Evicel
Evicel Uses, Dosage, Side Effects, Food Interaction and all others data.
Human thrombin is a sterile solution, pH 6.8-7.2, containing highly purified human thrombin for the activation of clotting. Thrombin is a highly specific serine protease encoded by the F2 gene that transforms soluble fibrinogen into insoluble fibrin. This transformation mimics the final coagulation cascade step which involves the clotting mass that adheres to the wound surface and achieves hemostasis and sealing of open tissues.
In particular, while human thrombin products are made from pooled human source plasma, recombinant thrombin is a human coagulation protein produced via recombinant DNA technology from a genetically modified Chinese hamster ovary cell line . Furthermore, human thrombin is manufactured by chromatographic purification of prothrombin from cryo-poor plasma followed by activation with calcium chloride .
Clinical pharmacodynamic studies with human thrombin have not been performed at this time .
| Trade Name | Evicel |
| Generic | Human Fibrinogen + Human Thrombin |
| Type | Injection |
| Therapeutic Class | |
| Manufacturer | Johnson & Johnson |
| Available Country | India, |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Human thrombin is a platelet activating factor used to treat minor bleeding.
Human thrombin is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules are accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical .
Evicel is also used to associated treatment for these conditions: Bleeding, Suture rupture, Myringoplasty
How Evicel works
Human thrombin (coagulation factor IIa) is a highly specific protease that transforms plasma fibrinogen into fibrin which, in the presence of clotting factor XIII in the patient's plasma, is cross-linked to form a stable clot . When applied to a surgical wound where bleeding is present, thrombin activates fibrinogen in the patient's plasma to form fibrin, which results in clot formation and hemostasis . The fibrin clot is stabilized by cross-linking occurring as a result of activation of the patient's endogenous factor XIII, which requires the presence of calcium .
Human thrombin does not require any intermediate physiological agent because it naturally clots the fibrinogen of the blood directly . Any failure to clot blood occurs in the rare case where the primary clotting defect is the absence of fibrinogen itself . The speed with which human thrombin clots blood is dependent upon the concentration of both the human thrombin used and fibrinogen present .
Toxicity
No cases of overdose have been reported at this time . The LD50 value for the mouse model is calculated to be approximately 3 gm/kg .
Volume of Distribution
Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted . Precisely because human thrombin is applied only topically, systemic exposure or distribution to other organs and tissues is not expected .
Elimination Route
Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted . Particularly because the agent is topical, systemic absorption is expected to be small .
Half Life
Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted .
Clearance
Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted .
Regardless, commercial human thrombin, like endogenous thrombin, is 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
Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted .
Nevertheless, commercial human thrombin products 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 Evicel
