dornase alpha, Pulmozyme

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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What is dornase alpha, and how does it work (mechanism of action)?

Dornase alpha is an inhaled drug for treating cystic fibrosis, a lung disease which is the most common fatal genetic disease in developed countries. The lungs continually secrete fluid into the airways to keep them moist. In cystic fibrosis, the fluid becomes thick because the amount of water it contains is reduced. The thickened fluid is difficult to cough up or spit out. It blocks the airways, making breathing difficult and promoting the growth of bacteria and infection. Infection destroys the tissues of the lungs, and it is the slowly progressive destruction of the lungs that is the major cause of disability and death in children with cystic fibrosis. The thick fluid contains high concentrations of deoxyribonucleic acid (DNA). Dornase alpha is a genetically engineered form of the human enzyme, deoxyribonuclease or DNAse. Dornase alpha breaks down the DNA and thereby reduces the thickness of the fluids. Dornase alpha was approved by the FDA in 1993.

What brand names are available for dornase alpha?

Pulmozyme

Is dornase alpha available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for dornase alpha?

Yes

What are the side effects of dornase alpha?

The most common side effects of dornase alpha include:

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What is the dosage for dornase alpha?

The recommended dose is one ampule (2.5 ml) inhaled once or twice daily using a recommended nebulizer.

Which drugs or supplements interact with dornase alpha?

Drug interaction studies have not been conducted. Dornase alpha is compatible with standard cystic fibrosis therapies including oral, inhaled and/or parenteral antibiotics, bronchodilators, enzyme supplements, vitamins, oral or inhaled corticosteroids, and analgesics.

Is dornase alpha safe to take if I'm pregnant or breastfeeding?

No damage has been noted to fetuses of pregnant animals exposed to high doses of dornase alpha. However, there are no studies in women. Therefore, physicians must weigh potential risks with the expected benefits of therapy when deciding whether or not to use dornase alpha in pregnancy.

It is not known whether dornase alpha is secreted in human milk. At most, very little dornase alpha would be expected in human milk after long-term aerosol use. However, because many drugs are secreted in human milk, physicians must still use caution when they consider the use of dornase alpha in nursing women.

What else should I know about dornase alpha?

What preparations of dornase alpha are available?

Single-use ampules; 2.5 ml (1 mg/ml)

How should I keep dornase alpha stored?

Dornase alpha must be kept in a refrigerator at 2 C to 8 C (36 F to 46 F) and protected from direct sunlight. The solution should be thrown away if it is cloudy or discolored. Since the ampule does not contain a preservative, the entire contents of the ampule must be used or thrown away after it is opened.

Reference: FDA Prescribing Information

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Reviewed on 6/17/2015
References
Reference: FDA Prescribing Information

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