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THROMBIN-JMI® (thrombin, topical, bovine origin) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use THROMBIN-JMI safely and effectively. See full prescribing information for THROMBIN-JMI.

THROMBIN-JMI® (Thrombin, Topical (Bovine) U.S.P.), Solution for topical use
Initial U.S. Approval: 1986

WARNING: SEVERE BLEEDING AND THROMBOSIS COMPLICATIONS

See full prescribing information for complete boxed warning

  • 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.

RECENT MAJOR CHANGES

Dosage and Administration, Reconstitution (2.1)4/2018

INDICATIONS AND USAGE

  • THROMBIN-JMI is a topical 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. (1)
  • THROMBIN-JMI may be used in conjunction with an absorbable gelatin sponge, USP. (1)

DOSAGE AND ADMINISTRATION

For topical use on the surface of bleeding tissue only. Do not inject. (2)

  • May be reconstituted with sterile isotonic saline at a recommended concentration of 1,000 to 2,000 International Units/mL or may be used in dry form on oozing surfaces. (2)

DOSAGE FORMS AND STRENGTHS

  • THROMBIN-JMI is available as 5,000 IU vial with 5 mL diluent and 20,000 IU vial with 20 mL diluent. (3)
  • THROMBIN –JMI Pump Spray Kit is available as 20,000 IU vial with 20 mL diluent, spray pump and actuator. (3)
  • THROMBIN-JMI Syringe Spray Kit is available as 5,000 IU vial with 5 mL diluent, spray tip and syringe and 20,000 IU vial with 20 mL diluent, spray tip and syringe. (3)
  • THROMBIN-JMI Epistaxis Kit is available as 5,000 IU vial with 5 mL diluent, nasal drug delivery device and syringe. (3)
  • THROMBIN-JMI is available in the Gelfoam-JMI™ Powder Kit (Gelfoam® Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 IU vial with 5 mL diluent. (3)
  • THROMBIN-JMI is available in the Gelfoam-JMI™ Sponge Kit (Gelfoam® Absorbable Gelatin Sponge, USP and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 IU vial with 5 mL diluent. (3)
  • THROMBIN-JMI® 5,000 IU Syringe Spray Kit is supplied in the GEL-FLOW™ Kit: GEL-FLOW™ Kit (GEL-FLOW™ NT Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., THROMBIN-JMI®, 5,000 IU Syringe Spray Kit). (3)

CONTRAINDICATIONS

  • Do not inject directly into the circulatory system. (4)
  • Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V. (4)
  • Do not administer to patients with a history of hypersensitivity to THROMBIN-JMI, its components and/or material of bovine origin. (4)
  • Do not use for treatment of severe or brisk arterial bleeding. (4)

WARNINGS AND PRECAUTIONS

  • Allergic reactions, including anaphylactic/anaphylactoid reactions, have been reported following administration of THROMBIN-JMI. (5.1)
  • Institute intensive supportive measures and treat individual symptoms. Secure the airway and establish adequate respiratory exchange. (5.1)
  • THROMBIN-JMI causes thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT. (5.2)
  • Inhibitory antibodies may develop in patients and interfere with hemostasis. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis. (5.3)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 2%) are hypersensitivity, bleeding, anemia, post-operative wound infection, thromboembolic events, hypotension, pyrexia, tachycardia and thrombocytopenia. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2019

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