PULMOZYME Nebuliser solution Ref.[8459] Active ingredients: Dornase alfa

Traceability of PULMOZYME

In order to improve the traceability of Pulmozyme the trade name of the administered dornase alfa and the batch number should be clearly recorded in the patient file.

Pulmozyme can be effectively and safely used in conjunction with standard cystic fibrosis therapies such as antibiotics, bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, and analgesics.

Pregnancy

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 (see section 5.3). Caution should be exercised when prescribing dornase alfa to pregnant women.

Breastfeeding

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 (see section 5.3).

Pulmozyme 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 Pulmozyme at the recommended dose regimen.

Adverse reactions attributed to Pulmozyme are rare (<1/1000). In most cases, the adverse reactions are mild and transient in nature and do not require alterations in Pulmozyme 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 Pulmozyme as evidenced by the high percentage of patients completing clinical trials with Pulmozyme.

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

Pulmozyme is an unbuffered aqueous solution and should not be diluted or mixed with other drugs or solutions in the nebuliser bowl. Mixing of this solution could lead to adverse structural and/or functional changes in Pulmozyme or the admixed compound.