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  • Envenomation Education
    • Get an overview of pit viper envenomation and its impact.
    • Strike Back Overview
      • Arm yourself with information and resources to help you provide the best treatment possible at every stage of pit viper envenomation.
    • About Pit Viper Envenomation
      • Get an overview of pit viper envenomation and its impact.
    • Achieving Control
      • Learn about the importance of resolving all 3 critical components of pit viper envenomation in order to achieve initial control.
    • Treatment Algorithm
      • Familiarize yourself with the step-by-step unified expert consensus treatment algorithm in order to effectively treat envenomation.
    • Myths About Treatments
      • Find out which common treatment myths to avoid.
    • Snakes in Your State
      • Find out which venomous snakes live in your state with our interactive map.
  • About CroFab®
    • Strike back early with CroFab®.
    • What is CroFab®
      • Use CroFab® to halt local effects, resolve systemic effects, and reduce coagulation abnormalities, regardless of snakebite severity.
    • Efficacy
      • Learn how CroFab® is clinically proven to help halt progression of North American pit viper envenomation.
    • Safety Profile
      • View the safety profile you can count on.
    • Manufacturing
      • Learn how CroFab® is manufactured with purity, precision, and purpose.
    • Patient Experiences
      • Watch video testimonials and review case studies of patient experiences with CroFab®.
    • Contact Us
      • Call for 24 hour medical information or to report an adverse reaction:
        1-877-377-3784
  • Treating With CroFab®
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    • Dosing and Administration
      • Read information about dosing and administration for complete envenomation control.
    • Reconstitution
      • Learn about the reconstitution process for CroFab®.
    • Preventing Recurrent Effects
      • Learn how to dose CroFab® in order to help prevent recurrence of coagulopathies.
  • Locating and Ordering
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    • Locate CroFab®
      • Locate where CroFab® is stocked in a facility near you.
    • How to Order CroFab®
      • Arm yourself with information for locating and procuring CroFab®.
    • Reimbursement
      • Review reimbursement information for CroFab®.
  • CroFab® Resources
    • Access resources and information about treatment with CroFab®.
    • Virtual Patient Simulation
      • Explore an interactive virtual patient simulation for treating potential pit viper envenomation.
    • SnakeBite911 App
      • Download the SnakeBite911 App for critical information about snakebite first aid and snakebite management and treatment.
    • Expert Video Insights
      • Watch videos of experts discussing envenomation and treatment with CroFab®.

    • Downloadable Resources
      • Access resources and information about treatment with CroFab®.
    • Clinical Articles
      • Review abstracts and clinical articles about crotaline snakebite management, including the consensus treatment algorithm.
  • Envenomation Education
    • Strike Back Overview
    • About Pit Viper Envenomation
    • Achieving Control
    • Treatment Algorithm
    • Myths About Treatments
    • Snakes in Your State
  • About CroFab®
    • What is CroFab®
    • Efficacy
    • Safety Profile
    • Manufacturing
    • Patient Experiences
    • Contact Us
  • Treating With CroFab®
    • Dosing and Administration
    • Reconstitution
    • Preventing Recurrent Effects
  • Locating and Ordering
    • Locate CroFab®
    • How to Order CroFab®
    • Reimbursement
  • CroFab® Resources
    • Virtual Patient Simulation
    • SnakeBite911 App
    • Downloadable Resources
    • Expert Video Insights
    • Clinical Articles
  • How to Order Call 1-844-293-0007
    CroFab® Replacement Policy
 

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BE THE FIRST TO LEARN CURRENT AND EMERGING SNAKEBITE MANAGEMENT INFORMATION

 

To report a suspected adverse event associated with CroFab®, please email vigilance@btgplc.com.
 

For general questions about CroFab®, please use the form hosted at the BTG website.

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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.

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.

BTG Logo
BTG and the BTG roundel logo are registered trademarks of BTG International Ltd.
CroFab ® is a registered trademark of BTG International Inc.
TIME IS TISSUE® is a trademark of Protherics Medicines Development Ltd., a BTG International group company. BTG Specialty Solutions Center™ is a trademark of BTG International Ltd. SnakeBite911 and the snakehead logo are trademarks of Protherics UK Ltd. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. ‭Google Play and the Google Play logo are trademarks of Google Inc.

© 2019 BTG International Inc. All rights reserved.
US-CRF-1900219 October 2019

To report suspected adverse reactions, contact BTG at
1-877-377-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

BTG Specialty Solutions CenterTM

Phone 1-844-293-0007 (Voice)
Fax 1-877-626-9910 (Fax)

24-hour Medical Information:

Phone 1-877-377-3784
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