Studies and Efficacy

Pulmozyme is a cornerstone of combination therapy.

Pulmozyme plays an essential part of a CF treatment plan by:

• Reducing the relative risk for exacerbations in patients with mild to moderate CF
• Improving lung function
• Having been a standard part of CF care for over 17 years

The Cystic Fibrosis Foundation guidelines strongly recommend Pulmozyme for use in CF patients 6 years and older who have moderate to severe lung disease in order to improve lung function.^†

^†Guideline statements are adapted from publication by Flume et al.

Clinical studies: efficacy and safety

Pulmozyme has a demonstrated safety profile in pediatric and adult patients.* (Ref. 1) Results of a pivotal clinical study showed that patients with mild or moderate CF taking Pulmozyme 2.5mg QD (n=322) experienced a significant 27% reduction in the relative risk of pulmonary exacerbations requiring parenteral antibiotics, and a 5.8% improvement in lung function.** (Ref. 1, 2)

*The efficacy of Pulmozyme has not been studied in patients less than five years of age.
**Study design: In this prospective trial, 968 clinically stable patients over 5 years of age were randomized to treatment with Pulmozyme 2.5 mg once daily, or placebo over a 6-month time period. Primary efficacy end points were reduction in infections requiring parenteral antibiotics and improvement in lung function (FEV₁).

Significantly reduced the risk of exacerbations
requiring parenteral antibiotics among patients with mild to moderate CF (FVC ≥40% of predicted)²
(P=0.015, Pulmozyme vs. placebo)

Significantly improved FEV₂
across all disease severities²
(P<0.001, Pulmozyme vs. placebo)

Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.

Because of limited experience with the administration of Pulmozyme to patients <5 years of age, its use should be considered only for those patients in whom there is potential for benefit in lung function or risk of respiratory infection.

Please see Patients under 5 years old for additional information.

Before prescribing Pulmozyme...

Be sure to take the following guidelines into consideration:

• Pulmozyme should be used in conjunction with standard therapies for CF.
• Pulmozyme should not be used in patients with known hypersensitivity to dornase alfa.
• The most commonly reported adverse events associated with the use of Pulmozyme include voice alteration, pharyngitis, laryngitis, rash, chest pain and conjunctivitis.

Please see Important Safety Information and accompanying full Prescribing Information.