Recothrom

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

• The most common adverse reaction reported was thromboembolic events.
• 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 Baxter Healthcare at 1-866-888-2472, or FDA at 1-800-FDA-1088 and www.fda.gov/medwatch.

• Pediatric Use: Safety and effectiveness have been established in pediatric patients 1 month of age and older. Safety and efficacy have not been established in neonates.
• Geriatric Use: No substantive differences in safety or effectiveness were observed between subjects 65 years old and over and younger subjects.
• Lactation: There is no information regarding the presence of the drug in human milk, the effects on the breastfed infant, or the effects on milk production.
• Pregnancy: There are no available data regarding use in pregnant women.

• 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.

5,000-unit and 20,000-unit vials of sterile powder for solution

• 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.