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8/6/2001

Companies Change Storage Condition for Antihemophilic Factor

Cheryl A. Thompson

The new formulations of recombinant antihemophilic factor, stabilized with sucrose not albumin, should not be stored for any length of time at room temperature, Bayer Corp. and Aventis Behring announced in late July. When originally introduced to the U.S. market, Bayer's Kogenate FS and Aventis's Helixate FS and Helixate NexGen could be stored at room temperature, not exceeding 25 degrees C (or 77 degrees F), for up to two months.

The change in storage condition to refrigeration at all times was made to ensure that the products maintain at least 80 percent of their labeled potency through the expiration date. All new packages of Kogenate and Helixate will include labeling indicating that the products should be stored at 2–8 degrees C.

Aventis also recently initiated a recall of Mononine lot X29601 (expiration date of Jan. 11, 2003), containing factor IX, because samples of the lot were found to have less than 80 percent of the labeled potency.

Bayer manufactures Helixate products for Aventis.