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 hydrolyzes the DNA in sputum of cystic fibrosis patients and reduces sputum viscoelasticity.
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 36.8 years. Cystic fibrosis is an inherited, recessive disease which is more common in Caucasians.
Safety The most common adverse events reported include voice alteration, pharyngitis, laryngitis, rash, chest pain and conjunctivitis.
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