Lepirudin
Also known as: CGP-39393, Lepirudin, r-Hirudin, Recombinant hirudin, Refludan
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Summary
Lepirudin is a 65‑amino‑acid recombinant form of hirudin used as a direct thrombin inhibitor for anticoagulation, primarily in patients with heparin‑induced thrombocytopenia. It was marketed under the brand Refludan but has been withdrawn from most markets.
Mechanism of Action
Recombinant hirudin fragment that binds tightly to the active site of thrombin, blocking conversion of fibrinogen to fibrin and inhibiting platelet activation.
Routes of Administration
Goals & Uses
- Prevention of thromboembolic eventsPreventiveModerate
- Alternative anticoagulation in heparin-allergic patientsHematologyModerate
- Prevention of thromboembolic complications in HIT with thrombosisHematology / ThrombosisHigh
- Anticoagulation in heparin-induced thrombocytopenia (HIT)Hematology / ThrombosisHigh
- AnticoagulationTherapeuticHigh
Contraindications
- Recent major surgerySurgicalModerate
- Hypersensitivity to hirudins or lepirudinAllergy / ImmunologyHigh
- Active major bleedingHemorrhagic RiskHigh
- Severe renal impairmentOrganHighKidney function concerns
- Bacterial endocarditisInfectious / CardiovascularModerate
- Severe uncontrolled hypertensionCardiovascularModerate
- Recent major surgery or organ biopsySurgicalHigh
- Active bleedingHemostasisHigh
Adverse Effects
- Allergic reactionsImmunologicalRare
- Injection site reactionsLocalUncommon
- HypotensionCardiovascularUncommonLow blood pressure
- Anaphylaxis / hypersensitivity reactionsImmunologyUncommon
- BleedingHematologicCommonAbnormal bleeding or hemorrhage
- FeverSystemicUncommonElevated body temperature
- Anti-hirudin antibody formationImmunologyCommon
- Bleeding (hemorrhage)HematologyCommon
- Renal function changesRenalUncommon
Drug Interactions
- Other anticoagulants (e.g., warfarin, direct oral anticoagulants)High
- Warfarin and other vitamin K antagonistsHigh
- Antiplatelet agents (e.g., aspirin, clopidogrel)Moderate
- Thrombolytics (e.g., alteplase, streptokinase)High
- NSAIDsModerateMay increase renal risk in susceptible patients
- Antiplatelet agents (e.g., aspirin, clopidogrel, GPIIb/IIIa inhibitors)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Renal impairmentOrgan ImpairmentAbsolute
- Pediatric patientsAgeRelative
- Patients with prior lepirudin exposureImmunologyRelative
- Elderly patientsAgeRelative
Regulatory Status
- European UnionWithdrawnApproved: Heparin‑induced thrombocytopeniaMarketing authorisation withdrawn in 2012.
- United StatesUnapprovedNever received FDA approval.
- United KingdomWithdrawnApproved: HITFormerly approved, now withdrawn.
Approved in the EU (2000) for HIT; never approved in the United States. Withdrawn from commercial availability in many regions after safety concerns and availability of newer agents.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Lepirudin?
Lepirudin is a 65‑amino‑acid recombinant form of hirudin used as a direct thrombin inhibitor for anticoagulation, primarily in patients with heparin‑induced thrombocytopenia. It was marketed under the brand Refludan but has been withdrawn from most markets.
What is Lepirudin used for?
Lepirudin is educationally associated with: Prevention of thromboembolic events, Alternative anticoagulation in heparin-allergic patients, Prevention of thromboembolic complications in HIT with thrombosis, Anticoagulation in heparin-induced thrombocytopenia (HIT), Anticoagulation. Educational only — not medical advice.
How is Lepirudin administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Lepirudin?
Reported adverse effects include: Allergic reactions, Injection site reactions, Hypotension, Anaphylaxis / hypersensitivity reactions, Bleeding, Fever, Anti-hirudin antibody formation, Bleeding (hemorrhage), Renal function changes. This list is not exhaustive — consult a qualified clinician.
Who should avoid Lepirudin?
Recorded contraindications: Recent major surgery, Hypersensitivity to hirudins or lepirudin, Active major bleeding, Severe renal impairment, Bacterial endocarditis, Severe uncontrolled hypertension, Recent major surgery or organ biopsy, Active bleeding. Consult a qualified clinician before use.