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Important Safety Information
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For related questions regarding CroFab, please contact the Specialty Solutions Center® at 1-844-293-0007, or email CroFab@btgsp.com.

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Experts Recommend Stocking CroFab at Any Facility That Provides Emergency Care 

Consensus Guidelines Article
  • 18 vials: for hospitals admitting snakebite patients*
  • 12 vials: for hospitals that stabilize & transfer snakebite patients*
  • Have a plan for urgent resupply if needed

*Physical stocking location may vary by institution and by drug preparation requirements.

The Following Suppliers Are Authorized Distributors of CroFab

AmerisourceBergen Corporation


ASD Healthcare*


Cardinal Health


Cardinal Health Specialty Pharmaceutical Distribution*


CuraScript*

FFF Enterprises, Inc.*


McKesson Corporation


McKesson Plasma and Biologics, LLC*


Morris & Dickson Co., LLC


Prodigy Health Supplier*

*Offers CroFab on consignment.

How CroFab Is Supplied
NDC#50633-110-12
DosingInitial dose may vary from a minimum of 4 to a maximum of 12 vials based on clinical judgment and severity of envenomation (see package insert for dosing guidelines)
StrengthEach vial contains up to 1 g of total protein
FormLyophilized powder
No. of Items / Containers2 vials/carton
Shelf Life5 Years

Watch Dr. Mark Ryan review why hospitals in areas with snakebites should always have CroFab in stock.

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Appropriate dosing achieves initial and sustained control of envenomation 

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References

  1. Dart RC, Goldfrank LR, Erstad BL, et al. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Ann Emerg Med. 2018;71(3):314-325.

  2. 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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