The Humate-P® Difference: High Quality & Quantity
Humate-P is called a von Willebrand factor (VWF) replacement therapy because it
replaces the VWF in your blood that is missing or that doesn't work properly. VWF
is a protein in your blood that helps blood to clot properly. (Click here for an
overview of How Clotting Works)
Humate-P® is indicated in adult and pediatric patients with 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® has the high quality (HMWMs) and high quantity (2.4:1 ratio)
of VWF, which are important in the effective treatment of von Willebrand disease
(VWD).
What you should know about the quality and quantity of VWF replacement therapy:
- Your VWF replacement therapy should resemble the VWF in normal human blood as closely
as possible, to be as effective as possible
- The VWF in normal human blood has a high percentage of high molecular weight multimers
(HMWMs)
- Among VWF-containing concentrates, Humate-P® has the most HMWMs, closely
resembling the VWF in normal human blood.1,3
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
- Berntorp E, Nilsson IM. Biochemical and in vivo properties of commercial virus-inactivated
factor VIII concentrates. Eur J Haematol. 1988;40:205-214.
- Metzner HJ, Hermentin P, Cuesta-Linker T, Langner S, Müller H-G, Friedbold J. Characterization
of factor VIII/von Willebrand factor concentrates using a modified method of von
Willebrand factor multimer analysis. Hemophilia. 1998;4(suppl 3):25-32.
- Berntorp E, Nilsson IM. Use of a high-purity factor VIII concentrate (Hemate P)
in von Willebrand's disease. Vox Sang. 1989;56:212-217.
© CSL Behring 2010. The product information presented on this site is intended for US residents only.