BRONCHITOL

What it is

Bronchitol contains 40 mg of mannitol. It is a powder for inhalation in hard capsules. Bronchitol contains mannitol that has been spray dried to achieve a respirable form and is delivered by use of a specific inhaler device. The inhalation of mannitol is intended to improve lung hygiene by correcting the impaired mucociliary clearance that is characteristic of cystic fibrosis. While the exact mechanism of action is unknown, inhaled mannitol may change the viscoelastic properties of mucus, increase the hydration of the periciliary fluid layer and contribute to increased mucociliary and cough clearance of the retained secretions.

Approved indications —

Cystic fibrosis in paediatric and adult populations six years and above as either an add-on therapy to dornase alfa or in patients intolerant to, or inadequately responsive to dornase alfa.

Dosing overview

The recommended dosage of Bronchitol is 400 mg twice a day, which requires the inhalation of the contents of 10 x 40 mg capsules via the inhaler device, twice a day. The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime. A bronchodilator must be administered 5-15 minutes before Bronchitol is used.

Key safety warnings

Haemoptysis has been commonly reported with Bronchitol in clinical studies in cystic fibrosis. Bronchitol has not been studied in patients with a history of significant episodes of haemoptysis greater than 60 mL in the previous 3 months. As a consequence, these patients should be carefully monitored, and Bronchitol should be withheld in the event of massive haemoptysis. A massive or serious haemoptysis is considered to be acute bleeding of 240 mL or more in a 24-hour period or recurrent bleeding of 100 mL per day over several days. The efficacy and safety of Bronchitol in patients with asthma has not been formally studied. Patients with asthma must be carefully monitored for worsening signs and symptoms of asthma after the initiation dose of Bronchitol. Bronchitol may cause bronchoconstriction or bronchospasm requiring treatment, even in patients who were not hyperresponsive to the initiation dose of inhaled mannitol. Bronchospasm should be treated with a bronchodilator or as medically appropriate. All patients should be formally reviewed after approximately six weeks of Bronchitol treatment to assess for signs and symptoms suggestive of drug induced bronchospasm. Cough was commonly reported with use of Bronchitol in clinical studies. Productive cough may be a beneficial component of mucus clearance. Patients should be trained to practice correct inhaler technique during treatment and advised to report persistent cough with the use of Bronchitol to their physician.

Contraindications

Hypersensitivity to mannitol or to any of the capsule ingredients. Bronchial hyperresponsiveness to inhaled mannitol.

PBS listing

A pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers is listed on the PBS with 2 PBS items under streamlined restriction at an ex-manufacturer price of A$447.30.

Regulatory history

Bronchitol was approved on 7 February 2011 for the treatment of cystic fibrosis in patients aged six years and above. In July 2017, the PBAC recommended a change to allow for PBS-subsidised use in combination with PBS-subsidised dornase alfa in patients who are inadequately responsive to monotherapy with dornase alfa.