CSL Behring Announces Availability of
Humate-P® with Smaller Diluent
—Innovation Means Added Convenience for Patients and Caregivers—
King of Prussia, PA—February 15, 2006—CSL Behring
today announced that Humate-P® (Antihemophilic
Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized) is now available
featuring a smaller diluent — 50 percent less in all assay sizes.
The new formulation, which bears the current safety and efficacy profile of Humate-P,
offers added convenience to patients, healthcare professionals, and caregivers who
administer Humate-P. Humate-P is the only factor concentrate approved by the U.S.
Food & Drug Administration for use in treating adult and pediatric patients
who experience spontaneous and trauma-induced bleeding episodes in severe von Willebrand
Disease (VWD), and in mild or moderate VWD where the use of desmopressin is known
or suspected to be inadequate.1
"CSL Behring continually strives to bring innovation to the healthcare marketplace
so we can offer products that enhance patients’ overall quality of life," said Paul
Perreault, CSL Behring Executive Vice President, Worldwide Commercial Operations.
"Humate-P with the smaller diluent is an excellent example of that effort. We are
pleased to be bringing it to those patients who can benefit from the convenience
it offers."
The smaller diluent size means that patients who use the new formulation can enjoy
the convenience of spending less time receiving their infusions. In addition, vial
and package sizes of the product are now smaller, translating to less required storage
space.
About von Willebrand disease
Von Willebrand disease, the most common hereditary bleeding disorder in the United
States, affects approximately 1 to 2% of the U.S. population.1 It is caused by a
deficiency or abnormality of the von Willebrand factor, a protein in the blood that
is necessary for normal blood clotting.1 Men and women are equally likely
to be affected by VWD.1 VWD is classified by type of defect, ranging
from Type I (the most common and mildest) to Type III (the least common and most
severe).2
Women with VWD are more likely than other women to experience heavy, prolonged menstruation.3
Other common symptoms of VWD include frequent nosebleeds and easy bruising.3
Bleeding can be mild or serious and can occur as a result of injury, or without
an obvious cause.3 More serious symptoms include bleeding into joints
and internal organs.3 An individual with any of the three types of VWD
may require special care during dental procedures, surgery, and childbirth.4
There is no "cure" for VWD, but different situations can be treated effectively
in different ways.5 Specific treatments may include: desmopressin acetate,
which, in patients with mild VWD, can release stored von Willebrand factor; von
Willebrand factor replacement therapies such as Humate-P; and oral contraceptives,
to reduce menstrual bleeding and to raise von Willebrand factor levels in the bloodstream.
About Humate-P®
Humate-P®, Antihemophilic Factor/von Willebrand Factor Complex (Human)
Dried, Pasteurized, is a factor replacement therapy with more than 19 years of demonstrated
safety and efficacy around the world. After more than one-half billion units infused,
there is no documented evidence of viral transmission with Humate-P. It is an injectable
product that works by replacing the von Willebrand factor/factor VIII missing in
patients with VWD. Humate-P contains the high molecular weight of multimers of von
Willebrand factor important for correcting the coagulation defect in patients with
VWD. The distribution of high molecular weight multimers in Humate-P corresponds
closely to that found in normal human plasma.
Humate-P® is contraindicated in individuals with a history of anaphylactic
or severe systemic response to antihemophilic factor or von Willebrand factor preparations
or to any of its components.
Thromboembolic events have been reported in VWD patients receiving coagulation factor
replacement, especially in the setting of known risk factors for thrombosis. Caution
should be exercised and antithrombotic measures considered.
Humate-P® is derived from human plasma. As with all plasma-derived products,
the risk of transmission of infectious agents, including viruses and, theoretically,
the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Although few adverse reactions have been reported in patients receiving Humate-P,
the most commonly reported are allergic-anaphylactic reactions, including urticaria,
chest tightness, rash, pruritus, edema, shock, chills and fever, and hypervolemia.
For patients undergoing surgery, the most common adverse reactions are postoperative
wound or injection-site bleeding.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate
about improving the quality of patients' lives, CSL Behring manufactures and markets
a range of safe and effective plasma-derived and recombinant products and related
services. The company's therapies are used in the treatment of immune deficiency
disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited
emphysema. Other products are used for the prevention of hemolytic diseases in the
newborn, in cardiac surgery, organ transplantation and in the treatment of burns.
The company also operates one of the world's largest plasma collection networks,
CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company
with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
###
1 Centers for Disease Control and Prevention. Bleeding Disorders.
Available at:
http://www.cdc.gov/ncbddd/hbd/hemophilia.htm
Accessed: March 28, 2007
2National Heart Lung and Blood Institute. What Is von Willebrand Disease?
Available at:
http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_All.html
Accessed: March 28, 2007
3National Heart Lung and Blood Institute. Signs and Symptoms of VWD.
Available at:
http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_SignsAndSymptoms.html
Accessed: March 28, 2007
4National Heart Lung and Blood Institute. Treatments for VWD.
Available at:
http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_Treatments.html
Accessed: March 28, 2007
5Centers for Disease Control and Prevention. Bleeding and Clotting Disorders
in Women.
Available at:
http://www.cdc.gov/ncbddd/hbd/women.htm
Accessed: March 28, 2007
Contact:
Sheila A. Burke
Director, Communications & Public Relations, Worldwide Commercial Operations
CSL Behring
610-878-4209
Sheila.Burke@cslbehring.com
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.
© CSL Behring 2010. The product information presented on this site is intended for US residents only.