Dornase Alfa (Inhalation)

Brand Names : Pulmozyme, rhDNase, DNase I

Proper Use of This 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.