In the U.S.—

In Canada—

Other commonly used names are: rhDNase; DNase I.

• Cystic fibrosis therapy adjunct

Dornase alfa (DOR-nayse AL-fa) is used in the management of cystic fibrosis. It is used every day with other cystic fibrosis medicines, especially antibiotics, bronchodilators (medicines that open up narrowed breathing passages), and corticosteroids (cortisone-like medicines).

Cystic fibrosis is a condition in which 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.

Dornase alfa is available only with your doctor's prescription, in the following dosage form:

Inhalation
• Inhalation solution (U.S. and Canada)

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 dornase alfa, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dornase alfa. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Dornase alfa has not been studied in pregnant women. However, this medicine has not been shown to cause birth defects or other problems in animals.

Breast-feeding—It is not known whether dornase alfa passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Dornase alfa has been studied in children 3 months of age and older and has not been shown to cause different side effects or problems in children than it does in adults, although coughing, runny or stuffy nose, and skin rashes were more common in children 3 months to 5 years of age than in other age groups.

Older adults—Dornase alfa has not been tested on enough patients 65 years and older. Cystic fibrosis is a disease that usually affects children and young adults. Although there is no specific information comparing use of dornase alfa in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Dornase alfa usually comes with patient instructions. Read them carefully before using this medicine.

Dornase alfa is packaged 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. Also, do not use an ampule of this medicine after the expiration date printed on the package.

Do not use dornase alfa solution if it is cloudy or discolored.

Dornase alfa must be used in a nebulizer with a compressor . Only the following nebulizers and compressors should be used with this medicine:

• Hudson T Up-draft II disposable jet nebulizer used with the Pulmo-Aide compressor
• Marquest Acorn II disposable jet nebulizer used with the Pulmo-Aide compressor
• Reusable PARI LC Jet+ nebulizer used with the PARI PRONEB compressor
• Reusable PARI BABY nebulizer used with the PARI PRONEB compressor
• Reusable Durable Sidestream jet nebulizer with the MOBILAIRE or the Porta-Neb compressor

Your health care professional will help you decide which nebulizer and compressor to use.

It is very important that you use dornase alfa only as directed. Use the mouthpiece provided with the nebulizer. Do not use a face mask with the nebulizer because less medicine will get into your lungs. Patients who are unable to inhale and exhale through the mouth for the entire nebulizer treatment may use the PARI BABY nebulizer with the supplied face mask. Make sure you understand exactly how to use this medicine in the nebulizer.

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.

To prepare the nebulizer for use:

• Wash your hands well with soap and water before putting the nebulizer together and preparing the medicine. This will help prevent infection.
• Put the nebulizer together only on a clean surface. If dirt or germs get on the nebulizer or in the medicine, they may cause infection.
• After you put the nebulizer together, test the compressor (following the manufacturer's directions) to make sure it works properly. If you have any questions about this, ask your health care professional.
• If you are using the Durable Sidestream jet nebulizer with the MOBILAIRE compressor, turn the compressor control knob all the way to the right and then turn on the compressor. The needle on the gauge vibrates between 35 and 45, which is the highest amount of pressure.

To prepare the medicine for use in the nebulizer:

• Remove one ampule of dornase alfa from the refrigerator. Squeeze the ampule before opening to make sure there are no leaks. Hold the tab at the base of the ampule firmly. Twist off the top of the ampule, but do not squeeze the body of the ampule while doing so.
• Take the cap off the nebulizer cup. Turn the opened ampule upside down over the cup. Squeeze the ampule gently until all the contents are emptied into the cup. It is very important that you use the full dose of this medicine.
• Replace the cap on the nebulizer cup. Connect the nebulizer and compressor, following the manufacturer's directions.
• Turn on the compressor. Make sure there is mist coming from the nebulizer.

To use the medicine in the nebulizer:

• Place the mouthpiece between your teeth and on top of your tongue. Close your lips around the mouthpiece. Be sure that you do not block the airflow with your tongue or teeth.
• Breathe normally, in and out, through your mouth. Do not breathe through your nose. If you have trouble breathing only through your mouth, use a nose clip.
• During treatment, moisture may collect in the long connecting tube of the nebulizer. This should be expected. However, if you notice a leak or feel moisture coming from the nebulizer during the treatment, turn off the compressor. Then check to make sure the nebulizer cap is sealed correctly before you continue the treatment.
• When the nebulizer begins 'spitting' gently tap the nebulizer cup. Continue breathing until the cup is empty or no more mist comes from the nebulizer.
• If you have to stop the treatment for some reason or if you start coughing during the treatment, turn off the compressor. To begin the treatment again, turn on the compressor and continue as before.
• The complete treatment usually takes 10 to 15 minutes. Be sure to inhale the full dose of dornase alfa.

After using dornase alfa:

• Turn off the compressor. Then take apart the nebulizer system.
• Follow the manufacturer's directions for care and cleaning of your nebulizer and compressor.

Dosing—

The dose of dornase alfa 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 dornase alfa. If your dose is different, do not change it unless your doctor tells you to do so.

• For inhalation dosage form (inhalation solution):
  • For cystic fibrosis:
    • Adults and children 5 years of age and older—The usual dose is 2.5 milligrams (mg) (one ampule), used in a nebulizer once a day for about 10 to 15 minutes. However, your doctor may want you to use this medicine two times a day at regularly spaced times.
    • Children 3 months to 5 years of age—The usual dose is 2.5 milligrams (mg) (one ampule), used in a nebulizer once a day for about 10 to 15 minutes.
    • Children up to 3 months of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, use 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.

Storage—

To store this medicine:

• Keep out of the reach of children
• Store away from heat and light.
• 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.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If your condition becomes worse while you are using this medicine, check with your doctor.

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 as soon as possible if any of the following side effects occur:

• Rare
  • Hives or welts;  itching;  redness of skin;  skin rash 
  
  

The following side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Chest pain or discomfort;  hoarseness ;  sore throat 
  
  

• Less common
  • Difficulty breathing;  fever;  redness, itching, pain, swelling, or other irritation of eyes ;  runny or stuffy nose;  upset stomach 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.