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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (L's) » Lepirudin



DESCRIPTION

REFLUDAN [lepirudin( rDNA) for injection] is a highly specific direct inhibitor of thrombin. Lepirudin (chemical designation: [Leul, Thr 2]-63-desulfohirudin) is a recombinant hirudin derived from yeast cells. The polypeptide composed of 65 amino acids has a molecular weight of 6979.5 daltons. Natural hirudin is produced in trace amounts as a family of highly homologous isopolypeptides by the leech Hirudo medicinalis. The biosynthetic molecule (lepirudin) is identical to natural hirudin except for substitution of leucine for isoleucine at the N-terminal end of the molecule and the absence of a sulfate group on the tyrosine at position 63.

The activity of lepirudin is measured in a chromogenic assay. One antithrombin unit (ATU) is the amount of lepirudin that neutralizes one unit of World Health Organization preparation 89/588 of thrombin. The specific activity of lepirudin is approximately 16,000 ATU/mg. Its mode of action is independent of antithrombin III. Platelet factor 4 does not inhibit lepirudin. One molecule of lepirudin binds to one molecule of thrombin and thereby blocks the thrombogenic activity of thrombin. As a result, all thrombin-dependent coagulation assays are affected, e.g., activated partial thromboplastin time (aPTT) values increase in a dose-dependent fashion (Roethig 1991).

REFLUDAN is supplied as a sterile, white, freeze-dried powder for injection or infusion and is freely soluble in Water for Injection USP or 0.9% Sodium Chloride Injection USP.

Each vial of REFLUDAN contains 50 mg lepirudin. Other ingredients are 40 mg mannitol and sodium hydroxide for adjustment of pH to approximately 7.





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