TRELEGY ELLIPTA

What it is

TRELEGY ELLIPTA is a powder for inhalation containing fluticasone furoate, umeclidinium (as bromide), and vilanterol (as trifenatate). It is presented as white powder in a light grey inhaler with a beige mouthpiece cover and a dose counter. The medicine combines three classes of medication: an inhaled corticosteroid (fluticasone furoate), a long-acting muscarinic receptor antagonist or LAMA (umeclidinium), and a selective long-acting beta 2-receptor agonist or LABA (vilanterol).

Approved indications

— Maintenance treatment of asthma in adult patients who are not adequately controlled with a combination of inhaled corticosteroid and a long-acting beta 2-agonist. — Maintenance treatment of adults with moderate to severe COPD who require treatment with LAMA+LABA+ICS.

Dosing overview

TRELEGY ELLIPTA should be administered once daily, either morning or evening, but at the same time each day. TRELEGY ELLIPTA 100/62.5/25 micrograms should be considered for patients who require a low to mid dose of ICS in combination with a LAMA and a LABA. TRELEGY ELLIPTA 200/62.5/25 micrograms should be considered for patients who require a higher dose of ICS in combination with a LAMA and a LABA.

Key safety warnings

Pneumonia is a known risk in patients with COPD, and pneumonia events including those requiring hospitalisation have been observed in patients with COPD receiving fluticasone furoate/umeclidinium/vilanterol. Fatal cases of pneumonia have been reported with use of inhaled corticosteroid-containing drugs. Risk factors for pneumonia in patients with COPD receiving inhaled corticosteroid-containing drugs include current smoking status, history of pneumonia, low body mass index and severe COPD. Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing and may be life-threatening; treatment should be discontinued immediately and alternative therapy instituted if necessary. Cardiovascular effects such as cardiac arrhythmias including atrial fibrillation and tachycardia may occur after administration of muscarinic receptor antagonists or sympathomimetic agents; TRELEGY ELLIPTA should be used with caution in patients with unstable or life-threatening cardiovascular disease. Systemic corticosteroid effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods, though these effects are much less likely than with oral corticosteroids; possible effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, and psychological or behavioural effects. Due to its antimuscarinic activity, TRELEGY ELLIPTA should be used with caution in patients with narrow-angle glaucoma or urinary retention.

Contraindications

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

PBS listing

Two strengths are registered on the ARTG: TRELEGY ELLIPTA 100/62.5/25 micrograms (first listed 16 January 2018) and TRELEGY ELLIPTA 200/62.5/25 micrograms (first listed 10 May 2021). PBAC recommended Authority Required (Streamlined) listing in December 2017 for treatment of patients with moderate to severe COPD. In November 2021, PBAC recommended listing for severe asthma.

Regulatory history

TRELEGY ELLIPTA 100/62.5/25 micrograms was first registered on the ARTG on 16 January 2018. In December 2017, PBAC recommended Authority Required (Streamlined) listing for the treatment of patients with moderate to severe COPD. TRELEGY ELLIPTA 200/62.5/25 micrograms was registered on the ARTG on 10 May 2021. In November 2021, PBAC recommended listing for severe asthma.