Customer Contact Center:
1-888-PLMZYME (756-9963)

Indication

Pulmozyme® (dornase alfa) is indicated for daily administration along 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 injectable antibiotics.

Important Safety Information

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.

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.

Pediatric Use

The safety and effectiveness of Pulmozyme have been established in patients 5 years of age and older. While clinical trial data are limited in patients younger than 5 years of age, the use of PULMOZYME should be considered for pediatric CF patients who may experience potential benefit in lung function or who may be at risk of respiratory tract infection.

The safety of Pulmozyme given by daily inhalation for 2 weeks has been studied using 98 CF patients with 65 of them aged 3 months to <5 years (younger group) and 33 aged 5 years to <10 years (older group). The PARI BABY™ reusable nebulizer (which uses a face mask instead of a mouthpiece) was used in patients who were unable to show that they could breathe in or out using their mouth throughout the entire treatment period. Overall, the kind of side effects observed in children was similar to those seen in larger trials in older patients.

Customer Contact Center

1-888-PLMZYME (756-9963)

Pulmozyme Access Solutions®

Nebulizers and compressors

You need a nebulizer and a compressor to take Pulmozyme. However, not all nebulizers and compressors are the same. Your doctor or healthcare team can help you make the selection that best fits your needs. Here are some things you may want to talk about:

  • Is it FDA approved? Did you know that the FDA approves the use of certain nebulizers and compressors for certain medicines? See a list of FDA-approved nebulizers and compressors below.
  • What is your lifestyle like? This is an investment in your health, so you will want it to fit into your life. Consider what conveniences you need. For example, nebulizers/compressors may have different delivery times and cleaning instructions.
  • Will a child use it? Certain nebulizers are designed especially for younger children and have features such as a mask instead of a mouthpiece.
  • How much will it cost? Costs, out-of-pocket expenses, and insurance coverage can vary. If you need help to better understand your insurance coverage, Pulmozyme Access Solutions® may be able to help.
    A new nebulizer, the eRapid® (PARI) Nebulizer System, has been approved by the FDA for use with Pulmozyme. Payer coverage and patient out-of-pocket costs vary and may change over time. Patients should consult with the specialty pharmacies that distribute eRapid, who will help navigate insurance coverage and possible reimbursement challenges.

Now Available for Use with Pulmozyme

eRapid® (PARI) Nebulizer System

Quick treatments with Pulmozyme

The eRapid® (PARI) Nebulizer System, newly FDA-approved for use with Pulmozyme, delivers short treatment times1 in a system that is:

  • Small
  • Portable
  • Quiet
  • Quick*
PARI eRapid Nebulizer System

For more information on eRapid, call PARI at (866) 335-6943, or visit PARI.com
Ask your doctor if eRapid® with Pulmozyme might be right for your CF treatment.

*The average nebulization time for the eRapid Nebulizer System is approximately 2-3 minutes compared to the LC® Plus Jet Nebulizer which is approximately 6-10 Minutes.2,3

Compare FDA-approved nebulizers/compressors.

The following chart lists all the nebulizer and compressor combinations that are approved for use with Pulmozyme.

Jet NebulizerCompressor
Hudson "T" Up-draft II® with Pulmo-Aide®
Marquest Acorn II® withPulmo-Aide®
PARI LC® PLUS Reusable* withPARI PRONEB®
PARI BABY™* withPARI PRONEB®
Durable Sidestream®* withMOBILAIRE™
Durable Sidestream®* withPorta-Neb®
Nebulizer System
eRapid® (PARI) 

* Dishwasher-safe.
Invacare Corporation. Used with permission.

Using your nebulizer and compressor

Always follow the instructions provided by your CF healthcare team for taking Pulmozyme, and be sure that you use the full dose.


Pulmozyme should not be diluted or mixed with other drugs in the nebulizer.

Consult your CF healthcare team for their recommendation of nebulizer and compressor and instructions for their use or if you have any other questions about Pulmozyme or these delivery systems. Follow the manufacturer's recommendations for care and use of your nebulizer and compressor.

Please see Important Safety Information and accompanying full
Prescribing Information.

References
  1. Naehrig S, Lang S, Schiffl H, et al. Lung function in adult patients with cystic fibrosis after using the eFlow rapid for one year. Eur J Med Res. 2011;16(2):63-66.
  2. Scherer T, Geller D, Owyang L, et al. A technical feasibility study of Dornase alfa delivery with eFlow® Vibrating Membrane Nebulizers: Aerosol characteristics and physicochemical stability. Journal of Pharmaceutical Sciences. 2011;100(1):98-109.
  3. Data on File. Genentech, a member of the Roche Group.