate 200 microgram/vilanterol 25 microgram powder for inhalation were first registered on the ARTG on 17 April 2014. In March 2017, the PBAC considered that fluticasone furoate and propionate esters are different drugs for section 85(2) purposes.