Thrombin Topical Recombinant

1 INDICATIONS AND USAGE RECOTHROM Thrombin topical (Recombinant), 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 in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.

6 ADVERSE REACTIONS Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM Thrombin topical (Recombinant) in all completed clinical trials (N=644) [see Warnings and Precautions (5.1) ] . Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin [see Adverse Reactions (6.2) ] . • The most common adverse reaction (incidence 6%) was thromboembolic events. (5.1 , 6) • Antibody formation to RECOTHROM Thrombin topical (Recombinant) occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary There are no available data regarding RECOTHROM Thrombin topical (Recombinant) in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with RECOTHROM. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

5 WARNINGS AND PRECAUTIONS • RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system. (5.1) • Hypersensitivity reactions, including anaphylaxis, may occur. (5.2) 5.1 Thrombosis RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT. 5.2 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM Thrombin topical (Recombinant) is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins [see Contraindications (4) and Description (11) ] . 4 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 a history of hypersensitivity to RECOTHROM Thrombin topical (Recombinant) or any components of RECOTHROM. • Do not use in patients with known hypersensitivity to hamster proteins.