Thrombin topical (bovine) can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies against bovine thrombin. Bleeding may result from the development of antibodies against factor V. These may cross-react with human factor V and lead to its deficiency. Do not re-expose patients to thrombin topical (bovine) if there are known or suspected antibodies to bovine thrombin and/or factor V. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
Hemostasis aid: Topical: Note: For topical use only; do not administer IV or intra-arterially:
Recothrom: Infants, Children, and Adolescents: Dose depends on area to be treated including size of and number of bleeding sites; may apply directly or in conjunction with an absorbable gelatin sponge.
Thrombin-JMI: Limited data available: Note: While reports in the literature have documented use in pediatric patients, they have focused on the development of coagulopathies due to inhibitor formation after bovine thrombin; few reports indicate dosing used (Barrett 1999; Crow 2007; Rodgers 2011; Savage 2007); dosing presented is reflective of manufacturer's labeling.
Infants, Children, and Adolescents:
Solution: Apply 1,000 to 2,000 units/mL of solution where bleeding is profuse. Apply 100 units/mL for bleeding from skin or mucosal surfaces (eg, skin grafting, dental extractions, plastic surgery).
Powder: May apply dry powder directly to the site on oozing surfaces.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Thrombin, topical (human and bovine): Drug information")
Hemostasis aid: Topical: Note: For topical use only; do not administer intravenously or intra-arterially:
Recothrom: Dose depends on area to be treated. Apply to the bleeding site directly or in conjunction with absorbable gelatin sponge.
Thrombi-Gel: Apply directly over source of the bleeding with adjunct manual pressure until hemostasis is achieved.
Thrombin-JMI:
Solution: Apply 1,000 to 2,000 units/mL of solution where bleeding is profuse. Apply 100 units/mL for bleeding from skin or mucosal surfaces (eg, skin grafting, dental extractions, plastic surgery).
Powder: May apply dry powder directly to the site on oozing surfaces.
Thrombi-Pad: Apply dry or wetted pad directly over source of bleeding with adjunct manual pressure. If desired, product may be left in place for up to 24 hours; do not leave in the body.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Pad, topical [preservative free; bovine derived]:
Thrombi-Pad 3x3: ≥200 units (10s)
Powder for reconstitution, topical [bovine derived]:
Thrombin-JMI: 5000 units, 20,000 units [supplied with diluent]
Thrombin-JMI Epistaxis kit: 5000 units [supplied with diluent]
Thrombin-JMI Pump Spray Kit: 20,000 units [supplied with diluents]
Thrombin-JMI Syringe Spray Kit: 5000 units; 20,000 units [supplied with diluent]
Powder for reconstitution, topical [preservative free; recombinant]:
Recothrom: 5000 units; 20,000 units [production involves products derived from hamster and snake sources; supplied with diluent]
Recothrom Spray Kit: 20,000 units [production involves products derived from hamster and snake sources; supplied with diluent]
Sponge, topical [preservative free; bovine derived]:
Thrombi-Gel 10: ≥1000 units (10s)
Thrombi-Gel 40: ≥1000 units (5s)
Thrombi-Gel 100: ≥2000 units (5s)
No
Topical: For topical use only; do not administer IV or intra-arterially.
Recothrom: May apply reconstituted solution directly using spray applicator kit or in combination with absorbable gelatin sponge.
Use with spray applicator: Use the sterile bowl in kit as receptacle for reconstituted solution; refer to spray kit manufacturer's labeling for spray pump and syringe spray assembly and use.
Use with gelatin sponge: Transfer solution to sterile container and immerse gelatin sponge(s) into solution until completely saturated; gently squeeze to remove excess solution; apply sponge(s) to bleeding site in a single layer.
Thrombin-JMI: May be applied directly as a powder or as reconstituted solution. Sponge (do not wipe) application surface prior to use, if possible. Product is most effective when it mixes freely with blood as soon as it reaches the surface. Avoid sponging of treated surfaces.
Use as topical solution: Flood surface using a sterile syringe with a small-gauge needle or use in conjunction with Thrombin-JMI pump spray kit, syringe spray kit, or epistaxis kit; refer to manufacturer's kit labeling for assembly and use.
