The only FDA-approved mucus-altering therapy, Pulmozyme plays a distinct role in the fight against cystic fibrosis (CF)
Take a deep dive into the lungs of a CF patient and see how Pulmozyme facilitates the clearance of mucus 1
Pulmozyme targets extracellular DNA, to break up and loosen CF mucus 1,11
Pulmozyme is a mucolytic that targets and cleaves the extracellular DNA to decrease mucus viscosity. It is a solution of recombinant human deoxyribonuclease I, an enzyme with a primary amino acid sequence that is identical to the native human enzyme. 1
The distinct mechanism of action (MOA) of Pulmozyme breaks up mucus and affects the CF cycle of obstruction, infection, and inflammation 11
In CF, thick mucus laden with extracellular DNA hinders mucociliary
clearance, contributing to the cycle of obstruction, infection, and
inflammation that ultimately leads to lung damage.
Pulmozyme is the only FDA-approved mucolytic that breaks up mucus to affect the obstruction-infection-inflammation cycle. 11
In vitro, Pulmozyme cleaves neutrophil-derived DNA. 1,3-6
This action has been shown to reduce sputum viscoelasticity, allowing CF patients to clear mucus more easily. 1,3-6
Pulmozyme helps reduce the risk of exacerbations in CF patients with an FVC ≥ 40% of predicted 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.
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.
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%).