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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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Pulmozyme Access Solutions®

Safety Information

Contraindications

Pulmozyme should not be used in patients who are allergic to any of its ingredients. Pulmozyme should be used in conjunction with standard therapies for CF.

Adverse Reactions

When starting Pulmozyme therapy, patients may experience change in or loss of voice, discomfort in the throat, chest pain, red watery eyes, rash, dizziness, fever, or runny nose. These side effects are usually mild and short-lived.

Pediatric Use

There is a limited amount of information available concerning the usage of Pulmozyme in patients who are younger than 5 years. The decision to use Pulmozyme in these patients is made after considering the potential for a benefit in lung function or in decreasing the risk of RTEs.

Important Safety Considerations

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. There were more reports of cough, moderate to severe cough, runny nose, and rash in the younger group of patients. Other reported events tended to be of mild to moderate severity. The kind of side effects reported was similar to that of Pulmozyme when used in the larger trials that studied older patients.

For further information, please see the Pulmozyme full prescribing information. If you have questions, please discuss them with your CF healthcare team.