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Treatment With CroFab^®

Strike Back Early With CroFab^®

Regardless of snakebite severity, treat with CroFab^® to*:

Halt local effects, edema, ecchymosis, and treat the source of the pain¹
Resolve systemic effects, such as nausea, vomiting, dizziness, or tachycardia¹
Reduce coagulation abnormalities, such as thrombocytopenia, hyperfibrinogenemia, and spontaneous bleeding^1,2

*Efficacy determined using the snakebite severity score (SSS), a validated objective tool for the clinical evaluation of North American pit viper snakebite in adults. The total score reflects patient evaluation on 6 dimensions: cardiovascular system, local wound, gastrointestinal system, hematologic symptoms, pulmonary system, and central nervous system. The higher the total score, the more severe the snakebite.¹

Treat with confidence

Comprehensive coverage of all US pit viper venoms¹
A safety profile you can count on¹
Included in unified consensus algorithm³

Learn about the expert recommended treatment in cases of pit viper envenomation.

What is CroFab^®?

References:

1. CroFab^® [prescribing Information]. BTG International Inc; May 2017. 2. Dart RC, McNally J. Efficacy, safety, and use of snake antivenoms in the United States. Ann Emerg Med. 2001;37(2):181-188. 3. Lavonas EJ, Ruha AM, Banner W, et al. Unified treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop. BMC Emerg Med. 2011;11:2.

Strike Back Envenomation Education

Access resources that are critical for treating pit viper envenomation.

Algorithm

Review the expert consensus for managing pit viper snakebites.

Webinars

View presentations by snakebite experts on envenomation and treatment.

Dosing + Administration

Learn how to dose CroFab® to gain and continue control of pit viper envenomation.

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 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.‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬

‭‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬© 2018 BTG International Inc. All rights reserved.
US-CRF-1800053 August 2018‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬

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 Center^TM

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

24-hour Medical Information:

1-877-377-3784