Dornase alfa Other names: Desoxyribonuclease Dornase alpha

The safety of dornase alfa has not been established in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, or embryofoetal development. Caution should be exercised when prescribing dornase alfa to pregnant women.

When dornase alfa is administered to humans according to the dosage recommendation, there is minimal systemic absorption; therefore no measurable concentrations of dornase alfa would be expected in human milk. Nevertheless, caution should be exercised when dornase alfa is administered to a breast-feeding woman.

Dornase alfa has no or negligible influence on the ability to drive and use machines.

The adverse event data reflect the clinical trial and post-marketing experience of using dornase alfa at the recommended dose regimen.

Adverse reactions attributed to dornase alfa are rare (<1/1000). In most cases, the adverse reactions are mild and transient in nature and do not require alterations in dornase alfa dosing.

Eye disorders: Conjunctivitis.

Respiratory, thoracic and mediastinal disorders: Dysphonia, dyspnea, pharyngitis, laryngitis, rhinitis (all non-infectious).

Gastrointestinal disorders: Dyspepsia.

Skin and subcutaneous tissue disorders: Rash, urticaria.

General disorders: Chest pain (pleuritic/non-cardiac), pyrexia.

Investigations: Pulmonary function tests decreased.

Patients who experience adverse events common to cystic fibrosis can, in general, safely continue administration of dornase alfa as evidenced by the high percentage of patients completing clinical trials with dornase alfa.

In clinical trials, few patients experienced adverse events resulting in permanent discontinuation from dornase alfa, and the discontinuation rate was observed to be similar between placebo (2%) and dornase alfa (3%).

Upon initiation of dornase alfa therapy, as with any aerosol, pulmonary function may decline and expectoration of sputum may increase.

Less than 5% of patients treated with dornase alfa have developed antibodies to dornase alpha and none of these patients have developed IgE antibodies to dornase alfa. Improvement in pulmonary function tests has still occurred even after the development of antibodies to dornase alfa.