Onbrez Breezhaler

What it is

Atectura Breezhaler is a combination of indacaterol, a long-acting beta 2-adrenergic agonist (LABA), and mometasone furoate, an inhaled synthetic corticosteroid (ICS). The product is supplied as powder for inhalation in hard capsules. Three strengths are available: 125/62.5 micrograms, 125/127.5 micrograms, and 125/260 micrograms delivered dose. The capsules are supplied with an Atectura Breezhaler inhalation device to permit oral inhalation of the contents of the capsule shell.

Approved indications —

Asthma in adults and adolescents 12 years of age and older in patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta 2-agonists — Asthma in adults and adolescents 12 years of age and older in patients not adequately controlled with long-acting beta 2-agonists and low dose of inhaled corticosteroids and "as needed" inhaled short-acting beta 2-agonists

Dosing overview

The maximum recommended dose is Atectura Breezhaler 125/260 micrograms once daily. Regular daily use is necessary to maintain control of asthma symptoms and use should be continued even when asymptomatic. No dose adjustment is required in patients with renal impairment or in elderly patients 65 years of age or older. The safety and efficacy of Atectura Breezhaler in paediatric patients below 12 years of age have not been established.

Key safety warnings

Atectura Breezhaler should not be used to treat acute asthma symptoms including acute episodes of bronchospasm, for which a short-acting bronchodilator is required. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician. Immediate hypersensitivity reactions have been observed after administration of Atectura Breezhaler. If signs suggesting allergic reactions occur, in particular angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria, or skin rash, Atectura Breezhaler should be discontinued immediately and alternative therapy instituted. Administration of Atectura Breezhaler may result in paradoxical bronchospasm which can be life-threatening. If paradoxical bronchospasm occurs, Atectura Breezhaler should be discontinued immediately and alternative therapy instituted. Like other medicinal products containing beta 2-adrenergic agonists, Atectura Breezhaler may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. If such effects occur, treatment may need to be discontinued. Atectura Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta 2-adrenergic agonists. Long acting beta 2-adrenergic agonists (LABA) or LABA containing combination products such as Atectura Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or who are being treated with medicinal products affecting the QT interval. Systemic effects may occur with inhaled corticosteroids, particularly at high doses prescribed for prolonged periods. Possible systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataracts, glaucoma, and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. It is therefore important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

Contraindications

Atectura Breezhaler is contraindicated in patients with hypersensitivity to any of the active substances or excipients.

PBS listing

Two PBS items are listed for each strength: 150 micrograms and 300 micrograms capsules for oral inhalation. The restriction type is restricted, with an ex-manufacturer price of A$42.70 per item.

Regulatory history

The product was initially approved on 2 July 2010 as Onbrez Breezhaler, a long-acting β2-agonist indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease. ARTG registrations for Onbrez Breezhaler were first listed on 3 August 2010. The medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.