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Prescribing Information
Important Safety Information
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Safety Profile

CroFab Has an Established Safety Profile Backed by Over 20 Years of Clinical Experience 

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

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


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. 

 

Medically Significant Late Bleeding Is Uncommon After Treatment With CroFab 

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†
Late bleeding pie chart


*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 envenomation 

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

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Experts recommend stocking CroFab at any facility that provides emergency care 

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References

  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.

Indication and Important Safety Information
Indication

CroFab® Crotalidae Polyvalent Immune Fab (Ovine) is a sheep-derived antivenin indicated for the management of adult and pediatric patients with North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes which includes rattlesnakes, copperheads and cottonmouths/water moccasins.

Important Safety Information
Contraindications

Do not administer CroFab® to patients with a known history of hypersensitivity to any of its components, or to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.

Warnings and Precautions

Coagulopathy: 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; one patient required re-hospitalization and additional antivenin administration. Recurrent coagulopathy may persist for 1 to 2 weeks or more. Patients who experience coagulopathy due to snakebite should be monitored for recurrent coagulopathy for up to 1 week or longer. During this period, the physician should carefully assess the need for re-treatment with CroFab® and use of any type of anticoagulant or anti-platelet drug.

Hypersensitivity Reactions: Severe hypersensitivity reactions may occur with CroFab®. In case of acute hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions, discontinue infusion and institute appropriate emergency treatment. Patients allergic to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also have an allergic reaction to CroFab®. Follow-up all patients for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia).

Adverse Reactions

The most common adverse reactions (incidence ≥ 5% of subjects) reported in the clinical studies were urticaria, rash, nausea, pruritus and back pain. Adverse reactions involving the skin and appendages (primarily rash, urticaria, and pruritus) were reported in 12 of the 42 patients. Two patients had a severe allergic reaction (severe hives and a severe rash and pruritus) following treatment and one patient discontinued CroFab® due to an allergic reaction. Recurrent coagulopathy due to envenomation and requiring additional treatment may occur.

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