Dornase Alfa
Pronunciation: (DOOR-nase AL-fa).
- Generic name
- dornase alfa
- Brand names
- Dornazyme, Dornase, Pulmozyme
- Drug class
- Mucolytic enzyme
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What dornase alfa is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how dornase alfa works
Dornase alfa is a recombinant human deoxyribonuclease I (rhDNase). It selectively cleaves extracellular DNA present in the thick, purulent sputum of cystic fibrosis patients. By hydrolyzing DNA, it reduces mucus viscosity and elasticity, facilitating improved airway clearance and reducing the risk of infection. (1) (2)
What dornase alfa is used for
Cystic fibrosis
Used in conjunction with standard cystic fibrosis therapies to improve pulmonary function, and to reduce the risk of respiratory tract infections in patients with forced vital capacity (FVC) 40% of predicted or greater. (2)
Before taking dornase alfa
Do not take / not appropriate for
- Contraindicated in patients with known hypersensitivity to dornase alfa or any excipients. (Contraindication) (2)
- Safety in pregnancy and lactation has not been fully established. (Contraindication) (2)
- use only if clearly needed. (Contraindication) (2)
Tell your clinician about
(2)How to take dornase alfa
- General Instructions: Use dornase alfa exactly as prescribed by your healthcare provider. Do not change your dose or stop using it without consulting your doctor.. Adult Dosing: The usual adult dose is 2.5 mg inhaled once daily using a recommended nebulizer system. Some patients may benefit from twice-daily dosing.. Pediatric Dosing: For children 5 years and older, the recommended dose is also 2.5 mg inhaled once daily. Safety and efficacy in children under 5 years have not been established.. Administration: Administer the solution via a jet nebulizer connected to an air compressor. Do not mix with other medications in the nebulizer. Follow cleaning instructions for the device.. When To Stop: Do not stop using dornase alfa without consulting your healthcare provider, even if you feel better. Discontinuation may worsen lung symptoms.. Storage: Store unopened ampules in the refrigerator (2°C to 8°C/36°F to 46°F). Protect from strong light. Do not freeze. Once opened, use immediately.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule; do not take an extra dose to make up for it.
Overdose
Overdose is unlikely with inhaled dornase alfa. If you suspect an overdose or experience unusual symptoms, seek medical attention immediately. Supportive care is recommended. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Voice alteration
Incidence: Reported in the clinician-authored database; frequency not established
Pharyngitis
Incidence: Reported in the clinician-authored database; frequency not established
Rash
Incidence: Reported in the clinician-authored database; frequency not established
Chest pain
Incidence: Reported in the clinician-authored database; frequency not established
Conjunctivitis
Incidence: Reported in the clinician-authored database; frequency not established
Dyspnea
Incidence: Reported in the clinician-authored database; frequency not established
Fever
Incidence: Reported in the clinician-authored database; frequency not established
Bronchospasm
Incidence: Reported in the clinician-authored database; frequency not established
Laryngitis
Incidence: Reported in >=3% of patients over placebo in clinical trials
Rhinitis
Incidence: Reported in >=3% of patients over placebo in clinical trials
Transient decrease in lung function (FVC decrease of 10% or more)
Incidence: Reported in >=3% of patients over placebo in clinical trials
Serious warnings
For inhalation use only—do not inject or swallow — serious
Symptoms: For inhalation use only—do not inject or swallow. Use only with prescribed nebulizer equipment. Monitor for signs of allergic reaction. Consult your doctor if you are pregnant or breastfeeding. Keep out of reach of children.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindicated in patients with known hypersensitivity to dornase alfa, to Chinese Hamster Ovary (CHO) cell products, or to any product component — serious
Symptoms: Contraindicated in patients with known hypersensitivity to dornase alfa, to Chinese Hamster Ovary (CHO) cell products, or to any product component. Use caution in patients with a history of severe allergic reactions to proteins. Safety in pregnancy and lactation has not been fully established; use only if clearly needed.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Dornase alfa has minimal systemic absorption, so drug interactions are rare. However, do not mix with other medications in the nebulizer. Always inform your healthcare provider about all medicines you use, including inhaled therapies. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Animal studies have not shown fetal harm at doses roughly 600 times the human dose. Human pregnancy data are limited, so discuss continuing dornase alfa during pregnancy with the clinician managing your cystic fibrosis care. (2)
Breastfeeding
It is not known whether dornase alfa passes into human breast milk; animal data suggest only minimal transfer (well under 1% of the level in the parent's blood). Discuss breastfeeding plans with your healthcare provider. (2)
Children
Frequency: Once daily. Weight Based: Not recommended for pediatric use.. Max Daily Dose: 2.5 mg. Max Single Dose: 2.5 mg. Age Restrictions: Safety not established in children under 5 years of age. (2)
Renal_impairment
The FDA label reviewed for this page has no dedicated renal- or hepatic-impairment section for dornase alfa (Pulmozyme); it is delivered by inhalation with minimal systemic absorption and no specific organ-impairment dosing adjustment is given. Renal and hepatic status should be assessed by the prescriber. (2)
Hepatic_impairment
The FDA label reviewed for this page has no dedicated renal- or hepatic-impairment section for dornase alfa (Pulmozyme); it is delivered by inhalation with minimal systemic absorption and no specific organ-impairment dosing adjustment is given. Renal and hepatic status should be assessed by the prescriber. (2)
Monitoring
(2)Storage
Store unopened ampules refrigerated at 2-8°C (36-46°F) in their protective foil pouch, protected from light and heat. Do not freeze. Ampules should not be left at room temperature (72-82°F) for more than 60 hours in total. Once an ampule is opened, use it right away.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Cystic fibrosis
Dose summary: 2.5 mg once daily via nebulization.
