Breo™ Ellipta® (fluticasone furoate and vilanterol trifenatate) is a combined inhaled corticosteroid (ICS) and selective long-acting beta2-adrenergic agonist bronchodilator (LABA) administered once daily using the new Ellipta® pre-loaded dry powder inhaler (DPI).
Approved indications are for the treatment of patients aged 12 years and older with moderate to severe asthma (200/25 microgram strength) or chronic obstructive pulmonary disease (COPD) (100/25 microgram and 200/25 microgram strengths).
Changes in forced expiratory volume (FEV1) are similar to twice daily fluticasone propionate and salmeterol (Seretide®); however, one COPD study demonstrated significantly improved 24 hour weighted mean FEV1 at 12 weeks.
Breo™ Ellipta® is recommended for inclusion as a restricted benefit on the Pharmaceutical Benefits Scheme for asthma patients, given similar benefit to other ICS/LABA combinations. However, while once daily dosing is more convenient; concerns have been raised with regard to adverse cardiovascular effects with very long acting LABAs and limited long-term safety data for fluticasone furoate and vilanterol trifenatate.
The National Prescribing Service supports the use of ICS/LABA combination products, compared with LABA alone (which is no more effective than placebo in asthma flare-up prevention).
Please review full product information before prescribing.
- Breo™ Ellipta® (fluticasone furoate and vilanterol trifenatate) Australian approved product information. Abbotsford: GlaxoSmithKline Pty Ltd. Approved 17 April 2014, amended 9 July 2014.
- Breo™ Ellipta® (fluticasone furoate and vilanterol trifenatate) Australian approved consumer medicine information. Abbotsford: GlaxoSmithKline Pty Ltd. Approved 17 April 2014.
- GlaxoSmithKline Pty Ltd. Breo™ Ellipta® (fluticasone furoate/vilanterol trifenatate) approved in Australia for Asthma and COPD. Abbotsford: GlaxoSmithKline Pty Ltd; 2014.
- National Prescribing Service (NPS). Combination inhalers for asthma treatment. Surry Hills, NSW: NPS; 2014.
- Pharmaceutical Benefits Advisory Committee. Public Summary Document – Fluticasone Furoate and Vilanterol Trifenatate (Breo™ Ellipta®, GlaxoSmithKline Australia Pty Ltd). Canberra: PBS; 2014.
- Pharmaceutical Benefits Advisory Committee. Recommendations made by the PBAC – March 2014. Canberra: PBS; 2014.
- Pharmaceutical Society of Australia. Breo™ Ellipta®. Aust Pharm 2014;33(6):78.