SPIRIVA

What it is

Tiotropium is a long-acting, specific antimuscarinic (anticholinergic) agent. Tiotropium is topically (broncho-) selective when administered by inhalation, with high potency and slow receptor dissociation associated with significant and long-acting bronchodilation in patients with chronic obstructive pulmonary disease (COPD). SPIRIVA is available as tiotropium 18 micrograms powder for inhalation (in capsule) and as tiotropium 2.5 micrograms per actuation solution for inhalation.

Approved indications

— Long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). — Prevention of COPD exacerbations. — Severe uncontrolled asthma (as add-on therapy). — Severe asthma in children and adolescents aged 6 to 17 years.

Dosing overview

The recommended dosage of SPIRIVA is inhalation once daily, with a delivered dose of 10 micrograms of tiotropium per capsule.

Key safety warnings

Tiotropium, as a once-daily maintenance bronchodilator, should not be used for the treatment of acute episodes of bronchospasm (rescue therapy). Immediate hypersensitivity reactions may occur after administration of tiotropium. As with other anticholinergic drugs, tiotropium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Tiotropium was associated with a non-significant increase in the risk of urinary retention and a significant increase in the risk of micturition difficulties. Tiotropium should be used with caution in patients with recent myocardial infarction less than 6 months, any unstable or life-threatening cardiac arrhythmia requiring intervention or a change in drug therapy in the past year, or hospitalisation for heart failure (NYHA Class III or IV) within the past year, as these patients were excluded from clinical trials and these conditions may be affected by the anticholinergic mechanism of action. Care must be taken not to allow the powder or spray to enter the eyes, as eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma, and specialist advice should be sought immediately if any combination of these symptoms develops. Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.

Contraindications

SPIRIVA is contraindicated in patients with a history of hypersensitivity to tiotropium bromide, atropine or its derivatives (such as ipratropium or oxitropium), or to any other component of the product.

PBS listing

SPIRIVA capsule containing powder for oral inhalation 18 micrograms is listed on the PBS with 2 items under a restricted arrangement, with an ex-manufacturer price of A$28.82. SPIRIVA solution for oral inhalation 2.5 micrograms per actuation (60 actuations) is listed with 3 PBS items under a restricted streamlined arrangement, with an ex-manufacturer price of A$57.64 for the pack of 2 cartridges. An additional 6 PBS items are available for the 2.5 micrograms solution (60 actuations) as a single pack under restricted streamlined listing at A$28.82.

Regulatory history

SPIRIVA tiotropium 18 micrograms powder for inhalation was first listed on the ARTG on 30 May 2002. In March 2016, the PBAC recommended restricted benefit listing of tiotropium as add-on therapy for severe uncontrolled asthma. In August 2017, the PBAC accepted the key findings presented in a review report on COPD medicines and recommended changes to PBS restrictions for COPD treatments. In November 2018, the PBAC recommended authority required streamlined listing for severe asthma in children and adolescents aged 6 to 17 years. SPIRIVA RESPIMAT solution for inhalation was first listed on the ARTG on 4 March 2020. In November 2024, the PBAC recommended general schedule authority required streamlined listing of a new pack size of 2 cartridges × 60 actuations.