High-Quantity von Willebrand factor (VWF)

In addition to containing high quality multimers, Humate-P^® also contains high quantity VWF in proportion to the amount of factor VIII (FVIII) it contains. This is important because the mainstay of von Willebrand disease (VWD) treatment is the replacement of the deficient protein [VWF]¹

As shown below, on average, Humate-P^® contains an average ratio of VWF:RCo to FVIII activity of 2.4 to 1.

Quantity: High ratio of VWF:RCo to factor VIII (FVIII)

Humate-P^® contains larger amounts of VWF than it does factor VIII¹

— The average ratio of VWF:RCo to FVIII activity is 2.4 to 1²

International unit (IU) activity of VWF:RCo and factor VIII per vial of Humate-P^®1

VWF:RCo/vial	FVIII/vial	Ratio	Diluent
600 IU	250 IU	2.4 to 1	5 mL
1200 IU	500 IU	2.4 to 1	10 mL
2400 IU	1000 IU	2.4 to 1	15 mL

Because VWF:RCo is the most accepted and specific method for determining VWF activity,³ VWF:RCo units are used to calculate the amount of VWF necessary for dosing
High ratio of VWF:RCo to FVIII can allow adjustment of VWF levels without raising factor VIII levels to unacceptable levels⁴

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

Mannucci PM. Treatment of von Willebrand’s disease. N Engl J Med. 2004;351:683-694.
Data on file, 2005, CSL Behring LLC.
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;87:224-230.
Kraaijenhagen RA, in't Anker PS, Koopman MMW, et al. High plasma concentration of factor VIIIc is a major risk factor for venous thromboembolism. Thromb Haemost. 2000;83:5-9.