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CroFab® Crotalidae Polyvalent Immune Fab (Ovine) Prescribing Information
 
 
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Angie Malone
Harrison Leifer DiMarco Public Relations
100 MerrickRd.
Rockville Centre, NY 11570
Phone: 516.536.2020
Fax: 516.536.2641

amalone@hldblankman.com 
 

National Snakebite Experts

Tom Arnold, MD Steve Curry, MD Mark Ryan PharmD
Louisiana Poison Center Banner Health Systems Louisiana Poison Center
Shreveport, LA Phoenix, AZ Shreveport, LA
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William Banner, JR., MD
Richard C. Dart, MD, PhD, ABAT Anthony Pizon, MD
Saint Francis Hospital Rocky Mountain Poison Control West Virginia Poison Center
Tulsa, OK Denver, CO Charleston, WV
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Jeffrey Bernstein, MD
Ed Hall, MD Univ. of Pittsburgh
FL Poison Information Network So. Georgia Surgical Associates School of Medicine
Miami, FL Thomasville, GA Pittsburgh, PA
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Rebecca Bowers, MD
Russ Kerns, MD William Richardson
University of Kentucky Carolinas Medical Center Palmetto Poison Center
Lexington, KY Charlotte, NC  Columbia, SC
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Sean P. Bush, MD, FACEP
Dan Keyler, PharmD Rutherfoord S. Rose, PharmD
Loma Linda Univ. Medical Center Minneapolis Poison Center Virginia Poison Center
Loma Linda, CA Minneapolis, MN Richmond, VA
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Richard Clark, MD
Erica Liebelt, MD Anthony Scalzo, MD
CA Poison Control Systems Regional Poison Control Center Missouri Regional Poison Center
San Diego, CA Birmingham, AL St. Louis, MO
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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 CroFab® full prescribing information link at left for complete prescribing information, including events, precautions or warnings.

* © CroFab® is manufactured by/registered trademarks of Protherics US Inc., Brentwood, TN  37027 and distributed by Savage Laboratories®