Instructions for how to administer Pulmozyme with a vibrating mesh nebulizer

There are 2 ways to administer Pulmozyme, with a vibrating mesh nebulizer or with a jet nebulizer and compressor.
See instructions for using a jet nebulizer and compressor.

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Instructions for use with a vibrating mesh nebulizer

This information does not take the place of the Manufacturer’s Instructions for Use for the nebulizer.

The vibrating mesh nebulizer changes the Pulmozyme liquid medicine into a fine mist you inhale by breathing through a mouthpiece.

Do not use any other inhaled medicines in the nebulizer at the same time. Keep all other inhaled medication systems completely separate from Pulmozyme.

The eRapid Nebulizer system should only be used by adults and children who can use a mouthpiece, and not by younger children who need a mask to take Pulmozyme.

Follow the instructions on this page to give Pulmozyme using a vibrating mesh nebulizer.


Important Information You Need to Know Before Using Pulmozyme

Read and follow the nebulizer manufacturer’s instruction manual for correct use and maintenance:

  • to clean the nebulizer before first use and after each use as recommended
  • to disinfect the nebulizer parts by using the disinfecting method recommended
  • to replace nebulizer parts as recommended

Supplies you will need to give a dose of Pulmozyme:

  • 1 Pulmozyme ampule (See Figure A)
  • Vibrating mesh nebulizer and its components
  • Nose clip (optional) (See Figure B)
  • Manufacturer’s Instructions for Use
Pulmozyme® (dornase alfa) ampule
1 ampule of Pulmozyme
Figure A
Nose clip
Nose clip (optional)
Figure B

Preparing the vibrating mesh nebulizer:

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 ampule and nebulizer. This helps prevent infection (See Figure C)
Wash hands
Figure C

Step 2. Gather the nebulizer and test it

  • Place the vibrating mesh nebulizer on a clean, flat table surface within reach
  • Make sure you have followed the Manufacturer’s Instructions for Use to ensure that the nebulizer is charged and ready for use

Step 3. Gather the Pulmozyme ampule and check the expiration date

  • Remove 1 foil pouch of Pulmozyme from the refrigerator. Open the foil pouch and remove 1 ampule of Pulmozyme. 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 ampule if the expiration date has passed
Check the ampule
Figure D

Step 4. Check the Pulmozyme 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 liquid in the ampule and make sure it is clear and free of particles
  • Do not use Pulmozyme if the liquid is cloudy or discolored. Take the Pulmozyme back to the pharmacy, hospital, or clinic that gave you the medicine
Check expiration date
Figure E

Step 5. Put together the vibrating mesh nebulizer

  • Assemble the nebulizer according to the Manufacturer’s Instructions for Use for step-by-step instructions for how to put together your nebulizer

Step 6. Prepare and take your treatment with Pulmozyme

  • Open the Pulmozyme ampule
  • Hold the tab at the bottom of the Pulmozyme ampule firmly. Twist off the top. Do not squeeze the body of the ampule (See Figure F)
Open ampule
Figure F
  • Turn the ampule upside down and squeeze gently to empty the medicine into the medicine cup. Keep squeezing until the ampule is empty. It is very important that you squeeze out all the medicine in the ampule
  • Read the Manufacturer’s Instructions for Use on how to turn the nebulizer on and off, and follow the steps for how to take your nebulized treatment, how to breathe through the mouthpiece or facemask, how to restart treatment if you need to stop before you are finished, and how to confirm that your treatment is complete
  • Breathe slowly in and out through your mouth when using a mouthpiece. Do not block medicine flow with your tongue
  • Do not breathe through your nose when using a mouthpiece. If you have problems breathing only through your mouth, use a nose clip (See Figure B)

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).
Pulmozyme® (dornase alfa) nebulizer cup
Figure H
Nebulizer cup cap face up
Figure I

Step 8. Open the Pulmozyme ampule

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

After Your Treatment with Pulmozyme:

Step 9. Clean the nebulizer

  • Throw away the empty Pulmozyme ampule in your household trash
  • Clean the nebulizer thoroughly after each use. Follow the Manufacturer’s instruction manual for cleaning the nebulizer
  • All nebulizer parts must be cleaned after each use and disinfected after each day of use as recommended in the Manufacturer’s instruction manual
  • Replace the handset as recommended in the Manufacturer’s instruction manual

How should I store Pulmozyme?

  • Store Pulmozyme ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil pouch to protect from light and heat until you are ready to use them. When the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat
  • When traveling, Pulmozyme ampules should be kept cold in their protective foil pouch to protect from light and heat
  • Protect Pulmozyme from excessive heat and strong light
  • Do not use Pulmozyme if the ampules have been exposed to room temperature (22°C to 28°C/72°F to 82°F) for more than a total of 60 hours or if the solution has turned cloudy or discolored
  • Do not use Pulmozyme past the expiration date printed on the ampule

Important Safety Information

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.