Approved January 17, 2008

THROMBIN HUMAN, RECOMBINANT
(FDA Category 1S)

RECOTHROM(TM) (ZymoGenetics, Inc) is a coagulation protein that clots the fibrinogen of the blood directly without the aid of a physiological agent. It is a highly specific protease that converts fibrinogen into fibrin. Thrombin human, recombinant is made by recombinant DNA technology from a genetically modified Chinese hamster ovary cell line without additives of human or animal origin.

DOSING INFORMATION: Thrombin is applied topically to the surface of the bleeding tissue with or without an absorbable gelatin sponge, amount required depends upon the area of tissue being treated and the method of application.

PHARMACOKINETICS: Human thrombin, recombinant is inactivated in less than 5 minutes after formation of complexes with endogenous inhibitors such as antithrombin III. The complexes are subsequently cleared by the liver.

CAUTIONS: Contraindicated when arterial bleeding is massive or brisk. Extensive intravascular clotting and even death may occur if administered by direct circulatory injection. There is a potential risk of allergic reaction in patients with a hypersensitivity to snake proteins. The most common adverse event is incision site complication.

FDA APPROVED INDICATIONS: Thrombin human, recombinant is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.