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Recothrom (thrombin (recombinant))

Topical Hemostatics Topical Vial (Ea)

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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)
Drug class: Topical Hemostatics
Therapeutic class: Hematological Agents

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Recothrom:

  • 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.

Drug interactions

Formal drug interaction studies with thrombin alfa (thrombin (recombinant)) have not been performed to date.

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.

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.

Precautions

No enhanced messaging available.

ICD codes

CodeTypeDescription
Surgical hemostasis adjunct
0W300ZZICD10PCSControl bleeding in head, open approach
0W303ZZICD10PCSControl bleeding in head, percutaneous approach
0W304ZZICD10PCSControl bleeding in head, percutaneous endoscopic approach
0W310ZZICD10PCSControl bleeding in cranial cavity, open approach
0W313ZZICD10PCSControl bleeding in cranial cavity, percutaneous approach
0W314ZZICD10PCSControl bleeding in cranial cavity, percutaneous endoscopic approach
0W320ZZICD10PCSControl bleeding in face, open approach
0W323ZZICD10PCSControl bleeding in face, percutaneous approach
0W324ZZICD10PCSControl bleeding in face, percutaneous endoscopic approach
0W330ZZICD10PCSControl bleeding in oral cavity and throat, open approach
0W333ZZICD10PCSControl bleeding in oral cavity and throat, percutaneous approach
0W334ZZICD10PCSControl bleeding in oral cavity and throat, percutaneous endoscopic approach
0W337ZZICD10PCSControl bleeding in oral cavity and throat, via natural or artificial opening
0W338ZZICD10PCSControl bleeding in oral cavity and throat, via natural or artificial opening endoscopic
0W33XZZICD10PCSControl bleeding in oral cavity and throat, external approach
0W340ZZICD10PCSControl bleeding in upper jaw, open approach
0W343ZZICD10PCSControl bleeding in upper jaw, percutaneous approach
0W344ZZICD10PCSControl bleeding in upper jaw, percutaneous endoscopic approach
0W350ZZICD10PCSControl bleeding in lower jaw, open approach
0W353ZZICD10PCSControl bleeding in lower jaw, percutaneous approach
0W354ZZICD10PCSControl bleeding in lower jaw, percutaneous endoscopic approach
0W360ZZICD10PCSControl bleeding in neck, open approach
0W363ZZICD10PCSControl bleeding in neck, percutaneous approach
0W364ZZICD10PCSControl bleeding in neck, percutaneous endoscopic approach
0W380ZZICD10PCSControl bleeding in chest wall, open approach
0W383ZZICD10PCSControl bleeding in chest wall, percutaneous approach
0W384ZZICD10PCSControl bleeding in chest wall, percutaneous endoscopic approach
0W390ZZICD10PCSControl bleeding in right pleural cavity, open approach
0W393ZZICD10PCSControl bleeding in right pleural cavity, percutaneous approach
0W394ZZICD10PCSControl bleeding in right pleural cavity, percutaneous endoscopic approach
0W3B0ZZICD10PCSControl bleeding in left pleural cavity, open approach
0W3B3ZZICD10PCSControl bleeding in left pleural cavity, percutaneous approach
0W3B4ZZICD10PCSControl bleeding in left pleural cavity, percutaneous endoscopic approach
0W3C0ZZICD10PCSControl bleeding in mediastinum, open approach
0W3C3ZZICD10PCSControl bleeding in mediastinum, percutaneous approach
0W3C4ZZICD10PCSControl bleeding in mediastinum, percutaneous endoscopic approach
0W3D0ZZICD10PCSControl bleeding in pericardial cavity, open approach
0W3D3ZZICD10PCSControl bleeding in pericardial cavity, percutaneous approach
0W3D4ZZICD10PCSControl bleeding in pericardial cavity, percutaneous endoscopic approach
