Pulmozyme 1 mg/mL

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About Pulmozyme

What Pulmozyme is used for

PULMOZYME is used to treat patients with cystic fibrosis. It helps to break down the thick mucous in the airways, which improves lung function and reduces the risk of respiratory tract infections.

What Pulmozyme does

PULMOZYME contains the active ingredient dornase alfa (also called recombinant human deoxyribonuclease I or rhDNase) which is a man-made protein similar to a natural protein in your body called DNase. PULMOZYME works by helping to break down the thick mucous produced in the lungs of patients with cystic fibrosis.

When Pulmozyme should not be used

If you are allergic to PULMOZYME or any of the ingredients it contains.

What the medicinal ingredient is

dornase alfa

What the important nonmedicinal ingredients for Pulmozyme are

calcium chloride, sodium chloride and water

What dosage forms Pulmozyme comes in

Ampoule 2.5 mg

Warnings and Precautions

BEFORE using PULMOZYME talk to your doctor or pharmacist if:

• you are allergic to other medicines, including those not prescribed by your doctor

• you are taking any other medicines, including those not prescribed by your doctor

• you are pregnant, plan to become pregnant, or are breastfeeding

This information will help your doctor and you decide whether you should use PULMOZYME and what extra care may need to be taken while you are on the medicine.

Interactions with Pulmozyme

You should continue to take your standard cystic fibrosis treatment while you are on PULMOZYME (for example, antibiotics, bronchodilators, enzyme supplements, vitamins, corticosteroids and pain killers).

Proper Use of Pulmozyme

Usual dose

The usual dose is the contents of one ampoule to be inhaled each day. Some patients may benefit from taking PULMOZYME twice a day. Your doctor will decide the best dose for you.

DO NOT INHALE PULMOZYME UNTIL YOUR DOCTOR HAS THOROUGHLY TRAINED YOU IN THE PROPER TECHNIQUE.

PULMOZYME should be administered only using the nebulizers and compressors listed in Table 1.

Keep all other inhaled medication systems completely separate from PULMOZYME. Do not use any other inhaled medications in the nebulizer at the same time. Do not use a mask. Use the mouthpiece provided with each nebulizer kit.

If you are unable to breathe through your mouth for the entire nebulization period, you may use the reusable PARI BABY nebulizer. It is recommended that patients under 5 years of age use the PARI BABY nebulizer. Please talk to your doctor about using the PARI BABY nebulizer before you do this. The PARI BABY nebulizer is identical to the PARI LC Jet + system except that the mouthpiece is replaced by a tight-fitting facemask connected to an elbow piece.

Items needed for administration:

• 1 ampoule of PULMOZYME

• Compressor

• Nebulizer cup and screw on or snap on cap

• Plastic T connector (not needed for PARI BABY)

• Flexible aerosol tube (not needed for PARI BABY)

• Clean mouthpiece or PARI BABY facemask

• Long connecting tube

• Nose clip (optional, not needed for PARI BABY)

THE FOLLOWING INSTRUCTIONS ARE A GUIDE FOR ASSEMBLY OF THE RECOMMENDED NEBULIZER SYSTEMS.

Preparing the Treatment

1. Wash your hands thoroughly with soap and water before preparing the medication. This helps prevent infection.

2. Clean a table surface and lay out the nebulizer components. Place the compressor on the table within reach. Test the compressor by turning it on and putting your finger in front of the “air out” port to feel air flowing. Turn off the compressor.

3. Remove one ampoule of PULMOZYME from its pouch stored in the refrigerator and make sure the expiration date has not passed. Test the ampoule for leaks by turning it upside down and gently squeezing. If there appears to be a leak, do not use that ampoule of PULMOZYME. Next, check the PULMOZYME solution. It should be clear and free of particles. Do not use the PULMOZYME solution if it is cloudy or discoloured, but return it to your doctor or pharmacist.

