Refludan

Refludan is the brand name for lepirudin, a recombinant form of hirudin, a natural direct thrombin inhibitor derived from the medicinal leech. It acts by binding to thrombin, inhibiting the conversion of fibrinogen to fibrin and reducing thrombin-mediated platelet activation. As a direct thrombin inhibitor, it affects both circulating and clot-bound thrombin.

Clinical use of Refludan has been primarily as an anticoagulant in patients with heparin-induced thrombocytopenia (HIT). It has also been used in certain surgical settings, such as cardiopulmonary bypass, where heparin cannot be used. Administration is by intravenous infusion, and dosing is guided by coagulation tests such as the activated partial thromboplastin time (aPTT).

Pharmacokinetics and administration considerations: Lepirudin is predominantly eliminated by the kidneys. The half-life is roughly 1.5 to 2.5 hours in patients with normal renal function and is prolonged in renal impairment, requiring careful dose adjustment and monitoring.

Safety and reversal: The main risk is bleeding, which increases with higher doses or impaired renal function. There is no specific, rapidly acting antidote to lepirudin; discontinuation and supportive care are the main management strategies, and in some circumstances procedures to remove the drug can be considered. Rare hypersensitivity reactions may occur, including anaphylaxis with exposure.

Regulatory status: Refludan was approved in several regions for HIT and related indications, but its use has declined in many markets with the availability of newer direct thrombin inhibitors such as argatroban and bivalirudin. Availability and approved indications vary by country.