What is dornase alfa (inhalation)?
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.
What should I discuss with my healthcare provider before taking dornase alfa (inhalation)?
Do not use dornase alfa if you have had an allergic reaction to it or to other Chinese
Hamster Ovary cell products.
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.
How should I take dornase alfa (inhalation)?
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.
What happens if I miss a dose of dornase alfa (inhalation)?
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.
Where can I get more information about dornase alfa (inhalation)?
Your pharmacist has information about dornase alfa (inhalation) written for health professionals that you may read.
What are the possible side effects of dornase alfa (inhalation)?
If you experience any of the following serious side effects while taking dornase alfa, seek
emergency medical attention or contact your doctor immediately:
-
an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives);
-
increased difficulty breathing;
-
chest pain; or
-
fever.
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:
-
voice alteration;
-
sore throat;
-
rash;
-
laryngitis;
-
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.
What is the most important information I should know about dornase alfa (inhalation)?
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.
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.
What should I avoid while taking dornase alfa (inhalation)?
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.
What other drugs will affect dornase alfa (inhalation)?
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.
What happens if I have an overdose of dornase alfa (inhalation)?