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Dosing Decrease to 1.0 mL/kg (50 mg/kg) and Expiration Date Extension for Botulism Immune Globulin Intravenous (Human) (BIG-IV) Lot 5 to March 02, 2015.
This is to provide you with important information regarding Botulism Immune Globulin Intravenous (Human) (BIG-IV), commonly referred to as BabyBIG®. BabyBIG® is indicated for treatment of infant botulism caused by toxin types A or B in patients below one year of age. This product was manufactured by Baxter Healthcare Corporation for the California Department of Public Health (CDPH) Infant Botulism Treatment and Prevention Program.
FDA has approved CDPH’s request to decrease the BabyBIG® Lot 5 dosage to 1.0 mL/kg (50 mg/kg) and extend the expiration date to 66 months from the date of manufacture (March 02, 2015). Decreasing the dosage to 1.0 mL/kg (50 mg/kg) will extend the supply and availability of sufficiently potent product. The expiry extension is based upon FDA evaluation of stability data, which determined that this lot of product will maintain stability and potency through March 02, 2015.
BabyBIG® is the only product indicated for treating infant botulism resulting from toxin types A or B. Lot 5 is the only lot of BabyBIG® currently in distribution.
The manufacturer is providing an update on dosing and the revised expiration date via a Dear Health Care Provider Letter.
Botulism Immune Globulin Intravenous (Human) (BIG-IV)