For US Healthcare Professionals Important Safety Information Full Prescribing Information

Safety Profile

CroFab Has an Established Safety Profile Backed by Over 20 Years of Clinical Experience1,2

More than 50,000 patients have been treated to date with CroFab infographic

Studied in adult and pediatric patients with envenomations of all levels of severity from all 3 species of North American pit vipers1

CroFab Was Designed to Reduce the High Incidence of Hypersensitivity Associated With Previous Antivenom Therapy3

Postmarketing data from 2 studies showed low rates of hypersensitivity reactions (1.4%; N=1340 and 2.7%; N=373) in patients treated with CroFab.4,5

Medically Significant Late Bleeding Is Uncommon After Treatment With CroFab6

In a systematic review of published postmarketing cohort studies, CroFab administration was associated with:

  • Low rates of reported late bleeding*
  • Low rates of medically significant late bleeding

Pie graph showing low rates of late bleeding with CroFab from 19 cohort studies

*A late bleeding event was defined as blood loss that was first noted after initial control of the envenomation syndrome, as defined by the study author or using standard criteria, was achieved.
Medically significant late bleeding was defined a priori as any bleeding event associated with hypotension (systolic blood pressure <90 mm Hg, or appropriate pediatric norms), significant tachycardia (pulse rate >140 beats/min or appropriate pediatric norms), a decrease in hemoglobin level ≥3 g/dL, or a decrease in hematocrit level ≥8 g/dL from previously measured levels, or treated with surgery, rehospitalization, or red blood cell transfusion.

CroFab Clinical Studies

Review publications evaluating efficacy and safety for CroFab

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CroFab is clinically proven to achieve initial control of envenomation1

Examine the Data
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Appropriate dosing achieves initial and sustained control of envenomation1

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Experts recommend stocking CroFab at any facility that provides emergency care7

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1. CroFab®. Prescribing information. BTG International Inc.; August 2018. 2. Data on file. BTG International Inc.  3. Dart RC, Seifert SA, Carroll L, et al. Affinity-purified, mixed monospecific crotalid antivenom ovine fab for the treatment of crotalid venom poisoning. Ann Emerg Med. 1997;30(1):33-39. 4. Kleinschmidt K, Ruha AM, Campleman S, Brent J, Wax P; ToxIC North American Snakebite Registry Group. Acute adverse events associated with the administration of Crotalidae polyvalent immune Fab antivenom within the North American Snakebite Registry. Clin Toxicol. 2018;56(11):1115-1120. 5. Khobrani M, Huckleberry Y, Boesen KJ, Aljabri A, Alharthi M, Patanwala AE. Incidence of allergic reactions to Crotalidae polyvalent immune Fab. Clin Toxicol. 2019;57(3):164-167. 6. Lavonas EJ, Khatri V, Daugherty C, Bucher-Bartelson B, King T, Dart RC. Medically significant late bleeding after treated crotaline envenomation: a systematic review. Ann Emerg Med. 2014;63(1):71-78. 7. Dart RC, Goldfrank LR, Erstad BL, et al. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Ann Emerg Med. 2018;71(3):314-325.