Ordering Information | THROMBIN-JMI® (Thrombin, Topical [Bovine] U.S.P.)

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.

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.

Adapted from
USPI: THROMBIN-JMI Revised March 2024; LAB-0604-14.0

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