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Indication

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.

Important Safety Information

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.

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 further information, please see the Pulmozyme full Prescribing Information.

Pediatric Use

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.

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Patient Under 5 Years Old

Taking Pulmozyme

There is limited experience with the administration of Pulmozyme in patients under five, so its use should be considered only for those patients in whom there is a potential for benefit in lung function or in risk of respiratory tract infections.

To learn more about the safety of Pulmozyme in pediatric patients, one study assessed its use in two age groups: younger patients (three months to less than five years of age) and older patients (five years to less than 10 years of age).

  • In this study, side effects were generally similar in both age groups.
  • There were more reports of cough, moderate to severe cough, runny nose, and rash in the younger group of patients.
  • The kind of side effects reported was similar to that of Pulmozyme when used in larger trials that studied older patients.

Trials or studies demonstrating efficacy in Pulmozyme in patients <5 have not been conducted.

Data in studies conducted in the adult setting cannot be extrapolated to patients <5.

Your CF Care Team is the best source of information about CF and Pulmozyme. Talk to your doctor if you have questions or to see if Pulmozyme is right for your child.