FDA approves Recothrom

The U.S. Food and Drug Administration today has approved Recothrom, the first clotting solution manufactured using recombinant DNA techniques to help stop small blood vessels from bleeding after surgery.

Recothrom is a topical thrombin solution. Thrombin is a protein involved in the production of fibrin, a different protein necessary for blood to clot.

Recombinant DNA is the result of a genetic modification process that enables scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

After surgery, bleeding from small blood vessels, such as capillaries, can cause significant blood loss. Physicians can apply Recothrom during surgery when standard surgical techniques for stopping blood loss are ineffective or impractical.

Recothrom is made from Chinese Hamster Ovary cells (CHO), which have been genetically modified to produce human thrombin. These CHO cells are free from known infectious agents, and Recothrom undergoes an additional process of viral inactivation.

In a study of 411 patients undergoing various surgical procedures, Recothrom met the primary indicator of effectiveness, which was control of bleeding within 10 minutes. Recothrom was also evaluated on secondary indicators of effectiveness, which were control of bleeding within three and six minutes. These measures of Recothrom's effectiveness were not inferior to ones displayed by the study's active control, a licensed topical thrombin derived from cattle plasma.

Adverse events reported during the studies included incision site complications and pain related to the surgical procedure, and nausea.

Source: FDA

Highlights of Recothrom Prescribing Information

Recothrom Thrombin, topical (Recombinant) powder for solution
For Topical Use only

These highlights do not include all of the information needed to use Recothrom safely and effectively. See full prescribing information for Recothrom.

Recothrom Indications and Usage

Recothrom 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. May be used in conjunction with an absorbable gelatin sponge, USP.

Recothrom Dosage and Administration

• For topical use only. DO NOT INJECT
• Reconstitute Recothrom powder with sterile 0.9% sodium chloride injection, USP, yielding a solution containing 1000 IU/mL.
• Apply Recothrom solution directly to bleeding site surface or in conjunction with absorbable gelatin sponge. The amount required depends upon the area of tissue to be treated.

Dosage Forms and Strengths

5000-IU vial of sterile powder for solution

Recothrom Contraindications

• Do not inject directly into the circulatory system.
• Do not use for the treatment of massive or brisk arterial bleeding.
• Do not administer to patients with known hypersensitivity to Recothrom, any components of Recothrom or hamster proteins.

• Potential risk of thrombosis if absorbed systemically.
• In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction.

Adverse Reactions

• Adverse events were reported with similar frequency in the two treatment groups. The most common adverse event reported was incision site complication.
• Treatment with Recothrom resulted in a statistically significantly lower incidence of specific anti-product antiboddevelopment. Three of 198 (1.5%, 95% CI; 0 to 4%) of the patients in the Recothrom arm developed specific anti-thrombin product antibodies (one patient also developed anti-CHOhost cell protein antibodies). Forty-three of 200 subjects, (22%, 95% CI; 16 to 28%) in the bovine thrombin arm developed specifiantibodies to bovine thrombin product. None of the antibodies in the Recothrom group neutralized native human thrombin. Antibodies against bovine thrombin product were not testedneutralization of native human thrombin. Development of antibodies in either group did not lead to any as excessive bleeding.
• Limited data (n=6) are available on repeat exposure to Recothrom.

To report SUSPECTED ADVERSE REACTIONS, contact ZymoGenetics, Inc. at 1-888-784-7662, or FDA at 1-800-FDA-1088 and www.fda.gov/medwatch.

• For topical use only. DO NOT INJECT
• Reconstitute Recothrom powder with sterile 0.9% sodium chloride injection, USP, yielding a solution containing 1000 IU/mL.
• Apply Recothrom solution directly to bleeding site surface or in conjunction with absorbable gelatin sponge. The amount required depends upon the area of tissue to be treated.

Dosage Forms and Strengths

5000-IU vial of sterile powder for solution