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Instructions for how to administer Pulmozyme with a vibrating mesh nebulizer18

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.

Quick Links

Instructions for use with a vibrating mesh nebulizer
Preparing the vibrating mesh nebulizer
Taking your dose of Pulmozyme
After Your Treatment with Pulmozyme
How to store Pulmozyme

Instructions for Use

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.

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 Pulmozyme ampule
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 expiration date
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 the ampule
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
  • Pour the full Pulmozyme dose into the nebulizer as shown in the Manufacturer’s Instructions for Use
  • 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
  • Gather the nebulizer and test the compressor
  • Open the Pulmozyme ampule

After Your Treatment with Pulmozyme:

Step 7. Clean the nebulizer

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

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 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

 

Approved Equipment

See what equipment is approved for use with Pulmozyme

Next Page: Patient and Practice Resources

Important Safety Information

Indication and Usage

Pulmozyme (dornase alfa) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients 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 parenteral antibiotics.

Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.

The most common adverse reactions associated with the use of Pulmozyme include: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥ 10%, fever, dyspepsia, and dyspnea. There have been no reports of anaphylaxis attributed to the administration of Pulmozyme. Mild to moderate urticaria and mild skin rash have been observed and have been transient.

Pediatric Use

The safety and effectiveness of Pulmozyme in conjunction with standard therapies for cystic fibrosis have been established in pediatric patients. Use of Pulmozyme in pediatric patients is supported by evidence in the following age groups:

  • Patients 5 to 17 years of age: A randomized, placebo-controlled trial of 303 of clinically stable cystic fibrosis patients 5 to 17 years of age who received Pulmozyme.
  • Patients less than 5 years: Extrapolation of efficacy data in patients 5 years of age and older with additional safety data in 65 pediatric patients aged 3 months to less than 5 years who received Pulmozyme 2.5 mg daily by inhalation for 2 weeks.

The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 pediatric patients with cystic fibrosis 3 months to 10 years of age (65 aged 3 months to < 5 years, 33 aged 5 to ≤ 10 years). The PARI BABYTM reusable nebulizer (which uses a facemask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger; and 2/33, 6% of the older patients). Overall, the nature of adverse reactions was similar to that seen in the placebo-controlled trials in older patients. The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45%; compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37%; compared to 6/33, 18%). The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35%; compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33, 0%).

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.

Please see Pulmozyme full Prescribing Information for additional Important Safety Information.

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