Locate CroFab

Hospitals That Stock CroFab

*BTG International Inc. cannot guarantee the availability of CroFab® Crotalidae Polyvalent Immune Fab (Ovine) at the facilities listed on this page. Based on the most current information avialable to BTG International Inc., these institutions have purchased CroFab® Crotalidae Polyvalent Immune Fab (Ovine).

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

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.

Please see full Prescribing Information.

SERB® and the SERB logo are registered trademarks of SERB S.à.r.l.
BTG® is a registered trademark 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 SERB group company. 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.

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.

US-CRF-2300086/October 2023

BTG Specialty Solutions Center ™