dornase alfa: clinical use

Prescribing considerations

• Confirm that licensed age and lung-function criteria are met.
• Continue comprehensive cystic fibrosis care, including airway clearance.
• Record the product name and batch number for biological-medicine traceability.
• Expect possible increased expectoration or a temporary decline in pulmonary function after initiation.
• Use only a suitable nebuliser system; ultrasonic nebulisers may inactivate the protein or deliver it inadequately.

Contraindications and cautions

• Hypersensitivity to dornase alfa or any excipient.
• Efficacy and safety are not established below 5 years of age or when forced vital capacity is below 40% predicted; specialist assessment is required.

Monitoring

• Assess symptoms, sputum clearance, pulmonary function and respiratory exacerbations.
• Review adherence, inhalation technique and nebuliser maintenance.
• Review troublesome respiratory symptoms, rash, urticaria or other suspected adverse reactions.

Clinical pharmacology

Dornase alfa is recombinant human deoxyribonuclease I. It hydrolyses extracellular DNA in purulent airway secretions, reducing sputum viscoelasticity. Inhaled treatment produces low systemic exposure and is expected to be metabolised by proteases.

Formulation and product differences

• The product is a clear, colourless to slightly yellow, unbuffered nebuliser solution in a single-use ampoule.
• It contains sodium chloride, calcium chloride dihydrate and water for injections.
• It must be used undiluted and not mixed with other medicines or solutions in the nebuliser.
• Compatible jet systems and the eFlow Rapid system are described in the product information; ultrasonic nebulisers may be unsuitable.