Renal context: The FDA label reviewed for this page states no renal-impairment dosing guidance for dornase alfa; as an inhaled enzyme with minimal systemic absorption, no dose adjustment is specified. Renal status should be assessed by the prescriber. (1) (2)
Hepatic guidance
The FDA label reviewed for this page has no dedicated hepatic-impairment section for dornase alfa; as an inhaled enzyme with minimal systemic absorption, no dose adjustment is specified. Hepatic status should be assessed by the prescriber.
Frequently asked questions
What is dornase alfa used for?
Dornase alfa is used to help manage cystic fibrosis by thinning and loosening mucus in the lungs, making it easier to clear and reducing the risk of lung infections.
How should I use dornase alfa?
Use dornase alfa exactly as prescribed, usually once daily via a nebulizer. Do not mix with other medications in the nebulizer, and follow device cleaning instructions.
Can children use dornase alfa?
Yes, dornase alfa is approved for use in children 5 years and older. Safety and effectiveness in children under 5 years have not been established.
What should I do if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed one and continue your regular schedule. Do not take an extra dose to make up for it.
Are there any serious side effects?
Serious side effects are rare but may include severe allergic reactions, chest pain, or sudden breathing difficulties. Seek medical attention if these occur.
Can I use dornase alfa with other inhaled medications?
Do not mix dornase alfa with other medications in the nebulizer. If you use multiple inhaled therapies, use them separately as directed by your healthcare provider.
How should I store dornase alfa?
Store unopened ampules in the refrigerator and protect from light. Do not freeze. Use opened ampules immediately.
What happens if I take too much Dornase alfa?
If you suspect an overdose of Dornase alfa, it is crucial to seek emergency medical attention immediately. While specific overdose symptoms are not extensively documented for this medication, any unusual or severe reactions should be reported to a healthcare professional. Prompt medical evaluation can help manage any potential adverse effects and ensure your safety.
Can I drink alcohol while taking Dornase alfa?
There are no known direct interactions between Dornase alfa and alcohol. However, it is generally advisable to consult your healthcare provider regarding alcohol consumption while undergoing treatment for cystic fibrosis. Alcohol can sometimes exacerbate respiratory symptoms or interact with other medications you may be taking, so personalized advice is recommended.
Is Dornase alfa safe during pregnancy?
Dornase alfa's pregnancy category requires consultation with a doctor. The safety of Dornase alfa during pregnancy has not been definitively established, and its use should be carefully considered. It is essential to discuss the potential risks and benefits with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, to make an informed decision.
What is the mechanism of action of dornase alfa?
Dornase alfa is a recombinant human deoxyribonuclease I (rhDNase). It selectively cleaves extracellular DNA present in the thick, purulent sputum of cystic fibrosis patients. By hydrolyzing DNA, it reduces mucus viscosity and elasticity, facilitating improved airway clearance and reducing the risk of infection. (1) (2)
What is the generic name of Dornase Alfa?
The generic name is dornase alfa. It is sold under brand names including Dornazyme, Dornase, Pulmozyme.
What class of drug is dornase alfa?
Dornase Alfa is classed as: Mucolytic enzyme.
References
- Dornase alfa — clinician-authored medicine recordMedGuideGlobal · Internal Database · accessed 2026-08-06 · source 1
- PULMOZYME (dornase alfa) solution, prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
- Dornase Alfa — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Pulmozyme — FDA approval record (Drugs@FDA BLA103532)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- dornase alfa — RxNorm normalized drug concept (RXCUI 337623)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient dornase alfa names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Pulmozyme1 mg/mL · genentech, inc.
Canada
- PULMOZYME