Humate-P: Human Plasma-derived von Willebrand factor (HP-VWF/FVIII) Concentrate

Humate-P is a VWF/FVIII replacement therapy that delivers results, patient after patient, treatment after treatment, decade after decade.

In the treatment of VWD, Humate-P stands alone. Humate-P is the only human plasma-derived von Willebrand factor (HP-VWF/FVIII) concentrate that:

Is approved for the treatment of VWD and for the prevention of excessive bleeding during and after surgery
Can be used for prevention of bleeding during and after surgery in all VWD types* and for all procedures

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. (see Important Safety Information for Humate-P).

HP-VWF/FVIII Concentrate

Humate-P works by replacing the VWF/FVIII complex that is deficient or defective in patients with von Willebrand disease. The HP-VWF/FVIII concentrate is purified from pooled human plasma from many carefully screened plasma donors and contains the clotting proteins VWF and FVIII.

* Use in adult and pediatric patients for the treatment of spontaneous and trauma-induced bleeding episodes and prevention of excessive bleeding during and after surgery in severe VWD, and in mild to moderate VWD where use of desmopressin is known or suspected to be inadequate.

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.