Proven Across All VWD Types

Effective across many clinical applications

Humate-P provides reliable hemostatic control across all VWD types, including type 3—the most severe form.1-4

Bleeding episodes

Efficacy rated excellent/good by physicians in:

  • 97% (332 of 344) of bleeding episodes involving 97 subjects2,a
    • 100% in patients with VWD Type 1, 2A, 2B; and 95% in patients with Type 3 VWD2,a
  • 98% (52 of 53) of urgent bleeding events in 33 subjects1,b

During and after surgery

Efficacy rated excellent/good by physicians in:

  • 100% (35 of 35) of surgeries involving 35 subjects with VWD Type 1, 2A, 2B, or 3
    • In the US study, all efficacy assessments were reviewed by an independent Data Safety Monitoring Board (DSMB). The DSMB agreed with the investigators’ assessments of the overall hemostatic efficacy for all but 2 subjects (neither of whom had Type 3 VWD). Based on this, the DSMB judged hemostatic efficacy as "effective" in 33 (94.3%)(95% CI: 81.1% to 99.0%) of the 35 subjects.
  • 96% (26 of 27) of surgeries on the day of surgery and in 100% on the next day and on day 143,c
  • 100% of 42 total urgent surgeries involving 39 subjects with VWD Type 1, 2A, 2B, or 34,d
  • 99% of 67 surgical cases involving 83 subjects with VWD Type 1, 2A, 2B or 32,a
  • Retrospective review of 97 Canadian patients. Excellent was defined as hemostasis achieved/complete cessation of bleeding. Good was defined as slight oozing/partial but adequate control of bleeding and did not require additional product for unplanned treatment.2
  • Prospective, multicenter, open-label, nonrandomized study designed to evaluate safety and efficacy of Humate-P in VWD patients with urgent bleeding episodes who underwent urgent and necessary surgery. Excellent/good was defined as similar hemostasis to that expected for persons without known bleeding disorders.1
  • Prospective, multicenter, open label cohort study to determine the feasibility of dosing VWF/FVIII concentrate based on PK analysis in 29 VWD subjects undergoing elective surgery. Excellent was defined as clinical hemostasis within normal limits. Good was defined as slight oozing.3
  • Prospective, multicenter, open-label, non-randomized study designed to evaluate the safety and hemostatic efficacy of Humate-P in subjects with VWD who underwent urgent or emergent, non-elective surgery. Excellent/good was defined as adequate—similar to that expected for persons without known bleeding disorders.4

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.

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 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 2018. The product information presented on this site is intended for US residents only. 11-HUM-082

References

  1. 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.
  2. 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.
  3. 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.
  4. 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.