Important Safety Information Full Prescribing Information

How To Order CroFab®

The following suppliers are authorized distributors of CroFab®:

 
  • AmerisourceBergen Corporation
  • ASD Healthcare
  • BDI Pharma, Inc.
  • BioCARE
  • Cardinal Health
  • Cardinal Health Specialty Pharmaceutical Distribution
  • FFF Enterprises, Inc.
  • H.D. Smith Wholesale Drug Co.
  • McKesson Corporation
  • McKesson Plasma and Biologics, LLC
  • Morris & Dickson Co., LLC
  • Prodigy Healthcare Supplier Corporation
How CroFab® is supplied
NDC# 50633-110-12
Dosing Initial dose is 4-6 vials, repeat until initial control is achieved, follow by 2 vials, every 6 hours, for 3 doses (see package insert for dosing guidelines)
Strength Each vial contains up to 1 gram of total protein
Form Lyophilized powder
No. of Items/Container 2 vials/carton

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For related questions regarding CroFab®, please contact the BTG Specialty Solutions CenterTM at 1-844-293-0007, or email CroFab@btgplc.com

Envenomation is unpredictable 2, 3

  • Impact can begin in minutes or be delayed for hours 3, 4
  • Effects vary widely from patient to patient 3
  • May last for days when venom lingers 5, 6

Local and systemic damage can be irreversible 4

  • Contributing to morbidity and mortality 4, 7
 

TIME IS TISSUE™

Material Safety Data Sheet for CroFab®
TO REPORT AN ADVERSE REACTION OR FOR 24-HOUR MEDICAL INFORMATION, CALL 1-844-293-0007.

Treatment Algorithm

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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

The most common adverse reactions reported in the clinical studies were urticaria, rash and nausea. 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. Anaphylaxis and hypersensitivity reactions can occur, and patients should be monitored closely during treatment. CroFab® should not be administered to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.

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 rehospitalization 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.

Terms

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