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CroFab®
Crotalidae Polyvalent Immune Fab (Ovine) is
indicated for the management of patients with
minimal to moderate North American Crotalid
envenomation (this subfamily includes
rattlesnakes, cottonmouths & copperheads.)
Early use of CroFab® (within 6 hours
of snakebite) is advised to prevent clinical
deterioration and the occurrence of systemic
coagulation abnormalities.
Important Safety
Information
The most common adverse events reported in
clinical studies were mild or moderate reactions
involving the skin and appendages (primarily
urticaria, rash or pruritus), which occurred in
14 out of 42 patients. Three patients
experienced a serious adverse event. Two
patients had a severe allergic reaction (severe
hives and a severe rash and pruritus) following
treatment. One patient had a recurrent
coagulopathy due to envenomation, which required
re-hospitalization and additional antivenin
administration. 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.
Recurrent coagulopathy may persist for one to
two weeks or more. One patient discontinued
CroFab® therapy due to an allergic
reaction. Patients with allergies to papain,
chymopapain, other papaya extracts or the
pineapple enzyme bromelain may also be at risk
for an allergic reaction to CroFab®.
Please click on the
CroFab® full prescribing information
link at left for complete prescribing
information, including events, precautions or
warnings.
* © CroFab® is manufactured
by/registered trademarks of Protherics US Inc.,
Brentwood, TN 37027 and distributed by Savage
Laboratories® |