"The HHS Office on Women's Health (OWH) today launched its new heart attack awareness campaign targeting Spanish-speaking women age 50 and over. The "Haga La Llamada, ¡No Pierda Tiempo!" campaign builds on OWH's successful "Make the Call, Don't Mi"...
REFLUDAN ® 50 mg/Vial
[lepirudin (rDNA)] For Injection
- Patient Information:
Details with Side Effects
REFLUDAN [lepirudin (rDNA) for injection] is a highly specific direct inhibitor of thrombin. Lepirudin, (chemical designation: [Leu1, Thr2]-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 neu-tralizes 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, eg, activated partial thromboplastin time (aPTT) and prothrom-bin time (PT /INR) values increase in a dose-dependent fashion (Roethig 1991).
REFLUDAN (lepirudin) is supplied as a sterile, white, freeze-dried powder for injection or infusion and is freely soluble in Sterile Water for Injection USP or 0.9% Sodium Chloride Injection USP.
Each vial of REFLUDAN contains 50 mg lepirudin. Other ingre-dients are 40 mg mannitol and sodium hydroxide for adjust-ment of pH to approximately 7.
Last reviewed on RxList: 7/31/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Refludan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.