Humate-P: Purified to Meet High Safety Standards

An unyielding dedication to product safety

CSL Behring’s Integrated Safety System helps ensure that the product meets high quality and safety standards. The collecting, processing, and packaging procedures of Humate-P are designed to:

  • Retain inherent properties of the VWF and FVIII proteins
  • Help ensure product purity and viral safety. The risk of virus transmission cannot be completely eliminated.

Committed to quality

CSL Behring is dedicated to meeting or exceeding the most stringent international standards for plasma-product safety in accordance with guidelines from worldwide regulatory agencies.

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Designed to maximize virus inactivation and removal while maintaining biological integrity

Humate-P undergoes multiple steps during manufacturing to reduce the risk of virus transmission:

  1. Cryoprecipitation
  2. Al(OH)3 adsorption, glycine precipitation, and NaCl precipitation, studied in combination
  3. Pasteurization in aqueous solution for 10 hours at 60°C

The power of heat treatment

This heat treatment step illustrated below has been proven to inactivate both enveloped and non-enveloped viruses.

Humate-P Pasteurization

The risk of virus transmission cannot be completely eliminated.

Important Safety Information

Antihemophilic Factor/von Willebrand Factor Complex (Human), 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 risk factors for thrombosis.

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

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

Please see full prescribing information.

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The information provided here is primarily intended for use by physicians and other 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.

Treatment for VWD patients

© CSL Behring 2019. The product information presented on this site is intended for US residents only. 11-HUM-082


  1. Data on file. CSL Behring LLC.