Dornase alfa is a therapy included in the category of mucolytics, a class of drugs designed to break down the thick secretions in the airways. The therapy is often prescribed as part of a treatment plan for patients who suffer from cystic fibrosis (CF) due to its ability to expel mucus, improve airflow, prevent the build-up of bacteria, and reduce the prevalence of lung infections. Patients often find they can cough the mucus out in an easier manner with this treatment.
Dornase alfa is currently commercialized in the United States under the brand name Pulmozyme and is produced by Genentech. The medication is distributed in the form of a sterile, clear, colorless, highly purified solution in single-use ampules to be inhaled through the mouth. Each ampule includes 2.5 mL of the solution to be delivered into the nebulizer bowl.
History of Dornase Alfa
In the 1990s, Genentech presented data on the benefits of treatment with dornase alfa to support its request to commercialize Pulmozyme. The inhalation solution was first cleared for marketing by the U.S. FDA in December 1993 after a placebo-controlled study of 320 subjects that examined the safety and efficacy of Pulmozyme over a 12-week period. The original indication stated the drug was to be used in “the management of mild to moderate cystic fibrosis in conjunction with standard therapies to reduce the incidence of respiratory tract infections requiring parenteral antibiotics and to improve pulmonary function.” The therapy went on to be indicated for patients with advanced cystic fibrosis as well.
How Dornase Alfa Works
Dornase alfa is a synthetic protein given to patients in the form of an inhaled solution administered through an aerosol mist produced by a compressed air-driven nebulizer or an approved nebulizer system. CF patients are usually recommended doses of one 2.5 mg single-use ampule inhaled once daily, but some patients may benefit from using it twice a day, according to the doctor’s recommendations.
The medication works by thinning pulmonary secretions, enabling patients to expel and avoid the accumulation of thick mucus, while also reducing the risk of respiratory tract infections and improving patients’ lung function.
According to the Cystic Fibrosis Foundation, “dornase alfa acts like scissors by cutting up the long DNA strands contained in white blood cells. By cutting these strands into shorter pieces, dornase alfa helps to break up the thick, sticky mucus that often leads to lung infections.”
Other Details About Dornase Alfa
There are no known interactions between dornase alfa and other medications, but it is still important for patients to tell their doctors about any prescription or over-the-counter medication or supplements they are taking when prescribed the drug. Also, the effects of the drug in pregnant women or women who are breast-feeding are not fully understood.
The most common side effects associated with dornase alfa are sore or dry throat and hoarseness, while eye redness or irritation may also occur, but less frequently. In the case of an allergic reaction, increased difficulty breathing, chest pain, fever, voice alteration, sore throat, rash, laryngitis, eye redness, irritation, inflammation, or nasal stuffiness or discharge, patients should consult a physician immediately.
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