Recothrom Spray Kit (thrombin (recombinant))
Last reviewed · Source: First Databank (FDB) drug data
Overview
Thrombin alfa (thrombin (recombinant)), a biosynthetic (recombinant DNA origin) preparation of naturally occurring human thrombin, is a topical hemostatic agent.
Thrombin alfa (thrombin (recombinant)) is a sterile, lyophilized powder containing thrombin prepared using recombinant DNA technology. Thrombin alfa is structurally and pharmacologically similar to endogenous human thrombin; the amino acid sequences of both proteins are identical.
Activated by both the intrinsic and extrinsic blood coagulation pathways, 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 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.
Clot integrity and time to hemostasis are dependent on concentrations of thrombin and fibrinogen present during clot formation.
Studies with radiolabeled drug in animal models indicate that thrombin alfa is rapidly (less than 5 minutes) inactivated in the circulation after complexation with endogenous inhibitors; the resulting complexes are then removed by the liver.
Thrombin alfa is prepared by recombinant DNA technology in a genetically modified mammalian cell (Chinese hamster ovary) expression system free of known infectious agents; the drug does not contain human or animal additives. The manufacturing process includes additional purification steps (nanofiltration, solvent/detergent) to further reduce the risk of viral transmission.
Generic name: thrombin (recombinant)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Recothrom Spray Kit:
- Surgical Hemostasis Adjunct
Dosing
The volume of thrombin alfa required to achieve hemostasis varies depending on the total number of bleeding sites, the surface area being treated, and the method of application. In clinical studies, most patients achieved hemostasis within 10 minutes following a single application of thrombin alfa.
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No dosing information is available for this tab.
Drug interactions
Formal drug interaction studies with thrombin alfa (thrombin (recombinant)) have not been performed to date.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Do not inject directly into the circulatory system. (See Thrombosis under Warnings/Precautions: Warnings, in Cautions.)
Treatment of massive or brisk arterial bleeding.
Known hypersensitivity to thrombin alfa (thrombin (recombinant)), hamster proteins, or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects reported in patients receiving thrombin alfa in clinical studies were incision site complications, procedural pain, nausea, constipation, insomnia, and vomiting; such adverse effects are expected to be common in a postoperative population and a causal relationship to the drug has not been established.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Thrombin alfa has been evaluated in a limited number of pediatric patients (12-17 years of age) undergoing burn wound excision prior to grafting. Manufacturer states that safety and efficacy in pediatric patients younger than 12 years of age have not been established.
Category C. (See Users Guide.)
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Among the total number of patients enrolled in the phase 2 and phase 3 pivotal trials of thrombin alfa applied with an absorbable gelatin sponge, 38% were 65 years of age or older, and 16% were 75 years of age or older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients and other clinical experience has not revealed any evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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