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Instructions for how to administer Pulmozyme with the eRapid™ Nebulizer System18

eRapid image

There are 2 ways to administer Pulmozyme (dornase alfa), with or without the eRapid™ Nebulizer System. See instructions for using a Jet Nebulizer and Compressor.

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Instructions for use with eRapid™ Nebulizer System
Preparing the eRapid nebulizer system
Taking your dose of Pulmozyme
After Your Treatment with Pulmozyme
How to store Pulmozyme

Patient-friendly, step-by-step instructions on administering Pulmozyme

Instructions for Use with the eRapid™ Nebulizer System

This information does not take the place of the Manufacturer’s eRapid Nebulizer System Instruction Booklet. This information is needed to show you the right way to use the eRapid Nebulizer System.

The eRapid Nebulizer System changes the Pulmozyme (dornase alfa) 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 (dornase alfa).

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 (dornase alfa).

Follow the instructions on this page to give Pulmozyme (dornase alfa) using the eRapid Nebulizer System. 

Supplies you will need to give a dose of Pulmozyme:

Pulmozyme® (dornase alfa) ampule
1 Pulmozyme ampule
Nose clip
Nose clip (optional)
Instruction booklet
Manufacturer’s eRapid Nebulizer System Instruction Booklet
eRapid nebulizer system
eRapid Nebulizer System, including the:
eRapid Nebulizer Handset (handset)
eBase Controller (controller)

 

4 AA batteries
AC power supply
Power source for the controller, using either:
4 “AA” batteries (disposable or rechargeable)
An AC power supply plugged into atypical wall outlet (110 volt power outlet)
Figure A

Preparing the eRapid nebulizer system:

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 it

  • Place the eRapid system parts on a clean, flat table surface within reach
  • Make sure the controller batteries are charged or that the unit is plugged into a power outlet (See Figure C)
  • Press and hold the ON/OFF button on the controller for a few seconds to test if the controller will turn on (See Figure D)
  • When controller is turned on, press and hold the ON/OFF button to turn the controller off
Power supply and Outlet
Figure C
ON/OFF button
Figure D

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 E). Do not use the Pulmozyme (dornase alfa) ampule if the expiration date has passed
Check expiration date
Figure E

Step 4. Check the Pulmozyme (dornase alfa) ampule

  • Check the ampule for leaks by turning it upside down and gently squeezing (See Figure F). 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
Check the ampule
Figure F

Step 5. Put together the eRapid nebulizer system

 

  • The eRapid Nebulizer System has several small parts that must be put together the right way to give your dose of Pulmozyme (dornase alfa) (Figure G)
  • The parts must be cleaned and disinfected at least 1 time before first use  
  • See the Manufacturer’s eRapid Nebulizer System Instruction Booklet for cleaning instructions and step-by-step instructions for how to put together your eRapid Nebulizer System (See Figure G)

 

Small parts and booklet
Figure G

Step 6. 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 H)
Open ampule
Figure H

Step 7. Pour the full Pulmozyme (dornase alfa) dose into the nebulizer

  • Turn the ampule upside down and squeeze gently to empty the medicine into the medication reservoir. Keep squeezing until the ampule is empty. It is very important that you squeeze out all the medicine in the ampule (See Figure I)
Dose into Medication reservoir
Figure I

Step 8. Place the cap on the medication reservoir

  • Line up the tabs on the medication cap with the slots on the medication reservoir (See Figure J)
  • Turn medication cap clockwise until it stops (See Figure J)
Medication reservoir Cap
Figure J

Step 9. Turn on the nebulizer

  • Press and hold the ON/OFF button on the controller for a few seconds (See Figure K) 
  • The controller will beep and the light will turn green. The nebulizer will start making mist (See Figure L)
ON/OFF button
Figure K
Green light and mist
Figure L

Taking your dose of Pulmozyme:

Step 10. Breathe through the mouthpiece

  • Place the mouthpiece between your teeth and on top of your tongue (See Figure M)
  • Breathe slowly in and out through your mouth
  • Do not block medicine flow with your tongue
  • Do not breathe through your nose. If you have problems breathing only through your mouth, use a nose clip (See Figure N)
  • If you need to stop treatment before you are finished, or you begin coughing, press and hold the ON/OFF button on the controller for 1 second (See Figure O) 
  • To restart your treatment, press and hold the ON/OFF button for 1 second
  • Continue your treatment until the controller beeps 2 times
  • The nebulizer will shut off by itself when your dose is complete. The complete treatment usually takes from 1 minute to 5 minutes
Mouth piece
Figure M
Nose clip
Figure N
ON/OFF button
Figure O

Step 11. Check that you received your full dose

  • After your treatment, about ⅕ teaspoon (1 mL) of medicine should be left in the medication reservoir (See Figure P)
  • Open the medication cap and check the medication reservoir. If more than ⅕ teaspoon (1 mL) is left in the medication reservoir, put the medication cap back on and continue treatment
  • When treatment is complete, throw away the ⅕ teaspoon (1 mL) of medicine that is left in the medication reservoir
Medication reservoir
Figure P

After Your Treatment with Pulmozyme:

Step 12. Cleaning the nebulizer

  • If the controller is on, turn off the controller by pressing and holding the ON/OFF button
  • Take apart the nebulizer system
  • Throw away the empty Pulmozyme (dornase alfa) ampule in your household trash
  • See the Manufacturer’s eRapid Nebulizer System Instruction Booklet for cleaning instructions (See Figure Q).
    • The handset, including the medication reservoir, medication cap, aerosol head, and mouthpiece, must be cleaned after each use and disinfected after each day of use
    • Use of the EasyCare cleaning aid is recommended for cleaning the aerosol head located inside the handset 1 time each week
    • Replace the handset after you use your eRapid Nebulizer System 90 times. Replace it even if you use the EasyCare cleaning aid
    • Your handset has been tested for only 90 doses of Pulmozyme (dornase alfa).  Delivery of the right dose of Pulmozyme (dornase alfa) cannot be certain after 90 doses
Instruction booklet
Figure Q

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 should be kept cold in its foil pouch
  • Protect Pulmozyme from excessive heat and 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

 

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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