Efficacy

Humate-P^® is effective for bleeding episodes in all types of VWD.¹

Number of bleeding episodes by desease type

A retrospective review of clinical safety and efficacy data obtained from 97 Canadian subjects showed Humate-P^® to be effective for bleeding episodes in patients with all types of VWD¹:

Humate-P^® was rated as "excellent/good" in all 109 patients (100%) with VWD types 1 and 2
Humate-P^® was rated as "excellent/good" in 198 of 208 patients (95%) with type 3 VWD—the most severe form

A US study involving 35 surgical patients with VWD and a European study involving 27 surgical patients with VWD assessed the safety and hemostatic efficacy of Humate-P^® 24 hours after the last Humate-P^® infusion or 14 days after surgery, whichever came earlier. Assessment of hemostatic efficacy showed:

Investigators rated efficacy as "excellent/good" for all 35 surgical subjects (100%) in the US study. The study was later reviewed by an independent Data Safety Monitoring Board (DSMB), which agreed with investigators' assessments of the overall hemostatic efficacy for all but two subjects (neither of whom had type 3 VWD); the DSMB judged hemostatic efficacy as "excellent/good" in 33 (94.3%) of the 35 subjects
Investigators rated efficacy as "excellent/good" for 26 of 27 surgical subjects (96.3%) in the European study

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

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.