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Prescribing Information
Important Safety Information
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Control With Confidence

The only antivenom derived from native US pit vipers to treat envenomations from all species of North American pit vipers 

Strength and Speed When You Need It Most

North American pit vipers across the United States icon

Clinically Relevant

Derived from geographically and clinically relevant US snakes 

See Our Venomics Approach
IgG antibody icon

Specifically Engineered

Designed with a spectrum of small, venom-specific protein (Fab) fragments 

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Copperhead Level 1 evidence icon

Proven Efficacy

Halted all clinically important effects of envenomation, with Level 1 evidence specifically for copperhead envenomation 

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Antivenom for Rattlesnakes, Cottonmouths, and Copperheads

Dosing for Initial and Sustained Control of Envenomation

Administer CroFab as soon as possible to prevent clinical deterioration 

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CroFab in Clinical Practice – Hear Real Patient Experiences

Daniel CroFab patient experience video thumbnail

Daniel
Daniel CroFab patient experience video thumbnail

Julia and Laura
Julie and Haley CroFab patient experience video thumbnail

Julie and Haley
Jessica CroFab patient experience video thumbnail

Jessica
Caitlyn CroFab patient experience video thumbnail

Caitlyn
References

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

  2. WHO Expert Committee on Biological Standardization. WHO Technical Report Series, No. 1004, Annex 5; 2017. Accessed September 13, 2023. https://cdn.who.int/media/docs/default-source/biologicals/blood-products/document-migration/antivenomglrevwho_trs_1004_web_annex_5.pdf?sfvrsn=ef4b2aa5_3&download=true

  3. 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.

  4. Gerardo CJ, Quackenbush E, Lewis B, et al. 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. Ann Emerg Med. 2017;70(2):233-244.

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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