Evithrom

Generic Name: human thrombin
Date of Approval: August 27, 2007
Company: Omrix Biopharmaceuticals, Ltd.

Treatment for: Bleeding

FDA Approves Evithrom

The U.S. Food and Drug Administration has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.

Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.

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Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.

In a clinical trial involving several hundred subjects, Evithrom was found comparable to cattle-derived thrombin in both safety and effectiveness.

Highlights of Evithrom Prescribing Information

These highlights do not include all the information needed to use Evithrom safely and effectively.

Indications and Usage

  • Evithrom is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
  • Evithrom may be used in conjunction with an Absorbable Gelatin Sponge, USP.

Dosage and Administration

  • For topical use only. DO NOT INJECT.
  • The amount of Evithrom required depends upon the area of tissue to be treated and the method of application. In clinical studies, volumes up to 10 ml were used in conjunction with Absorbable Gelatin Sponge, USP.
  • Thaw Evithrom prior to use. The time between thawing and application is restricted.
  • Vials are for single use only. Discard unused contents.

Dosage Forms and Strengths

  • Vials of 2 ml, 5 ml, or 20 ml frozen solution containing 800-1200 IU/ml of Thrombin, Topical (Human).

Contraindications

  • Do not inject Evithrom directly into the circulatory system.
  • Do not use Evithrom in individuals known to have anaphylactic or severe systemic reaction to human blood products.
  • Do not use Evithrom for the treatment of severe or brisk arterial bleeding.

Warnings and Precautions

  • May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of viral transmission.
  • Potential risk of thrombosis if absorbed systemically.

Adverse Reactions

  • Anaphylactic reactions may occur.
  • Adverse events were reported in the clinical trial with similar frequency in the two study groups (Evithrom or bovine thrombin group). The most common adverse event reported was procedural complications and pruritus. None of the adverse events reported was considered causally related to Evithrom administration.
  • Immunogenicity was evaluated by testing for the development of antibodies to highly purified antigens: human thrombin, human Factor V/Va, bovine thrombin and bovine Factor V/Va. None of the patients treated with Evithrom developed antibodies to human thrombin or to human Factor V/Va.

To report SUSPECTED ADVERSE REACTIONS, contact ETHICON Customer Support Center at (877) 384-4266 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Use in Specific Populations

  • Geriatrics: No differences in safety or effectiveness were observed between the elderly and younger patients. Greater susceptibility of older patients to adverse reactions cannot be ruled out.

Patient Counseling Information

Some viruses such as hepatitis A virus and parvovirus B19 are particularly difficult to remove or inactivate. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include: fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, fatigue and low-grade fever followed by nausea, vomiting and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear. If absorbed systemically Evithrom could potentially cause blood clotting disorders. Patients should be encouraged to consult their physician for any new or unusual symptoms.

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