Use with gelatin sponge: Immerse sponge strips into reconstituted thrombin solution; vigorously knead sponge with moistened gloved fingers until all air is expelled; apply saturated sponge to bleeding area; hold in place with gauze or cotton pledget using moderate pressure until hemostasis is achieved.
Use with Gel-Flow NT: The 5,000 unit syringe spray kit may be used to saturate gelatin powder in Gel-Flow NT; mixture may be smeared, filled, or pressed against surface to control bleeding; refer to Gel-Flow NT product labeling for preparation instructions.
For topical use only; do not administer intravenously or intra-arterially.
Recothrom: May apply reconstituted solution directly using ZymoGenetics spray applicator kit or in combination with absorbable gelatin sponge. When using spray applicator, use the sterile bowl in kit as receptacle for reconstituted solution; refer to spray kit manufacturer’s labeling for spray pump and syringe spray assembly and use. When used in conjunction with absorbable gelatin sponge(s), transfer solution to sterile container and immerse gelatin sponge(s) into solution until completely saturated; gently squeeze to remove excess solution; apply sponge(s) to bleeding site in a single layer.
Thrombi-Gel: After wetting, place directly over bleeding source and apply adjunct manual compression until hemostasis is achieved; may cut or roll to desired shape prior to wetting.
Thrombin-JMI: Sponge (do not wipe) application surface prior to use, if possible. Apply as dry powder or reconstituted solution. When used as a solution, flood surface using a sterile syringe with a small-gauge needle or use in conjunction with Thrombin-JMI pump spray kit, syringe spray kit, or epistaxis kit; refer to manufacturer’s kit labeling for assembly and use. The 5,000 unit syringe spray kit may be used to saturate gelatin powder in Gel-Flow NT; mixture may be smeared, filled or pressed against surface to control bleeding (refer to Gel-Flow NT product labeling for preparation instructions). When used in conjunction with absorbable gelatin sponge, immerse sponge strips into solution; vigorously knead sponge with moistened gloved fingers until all air is expelled; apply saturated sponge to bleeding area; hold in place with gauze or cotton pledget using moderate pressure until hemostasis is achieved. Product is most effective when it mixes freely with blood as soon as it reaches the surface. Avoid sponging of treated surfaces.
Thrombi-Pad: Apply dry or wet directly to the bleeding source and apply adjunct manual compression; may be left in place for up to 24 hours. To remove, do not disrupt clot by physical manipulation. If pad adheres to the site, irrigate with nonheparinized NS and remove.
All products: Store at 2°C to 25°C (36°F to 77°F) prior to reconstitution or wetting.
Recothrom: Do not freeze. Following reconstitution, may store at 2°C to 25°C (36°F to 77°F) for up to 24 hours.
Thrombi-Gel: After wetting, use within 3 hours.
Thrombin-JMI: Solutions may be stored at 2°C to 8°C (36°F to 46°F) for up to 24 hours or at room temperature for up to 8 hours after reconstitution.
Thrombi-Pad: If pad is wetted, use within 1 hour.
Hemostasis aid whenever minor bleeding from capillaries and small venules is accessible and control by standard surgical techniques is ineffective or impractical (Recothrom: FDA approved in ages ≥1 month and adults; Thrombin-JMI: FDA approved in adults).
Trauma dressing for temporary control of moderate to severe bleeding wounds; control of surface bleeding from vascular access sites and percutaneous catheters and tubes (Thrombi-Gel, Thrombi-Pad: FDA approved in adults).
Thrombin (topical) may be confused with antithrombin, Thrombate III
For topical use only. Do not administer intravenously or intra-arterially.
To reduce the risk of intravascular administration, the Institute for Safe Medication Practices (ISMP) has the following recommendations:
- Prepare, label, and dispense topical thrombin from the pharmacy department (including doses used in the operating room).
- Do not leave vial or syringe at bedside.
- Add auxiliary label to all labels and syringes stating “For topical use only - do not inject”.
- When appropriate, use solutions which can be applied with an absorbable gelatin sponge or use a dry form on oozing surfaces.
