Arnuity Ellipta

What it is

ARNUITY ELLIPTA is a powder for inhalation delivered via a light grey inhaler with a beige mouthpiece cover and a dose counter. It contains fluticasone furoate as its active ingredient, available in strengths of 100 micrograms or 200 micrograms per dose.

Approved indications

— Maintenance treatment of asthma in adult patients who are not adequately controlled with a combination of inhaled corticosteroid and a long-acting beta2-agonist.

Dosing overview

For asthma, the recommended dose is one inhalation of ARNUITY ELLIPTA 100 micrograms once daily or one inhalation of ARNUITY ELLIPTA 200 micrograms once daily. The 100 microgram strength should be considered for patients who require a low to mid dose of inhaled corticosteroid. The 200 microgram strength should be considered for patients who require a higher dose of inhaled corticosteroid. If patients are inadequately controlled on the 100 microgram dose, the dose may be increased to 200 micrograms, which may provide additional improvement in asthma control. ARNUITY ELLIPTA should be administered once daily, either morning or evening, but at the same time each day. After inhalation, the patient should rinse their mouth with water without swallowing.

Key safety warnings

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. Systemic corticosteroid effects may occur with inhaled corticosteroids, particularly at high doses prescribed for long periods, though these are much less likely than with oral corticosteroids; possible effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, and psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Ocular effects may be reported with corticosteroid use; patients presenting with vision changes should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or central serous chorioretinopathy. Inhaled corticosteroids should be used with caution in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Contraindications

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

PBS listing

ARNUITY ELLIPTA is listed on the PBS in strengths of 100 micrograms and 200 micrograms per dose, each containing 30 doses, with an ex-manufacturer price of A$14.87 for the 100 microgram strength and A$27.36 for the 200 microgram strength.

Regulatory history

ARNUITY ELLIPTA fluticasone furoate 100 microgram and 200 microgram powder for inhalation were first listed on the ARTG on 11 September 2015. In November 2015, the PBAC recommended ARNUITY ELLIPTA for asthma on an unrestricted benefit listing on a cost-minimisation basis to fluticasone propionate, with equi-effective doses of fluticasone furoate 100 microgram once daily equivalent to fluticasone propionate 250 microgram twice daily, and fluticasone furoate 200 microgram once daily equivalent to fluticasone propionate 500 microgram twice daily. A 50 microgram strength was first listed on the ARTG on 14 March 2019. In July 2019, the PBAC recommended the new 50 microgram strength for asthma on an unrestricted benefit listing on a cost-minimisation basis to fluticasone propionate 100 micrograms twice daily. In July 2021, the PBAC rescinded its asthma recommendation.