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Using THROMBIN-JMI
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Full Prescribing Information including BOXED WARNING Indication
THROMBIN-JMI safetyThe safety of THROMBIN-JMI® was evaluated in multiple clinical trials.1-5
  • The most common adverse reactions (incidence ≥2%) were hypersensitivity, bleeding, anemia, postoperative wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, and thrombocytopenia1 
  • In the 2006 study, no serious adverse reactions related to the gel treatment were reported1,5
  • In the 2007 study, the reported adverse reactions in the THROMBIN-JMI treatment group were: cardiac events (18%), hypersensitivity (17%), other infections (15%), bleeding (11%), postoperative wound infection (10%), and thromboembolic events (5%). The safety profiles for rhThrombin and bovine thrombin were similar1,2
  • In the 2008 study, serious adverse reactions (pyrexia and post-procedural hematoma) were reported in 2 patients receiving THROMBIN-JMI. The safety profiles for human thrombin and bovine thrombin were comparable1,3
  • In the 2019 study, the most common treatment-emergent adverse reactions (experienced by >5% of patients within a treatment group) were procedural pain, nausea, constipation, pruritus, muscle spasms, insomnia, pyrexia, and vomiting. No substantial differences in treatment-emergent adverse events incidences were noted between treatment groups1,4
Immunogenicity
Inhibitory antibodies may develop in patients and interfere with hemostasis. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis1

In the 2007 study, 5% of patients (10 out of 200) who received THROMBIN-JMI were positive at baseline for the presence of antibodies and 21.5% (43 out of 200) were positive after treatment1,2

In the 2008 study, 12.7% of patients (16 out of 126) who received THROMBIN-JMI demonstrated seroconversion for at least one of the four antibodies assayed1,3

In the 2019 study, 3.2% of patients (2 out of 61) who received THROMBIN-JMI showed low-level titers of antibodies to bovine factor V with no clinical relevance1,4

The percentages above are incomparable due to their differences in data.
The THROMBIN-JMI manufacturing process
THROMBIN-JMI has been chromatographically purified and further processed by ultrafiltration.1

THROMBIN-JMI undergoes multistep chromatographic purification and ultrafiltration. The manufacturing process for THROMBIN-JMI has been further improved by the addition of viral filtration and impurity reduction processes. Analytical studies demonstrate the capability of the current manufacturing process to remove significant amounts of extraneous proteins, and result in a reduction of factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay (<92 ng/mL, when reconstituted as directed). The clinical relevance of these findings is unknown.1

 Explore THROMBIN-JMI® (Thrombin, Topical [Bovine] U.S.P.) support materials. See helpful resourcesLoading

Please see full Prescribing Information, including BOXED WARNING, for THROMBIN-JMI.

References:THROMBIN-JMI (Thrombin, Topical [Bovine] U.S.P.) [prescribing information]. New York, NY: Pfizer Inc.; 2023.Chapman WC, Singla N, Genyk Y, et al. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007;205(2):256-265.Doria C, Fischer CP, Wood CG, Li PM, Marra S, Hart J. Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery. Curr Med Res Opin. 2008;24(3):785-794.Minkowitz H, Navarro-Puerto J, Lakshman S, et al; Clinical Investigation Study Group on Topical Thrombin (Human) Grifols in Surgery. Prospective, randomized, phase II, non-inferiority study to evaluate the safety and efficacy of topical thrombin (human) Grifols as adjunct to hemostasis during vascular, hepatic, soft tissue, and spinal open surgery. J Am Coll Surg. 2019;229(5):497-507.e1.Driver VR, Hanft J, Fylling CP, Beriou JM; Autologel Diabetic Foot Ulcer Study Group. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Manage. 2006;52(6):68-87.






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Indication THROMBIN-JMI is topical bovine thrombin 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 various types of surgeries, solutions of THROMBIN-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis. Please see full Prescribing Information, including BOXED WARNING for THROMBIN-JMI.
Important Safety Information

WARNING: SEVERE BLEEDING AND THROMBOSIS COMPLICATIONS

  • THROMBIN-JMI 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-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V.
  • Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
  • Do not inject directly into the circulatory system. Because of its action in the clotting mechanism, THROMBIN-JMI can cause extensive intravascular clotting or death.
  • Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V.
  • Do not administer to patients with a history of hypersensitivity to THROMBIN-JMI, its components and/or to material of bovine origin.
  • Do not use for treatment of severe or brisk arterial bleeding.
  • Allergic reactions, including anaphylactic/anaphylactoid reactions, have been reported following administration of THROMBIN-JMI.
  • Institute intensive supportive measures and treat individual symptoms. Secure the airway and establish adequate respiratory exchange.
  • THROMBIN-JMI causes thrombosis if it enters the circulatory system due to its action in the clotting system. Apply topically. DO NOT INJECT.
  • Inhibitory antibodies may develop in patients and interfere with hemostasis. Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V, due to the potential for these antibodies to interfere with hemostasis. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
  • Bleeding may result from the development of antibodies against factor V. These antibodies may cross-react with human factor V and lead to human factor V deficiency.
  • Thrombosis may result from the development of antibodies against bovine thrombin.
  • Because THROMBIN-JMI may cause the formation of clots in blood vessels if it enters the bloodstream, advise patients to consult their physician if they experience leg tenderness or swelling, chest pain, shortness of breath, or difficulty speaking or swallowing.
Most common adverse reactions (incidence greater than or equal to 2%) are hypersensitivity, bleeding, anemia, post-operative wound infection, thromboembolic events, hypotension, pyrexia, tachycardia and thrombocytopenia. In another study, the most common treatment-emergent adverse reactions (experienced by >5% patients within a treatment group) were procedural pain, nausea, constipation, pruritus, muscle spasms, insomnia, pyrexia, and vomiting.Animal reproduction studies have not been conducted with THROMBIN-JMI. It is also not known whether THROMBIN-JMI can cause fetal harm when administered to a pregnant woman. THROMBIN-JMI should be given to a pregnant woman only if clearly needed.It is not known whether this drug is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for THROMBIN-JMI and any potential adverse effects on the breastfed infant from THROMBIN-JMI or from the underlying maternal condition.Safety and effectiveness in children have not been established.Please see full Prescribing Information, including BOXED WARNING, for THROMBIN-JMI.INDICATIONTHROMBIN-JMI is topical bovine thrombin 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 various types of surgeries, solutions of THROMBIN-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.Adapted from
USPI: THROMBIN-JMI Revised March 2024; LAB-0604-14.0Please see full Prescribing Information, including BOXED WARNING, for THROMBIN-JMI.