Human thrombin

EVITHROM™ Thrombin, Topical (Human), 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 (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM™ Thrombin, Topical (Human), may be used in conjunction with an Absorbable Gelatin Sponge, USP. EVITHROM™ is a topical thrombin 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 (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM™ may be used in conjunction with an Absorbable Gelatin Sponge, USP.

Thrombin (coagulation Factor IIa) is a highly specific protease that transforms plasma fibrinogen into fibrin which, in the presence of 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.

For topical use only. DO NOT INJECT. Apply EVITHROM™ on the surface of bleeding tissue only. The amount of EVITHROM™ required depends upon the area of tissue to be treated and the method of application. In clinical studies, volumes up to 10 ml were used in conjunction with Absorbable Gelatin Sponge, USP.

Do not use in individuals known to have an anaphylactic or severe systemic reaction to EVITHROM™ or to human blood products. Do not use for the treatment of severe or brisk arterial bleeding. Do not use for treatment of severe or brisk arterial bleeding.

Potential risk of thrombosis if absorbed systemically. May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of viral transmission. Hypersensitivity reactions, including anaphylaxis, may occur.

The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM™) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. The most common adverse reactions (incidence 2%) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. None of the patients treated with EVITHROM™ developed antibodies to human thrombin or to human Factor V/Va. The clinical significance of these findings is unknown.

Store EVITHROM™ powder vials at 2- 25°C (36-77°F) for up to 2 years. Keep the vials protected from light. Store reconstituted EVITHROM™ solution at room temperature for up to 8 hours. Do not freeze or refrigerate EVITHROM™ once it has been reconstituted.