CroFab Labeling Updated With Extended Shelf Life, Removal of Mercury Warning

Warnings regarding mercury toxicity have been removed from the new labeling.
Warnings regarding mercury toxicity have been removed from the new labeling.

The labeling for CroFab (crotalidae polyvalent immune Fab [ovine]; BTG International) has been updated to include information on a new 60-month shelf life for the product as well as the removal of warnings regarding mercury toxicity. CroFab is a sheep-derived antivenin indicated for the management of adult and pediatric patients with North American crotalid (rattlesnakes, copperheads, cottonmouths/water moccasins) envenomation.

In a press release, the Company stated that as the manufacturing process has changed for CroFab, completely eliminating the use of mercury-containing compounds, references to the product containing mercury have been removed from the prescribing information. In addition, CroFab now has a 60-month shelf; previously the product was approved with a 36-month shelf life.

The new product information may not apply to certain lots of CroFab, so the prescribing information for the product should be reviewed to verify the product's shelf life and whether thimerosal was included in the manufacturing.

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CroFab should be administered to patients who develop signs of envenomation to prevent clinical deterioration. In clinical studies, CroFab was found to be effective when given within 6 hours of a snakebite.

For more information visit BTGplc.com.