Brand Name
Pulmozyme
Generic Name
Dornase
View Brand Information FDA approval date: December 30, 1993
Classification: Recombinant Human Deoxyribonuclease 1
Form: Solution
What is Pulmozyme (Dornase)?
PULMOZYME ® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis 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 a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis patients to improve pulmonary function.
Approved To Treat
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Phase II Study of Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer.
Summary: Germ cell tumors (GCTs) are highly curable malignancies; however, a subset of patients with relapsed or refractory disease after first- and second-line chemotherapy have a very poor prognosis, with long-term survival rates below 5%. New therapeutic strategies are needed in this setting. Emerging evidence indicates that extracellular DNA and markers of NETosis are associated with poor prognosis in ...
A Prospective, Randomized Multicenter, Double Blind Clinical Trial Comparing Inhaled Dornase Alfa and Its Placebo to Reduce the Incidence of Moderate to Severe ARDS in Ventilated Trauma Patients in the Intensive Care Unit
Summary: Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMP...
Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)
Summary: Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous thrombolytic therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for the trial. All participants will receive intravenous tenecteplase (or alteplase due to manufacturer shortage) and endovascular thrombectomy as st...
Related Latest Advances
Brand Information
Pulmozyme (dornase alfa)
1INDICATIONS AND USAGE
PULMOZYME
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.
2DOSAGE FORMS AND STRENGTHS
Inhalation solution: 2.5 mg/2.5 mL (1 mg/mL) clear, colorless solution in single-dose ampules.
3CONTRAINDICATIONS
PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.
4WARNINGS AND PRECAUTIONS
None.
5DRUG INTERACTIONS
Available data indicate there are no clinically important drug-drug interactions with PULMOZYME.
6DESCRIPTION
Dornase alfa is a recombinant human deoxyribonuclease I (rhDNase) an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase). The product is purified by column chromatography and tangential flow filtration. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons. The primary amino acid sequence is identical to that of the native human enzyme.
PULMOZYME (dornase alfa) inhalation solution is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer or a recommended nebulizer system
7HOW SUPPLIED/STORAGE AND HANDLING
PULMOZYME (dornase alfa) inhalation solution is a sterile, clear, colorless solution supplied in:
- 30 unit cartons containing 5 foil pouches of 6 single-dose ampules. Each 2.5 mL ampule contains 2.5 mg of dornase alfa (1 mg/mL): NDC 50242-100-40.
8PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (
9INSTRUCTIONS FOR USE
PULMOZYME
(dornase alfa)
Inhalation Solution
This Instructions for Use contains information on how to use PULMOZYME with Jet Nebulizers and Compressors
See the other side of this Instructions for Use for
Read and understand this Instructions for Use and the nebulizer manufacturer's instruction manual before you start taking Pulmozyme and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
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 you inhale 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 appropriate compressors as
Do not use any other inhaled medicines in the nebulizer at the same time. Keep all other inhaled medicine 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.
Follow the steps on this side of the Instructions for Use to give Pulmozyme using the following jet nebulizer systems
For additional information on an appropriate compressor to use with Pulmozyme, read the manufacturer's instruction manual for the recommended nebulizer.
Important Information You Need to Know Before Using PULMOZYME
Read and follow the nebulizer manufacturer's instruction manual for correct use and maintenance:
- to clean the nebulizer before first use and after each use as recommended.
- to disinfect the nebulizer parts by using the disinfecting method recommended.
- to replace nebulizer parts as recommended.
Supplies you will need to give a dose of Pulmozyme (See
- 1 Pulmozyme ampule
- Compressor
- Nebulizer cup and cap (screw-on or snap-on)
- Plastic T (not needed for Sidestream nebulizer or PARI BABY)
- Flexible aerosol tube (not needed for Sidestream nebulizer or PARI BABY)
- Mouthpiece (clean) or PARI BABY facemask
- Long connecting tube
- Nose clip (optional, not needed for PARI BABY)
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License No. 1048
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License No. 1048
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 02/2024
10INSTRUCTIONS FOR USE
PULMOZYME
(dornase alfa)
Inhalation Solution
This Instructions for Use contains information on how to use PULMOZYME with the following recommended vibrating mesh nebulizers:
See the other side of this Instructions for Use for
Read and understand this Instructions for Use and the nebulizer manufacturer's instruction manual before you start taking Pulmozyme and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
This information does not take the place of the manufacturer's instruction manual for the vibrating mesh 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 side of the Instructions for Use to give Pulmozyme using a vibrating mesh nebulizer.
Important Information You Need to Know Before Using PULMOZYME
Read and follow the nebulizer manufacturer's instruction manual for correct use and maintenance:
- to clean the nebulizer before first use and after each use as recommended
- to disinfect the nebulizer parts by using the disinfecting method recommended
- to replace nebulizer parts as recommended
Supplies you will need to give a dose of PULMOZYME:
- 1 Pulmozyme ampule (See
- Vibrating mesh nebulizer and its parts
- Manufacturer's instruction manual for the vibrating mesh nebulizer
- Nose clip (optional) (See
How should I store Pulmozyme?
- Store Pulmozyme ampules at a refrigerated temperature between 36°F to 46°F (2°C to 8°C) 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 refrigerated 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 at 72°F to 82°F (22°C to 28°C) 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.
Genentech, Inc.
A Member of the Roche Group
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 02/2024
Representative sample of labeling (see the
11PRINCIPAL DISPLAY PANEL - 2.5 mg/2.5 mL Ampule Pouch Carton
NDC 50242-100-40
DORNASE ALFA
PULMOZYME
INHALATION SOLUTION
2.5 mg/2.5 mL
Each carton contains 5 foil pouches
KEEP REFRIGERATED
11013278
Genentech, Inc.
