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CSL Behring Receives FDA Approval To Extend Shelf Life Of Hizentra(R) From 18 Months To 24 Months
Article Date: 20 Aug 2010 - 2:00 PDT
CSL Behring announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA, is also the first and only SCIg in the U.S. that may be stored at room temperature.
Hizentra is indicated for the treatment of primary immunodeficiency (PI). PI is a group of disorders, usually genetic, that result from a dysfunctional immune system. This condition prevents patients from fighting off infections caused by common germs.
Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature (up to 25°C [77°F]) for up to 24 months. Because no refrigeration is necessary, Hizentra is always ready to use without warming, offering patients and physicians convenience and portability.
"CSL Behring continually enhances the products in our broad portfolio based on what we know patients and their healthcare providers need and want," said Robert Lefebvre, Vice President and General Manager, U.S. Commercial Operations at CSL Behring. "The ability to store Hizentra without refrigeration for up to two years is an innovation that can positively impact busy and active patients managing their primary immunodeficiency at home or in any setting that is convenient for them."
The sBLA for Hizentra was based on a study assessing the product's stability. Physicochemical, biological and immunological parameters were assessed over 24 months' storage under controlled conditions at 25°C (77°F). The data generated from this study support that when Hizentra is stored at room temperature (up to 25ºC [77ºF]) and protected from light, it is stable for up to 24 months.
Hizentra with 24-month shelf life packaging is expected to be available later this year. Current Hizentra patients are encouraged to contact their physician with any questions regarding the shelf life of their current supply.
Hizentra is part of the immunoglobulin (Ig) franchise for CSL Behring. This comprehensive Ig product portfolio also includes the first U.S. FDA-approved subcutaneous immunoglobulin and the first proline-stabilized intravenous immunoglobulin. CSL Behring manufactures Hizentra at its state-of-the art facility in Bern, Switzerland, where advanced technologies are applied to further ensure product safety and ample supply. This facility represents the long-term commitment of CSL Behring to global Ig markets.
Important Safety Information
Hizentra®, Immune Globulin Subcutaneous (Human) is indicated for the treatment of patients with primary immunodeficiency (PI).
Hizentra is 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. If anaphylactic reactions are suspected, administration should be discontinued immediately and the patient treated as medically appropriate. Because Hizentra contains the stabilizer L-proline, it is also contraindicated in patients with hyperprolinemia.
The most common drug-related adverse reactions, observed in 5 percent or more of subjects in the clinical study, were local injection-site reactions, headache, vomiting, pain, and fatigue.
Monitor patients for reactions associated with IVIg treatment that might occur with Hizentra, including renal dysfunction/failure, thrombotic events, aseptic meningitis syndrome (AMS), hemolysis and transfusion-related acute lung injury (TRALI).
About Primary Immunodeficiencies
Nearly 150 types of PIs exist. For individuals with PI, many of them children, infections may not improve as expected with usual treatments and may keep returning. As a result, patients may face repeated rounds of antibiotics or hospitalization for treatment. Repeated infections can lead to organ damage, which over time can become life-threatening.
Collectively, PIs affect an estimated 10 million people worldwide, and the incidence is estimated to be 1 in 10,000. Due to the X-linked inheritance in many PI syndromes, more males are affected than females.
Source:
CSL Behring
