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Indication Statement:

Daily administration of Pulmozyme (dornase alfa) 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

  • Pulmozyme should not be used in patients with known hypersensitivity to dornase alfa, or any ingredients of the product.
  • Pulmozyme should be used in conjunction with standard therapies for CF.
  • Most common reported adverse events associated with the use of Pulmozyme include: voice alteration, pharyngitis, laryngitis, rash, chest pain, and conjunctivitis.

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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.