Instructions for how to administer Pulmozyme with a Jet Nebulizer and Compressor

Jet Nebulizer image

There are 2 ways to administer Pulmozyme (dornase alfa), with a Jet Nebulizer and Compressor or with a portable nebulizer like the  eRapid™ Nebulizer System. For instructions using the portable eRapid™ Nebulizer System, go here

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Instructions for Use with Jet Nebulizers and Compressors

A nebulizer and a compressor are used together to give a dose of Pulmozyme (dornase alfa). 
A nebulizer changes the Pulmozyme (dornase alfa) liquid medicine into a fine mist inhaled by breathing through a mouthpiece. A compressor gives the nebulizer power and makes the nebulizer work.
Pulmozyme (dornase alfa) should only be used with the approved nebulizers and compressors or with the eRapid® Nebulizer System.

Any other inhaled medicines should not be used in the nebulizer at the same time. Keep all other inhaled medication systems completely separate from Pulmozyme (dornase alfa). 

A mask should not be used. The mouthpiece provided with each nebulizer kit should be used. 
If a child cannot breathe in or breathe out by mouth, you may use the PARI BABY
reusable nebulizer, but should first discuss it with a doctor. The PARI BABY nebulizer is the same as the PARI LC Plus Jet system, except the mouthpiece is replaced by a tight-fitting face mask connected to an elbow piece.


Steps to administer Pulmozyme using approved jet nebulizer systems

Supplies you will need to give a dose of Pulmozyme:

Ampule of Pulmozyme® (dornase alfa)

1 ampule of Pulmozyme

Compressor

Compressor

Nebulizer Cup and Cap

Nebulizer cup and screw-on or snap-on cap

Plastic T

Plastic T connector (not needed for Sidestream nebulizer or PARI BABY™)

Tube

Flexible aerosol tube (not needed for Sidestream nebulizer or PARI BABY™)

Mouthpiece

Clean mouthpiece or PARI BABY™ facemask

Reservoir Tube

Long connecting tube

Nose Clip

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

Figure A

Remember to communicate these important instructions to patients/caregivers:

Step 1. Clean a flat table surface and wash your hands

  • Clean a flat table surface
  • Wash your hands well with soap and water before using the Pulmozyme (dornase alfa) ampule and nebulizer. This helps prevent infection (See Figure B)
Wash hands
Figure B

Step 2. Gather the nebulizer and test the compressor

  • Place the nebulizer parts on a clean, flat table surface within reach 
  • Test the compressor by turning it on and putting your finger in front of the "air out" or "air" port to feel air flowing. Turn off the compressor (See Figure C)
  • For the MOBILAIRE™ compressor only, turn the pressure control knob fully to the right for the highest pressure output
On/off button
Figure C

Step 3. Gather the Pulmozyme (dornase alfa) ampule and check the expiration date

  • Remove 1 foil pouch of Pulmozyme (dornase alfa) from the refrigerator. Open the foil pouch and remove 1 ampule of Pulmozyme (dornase alfa). Put the remaining ampules back in the foil pouch and return them to the refrigerator
  • Check the expiration date printed on the ampule (See Figure D). Do not use the Pulmozyme (dornase alfa) ampule if the expiration date has passed
Ampule
Figure D

Step 4. Check the Pulmozyme (dornase alfa) ampule

  • Check the ampule for leaks by turning it upside down and gently squeezing (See Figure E). Do not use the ampule if it is leaking. Throw it away and get a new one
  • Check the Pulmozyme (dornase alfa) liquid in the ampule and make sure it is clear and free of particles
  • Do not use Pulmozyme (dornase alfa) if the liquid is cloudy or discolored. Take the Pulmozyme (dornase alfa) back to the pharmacy, hospital, or clinic that gave you the medicine
Ampule
Figure E

Step 5. Attach the tube to the compressor

  • Attach the long connecting tube to the "air out" or "air" port on the compressor (See Figure F)
Tubing
Figure F

Step 6. Attach the mouthpiece.

  • Skip to Step 7 if you use the Sidestream nebulizer or the PARI BABY™ nebulizer
  • Push the mouthpiece into the wider end of the plastic T. Attach the flex tube to the other end of the T (See Figure G)
Mouthpiece
Figure G

Step 7. Remove the cap from the cup

  • Unscrew or unsnap the cap from the nebulizer cup (See Figure H) 
  • Put the nebulizer cup on the table face up and place the cap upside down on a clean surface (See Figure I)

Nebulizer cup
Figure H
Nebulizer cup face up
Figure I

Step 8. Open the Pulmozyme (dornase alfa) ampule

  • Hold the tab at the bottom of the Pulmozyme (dornase alfa) ampule firmly. Twist off the top. Do not squeeze the body of the ampule (See Figure J)
Open ampule
Figure J

Step 9. Pour the full Pulmozyme (dornase alfa) dose into the nebulizer

 

  • Turn the ampule upside down and squeeze gently to empty the medicine into the nebulizer cup. Keep squeezing until the ampule is empty. It is very important you squeeze all of the medicine out of the ampule (See Figure K)
  • Screw or snap the cap onto the nebulizer cup (See Figure L)

 

Pour ampule into cup
Figure K
Green light and mist
Figure L

Step 10. Connect the plastic T

 

  • Connect the plastic T to the nebulizer cap (See Figure M)
  • If you are using the Sidestream nebulizer, attach the mouthpiece to the top of the nebulizer (See Figure N)
  • If you are using the PARI BABY™ nebulizer, connect the elbow piece and mask to the nebulizer outlet (See Figure O)

 

Cap
Figure M
Mouthpiece
Figure N
Elbow and mask
Figure O

Step 11. Attach the tube to the cup

  • Connect the open end of the long tube to the port on the bottom of the nebulizer cup by pushing up firmly (See Figure P)

Connect tube to cup
Figure P

Step 12. Turn on the compressor

  • Turn on the compressor and check to see that mist is coming out of the nebulizer (See Figure Q)
  • If you are using the MOBILAIRETM compressor, turn the compressor control knob fully to the right, then turn on the compressor. The pressure gauge should move between 35 psi and 45 psi, the highest pressure output (See Figure R)
Mist
Figure Q
Gauge and knob
Figure R

Taking a dose of Pulmozyme with a nebulizer:

Step 13. Breathe through the mouthpiece.

