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CroFab® Crotalidae Polyvalent Immune
Fab (Ovine)
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®.
DigiFab® Digoxin
Immune Fab (Ovine)
DigiFab® Digoxin
Immune Fab (Ovine) is indicated for the treatment of patients with
life-threatening or potentially life-threatening digoxin toxicity or overdose.
DigiFab® is
indicated for the same conditions as Digibind®*. Clinical claims,
indications and usage of DigiFab® are IDENTICAL to Digibind®.
Neither product is indicated for milder cases of digitalis toxicity.
Exacerbation of low cardiac output states and congestive heart failure due to the withdrawal of inotropic effect of digitalis; hypokalemia due to reactivation of the sodium-potassium ATPase; rapid ventricular response in patients with atrial fibrillation due to the withdrawal of the effects of digitalis on the atrioventricular node and rare allergic reactions. Patients with allergies to papain, chymopapain, other papaya extracts or the pineapple enzyme bromelain may be at risk for an allergic reaction to DigiFab. DigiFab is an animal protein, monitor for delayed allergic reactions and hypersensitivity. Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked.
In the clinical trials of DigiFab, 6 of 15 patients in the digoxin overdose study had a total of 17 adverse experiences, most were mild to moderate in nature and all were deemed “remotely associated” with DigiFab. Three events were deemed “severe”, all occurred in one patient and consisted of the following: pulmonary edema, bilateral pleural effusion and renal failure. After reviewing the case, it was determined that these events were likely due to the loss of digoxin inotropic support in combination with the patient’s underlying medical condition. Of 8 healthy volunteers who received DigiFab, only 2 experienced an adverse reaction that was considered to be associated with DigiFab. The reactions were 1 episode of phlebitis of the infusion vein and 1 episode of moderate postural hypotension, which became mild prior to resolving.
*Digibind® is a registered trademark of GlaxoSmithKline. Neither GlaxoSmithKline nor Digibind® are related or affiliated with Nycomed US Inc.
Please click on
Products page for links to CroFab® and DigiFab®
indication, safety and product information.
* © CroFab®
and DigiFab® are manufactured by/registered trademarks of Protherics
US Inc., Brentwood, TN 37027 and distributed by Savage Laboratories®
© Kaon is a registered trademark of the Savage Laboratories® Division of Nycomed US Inc.
©2008 Savage Laboratories ® A division of Nycomed US Inc., Melville,
NY 11747. All rights reserved.