- When appropriate, use spray kits to help differentiate between parenteral products.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Hypotension (≥2%), tachycardia (≥2%), thromboembolism (5%)
Hematologic & oncologic: Anemia (≥2%), hemorrhage (≥2%; including major hemorrhage), thrombocytopenia (≥2%)
Hypersensitivity: Hypersensitivity reaction (≥2% )
Immunologic: Antibody development (≤2%)
Frequency not defined: Cardiovascular: Thrombosis
Postmarketing:
Hematologic & oncologic: Decreased clotting factors (factor V), disseminated intravascular coagulation, postoperative hematoma, prolonged partial thromboplastin time, prolonged prothrombin time
Hypersensitivity: Anaphylaxis, nonimmune anaphylaxis
Miscellaneous: Swelling
Known hypersensitivity to any component of the formulation.
Recothrom: Additional contraindications: Known hypersensitivity to hamster proteins; injection directly into the circulatory system; treatment of massive or brisk arterial bleeding.
Thrombi-Gel: Additional contraindications: Use in the closure of skin incisions.
Thrombin-JMI: Additional contraindications: Known sensitivity to material of bovine origin; injection directly into the circulatory system; re-exposure if there are known or suspected antibodies to bovine thrombin and/or factor V; treatment of severe or brisk arterial bleeding.
Thrombi-Pad: Additional contraindications: Known sensitivity to bovine-derived materials.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, may occur. Institute supportive measure and treat individual symptoms immediately.
Dosage form specific issues:
• Infection risk: Thrombi-Gel and Thrombi-Pad: Do not use in the presence of infection; use caution in areas of contamination.
• Nonabsorbable product: Thrombi-Pad: Do not use as a replacement for absorbable hemostats. Product is nonabsorbable; do not leave in the body.
• Proteins (snake and hamster origin): Recothrom: Use caution in patients with known hypersensitivity to snake or hamster proteins (manufacturing process uses a genetically modified hamster cell line and snake proteins); the potential for allergic reaction theoretically exists.
• Severe bleeding and thrombosis complications: Thrombin-JMI, Thrombi-Gel, and Thrombi-Pad only. [US Boxed Warning]: Thrombin topical (bovine) can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies against bovine thrombin. Bleeding may result from the development of antibodies against factor V. These may cross-react with human factor V and lead to its deficiency. Do not re-expose patients to thrombin topical (bovine) if there are known or suspected antibodies to bovine thrombin and/or factor V. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
Other warnings/precautions:
• Administration: For topical use only. Do not inject intravenously or intra-arterially. Intravascular clotting, possibly leading to death, may occur following injection. Powder and solution formulations may be used in combination with absorbable gelatin sponges; The 5,000 unit syringe spray kit may be used in conjunction with Gel-Flow NT.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program
There are no known significant interactions.
Animal reproduction studies have not been conducted.
Information related to the use of topical hemostatic agents in gynecologic surgery is limited; routine prophylactic use for postoperative bleeding is not recommended due to the increased risk of infection and other complications (ACOG 2020).
When applied to bleeding sites, activates platelets and catalyzes the conversion of fibrinogen to fibrin to promote hemostasis.
One unit is amount required to clot 1 mL of standardized fibrinogen solution in 15 seconds.
Kit (Thrombin-JMI Epistaxis External)
5000 unit (per each): $92.70
Kit (Thrombin-JMI External)
5000 unit (per each): $88.30
20000 unit (per each): $358.43
Kit (Thrombogen External)
10000 unit (per each): $34.39
Pads (Thrombi-Pad External)
3"X3" (per each): $68.41
Solution (reconstituted) (Recothrom External)
5000 unit (per each): $103.20
20000 unit (per each): $412.80
Solution (reconstituted) (Recothrom Spray Kit External)
20000 unit (per each): $418.80
Solution (reconstituted) (Thrombin-JMI External)
5000 unit (per each): $86.56
20000 unit (per each): $341.35
Solution (reconstituted) (Thrombogen External)
1000 unit (per each): $3.60
10000 unit (per each): $18.02
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