Product Dossier
BRALTUS
Product Dossier for BRALTUS (["tiotropium bromide","tiotropium"], Teva Pharma). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Teva Pharma
- Active ingredient: ["tiotropium bromide","tiotropium"]
- Therapeutic area: Respiratory
- Same area: NUCALA
- Same area: VENTOLIN
What it is
Braltus is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). Braltus contains tiotropium (as bromide monohydrate) and is a soft mist inhaler delivering a solution for inhalation, with a delivered dose of 2.5 microgram tiotropium per puff (2 puffs comprise one medicinal dose).
Approved indications
— Long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). — Prevention of COPD exacerbations.
Dosing overview
The recommended dose for adults is 5 microgram tiotropium given as two puffs from the BRALTUS inhaler once daily, at the same time of the day.
Key safety warnings
Braltus should not be used in the treatment of asthma as the efficacy and safety have not been studied in this indication. Braltus is not indicated for the treatment of acute episodes of bronchospasm, that is, as rescue therapy. As with other inhaled medicines, Braltus may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, Braltus should be discontinued immediately and alternative therapy substituted. Consistent with the anticholinergic activity of tiotropium, Braltus should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. In a meta-analysis of placebo-controlled trials, tiotropium was associated with a significant increase in the risk of micturition difficulties. Patients must be instructed in the correct administration of Braltus. Care must be taken not to allow the solution or mist to enter into the eyes. Braltus contains a long acting beta 2-adrenergic agonist. LABAs should be administered with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy and hypertension; in patients with convulsive disorders or thyrotoxicosis, in patients with known or suspected prolongation of the QT interval; and in patients who are unusually responsive to sympathomimetic amines.
Contraindications
Braltus is contraindicated in patients with hypersensitivity to tiotropium or to any of the excipients. Braltus is also contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, for example ipratropium or oxitropium.
Regulatory history
The TGA approved Braltus for registration on 31 October 2018, with its entry onto the ARTG on 15 November 2018. In November 2017, the PBAC recommended an amendment to allow tiotropium bromide to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.