EMA Approves Amended Product Label for CSL Behring’s Hizentra®
New Label Supports Greater Flexibility and Ability to Individualize Dosing
BERN, Switzerland — 04 December 2014
CSL Behring announced today that the European Medicines Agency (EMA) has approved the amended product labeling for
Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid. The new label provides the ability to individualize treatment with flexible dosing – to administer Hizentra at intervals from daily to once every two weeks (biweekly).
Hizentra, the first and only 20 percent subcutaneous immunoglobulin, is an important treatment option for people diagnosed with primary and secondary immunodeficiencies (PI and SID). Hizentra was first granted marketing authorization in April 2011, for all 29 European/European Economic Area member states.
Immunodeficiencies are a group of serious diseases that compromise the immune system, leaving patients particularly vulnerable to infection. Patients with immunodeficiencies require life-long treatment, and for many, immunoglobulin replacement therapy (IgG) is an essential part of staying healthy. Hizentra delivers consistent levels of IgG, with the convenience of daily to biweekly dosing to protect these patients against infection.
"The ability to customize the dosing regimen of Hizentra provides physicians with more options to meet the individual needs of patients on Ig therapy, including the potential to reduce infusion time and volume," said Bob Repella, Executive Vice President, Global Commercial Operations, CSL Behring. "CSL Behring understands that managing this life-long disorder can be challenging as patients' lifestyles and treatment requirements may change over time. The option to dose Hizentra at flexible intervals provides even more freedom to patients, by allowing them to manage their condition based on their specific needs, which could enhance treatment compliance and clinical outcomes."
EMA approval of the updated prescribing information for Hizentra is based on simulations by empirical population pharmacokinetic modeling. Patients should not change their dosing interval without first discussing it with their physician.
About Primary and Secondary Immunodeficiencies
Immunodeficiencies affect as many as 10 million people worldwide, and constitute a group of more than 150 diseases that affect the cells, tissues and proteins of the immune system. In people with primary or secondary immunodeficiency, certain components of the immune system are either absent or functioning inadequately, leaving them more susceptible to infection. In children, especially, infections may not improve with treatment as expected and may keep returning. As a result, patients may face repeated rounds of antibiotics and hospitalization for treatment. Repeated infections can lead to organ damage, which, over time, can become life-threatening.
Hizentra (Immune Globulin Subcutaneous [Human]), the first and only 20 percent SCIg developed for subcutaneous use, is approved in North America, Europe and Japan. In the United States, Hizentra is indicated for the treatment of patients with primary immunodeficiency, and contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations or components of Hizentra, and in persons with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity. For more information, including full U.S. prescribing information, visit
http://www.hizentra.com/. In all 29 European/European Economic Area member states and Japan, Hizentra is authorized for treating patients diagnosed with PI as well as secondary immunodeficiencies. For more information, including full Summary of Product Characteristics, visit
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
Natalie de Vane