Pulmozyme (dornase alfa)

A change in labeling has been approved for Pulmozyme Inhalation Solution, an aerosol treatment for cystic fibrosis (CF). Children under five may now be administered Pulmozyme. Pulmozyme had been previously approved by the FDA for use in CF patients five years or older.

Adverse events in the under five patient population included voice alteration, pharyngitis, laryngitis, rash, chest pain, and conjunctivitis. Cough, including moderate to severe cough, rhinitis, and rash were reported more frequently in these very young CF patients compared to older children.