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Clinical Articles

    Snake Antivenom Research

    "Total CroFab and Anavip Antivenom Vial Administration in US Rattlesnake Envenomations: 2019-2021"

    Journal of Medical Toxicology
    View an analysis of the American College of Medical Toxicology’s (ACMT) Toxicology Investigators Consortium (ToxIC) North American Snakebite Registry (NASBR) comparing antivenoms for crotalid (pit viper) envenomations from 2019 to 2021, which shows treatment with CroFab required fewer total vials and fewer administrations than a competitor.

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    "The Efficacy of Crotalidae Polyvalent Immune Fab (Ovine) Antivenom Versus Placebo Plus Optional Rescue Therapy on Recovery From Copperhead Snake Envenomation: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial"

    Annals of Emergency Medicine
    Clinical trial demonstrating how treatment with FabAV can reduce limb disability.

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    "Early Administration of Fab Antivenom Resulted in Faster Limb Recovery in Copperhead Snake Envenomation Patients"

    Clinical Toxicology
    Secondary analysis of a clinical trial demonstrating that patients treated with FabAV earlier had a significantly shorter time to full recovery than those treated late (median time: 17 versus 28 days, P=0.025).

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    "Antivenom Treatment Is Associated With Fewer Patients Using Opioids After Copperhead Envenomation"

    Western Journal of Emergency Medicine
    Secondary analysis of a clinical trial demonstrating that the proportion of patients using opioids for pain related to envenomation was smaller in the FabAV treatment group at all follow-up time points, and that the odds ratio of using opioids after hospital discharge among those who received placebo was 5.67 times that of those who received FabAV.

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    "Acute Adverse Events Associated With the Administration of Crotalidae Polyvalent Immune Fab Antivenom Within the North American Snake Bite Registry"

    Clinical Toxicology
    A retrospective study of 373 patients finds 2.7% incidence of adverse reactions overall, and a 1% incidence of severe adverse reactions.

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    "Incidence of Allergic Reactions to Crotalidae Polyvalent Immune Fab"

    Clinical Toxicology
    Retrospective study of 1340 CroFab patients finds low incidence (1.4%) of acute hypersensitivity reactions.

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    "Incidence of Immediate Hypersensitivity Reactions and Serum Sickness Following Administration of Crotalidae Polyvalent Immune Fab Antivenom: A Meta-analysis"

    Academic Emergency Medicine
    Systematic literature review and meta-analysis of immediate hypersensitivity reactions and serum sickness from FabAV.

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    "Medically Significant Late Bleeding After Treated Crotaline Envenomation: A Systematic Review"

    Annals of Emergency Medicine
    Study to estimate the proportion of patients with crotaline snake envenomation, treated with Crotalidae polyvalent immune Fab (ovine) antivenom, who develop medically significant late bleeding.

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    "Affinity-Purified, Mixed Monospecific Crotalid Antivenom Ovine Fab for the Treatment of Crotalid Venom Poisoning"

    Annals of Emergency Medicine
    First premarketing clinical study of CroFab, TAb001, to test the efficacy and safety of a new antivenom, affinity-purified, mixed monospecific crotalid antivenom ovine Fab in human subjects with minimal or moderate crotalid envenomation.

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    "A Randomized Multicenter Trial of Crotaline Polyvalent Immune Fab (Ovine) Antivenom for the Treatment of Crotaline Snakebite in the United States"

    Archives of Internal Medicine
    The second clinical trial of CroFab, TAb002, and the first randomized clinical trial of antivenom in the US showing efficacy and safety of CroFab in crotaline envenomation.

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    Guidelines and Reviews

    "Expert Consensus Guidelines for Stocking of Antidotes in Hospitals That Provide Emergency Care"

    Annals of Emergency Medicine
    Review the stocking guidelines established by an international expert consensus panel.

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    "Unified Treatment Algorithm for the Management of Crotaline Snakebite in the United States: Results of an Evidence-Informed Consensus Workshop"

    BMC Emergency Medicine
    Nine experts produce and align on a unified algorithm for treatment of crotaline envenomation.

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    "Surgical Considerations in the Management of Pit Viper Snake Envenomation"

    Journal of American College of Surgeons
    A 4-member panel of experts provides recommendations based on systematic review of key clinical questions regarding the surgical management of pit viper envenomation.

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    "Bedside Management Considerations in the Treatment of Pit Viper Envenomation"

    Journal of Emergency Nursing
    Review article highlighting the possible effects of snakebites as well as their assessment and treatment.

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    Choose CroFab icon

    CroFab: Strength and speed when you need it most

    Choose CroFab
    CroFab efficacy checkmark icon

    CroFab is clinically proven to achieve initial control of envenomation 

    Examine the Data
    CroFab dosing vial icon

    Appropriate dosing achieves initial and sustained control of envenomation 

    Learn How to Dose CroFab
    References

    1. CroFab®. Prescribing information. BTG International Inc.; August 2018.

    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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