GENERIC NAME: dornase alpha

BRAND NAME: Pulmozyme

DRUG CLASS AND MECHANISM: Dornase alpha is an inhaled drug for treating the lung disease of cystic fibrosis , 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.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Dornase alpha is supplied in single-use ampules. Each ampule contains 2.5 mL of a sterile, clear, colorless, solution containing 1.0 mg/mL dornase alpha with no preservative.

STORAGE: Dornase alpha must be kept in a refrigerator at 2-8°C (36-46°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.

PRESCRIBED FOR: Dornase alpha is used in the long-term management of patients with cystic fibrosis. Patients who received dornase alpha have been shown to have improved function of the lung, improved quality of life, and a reduction in the need for antibiotics (because of fewer infections of the lungs).

DOSING: The recommended dose in most patients is one 2.5 mg ampule inhaled once daily using a recommended nebulizer. Safety and efficacy have been demonstrated with the following nebulizers: the disposable jet nebulizer Hudson T Up-draft II and disposable jet nebulizer Marquest Acorn II in conjunction with a Pulmo-Aide compressor, and the reusable PARI LC Jet+ nebulizer, in conjunction with the PARI PRONEB compressor.

DRUG INTERACTIONS: There are no known interactions of drugs with dornase alpha.

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

NURSING MOTHERS: 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.

SIDE EFFECTS: The most common side effects with dornase alpha include alteration of voice, sore throat , laryngitis, rash, chest pain, red eyes, cough, nasal congestion, and rash.

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