Humate-P® Human Plasma-derived von Willebrand factor (HP-VWF/FVIII) Concentrate
Humate-P® is a factor replacement therapy with over 20 years of demonstrated
safety and efficacy.
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
- Contains high molecular weight multimers of VWF (HMW-VWF)
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 missing 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 FVIII and VWF, which are deficient or abnormal in VWD disease.
In over two decades and more than one-half billion units infused, there are no confirmed
reports of virus transmission with Humate-P®.1
* 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.
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
- Data on file, CSL Behring LLC.
© CSL Behring 2010. The product information presented on this site is intended for US residents only.