RECOTHROM® Thrombin, Topical (Recombinant)

RECOTHROM was approved by the U.S. Food and Drug Administration (FDA) on January 17, 2008. 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.

Indication: RECOTHROM Thrombin, topical (Recombinant) 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 (such as suture, ligature, or cautery) is ineffective or impractical.

IMPORTANT SAFETY INFORMATION

For topical use only – DO NOT INJECT directly into the circulatory system.

Potential risk of thrombosis if absorbed systemically.

Do not use for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.

The most common adverse events reported in clinical trials of RECOTHROM were incision site pain, procedural pain, and nausea. The serious adverse event that occurred in ≥1% (n=6/583) of patients exposed to RECOTHROM in these trials was atrial fibrillation. Overall, adverse events reported in clinical trials of RECOTHROM were consistent with those commonly observed in surgical patients.

For U.S. Full Prescribing Information click here.

Additional Information

For additional information, please visit www.RECOTHROM.com.