Berinert® 1500 IU Announcement
Berinert® is now available in a new reduced volume vial format
Ottawa, Canada — 04/07/2015
Berinert®, a human plasma-derived, pasteurized and nanofiltered C1-esterase inhibitor (C1-INH) concentrate, is now available in a new 1500 IU
"reduced volume" vial format.
The new Berinert® 1500 IU format is reconstituted with 3 mL of Sterile Water for Injection (Diluent). In Canada, Berinert® is indicated for the
treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) of moderate to severe intensity.*1
"It is part of our commitment to the HAE Community to continuously bring innovative improvements and provide more treatment options to patients
in Canada" said Philippe Hebert, General Manager of CSL Behring Canada. The existing vial size and formulation
(Berinert® 500 IU reconstituted with 10 mL Sterile Water for Injection) will also continue to be available. Berinert®, licensed since 2010,
is the first C1-INH available in Canada. Berinert® has been available for the treatment of HAE for over 30 years internationally, and has been used
for more than half a million treatments.2
About Hereditary Angioedema
HAE is a rare genetic disorder caused by a deficiency of C1-INH. It is inherited in an autosomal dominant manner. Symptoms of HAE include
episodes of edema, or swelling, in the hands, the feet, the face, the abdomen, and/or the larynx. Patients who have abdominal attacks of HAE
can experience episodes of extreme pain, diarrhea, nausea and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the
face or throat can result in upper airway closure, asphyxiation and, if untreated,
death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.
For further information about HAE, please visit the website of HAE Canada — http://haecanada.org ,
and the disease information website www.allabouthae.com
Berinert® is a highly purified, human, C1-INH concentrate that rapidly treats the fundamental cause of hereditary HAE symptoms
by providing C1-INH deficient patients with the missing human protein. Berinert® has been available for the treatment of HAE
for over 30 years internationally, and has been used for more than half a million treatments.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people
with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune
deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products
are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a global biopharmaceutical company
and a member of the CSL Group of companies. The parent company, CSL Limited (ASX:CSL), is headquartered in Melbourne, Australia. For more
information, visit http://www.cslbehring.com/.
Christopher Florentz, CSL Behring, 610-878-4316
* An HAE attack of moderate intensity is characterized by a degree of discomfort caused by clinical HAE symptoms that results in some interference with daily activities.
An HAE attack of severe intensity is characterized by a degree of discomfort caused by clinical HAE symptoms that makes it impossible to perform daily activities.
1 Product Monograph, Berinert® 500 / Berinert® 1500, December 23, 2014.
2 Data on file.