FOSTAIR

What it is

FOSTAIR is a pressurised inhalation containing beclometasone dipropionate and formoterol fumarate dihydrate. Two strengths are available: FOSTAIR 100/6, containing 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate per metered dose, and FOSTAIR 200/6, containing 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate per metered dose. The inhalation solution is contained in a pressurised aluminium container with a metering valve, inserted into a polypropylene plastic actuator with a mouthpiece and protective cap.

Approved indications

— Treatment of asthma in adults (18 years and older) where use of a combination product (inhaled corticosteroid and long-acting beta 2-agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta 2-agonist, or patients already adequately controlled on both inhaled corticosteroids and long-acting beta 2-agonists. — Symptomatic treatment of severe chronic obstructive pulmonary disease in adults (FOSTAIR 100/6 only) with FEV1 <50% predicted normal and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Dosing overview

**Asthma maintenance therapy** FOSTAIR 100/6: one or two inhalations twice daily with a maximum daily dose of four inhalations. The starting dose is one inhalation taken twice daily for patients inadequately controlled with an inhaled corticosteroid and short-acting beta-agonist or adequately controlled with an inhaled corticosteroid and long-acting beta-agonist. The dose should be increased to two inhalations taken twice daily if the patient's asthma is poorly controlled. FOSTAIR 200/6: two inhalations twice daily with a maximum daily dose of four inhalations, for maintenance therapy only. **Asthma maintenance and reliever therapy (FOSTAIR 100/6 only)** The recommended maintenance dose is one inhalation twice daily. Patients should take one additional inhalation as needed in response to symptoms, with an additional inhalation taken if symptoms persist after a few minutes. Patients should not take more than six inhalations on any single occasion, with a maximum daily dose of eight inhalations. **COPD (FOSTAIR 100/6 only)** Two inhalations twice daily.

Key safety warnings

FOSTAIR should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure, occlusive vascular diseases, particularly arteriosclerosis, arterial hypertension and aneurysm. Caution should be observed when treating patients with known or suspected prolongation of the QTc interval, as formoterol itself may induce prolongation of the QTc interval. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods, including Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, growth retardation in children and adolescents, cataract and glaucoma, and psychological or behavioural effects. It is important that patients are reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained. An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with chronic obstructive pulmonary disease receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies. Patients should be advised to rinse the mouth or gargle with water or brush the teeth after inhaling the prescribed dose to minimise the risk of oropharyngeal candida infection.

Contraindications

FOSTAIR is contraindicated in patients with hypersensitivity to beclometasone dipropionate, formoterol fumarate dihydrate or any of the excipients.

PBS listing

No source documents provided information about PBS listing status, item numbers, restriction types, or ex-manufacturer pricing for FOSTAIR.

Regulatory history

FOSTAIR 100/6 was first registered on the ARTG on 12 February 2020, and FOSTAIR 200/6 was first registered on 5 August 2022. The Pharmaceutical Benefits Scheme Advisory Committee recommended the product in November 2017 for maintenance treatment of asthma. A further recommendation for asthma maintenance treatment was issued in July 2020, and in July 2022 the product was recommended for asthma maintenance treatment in certain patients previously treated with oral corticosteroids or optimal doses of inhaled corticosteroids. In March 2024, PBAC rescinded a March 2022 recommendation for chronic obstructive pulmonary disease and recommended the product for asthma. An Australian Public Assessment Report was published on 20 January 2020.