It’s normal to have questions about cystic fibrosis (CF) and your treatment. This page will give you answers to some of the most frequently asked questions about treatment with Pulmozyme.
About Pulmozyme
In CF, your lungs produce extra-thick, sticky mucus. Laboratory studies have shown that Pulmozyme works to help make mucus thinner and looser. You can learn more about the clinical data supporting the use of Pulmozyme.
Treating CF is complicated, so it is important to take all of your treatments as your doctor prescribed them. Your doctor may prescribe other medications that help with other aspects of CF, such as:
- Bronchodilators help open airways
- Hydrators help increase moisture in thick mucus
- Airway clearance techniques help loosen and move mucus out of the way
- Antibiotics help prevent and treat infections
- Gene-specific treatments, which are known as cystic fibrosis transmembrane conductance regulator (CFTR) modulators, help keep a balance of salt and water in the lungs
Although you may not see or feel the signs and symptoms of CF, the disease may still be affecting your lungs. That's why it's so important to take Pulmozyme (dornase alfa) exactly as your doctor has prescribed.
In CF, your lungs produce extra-thick, sticky mucus. Pulmozyme plays a distinct role in the fight against CF: it helps make mucus thinner and looser.
- One of the causes of thickened mucus in the lungs is extracellular DNA
- As seen in laboratory studies, Pulmozyme uniquely cuts apart extracellular DNA by acting like an enzyme naturally found in the lungs
- Cutting up extracellular DNA can help make mucus thinner and looser, which can make it easier to clear your lungs
- When taken once-daily or twice-daily, Pulmozyme was shown to improve lung function in a clinical study of patients 5 years of age or older with a forced vital capacity (FVC) greater than or equal to 40% of predicted
You can learn more about the clinical data supporting the use of Pulmozyme here. If you have questions about the importance of taking Pulmozyme, talk to your doctor.
Every prescribed therapy plays a role to help you fight CF.
Pulmozyme is a mucolytic. In laboratory studies, Pulmozyme was shown to act like a protein already in your body to cut apart the sticky mucus your lungs produce, making it thinner and looser.
Gene-specific treatments, also called cystic fibrosis transmembrane conductance regulator (CFTR) modulators, were studied for use in patients with specific genetic mutations. Even though studies for these gene-specific treatments were not designed to look at the efficacy and safety of CFTR modulators in combination with existing treatments, patients in these studies stayed on their prescribed CF therapies (eg, Pulmozyme, tobramycin) throughout the studies.
Please contact your doctor and/or CF Care Team to discuss your specific treatment plan and the distinct role each of your prescribed therapies plays.
Pulmozyme was approved by the US Food and Drug Administration (FDA) in 1993, and was the first drug developed specifically for CF.
Pulmozyme has demonstrated safety in children 5 years of age or older, adolescents, and adults.
- The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 65 patients with CF aged 3 months to < 5 years
- Overall, the safety profile was similar to that seen in the placebo-controlled trials of older patients
- The number of patients reporting cough was higher in the younger age group compared to the older age group (45%; compared to 30%), as was the number reporting moderate to severe cough (37%; compared to 18%)
- The number of patients reporting rhinitis was higher in the younger age group compared to the older age group (35%; compared to 27%), as was the number reporting rash (6% compared to 0%)
Based on studies, patients may experience the following when using Pulmozyme:
- Change in or loss of voice
- Throat discomfort
- Rash
- Chest pain
- Red watery eyes
- Runny nose
- Lowering of lung function
- Fever
- Indigestion
- Shortness of breath
Mild to moderate hives and mild skin rash have been observed and have been short-lived. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Pulmozyme should not be used in patients who are allergic to any of its ingredients.
You should call your doctor if you experience any of these side effects or if any of these side effects are severe, get worse, or do not go away.
