Floseal

Uses

Floseal is a coagulation factor used to stop bleeding during surgery.

Bovine thrombin is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (like suture, ligature, or cautery) is ineffective or impractical . Additionally, topical bovine thrombin can also be used in combination with an absorbable gelatin sponge, USP .

Floseal is also used to associated treatment for these conditions: Refractory to surgical techniques Bleeding, Tissue Adhesions

How Floseal works

Bovine thrombin requires no intermediate physiological agent for its action . It activates platelets and catalyzes the conversion of fibrinogen to fibrin, which are essential steps for clot formation . Failure to clot blood occurs in the case where the primary clotting defect is the absence of fibrinogen itself . The speed with which the bovine thrombin clots blood is dependent upon the concentration of both the bovine thrombin and the fibrinogen present .

Toxicity

With regards to bovine thrombin, no cases of overdose have been reported so far . Bovine thrombin however, is capable of causing fatal severe bleeding or thrombosis . This thrombosis may result from the development of antibodies against bovine thrombin . Bleeding may result from the development of antibodies against bovine factor V . These antibodies may subsequently cross-react with endogenous human factor V and lead to its deficiency . Patients who are know or suspected to have antibodies to bovine thrombin and/or bovine factor V should not be re-exposed to the product . Patients who are administered bovine thrombin should be monitored for abnormal coagulation laboratory values, bleeding, or indeed, thrombosis .

LD50 values are available for rat and mouse models where rat subcutaneous LD50 > 40mg/kg, rat IP LD50 > 40mg/kg, and mouse subcutaneous LD50 > 50 mg/kg (in which the greater than symbol indicates that the toxicity endpoint being tested was not achievable at the highest dose used in the test) .

Regardless, the most common adverse reactions following administration of bovine thrombin include hypersensitivity, bleeding, anemia, post-operative wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, and/or thrombocytopenia .

Food Interaction

Volume of Distribution

Little has been reported about the systemic pharmacokinetics of bovine thrombin preparations , but owing to its topical mode of application, systemic exposure or distribution to other organs and tissues is not expected.

Elimination Route

Little has been reported about the systemic pharmacokinetics of bovine thrombin preparations , but owing to its topical mode of administration, it is expected that any kind of systemic absorption would be minimal.

Half Life

Unfortunately, little has been reported about the systemic pharmacokinetics of bovine thrombin preparations .

Clearance

Although little has been reported about the systemic pharmacokinetics of bovine thrombin preparations , it is expected that they are generally rapidly neutralized by naturally circulating plasma inhibitors limiting its duration of action and preventing the active form from diffusing into the general circulation .

Elimination Route

Although little has been reported about the systemic pharmacokinetics of bovine thrombin preparations , they are expected to act in much the same way as endogenous thrombin does. Natural bodily thrombin is cleared by two primary separate pathways: (1) through rapid formation of thrombin inhibitor complexes, which are recognized by hepatic receptors and degraded, and (2) via direct binding to thrombomodulin on the endothelium, followed by internalization and degradation . Specific thrombin inhibitors include ATIII, alpha-2M and heparin cofactor II .

Innovators Monograph

You find simplified version here Floseal