Adverse reactions : תופעות לוואי

4.8    Undesirable effects

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. Any suspected adverse events should be reported to the Ministry of Health according to the national regulation by using the form https://sideeffects.health.gov.il.