Based on studies, patients may experience the following when using Pulmozyme:
- Change in or loss of voice
- Throat discomfort
- Rash
- Chest pain
- Red watery eyes
- Runny nose
- Lowering of lung function
- Fever
- Indigestion
- Shortness of breath
Mild to moderate hives and mild skin rash have been observed and have been short-lived. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme.
You should call your doctor if you experience any of these side effects or if any of these side effects are severe, get worse, or do not go away.
These are not all the possible side effects of Pulmozyme. Please see the full Prescribing Information for additional Important Safety Information.
The recommended dose for most CF patients is Pulmozyme 2.5 mg once-daily.
Some patients over 21 may benefit from twice-daily treatment. You should ask your doctor whether prescribing Pulmozyme 2.5 mg twice-daily may be right for you.
Fortunately, there are a lot of resources to help people living with CF.
Taking Pulmozyme
The FDA has approved specific nebulizers/compressors to be used with Pulmozyme.
Five vibrating mesh nebulizers are recommended:
- eRapid® Nebulizer System
- Innospire Go
- Pulmogine Vibrating Mesh Nebulizer
- AireHealth Nebulizer™
- Intelligent Mesh Nebulizer
The following jet nebulizers and compressors have been FDA-approved for use with Pulmozyme:
- Hudson T Up-draft II® with a compressor with pressure and flow rate maximum 30 psi, 12 LPM
- Marquest Acorn II® with a compressor with pressure and flow rate maximum 30 psi, 12 LPM
- PARI LC® PLUS with a compressor with pressure and flow rate maximum 24 psi, 9 LPM
- PARI BABY™ with a compressor with pressure and flow rate maximum 24 psi, 9 LPM
- Durable Sidestream® with a compressor with pressure and flow rate maximum 25 psi, 7 LPM
Please contact your doctor and/or CF Care Team for more information about nebulizers and compressors, and for guidance in choosing products that are right for you.
Pulmozyme comes in sterile, single-use ampules that should be used completely. Because Pulmozyme has no preservatives, the entire contents must be used or discarded.
View complete preparation and dosing instructions here
- Ampules are stored in a protective foil pouch, and must be kept refrigerated and protected from light
- Do not expose Pulmozyme ampules to room temperatures for more than 60 hours
- Check the expiration date printed on the ampule. Do not use if the expiration date has passed
- Squeeze each ampule prior to use to check for leaks
- If solution is cloudy or discolored, discard the ampule
- Once opened, the entire contents of the ampule must be used or discarded
Finding the time and place to take your treatments, like Pulmozyme, isn’t always easy. But having a routine that fits your lifestyle can help you stay in control and assist in your fight against CF.
There are expiration dates stamped on each ampule. It is important to follow the stamped date and discard any ampules that expire.
Each sterile, single-use ampule of Pulmozyme (2.5 mg) is packaged in a protective foil pouch.
- The ampules should be left in their foil package and stored at a refrigerated temperature between 2°C to 8°C (36°F to 46°F)
- They should also be kept away from strong light
- Pulmozyme ampules should be kept cold when traveling, and do not expose them to room temperature (22°C to 28°C/72°F to 82°F) for more than a total of 60 hours
Financial Support
No matter what type of health insurance you have, and even if you have none at all, there may be options available to help you afford your Pulmozyme.
To get started with financial assistance enrollment, you will need:
- Patient information: full name, date of birth, mailing address, email, phone (home and/or mobile), and insurance information
- Prescribing doctor's information: complete contact information, primary diagnosis code, prescription details
- Patient's financial eligibility information: number of people in the patient's household (including patient), annual net household income
The application process will let you know if any additional forms are required based on the programs that may be right for you.
Need more help? Contact one of our specialists
Call 1-888-PLMZYME (1-888-756-9963) to speak live with one of our specialists.
Need help affording Pulmozyme?
Check out the financial assistance programs available to help patients, with or without insurance.
Downloadable resources
Get helpful documents and printable PDFs for people taking Pulmozyme.
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.