Hold the cursor over highlighted steps of the manufacturing process to learn how CroFab is specifically manufactured to ensure the safe and effective management of envenomation by pit vipers native to the United States.
Venom Collection From
Clinically Relevant Native Pit Vipers1
Cottonmouth/
Water Moccasin
Eastern
Diamondback
Mojave
Rattlesnake
Western
Diamondback
Antibody Collection From Australian Sheep1,2
Removal of FC Fragment to Reduce Hypersensitivity1,3,4
Affinity Purification to Increase Specificity and Reduce Adverse Reactions1,2
Four monospecific antivenoms are combined to become CroFab.1
1. CroFab®. Prescribing information. BTG International Inc.; August 2018. 2. Data on file. BTG International Inc. 3. Alvarenga LM, Zahid M, di Tommaso A, et al. Engineering venom’s toxin-neutralizing antibody fragments and its therapeutic potential. Toxins. 2014;6(8):2541-2567. 4. Laustsen AH, Gutiérrez JM, Knudsen C, et al. Pros and cons of different therapeutic antibody formats for recombinant antivenom development. Toxicon. 2018;146:151-175. 5. WHO Expert Committee on Biological Standardization. WHO Technical Report Series, No. 1004, Annex 5; 2017. Accessed June 13, 2022. 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
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.
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.
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).
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.
If you wish to report an adverse event or product quality complaint,
please call 1-877-377-3784.
You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
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US-CRF-2300086/October 2023
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