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Efficacy and Safety Data for Pulmozyme

Pulmozyme is proven to reduce the risk of exacerbation and improve lung function with once or twice-daily dosing.

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Exacerbation rate - once daily dosing
Exacerbation rate - twice daily dosing
Lung Function - once daily dosing
Lung Function - twice daily dosing

Exacerbation Rate Data

Clinically proven reduction of exacerbation risk in patients with an FVC ≥40% of predicted.1,2 Patients with early CF disease (FVC >85% of predicted) also benefited from Pulmozyme.1

Once-daily (QD) dosing: Pulmozyme clinical efficacy data1

Pulmozyme QD reduced the risk of CF exacerbations among patients ≥5 years of age with FVC ≥40% of predicted—including those with early CF disease (FVC >85% of predicted).1

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27%

risk reduction for exacerbations with QD dosing (P=0.015)1

Proportion of patients remaining exacerbation-free over 6 months10

Proportion of patient remaining exacerbation-free over 6 months

*An exacerbation is defined as a respiratory tract infection requiring parenteral antibiotics.

See clinical trial information

Twice-daily (BID) dosing: Pulmozyme clinical efficacy data1

When once-daily dosing isn't enough, keep appropriate patients fighting with Pulmozyme BID. Pulmozyme BID reduced the relative risk of exacerbations among patients ≥5 years of age with FVC ≥40% of predicted

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29%

risk reduction for exacerbations with BID dosing1 
Relative risk vs placebo, 0.71; P=0.007

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In patients with FVC ≥40% of predicted, Pulmozyme works to reduce risk of exacerbation even if patients don’t feel its effects1

If your patients over 21 years of age on Pulmozyme QD are experiencing exacerbations, consider BID dosing to help reduce their risk of further exacerbations1

IMPORTANT SAFETY INFORMATION

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

Incidence of first exacerbation1

  All patients (N=968) Baseline FVC >85% (N=370)
Placebo (n) 43% (325) 27% (131)
2.5 mg QD (n) 34% (322) 21% (121)
2.5 mg BID (n) 33% (321) 14% (118)

Adverse Reactions that Occurred in a Higher Proportion (≥3%) of Pulmozyme-Treated Patients than Placebo1

Trial 1: CF Patients with FVC ≥40% of predicted treated for 24 weeks

Adverse Reactions (of any severity or seriousness) Placebo n=325 Pulmozyme QD n=322 Pulmozyme BID n=321
Voice alteration 7% 12% 16%
Pharyngitis 33% 36% 40%
Rash 7% 10% 12%
Laryngitis 1% 3% 4%
Chest pain 16% 18% 21%
Conjunctivitis 2% 4% 5%

Trial 1: CF Patients with FVC ≥40% of predicted treated for 24 weeks

Adverse Reactions (of any severity or seriousness) showing differences less than 3% for:
  • Rhinitis
  • FVC decrease of ≥ 10% of predicted
  • Fever
  • Dyspepsia
  • Dyspena (when reported as serious)
See clinical trial information

Lung Function Data

Whether your patients with CF need once-daily or twice-daily dosing, fight CF with clinically proven lung function improvement

Once-daily (QD) dosing: Pulmozyme clinical trial data

Pulmozyme QD provided rapid and sustained lung function improvement.1,9

FEV1 change from baseline over 6 months in patients with FVC ≥40% of predicted9,10

5.8% FEV improvement at 6 month treatment duration
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Within 8 days of the start of treatment, mean FEV1 levels increased by 7.9% from baseline1

Twice-daily (BID) dosing: Pulmozyme clinical trial data

When once-daily dosing isn't enough, keep appropriate patients fighting with Pulmozyme BID. Pulmozyme BID provided rapid and sustained lung function improvement.

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Over 6 months: Mean FEV1 levels increased by 5.6% from baseline1,9

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Within 8 days of the start of treatment: Mean FEV1 levels increased by 9% from baseline1

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Pulmozyme works to help improve lung function even if patients don’t feel its effects1

Next Page: Trial Information

Important Safety Information

Indication and Usage

Pulmozyme (dornase alfa) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.

In CF 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.

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

The most common adverse reactions associated with the use of Pulmozyme include: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥ 10%, fever, dyspepsia, and dyspnea. There have been no reports of anaphylaxis attributed to the administration of Pulmozyme. Mild to moderate urticaria and mild skin rash have been observed and have been transient.

Pediatric Use

The safety and effectiveness of Pulmozyme in conjunction with standard therapies for cystic fibrosis have been established in pediatric patients. Use of Pulmozyme in pediatric patients is supported by evidence in the following age groups:

  • Patients 5 to 17 years of age: A randomized, placebo-controlled trial of 303 of clinically stable cystic fibrosis patients 5 to 17 years of age who received Pulmozyme.
  • Patients less than 5 years: Extrapolation of efficacy data in patients 5 years of age and older with additional safety data in 65 pediatric patients aged 3 months to less than 5 years who received Pulmozyme 2.5 mg daily by inhalation for 2 weeks.

The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 pediatric patients with cystic fibrosis 3 months to 10 years of age (65 aged 3 months to < 5 years, 33 aged 5 to ≤ 10 years). The PARI BABYTM reusable nebulizer (which uses a facemask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger; and 2/33, 6% of the older patients). Overall, the nature of adverse reactions was similar to that seen in the placebo-controlled trials in older patients. The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45%; compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37%; compared to 6/33, 18%). The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35%; compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33, 0%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see Pulmozyme full Prescribing Information for additional Important Safety Information.

    • Pulmozyme (dornase alfa) [package insert]. South San Francisco, CA: Genentech, Inc; 2024.

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    Non-US Residents visit: Pulmozyme.global