Dornase alfa

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Dornase alfa
Clinical data
Trade names Pulmozyme
AHFS/Drugs.com Monograph
MedlinePlus a694002
License data
Pregnancy
category
Routes of
administration 		Inhalation
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
CompTox Dashboard (EPA)
ECHA InfoCard 100.029.685 OOjs UI icon edit-ltr-progressive.svg
Chemical and physical data
Formula C1321H1999N339O396S9
Molar mass 29254.04 g·mol−1
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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]

Contents

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. [6] [7]

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. [8] [4]

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

References

  1. 1 2 "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. 1 2 3 4 5 6 "Pulmozyme- dornase alfa solution". DailyMed. 21 October 2020. Retrieved 9 January 2023.
  4. 1 2 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. 1 2 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.
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