Pulmozyme Efficacy & Tolerability: Tolerability Profile

Adverse reactions are rare (1<1000) at the recommended dose of 2.5mg OD (corresponding to 2500 U)1

  • Most adverse reactions are mild and transient, and did not require dose modifications
  • Few patients discontinued Pulmozyme due to an adverse event
  • Discontinuation rate for Pulmozyme (3%) was similar to that for placebo (2%)
  • Patients who experience adverse events common to cystic fibrosis can, in general, safely continue administration of Pulmozyme as evidenced by the high percentage of patients completing clinical trials with Pulmozyme
  • Upon initiation of dornase alfa therapy, as with any aerosol, pulmonary function may decline and expectoration of sputum may increase
  • Less than 5% of patients have developed antibodies to Pulmozyme
    • No patients have developed immunoglobulin E (IgE) antibodies to Pulmozyme
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  • Pulmozyme can be effectively and safely used in conjunction with standard cystic fibrosis therapies such as antibiotics, bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, and analgesics.
  • Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.
  • Please refer to the SmPC for full prescribing information.

EU SmPC

1. Pulmozyme SmPC, Electronic Medicines Compendium, accessed 10/8/18