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Instructions for how to administer Pulmozyme with a jet nebulizer and compressor18

Jet Nebulizer image

There are 2 ways to administer Pulmozyme, with a jet nebulizer and compressor or with a vibrating mesh nebulizer. For instructions in using a vibrating mesh nebulizer, go here

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Step-by-step instructions (PDF)
Instructions for use with jet nebulizers and compressors
Supplies you will need to give a dose of Pulmozyme
Important instructions to patients/caregivers
Taking a dose of Pulmozyme with a nebulizer
Using the PARI BABY™ nebulizer
After treatment with Pulmozyme
How to store Pulmozyme

Instructions for Use

Instructions for use with jet nebulizers and compressors18

A nebulizer and a compressor are used together to give a dose of Pulmozyme. 
A nebulizer changes the Pulmozyme liquid medicine into a fine mist inhaled by breathing through a mouthpiece. A compressor gives the nebulizer power and makes the nebulizer work.
Pulmozyme should only be used with the approved nebulizers and compressors or with a recommended vibrating mesh nebulizer.

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. 

Use the mouthpiece or face mask provided with the nebulizer kit.
If your child cannot breathe in or breathe out by mouth, you may use the PARI BABY™ reusable nebulizer, but you should discuss it with your doctor first. 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 Pulmozyme ampule

Compressor

Compressor

Nebulizer Cup and Cap

Nebulizer cup and cap (screw-on or snap-on)

Plastic T

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

Tube

Long connecting tube

Mouthpiece

Mouthpiece (clean) or PARI BABY™ facemask

Reservoir Tube

Flexible aerosol 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 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)
On/off button
Figure C

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
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
Ampule
Figure E

Step 5. Attach the long connecting 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 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

Step 9. Pour the full Pulmozyme dose into the nebulizer cup

  • 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 long connecting tube to the cup

  • Connect the open end of the long connecting 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)
Mist
Figure Q

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 to your child
  • Place the mouthpiece between your teeth and on top of your tongue (See Figure R) 
  • 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 S)
  • 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 T)
  • 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, treatment usually takes from 2 to 6 minutes
  • It is important to inhale the full dose of Pulmozyme. 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 U)
Mouthpiece
Figure R
Nose clip on
Figure S
Continue breathing
Figure T
Sealed tight
Figure U

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 V) 
  • 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
  • It is important that you try to keep the body of the nebulizer upright during the entire treatment (See Figure V). 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 W)
  • If you need to stop the treatment or your child begins to cough during treatment, turn the compressor off. Do not spill any Pulmozyme
  • 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. 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 X).

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

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 flexible aerosol tube and the long connecting tube
    Note: The Sidestream nebulizer does not use a flexible aerosol tube
  • Throw away the Pulmozyme 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 alsa) 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: Administering with Portable Nebulizer

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.

    • Pulmozyme (dornase alfa) [package insert]. South San Francisco, CA: Genentech, Inc; 2024.

      Pulmozyme (dornase alfa) [package insert]. South San Francisco, CA: Genentech, Inc; 2024.

    • Harms HK, Matouk E, Tournier G, et al; DNase International Study Group. Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. Pediatr Pulmonol. 1998;26(3):155-161.

      Harms HK, Matouk E, Tournier G, et al; DNase International Study Group. Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. Pediatr Pulmonol. 1998;26(3):155-161.

    • Chmiel JF, Konstan MW. Anti-inflammatory medications for cystic fibrosis lung disease: selecting the most appropriate agent. Treat Respir Med. 2005;4(4):255-273.

      Chmiel JF, Konstan MW. Anti-inflammatory medications for cystic fibrosis lung disease: selecting the most appropriate agent. Treat Respir Med. 2005;4(4):255-273.

    • Puchelle E, de Bentzmann S, Zahm JM. Physical and functional properties of airway secretions in cystic fibrosis—therapeutic approaches. Respiration. 1995;62(suppl 1):2-12.

      Puchelle E, de Bentzmann S, Zahm JM. Physical and functional properties of airway secretions in cystic fibrosis—therapeutic approaches. Respiration. 1995;62(suppl 1):2-12.

