Dear Humate-P^® User:

CSL Behring L.L.C. has identified an incidence of small holes in the blister packaging of the transfer set that is included in the Humate-P package. This finding affects our ability to ensure the safety of the transfer set. As a precaution, because of our commitment to patients, we are notifying all customers, users of Humate-P, and the U.S. Food and Drug Administration of our intentions to provide a replacement transfer set.

If you are in possession of Humate-P, please contact your product provider (homecare companies, hemophilia treatment centers, specialty pharmacies, distributors, hospitals, et.al) to obtain a replacement transfer device (Mix2Vial™). CSL Behring is making available the alternate transfer device (Mix2Vial) for all providers to replace the current transfer set.

Important note: There is nothing wrong with the Humate-P product or the diluent provided within the package. This is NOT a product integrity or safety issue. Rather, there is a potential safety issue with the transfer device. We have received no reports of a problem associated with a patient receiving Humate-P prepared with this transfer set. This is a theoretical risk only.

This notice pertains only to the transfer set that was packaged with Humate-P. It is important to note that there is no problem with the Humate-P product or diluent. THERE IS NO NEED TO RETURN ANY HUMATE-P VIALS TO YOUR PROVIDER.

If you should have questions regarding this letter, please contact:

• Natalie Thoma, R.Ph. or her associates at CSL Behring Consumer Affairs: 1-(888)-508-6978

In the event of an emergency (when additional shipment of Humate-P is required -such as surgery): the treating physician should contact Medical Affairs (800-504-5434) for authorization to release product for it to be shipped.

Thank you for your cooperation in this matter.

Sincerely,

Garrett E. Bergman, MD
Sr. Director, Medical Affairs

Please see full prescribing information.

Important Safety Information

Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P^® is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement, especially in the setting of known risk factors for thrombosis. Caution should be exercised and antithrombotic measures should be considered.

Humate-P^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Although few adverse reactions have been reported in patients receiving Humate-P^®, the most commonly reported are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, edema, shock, chills and fever, and hypervolemia.