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Humate-P: Preferred by More Clinicians

A time-tested treatment

Humate-P is the most prescribed VWF/FVIII concentrate treatment, with extensive clinical experience and a long record of success.1,2

  • More units infused than any other VWF/FVIII concentrate treatment1
  • Demonstrated safety and efficacy across multiple patient populations (infants, children, adolescents, and adults)2
  • Proven efficacy in clinical trials spanning more than 25 years and evaluating >1000 subjects2

© CSL Behring 2012. The product information presented on this site is intended for US residents only. 11-HUM-082

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.

References

  1. Data on file. CSL Behring LLC.
  2. Berntorp E, Archey W, Auerswald G, et al. A systematic overview of the first pasteurised VWF/FVIII medicinal product, Haemate P/Humate-P: history and clinical performance. Eur J Haematol. 2008;80(Suppl 70):3-35.