    • King M. Mucolytics and mucus clearance. In: Rubin BK, van der Schans CP, eds. Therapy for Mucus-Clearance Disorders. New York, NY: Marcel Dekker Inc; 2004:201-224.

      King M. Mucolytics and mucus clearance. In: Rubin BK, van der Schans CP, eds. Therapy for Mucus-Clearance Disorders. New York, NY: Marcel Dekker Inc; 2004:201-224.

    • Flume PA, Van Devanter DR. State of progress in treating cystic fibrosis respiratory disease. BMC Med. 2012;10:88.

      Flume PA, Van Devanter DR. State of progress in treating cystic fibrosis respiratory disease. BMC Med. 2012;10:88.

    • Drug development pipeline. Cystic Fibrosis Foundation website. https://www.cff.org/trials/pipeline. Accessed August 17, 2020.

      Drug development pipeline. Cystic Fibrosis Foundation website. https://www.cff.org/trials/pipeline. Accessed August 17, 2020.

    • Research milestones. Cystic Fibrosis Foundation website. https://www.cff.org/about-us/our-history. August 17, 2020.

      Research milestones. Cystic Fibrosis Foundation website. https://www.cff.org/about-us/our-history. August 17, 2020.

    • Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N Engl J Med. 1994;331(10):637-642.

      Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N Engl J Med. 1994;331(10):637-642.

    • Data on file. Genentech, a member of the Roche Group.

      Data on file. Genentech, a member of the Roche Group.

    • Cystic Fibrosis Foundation Patient Registry 2016 Annual Data Report. Bethesda, MD. ©2017 Cystic Fibrosis Foundation.

      Cystic Fibrosis Foundation Patient Registry 2016 Annual Data Report. Bethesda, MD. ©2017 Cystic Fibrosis Foundation.

    • Sly PD, Brennan S, Gangell C, et al. Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009;180(2):146-152. 

      Sly PD, Brennan S, Gangell C, et al. Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009;180(2):146-152. 

    • Sly PD, Gangell CL, Chen L, et al. Risk factors for bronchiectasis in children with cystic fibrosis. N Engl J Med. 2013;368(21):1963-1970.

      Sly PD, Gangell CL, Chen L, et al. Risk factors for bronchiectasis in children with cystic fibrosis. N Engl J Med. 2013;368(21):1963-1970.

    • Bakker EM, Volpi S, Salonini E, et al. Small airway deposition of dornase alfa during exacerbations in cystic fibrosis; a randomized controlled clinical trial. Pediatr Pulmonol. 2020;49(2):154-161.

      Bakker EM, Volpi S, Salonini E, et al. Small airway deposition of dornase alfa during exacerbations in cystic fibrosis; a randomized controlled clinical trial. Pediatr Pulmonol. 2020;49(2):154-161.

    • Trikafta [Package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2021. 

      Trikafta [Package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2021. 

    • Heijerman HGM, McKone EF, Downey DG, et al. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019;394(10212)1940-1948. 

      Heijerman HGM, McKone EF, Downey DG, et al. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019;394(10212)1940-1948. 

    • Middleton PG, Mall MA, Dřevínek P, et al. Elexacaftor–tezacaftor–ivacaftor for cystic fibrosis with a single Phe508del allele. N Engl J Med. 2019;381(19):1809-1819. 

      Middleton PG, Mall MA, Dřevínek P, et al. Elexacaftor–tezacaftor–ivacaftor for cystic fibrosis with a single Phe508del allele. N Engl J Med. 2019;381(19):1809-1819. 

    • Pulmozyme Instructions for Use. South San Francisco, CA: Genentech, Inc; 2024.

      Pulmozyme Instructions for Use. South San Francisco, CA: Genentech, Inc; 2024.

    • Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013;187:680-689.

      Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013;187:680-689.

    • Clancy JP. Ongoing research into CFTR modulation. Adv Stud Med. 2010;10(1):14-18.

      Clancy JP. Ongoing research into CFTR modulation. Adv Stud Med. 2010;10(1):14-18.

    • Treatments and therapies. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/. Accessed July 22, 2021. 

      Treatments and therapies. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/. Accessed July 22, 2021. 

    • Medications. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/Medications/. Accessed July 22, 2021.

      Medications. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/Medications/. Accessed July 22, 2021.

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