Company:

ZymoGenetics

Topical hemostatic

Thrombin [recombinant] 5000 IU/5mL; pwd for topical use after reconstitution; preservative-free.

Aid to hemostasis for minor bleeding/oozing from capillaries and venules when standard surgical techniques are inadequate or ineffective. May use with absorbable gelatin sponge.

Recothrom is a coagulation protein manufactured by recombinant DNA technology using a mammalian cell line (genetically engineered Chinese hamster ovary cells). It is identical in amino acid sequence and similar in structure to human thrombin. When applied topically to a bleeding site, it activates platelets and catalyzes the conversion of fibrinogen to fibrin, thereby contributing to clot formation.

The safety, efficacy, and immunogenicity of Recothrom was compared to that of bovine thrombin in combination with an absorbable gelatin sponge as adjuncts to hemostasis in surgery. This randomized, double-blind, multi-site phase 3 study was conducted in 411 patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access. Efficacy was evaluated by the incidence of hemostasis of mild-to-moderate bleeding within 10 minutes. For patients treated with Recothrom, the incidence of hemostasis within 10 minutes was 95.4% compared to 95.1% in the comparator group.

The most common adverse events were related to the procedure: incision complication, procedural pain, and nausea. The development of antibodies was evaluated by performing blood tests for antibodies to Recothrom or the bovine thrombin, CHO host-cell protein, and prothrombin activator. Treatment with Recothrom resulted in a significantly lower incidence of specific antibody to the product administered (1.5% for Recothrom vs. 22% for bovine thrombin). The development of antibodies in either group did not lead to any adverse events. Antibodies that developed in the Recothrom group did not neutralize native human thrombin.

Apply directly to bleeding area, or soak into absorbable gelatin sponge and apply in a single layer.

Not recommended.

Not for direct injection into circulatory system. Not for treatment of massive or brisk arterial bleeding. Hypersensitivity to hamster proteins.

Avoid systemic absorption (thrombosis may occur). Hypersensitivity to snake proteins. Pregnancy (Cat.C).

Incision site complication, infection, pain, bleeding, nausea/vomiting, cardiac events, thromboembolic events.

Single-use vial –1 (w. diluent, supplies)

2/8/08