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Indication and Usage

Daily administration of Pulmozyme® (dornase alfa) Inhalation Solution along with standard therapies is indicated in the management of cystic fibrosis patients to improve lung function. In patients with a forced vital capacity (volume of air exhaled with maximum effort and speed) greater than or equal to 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring the administration of injectable antibiotics.

In our pivotal study, safety and efficacy of daily administration has not been studied in patients beyond 12 months.

Important Safety Information

  • Pulmozyme should not be used in patients who are allergic to any of its ingredients. Pulmozyme should be used along with standard therapies for cystic fibrosis.
  • When starting Pulmozyme therapy, patients may experience change in or loss of their 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.

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

Pediatric Use

Because of the limited experience with the administration of Pulmozyme to patients younger than 5 years of age, 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.

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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.