REFLUDAN [lepirudin (rDNA) for injection]: the first direct thrombin inhibitor FDA-approved for heparin induced thrombocytopenia (HIT)

Learn more about the benefits of REFLUDAN
This section contains REFLUDAN laboratory and clinical efficacy data
This section contains efficacy data from principal clinical trials and a drug monitoring program of REFLUDAN for the treatment of heparin induced thrombocytopenia (HIT)
This section contains data from a prospective, historically-controlled trial to evaluate the anticoagulant efficacy of REFLUDAN in patients with confirmed heparin induced thrombocytopenia (HIT)
This section describes the combined risk of death, limb amputation, or new thromboembolic complication (TEC) in patients treated with REFLUDAN for heparin induced thrombocytopenia (HIT)
This section contains information regarding the safe administration of REFLUDAN for the treatment of heparin induced thrombocytopenia (HIT)
This section describes the dosage and administration of REFLUDAN in the treatment of heparin induced thrombocytopenia (HIT)
Heparin induced thrombocytopenia
A summary of pivotal trial data for REFLUDAN is covered in this section
This section provides access to a variety of resources to obtain in-depth information on heparin induced thrombocytopenia (HIT) and REFLUDAN
Find out what your peers are saying about heparin induced thrombocytopenia (HIT)...

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H.I.T. BACK with REFLUDAN to protect life and limb
Clinical Efficacy
Respond with REFLUDAN to protect
life and limb
73% relative reduction in combined risk of death amputation, and new thromboembolic complications (TECs) in patients with HIT
relative reduction in combined risk of death,
amputation, and new thromboembolic
complications (TECs) in patients with HIT*†1




63% relative reduction in specific risk for new TEC vs historical control†‡1, 2
Relative risk reductions in individual events in patients with HIT and baseline TECs vs historical controls
REFLUDAN reduced the relative risk of new TECs by 63% in the treatment of heparin induced thrombocytopenia (HIT) REFLUDAN reduced the relative risk of death by 49% in the treatment of heparin induced thrombocytopenia (HIT) Limb Amputation 38%


Efficacy Confirmed in Drug Monitoring Program



The safety and efficacy of lepirudin was examined in a post-marketing observational study. One group of HIT patients (n= 496) were treated with lepirudin for acute venous or arterial thromboembolism. All patients in this group had thrombocytopenia and experienced a TEC, and 77% had a positive HIPA test result. Only 5.2% of patients in this group developed new TECs, and 5.8% required limb amputation.3

Low incidence of TEC and/or limb amputation in patients with HIT and acute venous or arterial thromboembolism3

 
 New TECs 
 		  
 Limb Amputation 
 
 
 5.2% 
 		  
 5.8% 
 

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For information on platelet recovery, see Laboratory Efficacy



* Data from the HAT-1 clinical trial comparing REFLUDAN efficacy and safety in a total of 71 patients with confirmed HIT, vs 120 historical controls. Cumulative risk reduction for combined endpoint (death, limb amputation, and new TECs) at Day 35.
†All patients were diagnosed with HIT using a heparin-induced platelet activation assay. Historical control patients were treated according to hospital protocol with danaparoid, phenprocoumon, or other treatments.
‡Data from a meta-analysis of 2 prospective, clinical trials (HAT-1 and HAT-2) in patients with HIT and baseline TECs, evaluating REFLUDAN (n=113) vs historical control (n=91). Cumulative risk reduction for individual endpoints (death, limb amputation, and new TEC) at Day 35.



Clinical Efficacy
Laboratory Efficacy
Clinical Efficacy Data

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