Collagenase clostridium histolyticum
Clinical data | |
---|---|
Trade names | Xiaflex, Xiapex, Qwo |
Other names | AA-4500, collagenase clostridium histolyticum-aaes |
AHFS/Drugs.com | Monograph |
MedlinePlus | a612029 |
License data | |
Routes of administration | Intralesional injection |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
ECHA InfoCard | 100.029.608 |
Chemical and physical data | |
Molar mass | 114 kg/mol (AUX-I) 113 kg/mol (AUX-II) |
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Biochemically, it is a mixture of two C. histolyticum collagenases, ColH and ColG. A similar ointment preparation called
Uses
In February 2010, the
In February 2011, the European Commission's Committee for Medicinal Products for Human Use approved the product for the treatment of Dupuytren's contracture in adults with a palpable cord by 'properly trained' doctors.[6] Pfizer was reported to be working with Europe's national medicines regulatory bodies to launch the new treatment, hoping doctors could prescribe the treatment by late 2011.[7] However, the Swedish manufacturer abruptly[citation needed] withdrew distribution of this drug in Europe in March 2020 for commercial reasons.[8] Collagenase is no longer available on the National Health System except (of the UK?) as part of a small clinical trial.[9]
On November 7, 2012, BioSpecifics announced "BioSpecifics Technologies Corp. : Reports Third Quarter 2012 Financial Results". Auxilium's submission of a License Application to the FDA for Xiaflex for the potential treatment of Peyronie's disease, an excess of inelastic collagen causing penile curvature deformity. The FDA approved Xiaflex for the treatment of Peyronie’s disease in December 2013. Following this, Xiapex gained EU approval for the treatment of Peyronie’s disease in February 2015, making it the first and only biologic therapy indicated for the treatment of Peyronie's disease.
Side effects
The most common side effects include
Chemical properties
The substance is a constant mixture of two collagenases (AUX-I and AUX-II) with known
Pharmacology
The enzymes do not reach the bloodstream in significant amounts and are presumed to largely stay at the point of injection[12] until they are broken down by proteases.
The two collagenases act
Interactions
No interaction studies have been conducted because the drug does not reach the bloodstream and the liver. It is theorised that drugs interfering with
References
- FDA. Retrieved 22 Oct 2023.
- ^ "Collagenase ColH of Hathewaya histolytica (Clostridium histolyticum) [Q46085]". UniProt. Retrieved 26 December 2020.
- ^ "FDA Approves Xiaflex for Debilitating Hand Condition". Food and Drug Administration. February 2, 2010. Archived from the original on November 26, 2012. Retrieved March 16, 2010.
- ^ Pollack A (March 15, 2010). "Triumph for Drug to Straighten Clenched Fingers". The New York Times. Retrieved March 16, 2010.
- ^ Pollack A (March 15, 2010). "Bringing Movement Back to Clenched Hands". The New York Times. Retrieved March 16, 2010.
- ^ Xiapex: collagenase clostridium histolyticum, European Medicines Agency, Undated.Accessed: 20 March 2011.
- ^ Xiapex (Collagenase Clostridium Histolyticum) Authorised In The European Union For Dupuytren's Contracture, Medical News Today, Bexhill-on-Sea, East Sussex, 3 March 2011.Accessed: 19 March 2011.
- ^ "Xiapex". 17 September 2018.
- ^ "Dupuytren's Interventions: Surgery vs Collagenase - Trials and Statistics, University of York".
- ^ Xiapex summary of product characteristics
- ^ "Xiaflex for the Treatment of Cellulite".
- ^ ISBN 978-3-85200-196-8.
- ^ a b Klement A (9 May 2011). "Dupuytren'sche Kontraktur erstmals medikamentös behandelbar: Xiapex". Österreichische Apothekerzeitung (in German) (10/2011): 8.
External links
- "Collagenase clostridium histolyticum". Drug Information Portal. U.S. National Library of Medicine.