ZLB Biolasma IGIV product is readily available
"Rumors that our IGIV would be in short supply this spring and summer are false," said Pete DeHart, president, ZLB Bioplasma Inc. "We are taking orders and, in fact, are shipping more product per month than the distributor that represented our line last year."
ZLB Bioplasma AG is a subsidiary of the Australian biopharmaceutical company CSL Limited, which acquired the plasma fractionation business of the Swiss Red Cross in Bern, Switzerland, in August 2000. ZLB Bioplasma Inc. began shipping Immune Globulin Intravenous (Human) and Albumin (Hman), manufactured from plasma collected from U.S. donors, directly to the U.S. market in January 2001. Customers include major group purchasing organizations (GPOs), U.S. hospitals, home care companies and pharmacies.
Previously, IGIV processed in the Swiss fractionation facility was distributed in the U.S. by Novartis Pharmaceuticals under the Sandoglobulin® label. ZLB pioneered the development and large-scale manufacture of human intravenous immunoglobulins (IVIG) in the late 1970s. The company is currently the leading global producer of IVIG by volume.
CSL operates blood fractionation plants in both the Northern and Southern hemispheres. The Bern facility, one of the largest plasma processing facilities in the world, has been fully licensed by the FDA for the past 24 years.
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.
Albumin (Human) is contraindicated in patients with a history of incompatibility with the product or any of its components. ALBUMIN (Human) 5% may be contraindicated in patients with cardiac failure or severe anemia because of the risk of acute circulatory overload.
Albumin (Human) is made from human plasma, and as with all plasma-derived products, it 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.
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.