  • Skip to Step 14 if you are using the PARI BABY to give Pulmozyme (dornase alfa) to your child
  • Place the mouthpiece between your teeth and on top of your tongue (See Figure S) 
  • Breathe slowly in and out through your mouth. Do not block the airflow with your tongue
  • Do not breathe through your nose. If you have problems breathing only through your mouth, use a nose clip (See Figure T)
  • Do not be concerned if liquid droplets form 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 making mist (See Figure U)
  • If you need to stop treatment before you are finished, or you begin coughing, turn off the compressor and do not spill any of the medicine
  • To start treatment again, turn on the compressor and continue breathing slowly in and out through your mouth
  • The complete treatment usually takes from 10 to 15 minutes for most nebulizers and compressors
  • If you are using the Sidestream nebulizer with the MOBILAIRE™ or Porta-Neb compressors, treatment usually takes from 2 to 6 minutes
  • It is important to inhale the full dose of Pulmozyme (dornase alfa). If you find a leak or feel any moisture coming from the nebulizer during treatment, turn off the compressor and check to make sure the nebulizer cap is sealed correctly before continuing (See Figure V)
Mouthpiece
Figure S
Nose clip on
Figure T
Continue breathing
Figure U
Sealed tight
Figure V

If you are using the PARI BABY™ nebulizer to give Pulmozyme to your child, follow the instructions below in Step 14. If not go to Step 15.

Step 14. Breathing through the facemask 

During the treatment, your child may sit, lie down, or stand.

  • Place the facemask gently but firmly over your child’s nose and mouth (See Figure W) 
  • Make sure there are no air gaps between the mask and your child's face. This will help make sure that your child will get the full dose of Pulmozyme (dornase alfa)
  • It is important that you try to keep the body of the nebulizer upright during the entire treatment (See Figure W). The elbow piece will allow you to move the mask for a good fit while keeping the nebulizer body upright
  • When the nebulizer begins "spitting," gently tap the nebulizer cup and continue treatment until the nebulizer is empty or stops making a mist (See Figure X)
  • If you need to stop the treatment or your child begins to cough during treatment, turn the compressor off. Do not spill any Pulmozyme (dornase alfa)
  • If you have not removed the mask and you want to begin the treatment again, turn on the compressor
  • If you have removed the mask, repeat the steps above to replace the mask on your child’s face and restart the compressor 
  • The complete treatment usually takes from 10 to 15 minutes

It is important that your child inhale the full dose of Pulmozyme (dornase alfa). If you find a leak or feel moisture coming from the nebulizer during the treatment, turn off the compressor and make sure the nebulizer cap is sealed correctly before starting the compressor again (See Figure Y).

Place facemask on
Figure W
Tap the Nebulizer
Figure X
Seal Nebulizer cap
Figure Y

After your treatment with Pulmozyme:

Step 15. Prepare the nebulizer for cleaning and storage.

  • Turn off the compressor and take apart the nebulizer system. Set aside the flex tube and the long connecting tube
    Note: The Sidestream nebulizer does not use a flex tube
  • Throw away the Pulmozyme (dornase alfa) ampule in your household trash
  • Follow the manufacturer's recommendations for care of your nebulizer and compressor

How should I store Pulmozyme?

 

  • Store Pulmozyme (dornase alfa) in its foil pouch in the refrigerator between 36°F to 46°F (2°C to 8°C) until you are ready to use it
  • When traveling, Pulmozyme (dornase alfa) should be kept cold
  • Do not freeze Pulmozyme (dornase alfa)
  • Protect Pulmozyme (dornase alfa) from excessive heat and strong light
  • Do not use Pulmozyme (dornase alfa) if it has been left at room temperature for a total time of 24 hours or if it becomes cloudy or discolored
  • Do not use Pulmozyme (dornase alfa) past the expiration date printed on the ampule

 


Indication and Usage

Pulmozyme (dornase alfa) is indicated, along with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function.

In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring injectable antibiotics.

Pulmozyme should not be used in patients who are allergic to any of its ingredients.

Patients may experience the following when using Pulmozyme: change in or loss of their voice, discomfort in the throat, rash, chest pain, red watery eyes, runny nose, lowering of lung function, fever, indigestion, and shortness of breath. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Mild to moderate hives and mild skin rash have been observed and have been short-lived.

Pediatric Use

The safety and effectiveness of Pulmozyme along with standard therapies for cystic fibrosis have been established in pediatric patients. The use of Pulmozyme in pediatric patients at 5 to 17 years of age is supported by evidence from a randomized, controlled trial. The use of Pulmozyme in patients less than 5 years of age is supported by the efficacy data from the same randomized, controlled trial and additional safety data in pediatric patients aged 3 months to less than 5 years who received Pulmozyme.

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

For further information, please see the Pulmozyme full Prescribing Information. If you have questions, please discuss them with your CF Care Team.