0W3F0ZZICD10PCSControl bleeding in abdominal wall, open approach
0W3F3ZZICD10PCSControl bleeding in abdominal wall, percutaneous approach
0W3F4ZZICD10PCSControl bleeding in abdominal wall, percutaneous endoscopic approach
0W3G0ZZICD10PCSControl bleeding in peritoneal cavity, open approach
0W3G3ZZICD10PCSControl bleeding in peritoneal cavity, percutaneous approach
0W3G4ZZICD10PCSControl bleeding in peritoneal cavity, percutaneous endoscopic approach
0W3H0ZZICD10PCSControl bleeding in retroperitoneum, open approach
0W3H3ZZICD10PCSControl bleeding in retroperitoneum, percutaneous approach
0W3H4ZZICD10PCSControl bleeding in retroperitoneum, percutaneous endoscopic approach
0W3J0ZZICD10PCSControl bleeding in pelvic cavity, open approach
0W3J3ZZICD10PCSControl bleeding in pelvic cavity, percutaneous approach
0W3J4ZZICD10PCSControl bleeding in pelvic cavity, percutaneous endoscopic approach
0W3K0ZZICD10PCSControl bleeding in upper back, open approach
0W3K3ZZICD10PCSControl bleeding in upper back, percutaneous approach
0W3K4ZZICD10PCSControl bleeding in upper back, percutaneous endoscopic approach
0W3L0ZZICD10PCSControl bleeding in lower back, open approach
0W3L3ZZICD10PCSControl bleeding in lower back, percutaneous approach
0W3L4ZZICD10PCSControl bleeding in lower back, percutaneous endoscopic approach
0W3M0ZZICD10PCSControl bleeding in male perineum, open approach
0W3M3ZZICD10PCSControl bleeding in male perineum, percutaneous approach
0W3M4ZZICD10PCSControl bleeding in male perineum, percutaneous endoscopic approach
0W3N0ZZICD10PCSControl bleeding in female perineum, open approach
0W3N3ZZICD10PCSControl bleeding in female perineum, percutaneous approach
0W3N4ZZICD10PCSControl bleeding in female perineum, percutaneous endoscopic approach
0W3P0ZZICD10PCSControl bleeding in gastrointestinal tract, open approach
0W3P3ZZICD10PCSControl bleeding in gastrointestinal tract, percutaneous approach
0W3P4ZZICD10PCSControl bleeding in gastrointestinal tract, percutaneous endoscopic approach
0W3P7ZZICD10PCSControl bleeding in gastrointestinal tract, via natural or artificial opening
0W3P8ZZICD10PCSControl bleeding in gastrointestinal tract, via natural or artificial opening endoscopic
0W3Q0ZZICD10PCSControl bleeding in respiratory tract, open approach
0W3Q3ZZICD10PCSControl bleeding in respiratory tract, percutaneous approach
0W3Q4ZZICD10PCSControl bleeding in respiratory tract, percutaneous endoscopic approach
0W3Q7ZZICD10PCSControl bleeding in respiratory tract, via natural or artificial opening
0W3Q8ZZICD10PCSControl bleeding in respiratory tract, via natural or artificial opening endoscopic
0W3R0ZZICD10PCSControl bleeding in genitourinary tract, open approach
0W3R3ZZICD10PCSControl bleeding in genitourinary tract, percutaneous approach
0W3R4ZZICD10PCSControl bleeding in genitourinary tract, percutaneous endoscopic approach
0W3R7ZZICD10PCSControl bleeding in genitourinary tract, via natural or artificial opening
0W3R8ZZICD10PCSControl bleeding in genitourinary tract, via natural or artificial opening endoscopic
0X320ZZICD10PCSControl bleeding in right shoulder region, open approach
0X323ZZICD10PCSControl bleeding in right shoulder region, percutaneous approach
0X324ZZICD10PCSControl bleeding in right shoulder region, percutaneous endoscopic approach
0X330ZZICD10PCSControl bleeding in left shoulder region, open approach
0X333ZZICD10PCSControl bleeding in left shoulder region, percutaneous approach
0X334ZZICD10PCSControl bleeding in left shoulder region, percutaneous endoscopic approach
0X340ZZICD10PCSControl bleeding in right axilla, open approach
