This site is intended for U.S. healthcare professionals.

Visit Pfizer Medical

Menu

Close

Sign InLog Out ProductsOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysPfizer Dermatology Patient AccessExplore ContentEventsMaterialsVideosContact
Search

Menu

Close

HomeAbout
Using THROMBIN-JMI
Clinical StudiesClinical
StudiesEfficacySafety & ManufacturingSupport & OrderingSupport & OrderingMaterialsVideosOrdering InformationRequest a Representative
Full Prescribing Information including BOXED WARNING Indication
THROMBIN-JMI clinical studiesThe efficacy of THROMBIN-JMI® was evaluated in multiple clinical trials.1-4 THROMBIN-JMI provides effective hemostasis2-4 2007 STUDY THROMBIN-JMI (Thrombin, Topical [Bovine] U.S.P.) demonstrated comparable efficacy to recombinant human thrombin (rhThrombin)2

95% of patients treated with THROMBIN-JMI achieved hemostasis within 10 minutes2

Study design
  • Randomized, double-blind, controlled trial that compared rhThrombin to THROMBIN-JMI1,2
  • 206 patients received THROMBIN-JMI and 205 patients received rhThrombin as adjuncts to hemostasis in liver resection, spine, peripheral arterial bypass, and dialysis access surgeries1,2
  • 401 patients completed the trial1,2
  • Time to hemostasis (incidence within 10 minutes) was the primary efficacy endpoint2
  • Evaluation of safety and antigenicity were the secondary endpoints2
2008 STUDY The proportion of patients achieving hemostasis was equivalent for THROMBIN-JMI and plasma-derived human thrombin3

97% of patients treated with THROMBIN-JMI achieved hemostasis within 10 minutes3

Study design
  • Multicenter, prospective, randomized, double-blind, controlled trial that compared plasma-derived human thrombin to THROMBIN-JMI1,3
  • Patients received THROMBIN-JMI and human thrombin applied topically to the target bleeding site with a gelatin sponge during cardiovascular, neurologic, and general or post-traumatic procedures1,3
  • 152 patients received THROMBIN-JMI and 153 patients received human thrombin1,3
  • Achieving hemostasis within 10 minutes of product application was the primary efficacy endpoint3
  • Achieving hemostasis within 3 and 6 minutes of product application were the secondary efficacy endpoints3
The safety of THROMBIN-JMI was evaluated in multiple clinical trials1-5
  • The most common adverse reactions (incidence ≥2%) were hypersensitivity, bleeding, anemia, postoperative wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, and thrombocytopenia1
  • In the study versus rhThrombin, 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 similar2
  • In the study versus plasma-derived human thrombin, 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 comparable3
Immunogenicity
  • Inhibitory antibodies may develop in patients and interfere with hemostasis. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis1
  • In the study versus rhThrombin, 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 study versus plasma-derived human thrombin, 12.7% of patients (16 out of 126) who received THROMBIN-JMI demonstrated seroconversion for at least one of the four antibodies assayed1,3
The THROMBIN-JMI manufacturing process THROMBIN-JMI has been chromatographically purified and further processed by ultrafiltration1

Analytical studies demonstrate the current manufacturing process’ capability 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 significance 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.




To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2025 Pfizer Inc. All rights reserved.

PP-THR-USA-0576
You are now leaving Pfizer You are now leaving a Pfizer operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer.
 PP-THR-USA-0464
​​​​​​​
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.