CroFab® Crotalidae Polyvalent Immune Fab (Ovine) is indicated for the management of patients with minimal to moderate North American Crotalid envenomation (this subfamily includes rattlesnakes, cottonmouths & copperheads.)  Early use of CroFab® (within 6 hours of snakebite) is advised to prevent clinical deterioration and the occurrence of systemic coagulation abnormalities.

 Important Safety Information

The most common adverse events reported in clinical studies were mild or moderate reactions involving the skin and appendages (primarily urticaria, rash or pruritus), which occurred in 14 out of 42 patients.  Three patients experienced a serious adverse event.  Two patients had a severe allergic reaction (severe hives and a severe rash and pruritus) following treatment.  One patient had a recurrent coagulopathy due to envenomation, which required re-hospitalization and additional antivenin administration. In clinical trials, recurrent coagulopathy (the return of a coagulation abnormality after it has been successfully treated with antivenin), characterized by decreased fibrinogen, decreased platelets and elevated prothrombin time, occurred in approximately half of the patients studied. Recurrent coagulopathy may persist for one to two weeks or more.  One patient discontinued CroFab® therapy due to an allergic reaction.  Patients with allergies to papain, chymopapain, other papaya extracts or the pineapple enzyme bromelain may also be at risk for an allergic reaction to CroFab®.

Please click on the “View Full Prescribing Information” link above for full prescribing information, including events, precautions or warnings. 

* © CroFab® and DigiFab® are manufactured by/registered trademarks of Protherics US Inc., Brentwood, TN  37027 and distributed by Savage Laboratories®
© Kaon is a registered trademark of the Savage Laboratories® Division of Nycomed US Inc.
©2008 Savage Laboratories ®  A division of Nycomed US Inc., Melville, NY 11747. All rights reserved.