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Flexibility and Dosing

Humate-P® is labeled in VWF:RCo for dosing accuracy in von Willebrand disease (VWD)

  • Humate-P® vials are labeled (in IUs) in:
    — VWF:RCo activity for the treatment of VWD and
    — FVIII activity for the treatment of hemophilia A
  • Dosing corresponds with the VWF:RCo assay, the single most predictive assay for VWD2
    — Measures VWF activity3
    — Provides a quantitative measurement of VWF function by determining how well VWF helps platelets adhere to one another3
  • Dose is calculated based on an expected in vivo recovery of 2.0-IU/dL rise in VWF:RCo activity per every IU/kg of VWF:RCo administered
  • Ratio allows adjustment of VWF levels without raising FVIII to unacceptable levels1

New packaging enhancements for Humate-P®

Humate-P is more convenient than ever: Along with the Mix2Vial™ needle-free transfer device, Humate-P now has improved product packaging:

  • The new eco-friendly, recyclable tray protects vials in transit, and provides a secure space for reconstitution by holding vials in place
    • Environment-friendly while making reconstitution easier than ever for your VWD patients
  • Peel-off label stickers for 1200 IU VWF:RCo and 2400 IU VWF:RCo vials can be easily removed from the vials and placed in a log
    • Simplifies recordkeeping for your patients and their caregivers by easily tracking the precise amount of factor being infused and associated lot numbers
  • New box size allows for multiple boxes of Humate-P® to be easily stacked
    • Reduces the amount of space needed for storage
  • Mix2Vial™ needle-free transfer device is included in packaging

(Note: The product itself has not changed.)


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

  1. 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.
  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;87:224-230.
  3. Haen PJ. Disorders of hemostasis. In: Harris-Young L, ed. Principles of Hematology. Dubuque, Iowa: Wm C Brown Publishers;1995:375-389.
© CSL Behring 2010. The product information presented on this site is intended for US residents only.