Pulmozyme® (dornase alfa)

• Full Prescribing Information
• Material Safety Data Sheet

Indication

Daily administration of Pulmozyme 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

The most common adverse events reported include voice alteration, pharyngitis, laryngitis, rash, chest pain, and conjunctivitis. 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.

Pediatric Use

Because of the limited experience with the administration of Pulmozyme to patients younger than 5 years, its use should be considered only for those patients in whom there is a potential for benefit in pulmonary function or in risk of respiratory tract infection.

The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 patients with cystic fibrosis (65, aged 3 months to <5 years, 33, aged 5 to <10 years). The PARI BABY™ reusable nebulizer (which uses a face mask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger and 2/33, 6% of the older patients). The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45% compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37% as compared to 6/33, 18%). Other events tended to be of mild to moderate severity. The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35% compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33). The nature of adverse events was similar to that seen in the larger trials of Pulmozyme.

For additional safety information, please see the Pulmozyme full prescribing information at www.pulmozyme.com.