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.

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.

Safety In a randomized, placebo-controlled clinical trial in patients with FVC ≥40% of predicted, over 600 patients received Pulmozyme once or twice daily for six months; most adverse events were not more common on Pulmozyme than on placebo and probably reflected the sequelae of the underlying lung disease. The most common adverse events reported include voice alteration, pharyngitis, laryngitis, rash, chest pain and conjunctivitis. In most cases events that were increased were mild, transient in nature, and did not require alterations in dosing. Few patients experienced adverse events resulting in permanent discontinuation from Pulmozyme, and the discontinuation rate was similar for placebo (2%) and Pulmozyme (3%).

In a randomized, placebo-controlled trial of patients with advanced disease (FVC <40% of predicted) the safety profile for most adverse events was similar to that reported for the trial in patients with mild to moderate disease.

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