PULMICORT

What it is

BiResp Spiromax is a dry powder inhaler containing budesonide and formoterol (eformoterol) fumarate dihydrate. It is a multidose inspiratory flow driven, metered dose dry powder inhaler. The 200/6 strength delivers 160 micrograms of budesonide and 4.5 micrograms of formoterol per inhalation, while the 400/12 strength delivers 320 micrograms of budesonide and 9 micrograms of formoterol per inhalation.

Approved indications

— Treatment of asthma in adults 18 years and older, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations. — Symptomatic treatment of moderate to severe chronic obstructive pulmonary disease in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations.

Dosing overview

BiResp Spiromax is indicated in adults 18 years and older only, as the 100/6 dose is not available. For asthma, in patients using anti-inflammatory reliever therapy, patients take 1 inhalation of the 200/6 strength as needed in response to symptoms, with an additional inhalation if symptoms persist after a few minutes. No more than 6 inhalations should be taken on any single occasion, and a total daily dose of more than 8 inhalations is normally not needed, though up to 12 inhalations can be used temporarily. For maintenance therapy in asthma, the recommended dose is 1–2 inhalations of the 200/6 strength twice daily, with a maximum daily maintenance dose of 4 inhalations corresponding to 800 micrograms budesonide and 24 micrograms formoterol. For adults requiring a higher daily dose, 2 inhalations of the 400/12 strength twice daily can be used, with a maximum daily dose of 4 inhalations corresponding to 1600 micrograms budesonide and 48 micrograms formoterol. For COPD, the recommended dose is 2 inhalations of the 200/6 strength twice daily, with a maximum daily dose of 4 inhalations corresponding to 800 micrograms budesonide and 24 micrograms formoterol. Alternatively, 1 inhalation of the 400/12 strength twice daily can be used, with a maximum daily dose of 2 inhalations corresponding to 800 micrograms budesonide and 24 micrograms formoterol.

Key safety warnings

At higher than recommended doses, inhaled corticosteroids may have adverse effects including Cushing's syndrome, Cushingoid features, depression of the HPA axis, reduction of bone density, cataract, glaucoma and blurred vision, and retardation of growth rate in children and adolescents. Very rare cases of clinically relevant adrenal dysfunction have been reported in patients using inhaled budesonide at recommended doses. Clinically important disturbances of the HPA axis and adrenal insufficiency induced by severe stress may be related to inhaled budesonide in patients with prolonged treatment at the highest recommended dose or in those administered concomitant CYP3A4 inhibitors. Monitoring for signs of adrenal dysfunction is advisable in these patient groups. An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk with increasing steroid dose but this has not been demonstrated conclusively across all studies. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Caution is advised when formoterol is administered to patients with severe cardiovascular disorders such as ischaemic heart disease, tachyarrhythmias, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or severe heart failure. High doses of beta-2 agonists can lower serum potassium by inducing a redistribution from the extracellular to the intracellular compartment, potentially resulting in serious hypokalaemia. Particular caution is advised in acute exacerbation as the associated risk may be augmented by hypoxia. Paradoxical bronchospasm may occur in very rare cases, with an immediate increase in wheezing and shortness of breath after dosing.

Contraindications

BiResp Spiromax is contraindicated in patients with hypersensitivity to budesonide, formoterol or lactose.

PBS listing

BiResp Spiromax powder for oral inhalation 200 micrograms per dose in a 200-dose breath actuated device is listed on the PBS with 2 items, restriction type restricted and unrestricted, at an ex-manufacturer price of A$15.51. The 100 microgram strength (200 doses) has an ex-manufacturer price of A$8.65 with restricted and unrestricted restrictions. The 400 microgram strength (200 doses) has an ex-manufacturer price of A$20.53 with unrestricted and restricted restrictions.

Regulatory history

PULMICORT TURBUHALER dry powder inhalers containing budesonide (100, 200 and 400 microgram strengths) were first listed on the ARTG on 31 July 1991. In November 2017, the PBAC recommended an amendment to the PBS listing to allow budesonide and formoterol to be used as a maintenance and reliever therapy for asthma in adult and adolescent patients.