BRETARIS

What it is

BRETARIS contains aclidinium bromide. BRETARIS GENUAIR 322 micrograms inhalation powder consists of an adhesive mixture of micronised aclidinium bromide and α-lactose monohydrate, contained in a device-metered, dry powder inhaler. Aclidinium bromide is a competitive muscarinic receptor antagonist (also known as an anticholinergic), with subnanomolar affinity for all five human muscarinic receptor subtypes. Inhaled aclidinium bromide acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation.

Approved indications

— Long-term maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Dosing overview

The recommended dose is one inhalation of BRETARIS GENUAIR twice daily, once in the morning and once at night. BRETARIS GENUAIR should be administered in the morning and at night and should be taken 12 hours apart.

Key safety warnings

BRETARIS GENUAIR should not be used for the treatment of asthma; clinical trials of aclidinium bromide in asthma have not been conducted. As with other inhalation therapies, administration of BRETARIS GENUAIR may cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, treatment with BRETARIS GENUAIR should be discontinued immediately and alternative therapy instituted. Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, i.e. as a rescue therapy. In the event of a change in COPD intensity while the patient is being treated with BRETARIS GENUAIR so that the patient considers additional rescue medication is required, medical advice and a re-evaluation of the patient and the patient's treatment regimen should be conducted. BRETARIS GENUAIR should be used with caution in patients with a myocardial infarction during the previous 6 months, unstable angina, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the "New York Heart Association". Cardiac arrhythmias, including atrial fibrillation and paroxysmal tachycardia were seen after the administration of BRETARIS GENUAIR. Therefore, BRETARIS GENUAIR should be used with caution in patients with cardiac arrhythmias, a history of cardiac arrhythmias or with risk factors for cardiac arrhythmias. Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries. Consistent with its anticholinergic activity, BRETARIS GENUAIR should be used with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma.

Contraindications

BRETARIS GENUAIR is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, including ipratropium, oxitropium or tiotropium or to any other component of this product. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Regulatory history

BRETARIS GENUAIR was first approved on 25 March 2014. ARTG 206071 registers BRETARIS GENUAIR aclidinium (as bromide) 322 micrograms powder for inhalation inhaler, first listed 2014-03-25. In August 2017, the PBAC recommended changes to the PBS listing in relation to the Review Report on COPD medicines. The Committee recommended increasing the PBS restriction level to Authority Required (Streamlined) for ICS/LABA inhalers with dual listings, removing the current PBS requirement in LAMA/LABA restrictions to stabilise patients on individual monotherapy inhalers before commencing fixed-dose combination, and adding PBS restriction notes to check inhaler device technique and confirm COPD diagnosis with spirometry.