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Tachosil (fibrinogen/thrombin (human plasma derived))

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Thrombin (human), a preparation of human plasma-derived thrombin, is a topical hemostatic agent.

Thrombin (human) is a highly purified preparation of thrombin derived from pooled human plasma. Thrombin is prepared from its precursor, prothrombin, through a series of separation and purification steps followed by activation with calcium chloride. Manufacturing pools and individual units of plasma used in the preparation of thrombin (human) are screened for human viruses (e.g., hepatitis, HIV, parvovirus B19).

Additional viral inactivation and purification steps (e.g., solvent/detergent, nanofiltration) are employed to further reduce the risk of pathogen transmission.

Thrombin promotes hemostasis principally by converting fibrinogen to fibrin, the final step in the coagulation cascade. However, thrombin's effects in hemostasis are complex and include several other mechanisms (e.g., platelet activation and aggregation, activation of factor XIII leading to fibrin crosslinking and clot stabilization). Thrombin is capable of converting fibrinogen directly to fibrin at the site of vessel injury without the addition of other substances, thus providing a rationale for its use as a topical hemostatic agent.

Failure of thrombin to clot blood occurs in the rare instance when the primary clotting defect is the absence of fibrinogen. The rate at which thrombin clots blood depends on the concentration of thrombin and fibrinogen.

Thrombin (human) is stable for up to 2 years when stored at -18degreesC or colder. Unopened vials may be stored under refrigeration (2-8degreesC) for up to 30 days or up to the manufacturer's labeled expiration date, whichever comes first.

Generic name: fibrinogen/thrombin (human plasma derived)

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Tachosil:

  • Surgical Hemostasis Adjunct

Dosing

The volume of thrombin (human) required to achieve hemostasis varies depending on the size of the bleeding area and method of application. In clinical studies, volumes of up to 10 mL were used in conjunction with absorbable gelatin sponge preparations.

Drug interactions

There are no known drug interactions with thrombin (human).

Contraindications

Thrombin (human) should not be injected directly into the circulatory system. (See Thrombosis under Warnings/Precautions: Warnings, in Cautions.)

Treatment of massive or brisk arterial bleeding.

Known hypersensitivity (i.e., anaphylaxis) or severe systemic reaction to human blood products.

Adverse reactions

The most common adverse effects reported in patients receiving thrombin (human) in clinical trials were procedure-related complications (e.g., wound infection), nausea, pruritus, and laboratory abnormalities (e.g., decreased hematocrit, hemoglobin, lymphocytes, and red blood cells; increased neutrophils and leukocytes). Such effects are common in a postoperative population and have not been directly attributed to the drug.

Precautions

No enhanced messaging available.

ICD codes

No ICD codes are available for this drug.

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data