ZLB-manufactured IVIG products now 20% of U.S. market
A subsidiary of CSL Limited, a fast-growing biopharmaceutical company based in Melbourne, Australia, ZLB started distributing IMMUNE GLOBULIN INTRAVENOUS (HUMAN) - or IGIV - in January 2001. ZLB produces IGIV using the same manufacturing process as Panglobulin®, which ZLB continues to manufacture for the American Red Cross, and Sandoglobulin®, a ZLB product that was distributed in the U.S. by Novartis Pharmaceuticals Corp., but is no longer being manufactured for the U.S. market. ZLB estimates that the remaining supply of Sandoglobulin® will be replaced by IGIV by the end of the year.
"We are pleased with the success of the ZLB brand, considering we have been in the market such a short time and only recently brought on new distributors," Cathryn Hope, director of immunoglobulin products, ZLB Bioplasma Inc., said. "Obviously, physicians and pharmacists continue to find that IVIG is an effective therapy, and they like and trust ZLB's freeze-dried product."
IVIG is a plasma-derived product containing protective antibodies normally present in the blood of healthy individuals. It can replace the antibodies in people who are unable to produce them, thereby restoring an almost normal immune response and helping to prevent or reduce the severity of certain infections. It can also be used in the treatment of certain autoimmune diseases and bleeding disorders.
Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Immune Globulin Intravenous (Human), as with all plasma-derived products, may contain infectious agents such as viruses that can cause disease. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) is considered extremely remote.
Periodic monitoring of renal function and urine output is advised in patients with a potential increased risk for developing acute renal failure. Increases in creatinine and blood urea nitrogen with progression to oliguria or anuria requiring dialysis have been observed. Severe renal adverse events with Immune Globulin Intravenous (Human) have included acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis.
See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections of full Prescribing Information for important information intended to reduce the risk of acute renal failure.
About ZLB Bioplasma Inc.
Based in Glendale, Calif., ZLB Bioplasma Inc. distributes the human plasma-derived drugs Intravenous Immunoglobulin (IVIG) and Albumin in the United States. The company was founded in August 2000 to serve as a direct, reliable distribution link between its affiliate, ZLB Bioplasma AG, and its U.S. customers. ZLB Bioplasma AG is a subsidiary of CSL Limited, a global biotechnology and biopharmaceutical company established in 1915. CSL's headquarters are in Melbourne, Australia.
Source: ZLB Bioplasma Inc.