Medications and Drugs
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.
Reference: FDA Prescribing Information
Last Editorial Review: 12/14/2000 9:46:00 AM
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
- Drug Interactions - Learn about potential drug interactions you may be exposed to. Drug interactions can occur with prescription drugs, OTC medication, vitamins, herbs, and supplements.
- Cystic Fibrosis - Read about cystic fibrosis, a genetic disease of the mucus and sweat glands. Symptoms include bulky, foul smelling stools, abdominal pain, gas, malnutrition, and respiratory failure.
- Drugs: What You Should Know About Your Drugs - Find out what you should know about your drugs such as side effects, warnings and precautions, storage information, and if a generic version is as good as the brand name.
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