REVASC® - Login
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Pivotal Trials
REVASC has been studied for the prevention of venous thromboembolism (VTE) in over 2000 patients in Phase III clinical trials. REVASC administered SC at a dose of 15mg Q12H SC significantly reduced the risk of VTE in patients undergoing elective hip surgery compared to unfractionated heparin and enoxaparin with a comparable safety profile.
The following table outlines the design and results of these trials as presented in NEJM and JBJS:
1. Eriksson BI, et al. Prevention of thromboembolism with use of
recombinant hirudin. Results of a double-blind, multicenter trial comparing the efficacy of desirudin (REVASC) with that of unfractionated heparin in patients having a total hip replacement. J Bone Joint Surg. 1997;79:3216-233.
2. Eriksson BI, et al. A Comparison of recombinant hirudin with a
low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement. N Engl J Med. 1997;337:1329-1335.
Indications and Usage
REVASC is indicated for the prevention of deep vein thrombosis in patients undergoing elective hip or knee replacement.
REVASC is administered by subcutaneous administration at a recommended dose of 15 mg twice daily.
Contraindications
REVASC is contraindicated in patients with active bleeding and/or irreversible coagulation disorders; with severe renal or hepatic impairment; with severe uncontrolled hypertension and subacute bacterial endocarditis; during pregnancy; or in patients with a hypersensitivity to the active substance or to any of the excipients.
Special Warnings and precautions for use:
REVASC may cause allergic reactions including anaphylaxis and shock. Fatal anaphylactiod reactions have been reported in patients re-exposed to hirudin product therapy in a second or subsequent course of treatment.
REVASC should be used with caution in conditions with increased risk of bleeding such as major surgery, biopsy, a history of hemorrhagic stroke, intracranial or intraocular bleeding including diabetic retinopathy; recent stroke, severe uncontrolled hypertension, a cerebral ischaemic attack within 6 months, a known haemostatic disorder ( e.g. hemophilia, liver disease) or a history of gastrointestinal or pulmonary bleeding within the past 3 months.
Activated partial thromboplastin time (aPTT) should be monitored in patients at increased risk for bleeding and in patients with mild or moderate renal or liver impairment. Bleeding can occur at any site during therapy with REVASC.
REVASC should be used with care in patients receiving anticoagulants, and /or platelet inhibitors and/or non-steroidal anti inflammatory medicinal products. Monitoring for evidence of bleeding is advised.
Bleeding is the most common side effect with REVASC. In post-marketing surveillance, there have been rare reports of major hemorrhage, some of which were fatal. Rare reports of non-fatal anaphylactic or anaphylactoid reactions leading to shock have been reported. There is no antidote for REVASC. In case of bleeding complications plasma expanders or blood transfusions may be used if necessary.
Please see Full Prescribing Information for complete product information
About Pegmusirudin
Pegmusirudin is a Phase II investigational direct thrombin inhibitor with similar anti-thrombin properties to desirudin. Pegmusirudin has two molecules of PEG 5000 covalently attached which prolongs its plasma half life about 6 times, from 2-4 hours as seen with desirudin to 18-24 hours. This prolonged half life may provide for less frequent dosing of pegmusirudin compared with desirudin.1 This may be attractive in patients who require longer term anticoagulation, such as patients with cancer at risk of thrombosis.2
References
1. Esslinger HU, Haas S, Maurer R. Pharmacodynamic and safety results of PEG-Hirudin in healthy volunteers. Thromb Haemost. 1997 May;77(5):911-9.
2. Esser, U.Fiedler, R.Graeser. Antitumor efficacy of PEG-Hirudin, administered three times weekly, in an orthotopic AsPC-1 pancreas carcinoma model. Mol Cancer Ther 2009; 8: [abstr]
Ongoing Clinical Trials
Pegmusirudin is an investigational direct thrombin inhibitor with similar anti-thrombin properties to desirudin. Pegmusirudin has two molecules of PEG 5000 covalently attached which prolongs its plasma half life about 6 times, from 2-4 hours as seen with desirudin to 18-24 hours. This prolonged half life may provide for less frequent dosing of pegmusirudin compared with desirudin.1 Pegmusirudin is currently in pre-clinical development in cancer and cancer-related thrombosis.2
References
1. Esslinger HU, Haas S, Maurer R. Pharmacodynamic and safety results of PEG-Hirudin in healthy volunteers. Thromb Haemost. 1997 May;77(5):911-9.
2. Esser, U.Fiedler, R.Graeser. Antitumor efficacy of PEG-Hirudin, administered three times weekly, in an orthotopic AsPC-1 pancreas carcinoma model. Mol Cancer Ther 2009; 8: [abstr]