Article · Wikipedia archive · Last revised Jun 16, 2026

Dornase alfa

Dornase alfa, sold under the brand name Pulmozyme, is used for the treatment of cystic fibrosis. It is a recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. Dornase alfa hydrolyzes the DNA present in sputum/mucus and reduces viscosity in the lungs, promoting improved clearance of secretions. It is produced in Chinese hamster ovary cells.

Last revised
Jun 16, 2026
Read time
≈ 2 min
Length
453 w
Citations
16
Source
Wikipedia ↗
Dornase alfa
Clinical data
Trade namesPulmozyme
AHFS/Drugs.comMonograph
MedlinePlusa694002
License data
Pregnancy
category
  • AU: B11
Routes of
administration		Inhalation
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
CompTox Dashboard (EPA)
ECHA InfoCard100.029.685
Chemical and physical data
FormulaC1321H1999N339O396S9
Molar mass29254.04 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Dornase alfa, sold under the brand name Pulmozyme, is used for the treatment of cystic fibrosis.3 It is a recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA.3 Dornase alfa hydrolyzes the DNA present in sputum/mucus and reduces viscosity in the lungs, promoting improved clearance of secretions.3 It is produced in Chinese hamster ovary cells.3

Medical uses

Dornase alfa is indicated for the management of people with cystic fibrosis to improve pulmonary function.3

A 2021 Cochrane systematic review found that dornase alfa probably improves lung function (FEV1) compared with placebo/no dornase alfa at multiple time points (including one and six months), while evidence for quality-of-life outcomes was limited. Rash and voice change were reported more frequently than with control, and serious adverse effects were not reported in the included trials.4

Society and culture

Dornase alfa is an orphan drug.5

Research

Dornase alfa has been shown to improve lung function in non-cystic fibrosis pre-term infants atelectasis.67

Pharmacology

Mechanism of action

Dornase alfa is a recombinant human DNase I that selectively cleaves DNA, by hydrolyzing extracellular DNA in sputum/mucus it reduces mucus viscosity and improves clearance of secretions.84

Production

The FDA label states that dornase alfa is produced by genetically engineered Chinese hamster ovary (CHO) cells containing DNA encoding the native human DNase I protein.8

See also

See also

References

References

  1. "Australian Product Information: Pulmozyme (dornase alfa)". Roche Products Pty Limited. Archived from the original on 12 November 2020.
  2. "Pulmozyme Product information". Health Canada. 25 April 2012. Retrieved 9 January 2023.
  3. "Pulmozyme- dornase alfa solution". DailyMed. 21 October 2020. Retrieved 9 January 2023.
  4. Yang C, Montgomery M (March 2021). "Dornase alfa for cystic fibrosis". The Cochrane Database of Systematic Reviews. 2021 (3) CD001127. doi:10.1002/14651858.CD001127.pub5. PMC 8094421. PMID 33735508.
  5. Collier J (September 1995). "Dornase-alfa and orphan drugs". Lancet. 346 (8975): 633. doi:10.1016/S0140-6736(95)91460-9. PMID 7651014. S2CID 5456247.
  6. Erdeve O, Uras N, Atasay B, Arsan S (April 2007). "Efficacy and safety of nebulized recombinant human DNase as rescue treatment for persistent atelectasis in newborns: case-series". Croatian Medical Journal. 48 (2): 234–239. PMC 2080511. PMID 17436388.
  7. Hendriks T, de Hoog M, Lequin MH, Devos AS, Merkus PJ (August 2005). "DNase and atelectasis in non-cystic fibrosis pediatric patients". Critical Care. 9 (4) R351: R351–R356. doi:10.1186/cc3544. PMC 1269442. PMID 16137347.
  8. Pulmozyme (dornase alfa) inhalation solution: US Prescribing Information (FDA label, revised February 2024) (PDF) (Report). U.S. Food and Drug Administration. Retrieved 2025-12-24.