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Safety

Unwavering focus on viral safety
The Humate-P® pasteurization process is proven to inactivate enveloped and non-enveloped viruses in one complete step*1,2

The Humate-P® pasteurization process

The addition of stabilizing agents (removed later in the manufacturing process) preserves the von Willebrand factor high molecular weight multimers of Humate-P®.3

In over 20 years and more than one-half billion units infused, there are no confirmed cases of viral transmission with Humate-P®1.

Please see Important Safety Information about Humate-P®.


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.

References

  1. Data on file, 2005, CSL Behring LLC.
  2. Mannucci PM. Treatment of von Willebrand's disease. N Engl J Med. 2004;351:683-694.
  3. Mauler R, Merkle W, Hilfenhaus J. Inactivation of HTLV-III/LAV, hepatitis B and non-A/non-B viruses by pasteurization in human plasma protein preparations. Dev Biol Stand. 1987;67:337-351.
© CSL Behring 2010. The product information presented on this site is intended for US residents only.