Important Product Supply Information: Antivenin (Micrus fulvius) (Equine Origin) North American Coral Snake AntiveninPfaer Inc
235 East 42nd Street
New York, NY 10017
September 4, 2012
|Re:||IMPORTANT PRODUCT SUPPLY INFORMATION|
|Antivenin (Micrurus fulvius) (Equine Origin) North American Coral Snake Antivenin|
|FURTHER EXTENSION OF EXPIRATION DATING TO October 31, 2013LOT NO. 4030026|
Wyeth Pharmaceuticals (a subsidiary of Pfizer, Inc) would like to provide you with updated and very important information regarding Antivenin (Micrurus fulvius) (Equine Origin) North American Coral Snake Antivenin.
Last October, Wyeth Pharmaceuticals announced the extension of the expiration date of one lot of Antivenin, Lot No. 4030026, until October 31, 2012, an additional 48 months beyond the labeled expiration date of October 31, 2008.
Wyeth Pharmaceuticals, working closely with the U.S. Food and Drug Administration (FDA), is further extending the expiration date of Lot No. 4030026 for an additional 12 months. Wyeth Pharmaceuticals has stability data that indicate product from Lot No. 4030026 continues to be within applicable release specifications. As a result, product from this lot will now be deemed to expire on October 31, 2013.
As you may know, Wyeth Pharmaceuticals no longer manufactures Antivenin, and there is currently no alternative FDA-approved supplier of this product Accordingly, it is imperative that you do not discard any product you have in your inventory of Lot No.4030026. Please continue to maintain this product in your inventory and keep it available for use until October 31, 2013.
Pfizer is carefully managing Antivenin (Micrurus fulvius) inventories and will supply product only to direct customers.
Antivenin (Micrurus fulvius) (Equine Origin) is indicated for the treatment of envenomation caused by the bites of M. f. fulvius (eastern coral snake) and M. f. tenere (Texas coral snake).
Patients sensitive to Antivenin or horse serum may develop anaphylaxis. Therefore, it is essential that prior to intravenous or intramuscular Antivenin administration a proper skin test be performed, interpreted, and therapy modified if indicated. Since the possibility of a severe immediate reaction (anaphylaxis) always exists whenever horse serum is administered appropriate therapeutic agents, such as tourniquet, oxygen supply, epinephrine1:1000, and another injectable pressor amine (not corticosteroids) must be ready for immediate use.
Please see accompanying full Prescribing Information for indications and usage, dosage and administration, and important safety information. Also, the product Prescribing Information can be accessed at www.pfizer.com .
If you have any questions, please call our Customer Service Department at 1-800-666-7248.
Salomon Azoulay , M.D.
Senior Vice President
Emerging Markets and Established Products
Medical & Development Group