Thrombin (synthetic Human)
Thrombin (synthetic Human) Uses, Dosage, Side Effects, Food Interaction and all others data.
Thrombin Alfa is a human coagulation protein produced via recombinant DNA technology from a genetically modified CHO cell line. Thrombin Alfa is identical in amino acid sequence and structurally similar to naturally occurring human thrombin. Thrombin Alfa precursor is secreted to culture medium as single chain form that is proteolytically converted to a two-chain active form (using a protein derived from snakes) and is purified by a chromatographic process that yields a product having hemostatic activities similar to native human thrombin. The cell line used to manufacture Thrombin Alfa has been tested and shown to be free of known infectious agents. The cell culture process used in the manufacture of Thrombin Alfa employs no additives of human or animal origin. The purification process includes solvent-detergent treatment and nano-filtration steps dedicated to viral clearance. The thrombin alfa product ultimate comes from recombinant human prethrombin-1 .
Nevertheless, because the incidence of hemostasis within a timely manner is relatively comparable between the use of thrombin alfa and the placebo treatment in patient subjects, thrombin alfa is not currently approved by certain organizations like the European Medicines Agency .
As thrombin alfa, a recombinant thrombin, is considered to be identical in amino acid sequence and structural similarity to naturally occurring human thrombin, it is believed that thrombin alfa shares the same pharmacodynamics as endogenous or natural human thrombin coagulation factor .
| Trade Name | Thrombin (synthetic Human) |
| Generic | Thrombin alfa |
| Thrombin alfa Other Names | Human Thrombin (recombinant, glycosylated), Thrombin (synthetic human), Thrombin alfa |
| Type | |
| Protein binding | Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa . Protein binding data is subsequently not readily available, although thrombin alfa functions predominantly to interact with a very specific set of clotting factors - a function that endogenous thrombin (of which thrombin alfa is a recombinant replica of) is naturally designed to perform. |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Thrombin (synthetic Human) is a platelet activating factor used to treat minor bleeding.
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 (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age .
Additionally, thrombin alfa can be used in conjunction with an absorbable gelatin sponge, USP .
Thrombin (synthetic Human) is also used to associated treatment for these conditions: Minor bleeding
How Thrombin (synthetic Human) works
Specifically, thrombin alfa is a human serine protease that promotes hemostasis and acts locally when applied topically to a site of bleeding . In particular, thrombin alfa activates platelets and cleaves fibrinogen to fibrin, leading directly to clot formation. It also activates clotting factor XIII, leading to fibrin cross-linking and clot stability . The ability of thrombin alfa to bypass the initial enzymatic steps of the coagulation pathway provides a clear rationale as to why thrombin alfa may be used as a topical haemostatic agent .
Toxicity
Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa . Data regarding overdosage are not available. The predominant adverse reaction associated with thrombin alfa is the possibility of thrombosis or other thromboembolic events occurring .
Food Interaction
No interactions found.Volume of Distribution
Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa . Volume of distribution data is subsequently not readily available.
Elimination Route
Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa .
Nevertheless, observations of a subcutaneous administration of 350 U rhThrombin/kg resulted in a bioavailability of approximately 95% in male cynomolgus monkeys .
Half Life
Following intravenous administration, thrombin alfa exhibited an initial half-life of 0.17 hours (10.2 min) . Following either intravenous or subcutaneous administration, the agent demonstrated a terminal half-life of about 15 hours . This data follows administration of thrombin alfa to cynomolgus monkeys.
Clearance
Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa . Regardless, thrombin alfa, like natural thrombin, is known to be 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
Thrombin (synthetic Human), like endogenous 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 .
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