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July 25, 2007

Humate-P® Package Notification

Subject: Transfer set packaged with Humate-P® [Antihemophilic Factor / von Willebrand Factor Complex (Human)]

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

 


Important Safety Information


Humate-P is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate. Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes.

Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.

Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.

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

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

In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), and edema (swelling). For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, and epistaxis (nosebleed).

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The information provided herein is solely for use by physicians and healthcare professionals in the United States. The CSL Behring product listed may not have been approved in other countries and may not be available everywhere.

© CSL Behring 2010. The product information presented on this site is intended for US residents only.