Whether your cystic fibrosis (CF) patients need once-daily or twice-daily dosing

Fight CF with clinically proven reduction of exacerbation risk in patients with an FVC ≥ 40% of predicted

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

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). 1,17

Proportion of Cystic Fibrosis Patients Remaining Exacerbation-Free Over 6 Months of Pulmozyme Treatment Chart Proportion of Cystic Fibrosis Patients Remaining Exacerbation-Free Over 6 Months of Pulmozyme Treatment Chart

*An exacerbation is defined as a respiratory tract infection requiring parenteral antibiotics. 1

27% risk reduction for exacerbations with QD dosing(1) (P=0.15) 27% risk reduction for exacerbations with QD dosing(1) (P=0.15)

 

More patients remained exacerbation-free on Pulmozyme than on placebo 18

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.

Patients with early CF disease (FVC >85% of predicted) also benefited from Pulmozyme 1

Incidence of first exacerbation 1
  All patients (n=968) 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)

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

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. 1

29% risk reduction for exacerbations with BID dosing(1) Relative risk vs placebo, 0.71; P=0.007 29% risk reduction for exacerbations with BID dosing(1) Relative risk vs placebo, 0.71; P=0.007
If your patients over 21 years of age on Pulmozyme QD are experiencing exacerbations, consider BID dosing to help reduce their risk of further exacerbations If your patients over 21 years of age on Pulmozyme QD are experiencing exacerbations, consider BID dosing to help reduce their risk of further exacerbations
Clinical trial information 17
Type of study Prospective, randomized, placebo controlled
Population N=968; ≥ 5 years of age; FVC ≥ 40%
Treatment groups Pulmozyme 2.5 mg QD, Pulmozyme 2.5 mg BID, placebo
Study length 6 months
Primary endpoint results Reduction in respiratory infections requiring parenteral antibiotics; improvement in lung function (FEV1)

All patients also received standard therapies for CF.

Pulmozyme provides rapid and sustained lung function improvement 1,17

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.

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.

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.

For further information, please see the Pulmozyme full Prescribing Information.

Indication

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.

Pediatric Use

The safety and effectiveness of Pulmozyme have been established in pediatric patients 5 years of age and older. The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 65 patients with cystic fibrosis aged 3 months to < 5 years. While clinical trial data are limited in pediatric patients younger than 5 years of age, the use of Pulmozyme should be considered for pediatric CF patients who may experience potential benefit in pulmonary function or who may be at risk of respiratory tract infection.

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 BABY™ 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%).