Full Prescribing Information

Pulmozyme® (dornase alfa) Inhalation Solution is a sterile, clear, colorless, highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA.

Pulmozyme is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer system.

Launched in 1994, Pulmozyme was the first new therapeutic drug for the management of cystic fibrosis in over 30 years.

Status Daily administration of Pulmozyme in conjunction with standard therapies is indicated in the management of cystic fibrosis patients to improve pulmonary function. In 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.

Important Safety Information Pulmozyme should not be used in patients who are allergic to any of its ingredients. Pulmozyme should be used along with standard therapies for cystic fibrosis. When starting Pulmozyme therapy, patients may experience change in or loss of their voice, discomfort in the throat, chest pain, red watery eyes, rash, dizziness, fever, or runny nose. These side effects are usually mild and short-lived.

There is a limited amount of information available concerning the usage of Pulmozyme in patients who are younger than 5 years. The decision to use Pulmozyme in these patients is made after considering the potential for a benefit in lung function or in decreasing the risk of respiratory tract exacerbations.

The safety of Pulmozyme given by daily inhalation for 2 weeks has been studied using 98 CF patients with 65 of them aged 3 months to <5 years (younger group) and 33 aged 5 years to ≤10 years (older group). The PARI BABY™ reusable nebulizer (which uses a face mask instead of a mouthpiece) was used in patients who were unable to show that they could breathe in or out using their mouth throughout the entire treatment period. There were more reports of cough, moderate to severe cough, runny nose, and rash in the younger group of patients. Other reported events tended to be of mild to moderate severity. The kind of side effects reported was similar to that of Pulmozyme when used in the larger trials that studied older patients.

Proposed Mechanism of Action In vitro, Pulmozyme cleaves extracellular DNA in mucus of cystic fibrosis patients, reducing the adhesiveness and viscoelasticity of the mucus.

Disease Education Cystic fibrosis is a life-threatening disease involving a genetic mutation that disrupts the cystic fibrosis transmembrane regulator protein. This protein acts on an ion-specific channel that modulates salt and water transport. This ion-channel defect leads to poorly hydrated, thick, mucous secretions in the airways and severely impaired mucociliary clearance. Impairments in these vital lung defense mechanisms typically begin in early childhood. Chronic secondary infections invariably occur, resulting in progressive lung dysfunction and deterioration. Cystic fibrosis affects other organ systems as well, especially the digestive tract and reproductive organs. Respiratory failure accounts for approximately 90% of deaths in patients with cystic fibrosis.

According to the U.S. Cystic Fibrosis Foundation, the median average life expectancy for patients with cystic fibrosis is more than 37 years. Cystic fibrosis is an inherited, recessive disease which is more common in Caucasians.