Bringing Results in von Willebrand Disease

Humate-P® the most prescribed and most tested VWF/FVIII replacement treatment, with a long history of success1,2

Preferred

The most prescribed VWF/FVIII replacement therapy2
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Proven

Effective hemostatic control for all VWD types and across multiple types of bleeds3-6
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Purified

Integrated Safety System helps meet high product quality and safety standards1
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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.

The most commonly reported adverse reactions in patients receiving Humate-P 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, or 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.


© CSL Behring 2012. The product information on this site is intended for US residents only. 11-HUM-081

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.
  3. Gill JC, Ewenstein BM, Thompson AR, Mueller-Velten G, Schwartz BA, for the Humate-P Study Group. Successful treatment of urgent bleeding in von Willebrand disease with factor VIII/VWF concentrate (Humate-P): use of the ristocetin cofactor assay (VWF:RCo) to measure potency and to guide therapy. Haemophilia. 2003;9(6):688-695.
  4. Lillicrap D, Poon M-C, Walker I, Xie F, Schwartz BA, and members of the Association of Hemophilia Clinic Directors of Canada. Efficacy and safety of the factor VIII/von Willebrand factor concentrate, Haemate-P/Humate-P: ristocetin cofactor unit dosing in patients with von Willebrand disease. Thromb Haemost. 2002;87(2):224-230.
  5. Lethagen S, Kyrle PA, Castaman G, Haertel S, Mannucci PM, for the Haemate P Surgical Study Group. von Willebrand factor/factor VIII concentrate (Haemate P) dosing based on pharmacokinetics: a prospective multicenter trial in elective surgery. J Thromb Haemost. 2007;5(7):1420-1430.
  6. Thompson AR, Gill JC, Ewenstein BM, Mueller-Velten G, Schwartz BA; Humate-P Study Group. Successful treatment for patients with von Willebrand disease undergoing urgent surgery using factor VIII/VWF concentrate (Humate-P). Haemophilia. 2004;10(1):42-51.