0X343ZZICD10PCSControl bleeding in right axilla, percutaneous approach
0X344ZZICD10PCSControl bleeding in right axilla, percutaneous endoscopic approach
0X350ZZICD10PCSControl bleeding in left axilla, open approach
0X353ZZICD10PCSControl bleeding in left axilla, percutaneous approach
0X354ZZICD10PCSControl bleeding in left axilla, percutaneous endoscopic approach
0X360ZZICD10PCSControl bleeding in right upper extremity, open approach
0X363ZZICD10PCSControl bleeding in right upper extremity, percutaneous approach
0X364ZZICD10PCSControl bleeding in right upper extremity, percutaneous endoscopic approach
0X370ZZICD10PCSControl bleeding in left upper extremity, open approach
0X373ZZICD10PCSControl bleeding in left upper extremity, percutaneous approach
0X374ZZICD10PCSControl bleeding in left upper extremity, percutaneous endoscopic approach
0X380ZZICD10PCSControl bleeding in right upper arm, open approach
0X383ZZICD10PCSControl bleeding in right upper arm, percutaneous approach
0X384ZZICD10PCSControl bleeding in right upper arm, percutaneous endoscopic approach
0X390ZZICD10PCSControl bleeding in left upper arm, open approach
0X393ZZICD10PCSControl bleeding in left upper arm, percutaneous approach
0X394ZZICD10PCSControl bleeding in left upper arm, percutaneous endoscopic approach
0X3B0ZZICD10PCSControl bleeding in right elbow region, open approach
0X3B3ZZICD10PCSControl bleeding in right elbow region, percutaneous approach
0X3B4ZZICD10PCSControl bleeding in right elbow region, percutaneous endoscopic approach
0X3C0ZZICD10PCSControl bleeding in left elbow region, open approach
0X3C3ZZICD10PCSControl bleeding in left elbow region, percutaneous approach
0X3C4ZZICD10PCSControl bleeding in left elbow region, percutaneous endoscopic approach
0X3D0ZZICD10PCSControl bleeding in right lower arm, open approach
0X3D3ZZICD10PCSControl bleeding in right lower arm, percutaneous approach
0X3D4ZZICD10PCSControl bleeding in right lower arm, percutaneous endoscopic approach
0X3F0ZZICD10PCSControl bleeding in left lower arm, open approach
0X3F3ZZICD10PCSControl bleeding in left lower arm, percutaneous approach
0X3F4ZZICD10PCSControl bleeding in left lower arm, percutaneous endoscopic approach
0X3G0ZZICD10PCSControl bleeding in right wrist region, open approach
0X3G3ZZICD10PCSControl bleeding in right wrist region, percutaneous approach
0X3G4ZZICD10PCSControl bleeding in right wrist region, percutaneous endoscopic approach
0X3H0ZZICD10PCSControl bleeding in left wrist region, open approach
0X3H3ZZICD10PCSControl bleeding in left wrist region, percutaneous approach
0X3H4ZZICD10PCSControl bleeding in left wrist region, percutaneous endoscopic approach
0X3J0ZZICD10PCSControl bleeding in right hand, open approach
0X3J3ZZICD10PCSControl bleeding in right hand, percutaneous approach
0X3J4ZZICD10PCSControl bleeding in right hand, percutaneous endoscopic approach
0X3K0ZZICD10PCSControl bleeding in left hand, open approach
0X3K3ZZICD10PCSControl bleeding in left hand, percutaneous approach
0X3K4ZZICD10PCSControl bleeding in left hand, percutaneous endoscopic approach
0Y300ZZICD10PCSControl bleeding in right buttock, open approach
0Y303ZZICD10PCSControl bleeding in right buttock, percutaneous approach
0Y304ZZICD10PCSControl bleeding in right buttock, percutaneous endoscopic approach
0Y310ZZICD10PCSControl bleeding in left buttock, open approach
0Y313ZZICD10PCSControl bleeding in left buttock, percutaneous approach
0Y314ZZICD10PCSControl bleeding in left buttock, percutaneous endoscopic approach
0Y350ZZICD10PCSControl bleeding in right inguinal region, open approach
0Y353ZZICD10PCSControl bleeding in right inguinal region, percutaneous approach
