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Prescribing Information
Important Safety Information
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Mechanism of Action

CroFab Rapidly Binds to and Neutralizes Venom Toxins 

Watch this video to see how CroFab works.

Upon Administration, CroFab Gets to Work


CroFab is specifically designed to contain a spectrum of venom-specific Fab fragments targeting the range of complex toxins found in North American pit viper venoms. 

Envenomation Gif

Envenomation

North American pit viper venom contains a complex array of toxins that can result in a range of local, systemic, and/or hematologic effects 

Rapid Neutralization

Rapid Neutralization

The small size of venom-specific protein (Fab) fragments permits a rapid, large volume of distribution into tissue, allowing faster neutralization of venom toxins 

Rapid Clearnace

Rapid Clearance

Small protein (Fab) fragments also permit faster clearance, allowing for decreased immune system recognition and low incidence of hypersensitivity 

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CroFab is clinically proven to achieve initial control of envenomation 

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IgG antibody icon

A proven manufacturing process ensures only the most effective and highest quality venom-specific antibodies 

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Appropriate dosing achieves initial and sustained control of envenomation 

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References

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

  2. Ruha AM, Kleinschmidt KC, Greene S, et al. The epidemiology, clinical course, and management of snakebites in the North American Snakebite Registry. J Med Toxicol. 2017;13(4):309-320.

  3. Gutiérrez JM et al. [Erratum in: Nat Rev Dis Primers. 2017;3:17079]. Nat Rev Dis Primers. 2017;3:17063.

  4. Laustsen AH, María Gutiérrez J, Knudsen C, et al. Pros and cons of different therapeutic antibody formats for recombinant antivenom development. Toxicon. 2018;146:151-175.

  5. Data on file. BTG International Inc.

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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