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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.

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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Patients Under 5 Years Old

Prescribing Pulmozyme

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 benefit for:

  • Pulmonary function
  • Relative risk of respiratory tract infection (Ref. 1)

Adverse events in patients under 5

In patients under 5 years of age, only the safety profile of Pulmozyme has been studied.

In a clinical study, Pulmozyme, 2.5 mg by inhalation daily, was administered over 2 weeks to 98 patients with CF (65 patients aged 3 months to <5 years, 33 patients aged 5 to ≤10 years). (Ref. 2)

  Younger age group Older age group
Cough 45% 30%
Moderate to severe cough 37% 18%
Rhinitis 35% 27%
Rash 6% 0%

  • Reports of coughs, rhinitis and rash were more frequent in the younger age group vs the older age group; other events were of mild to moderate severity.
  • The frequency of adverse events was higher in the younger age group as compared to the older group.
  • The nature of adverse events was similar to that seen in the larger trials of Pulmozyme.

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.

*Study design: The prospective study compared Pulmozyme drug delivery levels and adverse events in children with cystic fibrosis in the two age groups: 3 months to less than 5 years of age (n=65) and five years to 10 years of age (n=33). All patients received 2.5 mg of Pulmozyme once daily for 2 weeks.

References
  1. Pulmozyme Prescribing Information. South San Francisco, CA: Genentech, Inc.; 2005.
  2. Pulmozyme Prescribing Information. South San Francisco, CA: Genentech, Inc.; 2005:2.
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