Pharmaceutical Approval Update: Topical (Human) Thrombin (Evithrom)

Manufacturer: Omrix Biopharmaceuticals Ltd., Oak
Island, NC

Indications: Used topically, Evithrom is a blood-clotting protein that aids hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and when control of bleeding by standard surgical techniques is ineffective or impractical. It may be used in conjunction with an absorbable gelatin sponge.

Drug Class: Human thrombin is derived from human plasma obtained from carefully screened and tested U.S. donors. The product has undergone steps to reduce the risk for transfusion-transmitted diseases.

Uniqueness of Drug: Thrombin helps to control bleeding during surgery. Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed.

Warnings and Precautions: Made from human plasma, Evithrom may carry a risk of transmitting infectious agents, such as viruses and, theoretically, the Creutzfeldt-Jakob disease agent. The risk of transmitting an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain virus infections, and by inactivating and removing certain viruses.

Despite these measures, thrombin products still have the potential to transmit disease. It is also possible that unknown infectious agents may be present in these products. Physicians and other health care providers should report all infections suspected to have been transmitted by Evithrom to the company. Physicians should discuss the risks and benefits of this product with their patients. There is a potential risk of thrombosis if it is absorbed systemically.

Dosage and Administration:

Before application: Thrombin should be thawed by one of these methods:

  • 2° to 8° C (in the refrigerator): Vials thaw within one day.
  • 20° to 25° C (at room temperature): Vials thaw within one hour.
  • 37° C for 2-mL and 5-mL vials only: Vials thaw within 10 minutes and must not be left at this temperature for longer than 10 minutes. The temperature must not exceed 37° C.

The flip-off plastic cap should be removed from the vial to expose the rubber stopper. With a sterile needle and syringe, the thrombin solution may be withdrawn from the glass vial. Alternatively, using aseptic techniques, the practitioner can remove the rubber stopper by removing the metal pull tab to transfer the thrombin into a sterile container. canadian pharmacy cialis

Thrombin is used topically and should be applied on the surface of bleeding tissue only. It should not be injected.
Thrombin alone:

  • The target surface should be sponged (not wiped) or suctioned free of blood before the product is applied.
  • A sterile syringe and small-gauge needle may be used to flood the surface with thrombin.
  • After treatment, the clot should not be sponged to ensure that it remains securely in place.

Thrombin in conjunction with an absorbable gelatin sponge:

  • Using aseptic technique, the practitioner transfers the thrombin into a sterile container.
  • The gelatin sponge, in its desired shape, is immersed in the thrombin solution.
  • The practitioner vigorously kneads the sponge with moistened gloved fingers until all air is expelled and the sponge can return to its original size and shape.
  • The saturated sponge is held in place with a gauze or cotton pledget. Moderate pressure is applied until hemo-stasis is achieved. The amount of thrombin required depends upon the area of tissue to be treated and the method of application. As an approximate guide, volumes up to 10 mL were used in clinical studies in which thrombin was used in conjunction with an absorbable gelatin sponge.

Vials are for a single use only. Unused contents must be discarded.

Dosage Forms and Strengths: Vials contain 2 mL, 5 mL, or 20 mL. Each vial contains 800 to1200 IU/mL of Evithrom.

Commentary: Topical human thrombin is a manufactured human plasma-derived alternative to the use of bovine protein-based thrombin, which is currently used to control bleeding in approximately one million surgical procedures each year in the U.S. Exposure to bovine-derived thrombin sometimes produces an immunogenic response in some patients. In patients who develop antibodies to bovine-derived thrombin, there is an increased risk of severe bleeding, thrombosis, anaphylac-tic shock, and an immunogenic response if they are re-exposed to these products.
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Evithrom helps stop oozing and minor bleeding from capillaries and small veins when control of bleeding by standard surgical techniques is not feasible. The product is applied to the surface of bleeding tissue, and it may be used along with an absorbable gelatin sponge.

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