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
Important Safety Information
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).
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.
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.