Heart & blood Direct thrombin inhibitor
Desirudin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Desirudin (formerly sold as Iprivask) is a recombinant form of hirudin, the natural anticoagulant from the medicinal leech, that was used to prevent blood clots after hip replacement surgery. It directly and specifically blocks thrombin, the central enzyme of the clotting cascade. It was FDA-approved in the U.S. in 2003, but Iprivask has since been discontinued and no desirudin product is currently sold in the U.S.
At a glance
- What it is
- A recombinant hirudin analog that directly inhibits thrombin
- Approved for
- Prevention of deep vein thrombosis after elective hip replacement surgery (approved in 2003; the product is no longer sold in the U.S.)
- Key fact
- In a pivotal trial it reduced confirmed deep vein thrombosis compared with unfractionated heparin
- Route
- Subcutaneous injection
- Evidence strength
- FDA approved
Summary
Desirudin is a recombinant hirudin once used to prevent clots after hip surgery. Learn how it blocks thrombin and why it is no longer sold in the U.S.
What is desirudin?
Desirudin, formerly sold under the brand Iprivask, is a recombinant version of hirudin, the anticoagulant protein that medicinal leeches use to keep blood flowing while they feed. Made in yeast rather than extracted from leeches, it is a highly specific thrombin inhibitor used to prevent blood clots in the legs after major orthopedic surgery. It was developed under the code CGP 39393 and approved in the United States in 2003.
How does desirudin work?
Desirudin is a direct thrombin inhibitor. Thrombin is the key enzyme at the end of the clotting cascade, responsible for converting fibrinogen into the fibrin that forms a clot and for further activating platelets. Desirudin binds thrombin tightly at two sites at once, both its active site and the region it uses to grip fibrinogen, essentially clamping the enzyme shut. Unlike heparin, it does not need the body's antithrombin to work and it can inhibit thrombin that is already bound within a clot.
That direct, antithrombin-independent action is useful for preventing the venous clots that can form after hip replacement, when immobility and surgical injury raise the risk. In its pivotal trial in elective hip replacement, desirudin reduced confirmed deep vein thrombosis compared with unfractionated heparin, without an increase in bleeding. It is given as a subcutaneous injection around the time of surgery.
Is it FDA-approved?
Editor’s note
Status: Desirudin was approved by the FDA in 2003 for the prevention of deep vein thrombosis in patients undergoing elective hip replacement surgery. The only brand, Iprivask, has since been discontinued in the U.S., and no generic is sold.
Category: FDA-approved · Primary body area: Heart & blood
Desirudin was approved by the FDA in 2003 for the prevention of deep vein thrombosis in patients undergoing elective hip replacement surgery. The only brand, Iprivask, has since been discontinued in the U.S., and no generic is sold.
What is desirudin prescribed for?
Desirudin was prescribed to prevent deep vein thrombosis in people having elective hip replacement surgery. As with other anticoagulants, particular caution applies when spinal or epidural anesthesia is involved, because of the risk of bleeding around the spine.
What are the side effects?
Common side effects include:
- Bleeding
- Injection-site reactions
- Anemia and nausea
More serious considerations include:
- Hemorrhage, the principal risk
- A warning that spinal or epidural anesthesia carries a risk of spinal bleeding and paralysis, a caution shared across anticoagulants
- Caution in kidney impairment, and the possible formation of antibodies to hirudin
Sources: FDA prescribing information for Iprivask; a trial of desirudin versus heparin in hip replacement (Eriksson et al., The Journal of Bone and Joint Surgery, 1997, DOI: 10.2106/00004623-199703000-00002), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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