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Prescribing Information
Important Safety Information
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Why Choose CroFab?

CroFab Is the Only Antivenom Derived From Native US Pit Vipers to Treat Envenomations From All Species of North American Pit Vipers 
CroFab Meets WHO Guidelines for Effective Snake Antivenom 


According to the World Health Organization (WHO), an effective antivenom is one derived from clinically relevant snakes native to the geographic region in which the antivenom is used. 

CroFab is the only antivenom derived from geographically and clinically relevant US snakes for comprehensive coverage of all North American pit viper envenomations. 

Cotton Mouth/Water Moccasin icon
Cotton Mouth/Water Moccasin photo thumbnail

Cottonmouth/
Water Moccasin

Mojave Rattlesnake icon
Mojave Rattlesnake photo thumbnail

Mojave
Rattlesnake

Eastern Diamondback icon
Eastern Diamondback photo thumbnail

Eastern
Diamondback

Western Diamondback icon
Western Diamondback photo thumbnail

Western
Diamondback

Cottonmouth
Water Moccasin - Coiled

Cottonmouth/
Water Moccasin

Rattlesnake
Mojave Rattlesnak Coiled

Mojave
Rattlesnake

Eastern Diamondback
Eastern Diamondback - Coiled

Eastern
Diamondback

Western Diamondback
Western Diamondback - Coiled for Strike

Western
Diamondback

CroFab Was Engineered to Neutralize a Broad Range of Clinically Relevant Toxins 


A Comprehensive Venomics Approach


Four snake species were strategically chosen based on their unique venom fingerprints, which together provide comprehensive coverage across the diverse venom compositions of North American pit vipers. 

High-performance liquid chromatography is used to separate and identify individual components of venom to define a unique venomic fingerprint for each snake type. 

Venom fingerprint

Hear why Dr. Thomas Arnold and Dr. William Banner choose CroFab.

Hear how CroFab helped real patients.

 

Jessica

 

Caitlyn

Icon tick

CroFab is clinically proven to achieve initial control of envenomation 

Examine the Data
Icon Binds

CroFab rapidly binds to and neutralizes venom toxins 

See the MOA
CroFab safety clipboard icon

CroFab safety is backed by more than 20 years of clinical experience 

View Safety Profile
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. Data on file. BTG International Inc.

  4. Tasoulis T, Isbister GK. Toxins (Basel). 2017;9(9):290

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

  6. Strickland JL et al. Sci Rep. 2018;8(1):17622.

  7. Riley BD et al. In: Nelson LS et al, eds. Goldfrank’s Toxicologic Emergencies. 9th ed. McGraw-Hill Professional; 2010.

  8. Borja M et al. Toxins (Basel). 2018;10(1):35.

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.

Please see full Prescribing Information.