4. Attach the long connecting tube to the “air out” port on the compressor.

5. Push the mouthpiece into the wider end of the plastic T. Attach the flex tube to the other end of the T. (For the PARI BABY, skip this step.)

6. Unscrew or unsnap the cap from the nebulizer cup. Put the cup on the table face up.

7. Hold the tab at the base of the ampoule of PULMOZYME firmly, taking care not to squeeze the body of the ampoule, and twist off the top.

8. Turn the ampoule upside-down and squeeze gently to empty contents into the nebulizer cup. Continue squeezing until the ampoule is empty. It is very important that you use the full dose of the drug. Screw or snap the cap onto the nebulizer cup.

9. Connect the plastic T to the nebulizer cap. (For the PARI BABY, connect the elbow piece and mask to the nebulizer outlet.)

10. Connect the open end of the long tube to the port on the bottom of the nebulizer cup by pushing up firmly.

11. Turn on the compressor and check to see that mist is coming out of the nebulizer.

Taking the Treatment

IF YOU ARE USING A NEBULIZER OTHER THAN PARI BABY USE THE FOLLOWING INSTRUCTIONS:

1. Place the mouthpiece between your teeth and on top of your tongue. Be sure that you do not block the airflow with your tongue. Breathe normally by inhaling and exhaling through your mouth. Do not breathe through your nose. If you have difficulty breathing only through your mouth, use a nose clip.

2. Do not be concerned if condensation collects in the long connecting tube during treatment. When the nebulizer begins “spitting”, gently tap the nebulizer cup and continue breathing until the nebulizer cup is empty, or stops producing mist.

If you are interrupted or begin coughing during treatment, turn off the compressor taking care not to spill any of the drug. To resume treatment, turn on the compressor and continue. The complete treatment usually takes from 10 to 15 minutes.

It is important to inhale the full dose of PULMOZYME. If you detect a leak or feel any moisture coming from the nebulizer during treatment, turn off the compressor and check to be sure the nebulizer cap is sealed correctly before continuing.

IF YOU ARE USING THE PARI BABY NEBULIZER TO GIVE PULMOZYME TO YOUR CHILD YOU SHOULD USE THE FOLLOWING INSTRUCTIONS:

1. Place the facemask gently but firmly over the nose and mouth of your child. Make sure there are no air gaps between the mask and your child's face. This will help ensure that your child will get the full dose of PULMOZYME. During the treatment your child may sit, lie down or stand. It is important that you try to keep the body of the nebulizer upright during the entire treatment period. The elbow piece will allow you to adjust the position of the mask while keeping the nebulizer body upright.

2. When the nebulizer begins “spitting”, gently tap the nebulizer cup and continue treatment until the nebulizer is empty or stops producing a mist.

   • If you are interrupted or your child beings to cough during treatment, turn the compressor off, taking care not to spill any PULMOZYME.

   • If you have not removed the mask and you wish to begin treatment again, simply turn on the compressor.

   • If you have removed the mask repeat Step 1. A complete treatment usually takes about 10 to 15 minutes.

3. It is important that you child inhale the full dose of PULMOZYME. If you detect a leak or feel moisture coming from the nebulizer during treatment, turn off the compressor and make sure the nebulizer cap is sealed correctly before starting the compressor again.

After the Treatment

Turn off the compressor and disassemble the nebulizer system, setting aside the flex tube and the long connecting tube.

FOLLOW MANUFACTURER'S RECOMMENDATIONS FOR CARE OF YOUR NEBULIZER AND COMPRESSOR.

Overdose

If you take more than the prescribed amount of PULMOZYME, contact your doctor right away.

Missed dose

If a dose of PULMOZYME is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.

Side Effects for Pulmozyme and What to Do About Them

The most common side effects are voice alteration, sore throat, laryngitis, cough, rash, chest pain, and conjunctivitis. These effects are generally mild and they usually go away within a few weeks after starting therapy.

This is not a complete list of side effects. For any unexpected effects while taking PULMOZYME, contact your doctor or pharmacist.