PULMOZYME

What it is

Pulmozyme is dornase alfa. Pulmozyme solution for inhalation contains 1.0 mg/mL dornase alfa. It is supplied as a clear, colourless to slightly yellowish nebuliser solution. Pulmozyme is an enzyme that cleaves extracellular DNA and reduces the viscosity of purulent lung secretions. The active ingredient is produced by genetically engineered Chinese hamster ovary cells containing DNA that encodes for the human protein, deoxyribonuclease I (DNase).

Approved indications

— Chronic administration of Pulmozyme is indicated for the management of demonstrated respiratory complications in cystic fibrosis.

Dosing overview

The recommended dose for use in most patients is one 2.5 mg single-use ampoule inhaled once per day using the recommended nebuliser. Patients over the age of 21 may benefit from twice daily dosing. Most patients gain optimal benefit from continued daily use of Pulmozyme. Patients should be instructed to take their medication every day. The complete contents of a single ampoule should be placed in the bowl of a jet nebuliser and used in conjunction with a source of compressed air (nominal flow rate 6–8 L/minute). Ultrasonic nebulisers may be unsuitable for delivery of Pulmozyme because they may inactivate Pulmozyme or have unacceptable aerosol delivery characteristics.

Key safety warnings

Upon initiation of Pulmozyme therapy, as with any aerosol, pulmonary function may decline and expectoration of sputum may increase. Events that increased in incidence in the double-blind, placebo-controlled trials increased with higher dose. The recommended dose should not be exceeded because of the dose-dependent occurrence of "irritant" side-effects with no additional efficacy. There have been no reports of serious allergic reactions or anaphylaxis associated with administration of dornase alfa. Less than 5% of patients treated with dornase alfa have developed antibodies to dornase alfa and none of these patients have developed IgE antibodies to dornase alfa. Improvement in pulmonary function tests have still occurred even after the development of antibodies to dornase alfa.

Contraindications

Pulmozyme is contraindicated in patients who develop or have known hypersensitivity to dornase alfa, Chinese hamster ovary cell products or any component of the product.

PBS listing

Pulmozyme 2.5 mg (2,500 units) solution for inhalation in 2.5 mL is listed on the PBS as 2 items with streamlined restriction at an ex-manufacturer price of A$745.49.

Regulatory history

Pulmozyme was first approved on 29 November 1994. ARTG registration 49822 for Pulmozyme dornase alfa 1 mg/mL spray solution ampoule was first listed 1994-11-29 under licence category RE.