Indication Statement:

Daily administration of Pulmozyme (dornase alfa) in conjunction with standard therapies is indicated in the management of cystic fibrosis (CF) patients to improve pulmonary function. In patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics. Safety and efficacy of daily administration have not been demonstrated in patients for longer than twelve months.

Important Safety Information

• Pulmozyme should not be used in patients with known hypersensitivity to dornase alfa, or any ingredients of the product.
• Pulmozyme should be used in conjunction with standard therapies for CF.
• Most common reported adverse events associated with the use of Pulmozyme include: voice alteration, pharyngitis, laryngitis, rash, chest pain, and conjunctivitis.