Enerzair Breezhaler

What it is

Enerzair Breezhaler is an inhalation powder containing indacaterol, glycopyrronium, and mometasone furoate in hard capsules for oral inhalation. The medicine is a combination of indacaterol (a long-acting beta2-adrenergic agonist), glycopyrronium (a long-acting muscarinic receptor antagonist), and mometasone furoate (an inhaled synthetic corticosteroid). Enerzair Breezhaler capsules are supplied with an inhalation device to permit oral inhalation of the contents. Two strengths are available: 114/46/68 micrograms and 114/46/136 micrograms, representing the delivered doses of indacaterol, glycopyrronium, and mometasone furoate respectively.

Approved indications

— Maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Dosing overview

The recommended dose is inhalation of the content of one capsule of Enerzair Breezhaler 114/46/68 micrograms or 114/46/136 micrograms once daily. The maximum recommended dose is Enerzair Breezhaler 114/46/136 micrograms once daily. Patients should be prescribed Enerzair Breezhaler containing the appropriate dosage of mometasone furoate for the severity of their disease. The safety and efficacy of Enerzair Breezhaler in paediatric patients below 18 years of age have not been established.

Key safety warnings

Enerzair Breezhaler should not be used to treat acute asthma symptoms including acute episodes of bronchospasm, for which a short-acting bronchodilator is required. Immediate hypersensitivity reactions have been observed after administration of Enerzair Breezhaler, and if signs suggesting allergic reactions occur, including angioedema, urticaria, or skin rash, the medicine should be discontinued immediately. Administration of Enerzair Breezhaler may result in paradoxical bronchospasm, which can be life-threatening, and if this occurs, the medicine should be discontinued immediately. Like other beta2-adrenergic agonists, Enerzair Breezhaler may produce clinically significant cardiovascular effects including increases in pulse rate, blood pressure, and related symptoms, and treatment may need to be discontinued if such effects occur. Enerzair Breezhaler should be used with caution in patients with cardiovascular disorders, convulsive disorders, thyrotoxicosis, or those unusually responsive to beta2-adrenergic agonists. Long-acting beta2-adrenergic agonist-containing products such as Enerzair Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or who are being treated with medicines affecting the QT interval. Like other anticholinergic medicines, Enerzair Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention, and patients should be advised about signs and symptoms of acute narrow-angle glaucoma. Systemic effects may occur with inhaled corticosteroids at high doses prescribed for prolonged periods, and it is important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

Contraindications

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

Regulatory history

Enerzair Breezhaler 114/46/68 micrograms and 114/46/136 micrograms were first listed on the Australian Register of Therapeutic Goods on 20 October 2020.