Generic Name: dornase alfa (inhalation) (DOOR nase AL fa)Brand Names: Pulmozyme
Dornase alfa is a synthetic protein that breaks down excess DNA in the pulmonary secretions of people with cystic fibrosis.
Dornase alfa is used to improve lung function in people with cystic fibrosis by thinning pulmonary secretions and reducing the risk of respiratory tract infections.
Dornase alfa may also be used for purposes other than those listed in this medication guide.
Ampules of dornase alfa do not contain a preservative. Once opened, the entire contents of the ampule must be used or discarded.Dornase alfa must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Dornase alfa should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.
Before using dornase alfa, tell your doctor if you have any other medical conditions or if you take other prescription or over-the-counter medicines. You may require a dosage adjustment or special monitoring during your treatment.Dornase alfa is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether dornase alfa passes into breast milk. Do not use dornase alfa without first talking to your doctor if you are breast-feeding a baby.
Use dornase alfa exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Dornase alfa is administered by inhalation using a recommended nebulizer. Your doctor or other healthcare provider will give you detailed instructions on the use and maintenance of the nebulizer.Do not dilute or mix the dornase alfa solution with any other drugs in the nebulizer. Mixing of dornase alfa with other drugs could lead to changes in the actions of the medications.
If you are also taking other respiratory medications, use them in the order directed by your doctor (e.g., a bronchodilator, followed by chest physiotherapy, then dornase alfa, etc.) Do not dilute or mix dornase alfa with other agents in the nebulizer at the same time.
Ampules of dornase alfa do not contain a preservative. It is intended for one-time use only. Once opened, the entire contents of the ampule must be used or discarded.Do not use any dornase alfa solution that is cloudy or discolored. Throw away any unused dornase alfa on the expiration date stamped on the ampule.
Dornase alfa should be used on a regular basis to get the most benefit.Dornase alfa must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Dornase alfa should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.
Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and use only the next regularly scheduled dose as directed. Do not use a double dose.
Symptoms of a dornase alfa overdose are not known.
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
increased difficulty breathing;
chest pain; or
Less serious side effects may be more likely to occur with the use of dornase alfa. Talk to your doctor if you experience any of the following side effects:
eye redness, irritation, or inflammation; or
nasal stuffiness or discharge.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Cystic Fibrosis:
2.5 mg (1 ampule) inhaled once daily using a recommended nebulizer. Some patients may benefit from twice daily administration.
Usual Pediatric Dose for Cystic Fibrosis:
> 5 years: 2.5 mg (1 ampule) inhaled once daily using a recommended nebulizer. Some patients may benefit from twice daily administration.
There are no known interactions between dornase alfa and other medicines. Talk to your doctor or pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with dornase alfa.