Pulmozyme Indication and Important Safety Information
Daily administration of Pulmozyme Inhalation Solution 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 12 months.
IMPORTANT SAFETY INFORMATION
- Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese hamster ovary cell products, or any component 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
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see full prescribing information for Pulmozyme, including additional Important Safety Information.