0Y354ZZICD10PCSControl bleeding in right inguinal region, percutaneous endoscopic approach
0Y360ZZICD10PCSControl bleeding in left inguinal region, open approach
0Y363ZZICD10PCSControl bleeding in left inguinal region, percutaneous approach
0Y364ZZICD10PCSControl bleeding in left inguinal region, percutaneous endoscopic approach
0Y370ZZICD10PCSControl bleeding in right femoral region, open approach
0Y373ZZICD10PCSControl bleeding in right femoral region, percutaneous approach
0Y374ZZICD10PCSControl bleeding in right femoral region, percutaneous endoscopic approach
0Y380ZZICD10PCSControl bleeding in left femoral region, open approach
0Y383ZZICD10PCSControl bleeding in left femoral region, percutaneous approach
0Y384ZZICD10PCSControl bleeding in left femoral region, percutaneous endoscopic approach
0Y390ZZICD10PCSControl bleeding in right lower extremity, open approach
0Y393ZZICD10PCSControl bleeding in right lower extremity, percutaneous approach
0Y394ZZICD10PCSControl bleeding in right lower extremity, percutaneous endoscopic approach
0Y3B0ZZICD10PCSControl bleeding in left lower extremity, open approach
0Y3B3ZZICD10PCSControl bleeding in left lower extremity, percutaneous approach
0Y3B4ZZICD10PCSControl bleeding in left lower extremity, percutaneous endoscopic approach
0Y3C0ZZICD10PCSControl bleeding in right upper leg, open approach
0Y3C3ZZICD10PCSControl bleeding in right upper leg, percutaneous approach
0Y3C4ZZICD10PCSControl bleeding in right upper leg, percutaneous endoscopic approach
0Y3D0ZZICD10PCSControl bleeding in left upper leg, open approach
0Y3D3ZZICD10PCSControl bleeding in left upper leg, percutaneous approach
0Y3D4ZZICD10PCSControl bleeding in left upper leg, percutaneous endoscopic approach
0Y3F0ZZICD10PCSControl bleeding in right knee region, open approach
0Y3F3ZZICD10PCSControl bleeding in right knee region, percutaneous approach
0Y3F4ZZICD10PCSControl bleeding in right knee region, percutaneous endoscopic approach
0Y3G0ZZICD10PCSControl bleeding in left knee region, open approach
0Y3G3ZZICD10PCSControl bleeding in left knee region, percutaneous approach
0Y3G4ZZICD10PCSControl bleeding in left knee region, percutaneous endoscopic approach
0Y3H0ZZICD10PCSControl bleeding in right lower leg, open approach
0Y3H3ZZICD10PCSControl bleeding in right lower leg, percutaneous approach
0Y3H4ZZICD10PCSControl bleeding in right lower leg, percutaneous endoscopic approach
0Y3J0ZZICD10PCSControl bleeding in left lower leg, open approach
0Y3J3ZZICD10PCSControl bleeding in left lower leg, percutaneous approach
0Y3J4ZZICD10PCSControl bleeding in left lower leg, percutaneous endoscopic approach
0Y3K0ZZICD10PCSControl bleeding in right ankle region, open approach
0Y3K3ZZICD10PCSControl bleeding in right ankle region, percutaneous approach
0Y3K4ZZICD10PCSControl bleeding in right ankle region, percutaneous endoscopic approach
0Y3L0ZZICD10PCSControl bleeding in left ankle region, open approach
0Y3L3ZZICD10PCSControl bleeding in left ankle region, percutaneous approach
0Y3L4ZZICD10PCSControl bleeding in left ankle region, percutaneous endoscopic approach
0Y3M0ZZICD10PCSControl bleeding in right foot, open approach
0Y3M3ZZICD10PCSControl bleeding in right foot, percutaneous approach
0Y3M4ZZICD10PCSControl bleeding in right foot, percutaneous endoscopic approach
0Y3N0ZZICD10PCSControl bleeding in left foot, open approach
0Y3N3ZZICD10PCSControl bleeding in left foot, percutaneous approach
0Y3N4ZZICD10PCSControl bleeding in left foot, percutaneous endoscopic approach

ICD code information from First Databank (FDB).

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