Description
Dornase alfa inhalation solution is used together with other medicines (eg, antibiotics, bronchodilators, and steroids) to control symptoms of cystic fibrosis. Cystic fibrosis is a condition in which a thick mucus is formed in the lungs and breathing passages. The mucus blocks the airways and increases the chance of lung infections. The infections then cause the mucus to become even thicker, making it more difficult to breathe.
Dornase alfa will not cure cystic fibrosis. However, when it is used every day, it helps make breathing easier and reduces the number of serious lung infections that require treatment with antibiotics.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmozyme® in children 5 years of age and older. Safety and efficacy have been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of Pulmozyme® have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to Chinese hamster ovary cell products—Should not be used in patients with this condition.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may cause your lung condition to become worse.
This medicine usually comes with patient instructions. Read them carefully before using the medicine. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you how to use it.
Dornase alfa should be used with the eRapid™ nebulizer system or a jet nebulizer that is connected to an air compressor. An air compressor is used with a nebulizer to turn the medicine into a fine spray. You will breathe in the spray through your mouth. To use:
- Dornase alfa inhalation solution comes in small plastic containers called ampules. Each ampule contains one full dose of dornase alfa. Do not use an ampule that has already been opened. Do not use a cloudy or discolored inhalation solution.
- Remove the ampule from the pouch. Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.
- Connect the nebulizer to the face mask or mouthpiece, then connect the nebulizer to the compressor.
- Use the mouthpiece of the nebulizer to breathe in Pulmozyme®. Do not use a face mask with the nebulizer because less medicine will get into your lungs.
- Patients who are unable to breathe in or breathe out by mouth may use the PARI BABY™ nebulizer with the supplied face mask. Make sure you understand exactly how to use this medicine in the nebulizer.
- Use the nebulizer for about 10 to 15 minutes, or until the medicine in the nebulizer cup is gone.
- Follow the manufacturer's directions for care and cleaning of the nebulizer and compressor.
- Do not mix any other medicine in the nebulizer with dornase alfa.
In order to receive the full effects of this medicine, you must use it every day as ordered by your doctor. If possible, dornase alfa should be used at about the same time each day. You may notice some improvement in your condition within the first week of treatment. However, some patients may not feel the full effects of this medicine for weeks or months.
If you are taking any other medicines for cystic fibrosis, keep taking them as you did before you started using dornase alfa, unless otherwise directed by your doctor. However, do not put any other inhaled medicine in the nebulizer at the same time that you use dornase alfa. Other inhaled medicines may be used in a clean nebulizer before or after your treatment with dornase alfa.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For inhalation dosage form (solution):
- For cystic fibrosis:
- Adults and children 5 years of age and older—2.5 milligrams (mg) (one ampule) once a day in the nebulizer.
- Children 3 months to 4 years of age—Dose must be determined by your doctor. The dose is usually 2.5 mg (one ampule) once a day in the nebulizer.
- Children younger than 3 months of age—Use and dose must be determined by your doctor.
- For cystic fibrosis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in the refrigerator in the foil pouches. However, keep the medicine from freezing. Do not leave this medicine out of the refrigerator for longer than 24 hours. If an ampule of medicine is left out for longer than this, it should be thrown away and a new ampule should be used.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits. This is to make sure that the medicine is working properly and to check for unwanted effects.
If your or your child's condition becomes worse while you are using this medicine, check with your doctor right away.
If any of your medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Body aches or pain
- chest pain
- congestion
- cough
- dryness or soreness of the throat
- fever
- hoarseness
- runny nose
- tender, swollen glands in the neck
- trouble breathing
- trouble swallowing
- voice changes
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Rash
- sneezing
- stuffy nose
Less common
- Acid or sour stomach
- belching
- burning, dry, or itching eyes
- discharge or excessive tearing
- heartburn
- indigestion
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- stomach discomfort, upset, or pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
