Is Pulmozyme® (dornase alfa) Right for Me?
In a study of patients 5 years and older with forced vital capacity (FVC) greater than or equal to 40%:
Patients taking Pulmozyme daily showed fewer lung infections requiring IV antibiotics and an improvement in lung function compared with those not taking Pulmozyme
Individual results from Pulmozyme may vary.
A prospective, randomized, placebo-controlled study evaluated the effects of once-daily and twice-daily administration of Pulmozyme on exacerbations of respiratory symptoms requiring IV antibiotics, and on pulmonary function. The study assessed adults and children five years of age or older with CF who had baseline FVC greater than or equal to 40% of predicted and were receiving standard therapies for cystic fibrosis. A total of 968 patients were treated for 24 weeks as outpatients with placebo (325 patients), 2.5 mg of Pulmozyme once a day (322 patients), or 2.5 mg of Pulmozyme twice a day (321 patients).
Selected Important Safety Information
Pulmozyme should not be used in patients who are allergic to any of its ingredients. Please see the continued Important Safety Information below and see the Pulmozyme full Prescribing Information for additional Important Safety Information.
More than 80% of patients with CF are prescribed Pulmozyme each year.
Pulmozyme (dornase alfa) is indicated for daily administration along with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring injectable antibiotics.
Pulmozyme should not be used in patients who are allergic to any of its ingredients.
Patients may experience the following when using Pulmozyme: change in or loss of their voice, discomfort in the throat, rash, chest pain, red watery eyes, runny nose, lowering of lung function, fever, indigestion, and shortness of breath. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Mild to moderate hives and mild skin rash have been observed and have been short-lived.
The safety and effectiveness of Pulmozyme have been established in patients 5 years of age and older. While clinical trial data are limited in patients younger than 5 years of age, the use of Pulmozyme should be considered for pediatric CF patients who may experience potential benefit in lung function or who may be at risk of respiratory tract infection.
The safety of Pulmozyme given by daily inhalation for 2 weeks has been studied using 98 CF patients with 65 of them aged 3 months to <5 years (younger group) and 33 aged 5 years to <10 years (older group). The PARI BABY™ reusable nebulizer (which uses a face mask instead of a mouthpiece) was used in patients who were unable to show that they could breathe in or out using their mouth throughout the entire treatment period. Overall, the kind of side effects observed in children was similar to those seen in larger trials in older patients.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
For additional Important Safety Information, please click here for the Pulmozyme full Prescribing Information. If you have questions, please discuss them with your CF Care Team.