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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 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)
This section describes how to dose and administer REFLUDAN for the treatment of heparin induced thrombocytopenia (HIT)
Dosing Calculator
This section describes the simple dose adjustments required when initiating REFLUDAN therapy in patients with renal impairment
This section describes the technique required for the reconstitution and dilution of REFLUDAN
This section describes the steps required to monitor and adjust REFLUDAN therapy
This section describes the technique required to make a safe transition from REFLUDAN to oral anticoagulation therapy
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

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H.I.T. BACK with REFLUDAN to protect life and limb
Reconstitution and Dilution


Reconstitution and further dilution are always carried out under sterile conditions.

Bolus dose

CAUTION:Preparation of REFLUDAN bolus injection requires dilution following reconstitution in order to obtain the final concentration of 5mg/mL




   Use one 50-mg vial of REFLUDAN
one 50-mg vial of REFLUDAN    Inject 1-mL Sterile Water for Injection USP or 0.9% Sodium Chloride Injection USP into vial; shake gently to obtain clear, colorless solution
   Transfer vial contents to sterile disposable syringe with >10 mL capacity
   Dilute solution to a total volume of 10 mL using Sterile Water for Injection USP, 0.9% Sodium Chloride USP, or 5% Dextrose Injection for a final concentration of 5 mg/mL

Continuous infusion



   Use two 50-mg vials of REFLUDAN
   Inject 1-mL Sterile Water for Injection USP or 0.9% Sodium Chloride Injection USP into each vial; shake gently to obtain clear, colorless solution
   Transfer contents of both vials into 1 infusion bag containing 500 mL or 250 mL of either 0.9% Sodium Chloride Injection USP or 5% Dextrose Injection
two 50-mg vials of REFLUDAN
  
—  Final concentration of 500-mL bag is 0.2 mg/mL
—  Final concentration of 250-mL bag is 0.4 mg/mL
   Determine appropriate infusion rate according to REFLUDAN concentration, patient weight, and creatinine clearance using the Dosing Calculator

Additional notes



   The reconstituted solution is to be used immediately; REFLUDAN is stable for 24 hours at room temperature (eg, during infusion)
   REFLUDAN should not be mixed with other drugs except for Sterile Water for Injection USP, 0.9% Sodium Chloride Injection USP or 5% Dextrose Injection
   Sterile conditions must be maintained during reconstitution and dilution



Dosage and Administration
Dosing Calculator
Patients with Renal Impairment
Reconstitution and Dilution
Monitoring and Adjusting REFLUDAN Therapy
A Straight Forward Transition to Oral Anticoagulation
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