CroFab®
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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®.
* © CroFab® and
DigiFab® are
manufactured by/registered
trademarks of Protherics US
Inc., Brentwood, TN 37027 and
distributed by Savage Laboratories® |