Dornase Alfa

PULMOZYME is recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. In preclinical in vitro studies, PULMOZYME hydrolyzes the DNA in sputum of CF patients and reduces sputum viscoelasticity.

• PULMOZYME ® is indicated, in conjunction 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 parenteral antibiotics.

• PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product. PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.contraindicated

The recommended dosage is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended nebulizer. ( 2.1 ) Some patients may benefit from twice daily administration. ( 2.1 ) See full prescribing information for the recommended nebulizers for use with PULMOZYME. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage, in most cystic fibrosis patients, is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended jet nebulizer connected to an air compressor system or via a vibrating mesh nebulizer [see Dosage and Administration (2.2) ] . Some patients may benefit from twice daily administration [see Clinical Studies (14) ] . 2.2 Administration Instructions Nebulizer Information Administer PULMOZYME via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask, or via a vibrating mesh nebulizer. Refer to Table 1 for the recommended Jet Nebulizers or Vibrating Mesh Nebulizers for use with PULMOZYME. No data are currently available to support the administration of PULMOZYME with other nebulizer systems. The eRapid Nebulizer System should only be used by adults and pediatric patients who can use a mouthpiece, and not by younger patients who need a mask to inhale PULMOZYME. Use the selected nebulizer in accordance with the manufacturer's instruction manual. Refer to the manufacturer's instruction manual on the use, maintenance, and replacement of the equipment, including cleaning and disinfection procedures for the selected nebulizer.

None. None. ( 5 )

The most common adverse reactions (occurring in ≥3% of patients treated with PULMOZYME over placebo) seen in clinical trials in CF patients were: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥10%, fever, and dyspnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to PULMOZYME in 902 patients, with exposures ranging from 2 weeks of daily administration up to once or twice daily administration for six months. PULMOZYME was studied in both placebo-controlled (n=804) and uncontrolled trials (n=98). The population of patients in placebo-controlled trials was with FVC ≥ 40% of predicted (n=643) or with more advanced pulmonary disease, FVC < 40% of predicted (n=161). The population in the uncontrolled trial included 98 pediatric patients with CF ranging from 3 months to 10 years of age. More than half of the patients received PULMOZYME 2.5 mg by inhalation once a day (n=581), while the rest of patients (n=321) received PULMOZYME 2.5 mg by inhalation twice a day. Placebo-Controlled Trials Trial 1 : Trial 1 was a randomized, placebo-controlled clinical trial in patients with FVC ≥ 40% of predicted.

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with PULMOZYME in pregnant women. However, animal reproduction studies have been conducted with dornase alfa. In these studies, no evidence of fetal harm was observed in rats and rabbits at doses of dornase alfa up to approximately 600 times the maximum recommended human dose (MRHD). The background risk of major birth defects and miscarriage for the cystic fibrosis population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data Reproductive studies have been performed in rats and rabbits at intravenous doses of dornase alfa up to 10 mg/kg/day (approximately 600 times the MRHD in adults). In a combined embryo-fetal development and pre- and post-natal development study, no evidence of maternal toxicity, embryotoxicity, or teratogenicity was observed when dornase alfa was administered to dams throughout organogenesis (Gestation days 6 to 17). Dornase alfa did not elicit adverse effects on fetal or neonatal growth when administered to dams throughout most of gestation and delivery (Gestation days 6 to 25) and nursing (Post-partum days 6 to 21).

Metabolism

When 2.5 mg PULMOZYME was administered by inhalation to eighteen CF patients, mean sputum concentrations of 3 µg/mL DNase were measurable within 15 minutes. Mean sputum concentrations declined to an average of 0.6 µg/mL two hours following inhalation.

• Dec 30, 1993BLABLA103532Genentech

1. 1Infective Pulmonary Exacerbation Of Cystic Fibrosis2,29512%
2. 2Cystic Fibrosis1,7509.0%
3. 3Hospitalisation1,3016.7%
4. 4Pneumonia1,2816.6%
5. 5Cough9895.1%
6. 6Off Label Use9534.9%
7. 7Infection9414.9%
8. 8No Adverse Event9294.8%
9. 9Dyspnoea9054.7%
10. 10Condition Aggravated6103.2%
11. 11Headache5382.8%
12. 12Pulmonary Function Test Decreased4902.5%
13. 13Death4792.5%
14. 14Malaise4672.4%
15. 15Haemoptysis4552.4%

The 10 most recently updated of 62 ClinicalTrials.gov registrations naming Dornase Alfa as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
  Completed · Phase 4 · Interventional · 41 enrolled · University of Colorado, Denver
  NCT00419380updated 2026-06-08
• Flush, Lyse, Operate
  Not yet recruiting · Phase 4 · Interventional · 30 enrolled · Dartmouth-Hitchcock Medical Center
  NCT07592520updated 2026-05-18
• Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months
  Recruiting · Phase 2 · Interventional · 304 enrolled · Fondation Ophtalmologique Adolphe de Rothschild
  NCT06723717updated 2026-05-08
• Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)
  Completed · Phase 2 · Interventional · 330 enrolled · University of Melbourne
  NCT05203224updated 2026-05-06
• Investigator Initiated Study to Assess the Safety of Combination of CLS-015 With Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive Large B Cell Lymphoma at Lymphodepletion.
  Recruiting · Phase 1 · Interventional · 12 enrolled · Tel-Aviv Sourasky Medical Center
  NCT07361224updated 2026-05-01
• Use of DNAse in Neutrophilic Asthma
  Completed · Phase 1 · Phase 2 · Interventional · 19 enrolled · National Jewish Health
  NCT03994380updated 2026-04-20
• I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
  Active not recruiting · Phase 2 · Interventional · 1,500 enrolled · QuantumLeap Healthcare Collaborative
  NCT04488081updated 2026-03-16
• Intrapleural Alteplase-Tyloxapol vs Intrapleural Alteplase-DNase in Pleural Infection
  Not yet recruiting · Observational · 80 enrolled · National University of Malaysia
  NCT07432373updated 2026-03-02
• Pleural Irrigation With Normal Saline Versus Intrapleural Fibrinolytic
  Completed · Interventional · 40 enrolled · National University of Malaysia
  NCT05903417updated 2026-02-24
• Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target)
  Completed · Phase 2 · Interventional · 39 enrolled · Fondation Ophtalmologique Adolphe de Rothschild
  NCT04785066updated 2026-01-22

Frequently asked questions

How does Dornase Alfa work?

PULMOZYME is recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. In preclinical in vitro studies, PULMOZYME hydrolyzes the DNA in sputum of CF patients and reduces sputum viscoelasticity.

What is Dornase Alfa used for?

According to FDA labeling, Dornase Alfa carries indications including: PULMOZYME ® is indicated, in conjunction 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 parenteral antibiotics.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dornase Alfa?

Dornase Alfa is classified as Mucolytics, Recombinant Human Deoxyribonuclease 1, Enzymatic Activity, Decreased Respiratory Secretion Viscosity, DNA Integrity Alteration.

What are the brand names for Dornase Alfa?

Dornase Alfa is marketed under brand names including Pulmozyme.

What are the contraindications for Dornase Alfa?

Dornase Alfa labeling lists contraindications including: PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product. PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.. Always consult the full prescribing information and a clinician.