Study Shows Privigen™10% Liquid Immunoglobulin Preparation for Intravenous Use, Is an Effective Replacement Therapy in Patients with Primary Immune Deficiencies
King of Prussia, PA — 17 March 2008
CSL Behring presented data today on the pharmacokinetic properties of its new immune globulin intravenous (human) 10% product, Privigen™. Researchers found that Privigen leads to immunoglobulin G (IgG) pharmacokinetic characteristics and specific antibody levels equivalent to those described for other intravenous immunoglobulin (IVIg) preparations. The study was presented at the American Academy of Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, U.S.
The study aimed to characterize the pharmacokinetic properties of Privigen in patients with Primary Immune Deficiencies (PI); a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system. Specifically, the study examined the half-lives of total IgG, IgG subclasses and various specific antibodies. Twenty five patients from a larger safety and efficacy study (conducted in the US, Switzerland and Germany), all of whom were diagnosed with PI, participated in this sub-study.
Richard Wasserman, M.D., of Pediatric Allergy/ Immunology Associates, Dallas TX, said, "The study shows that the pharmacokinetic properties of this new liquid IVIg product are useful for effective replacement therapy in patients with primary immune deficiency. The pharmacokinetic properties of Privigen allow the easy restoration and maintenance of antibody protection against infection."
Privigen uses L-proline (250 mmol/L), a naturally occurring amino-acid, at pH 4.8. Proline efficiently inhibits dimer formation and permits storage at room temperature during its entire shelf life.
In July 2007, the U.S. Food and Drug Administration (FDA) granted CSL Behring approval to market Privigen, an intravenous immunoglobulin (IGIV), for treating patients diagnosed with primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP). In January 2008, Health Canada granted the Notice of Compliance for Privigen. CSL Behring recently launched Privigen in the United States. An application is currently under review by European and Swiss Regulatory Authorities for licensing in certain European countries.
Important Safety Information
WARNING: Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with the administration of Immune Globulin Intravenous (Human) (IVIg) products in predisposed patients. Administer IVIg products at the minimum infusion rate possible. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIg products containing sucrose. Privigen™ does not contain sucrose. See full prescribing information for complete boxed warning.
Privigen™ is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolinemia, and in patients with selective IgA deficiency.
In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Also monitor patients with risk factors for thrombotic events, including a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity.
Aseptic meningitis syndrome (AMS) has been reported infrequently with Privigen™ and other IVIg treatments; AMS may occur more frequently with high doses and/or rapid infusion of IVIg. Hemolysis, hemolytic anemia, and pulmonary adverse events have also been reported. If transfusion-related acute lung injury is suspected, test product and patient for antineutrophil antibodies.
Privigen™ 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.
In clinical studies, the most common adverse reactions with Privigen™ were headache, pain, nausea, pyrexia/ hyperthermia, fatigue, chills, and anemia.
For more details and complete prescribing information on Privigen, please call the CSL Behring Medical Information Department at 1-800-504-5434.
About Primary Immune Deficiencies
These are a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system, keeping the patient from fighting off infections caused by everyday germs. For individuals with PI – many of them children – infections may not improve with treatment as expected, and may keep returning. As a result, patients may face repeated rounds of antibiotics or be hospitalized for treatment. Repeated infections can lead to organ damage, which, over time, can become life-threatening. In some severe cases of PI, infections may result in a patient being hospitalized repeatedly. Some infections, such as meningitis, may even result in death. Nearly 100 types of PIs exist. Most are inherited, but in some cases the cause is unknown.
No single treatment works for all of the different types of PI. Infusions of replacement antibodies (immune globulins or Ig) can help supplement the immune system to prevent infection in nearly three-quarters of those people living with PI whose disease is tied to an antibody deficiency.
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 disease in newborns, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.CSLBehring.com.
Sheila A. Burke
Director Public Relations & Communications
Worldwide Commercial Operations, CSL Behring
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