First Highly Pure, Liquid Rh0(D) Immune Globulin Intravenous (Human) Offers Flexibility, Comfort of IM and IV Use to U.S. Obstetricians and Patients
GLENDALE, Calif.--(BUSINESS WIRE)--Feb. 17, 2004-- The U.S. Food and Drug Administration (FDA) has approved Rhophylac®, the first liquid Rh0(D) Immune Globulin Intravenous (Human) -- or RhIGIV -- that can be administered intramuscularly (IM) or intravenously (IV), for sale in the U.S. Used in the prevention of hemolytic disease of the fetus and newborn (HDN), Rhophylac® provides a choice for physicians and patients who are concerned about the pain associated with IM administration, especially when multiple injections are required. ZLB Bioplasma manufactures Rhophylac® using the distinctive ChromaPlus(TM) process, which results in a highly pure therapeutic product that makes it possible to administer the product IV.
"For years, U.S. obstetricians have had no other choice than to give women painful IM shots to prevent HDN," said Craig Mendelsohn, M.D., J.D., Medical Director at ZLB Bioplasma Inc. "With the introduction of Rhophylac®, ZLB has provided the medical community its first liquid Rh immunoglobulin product that can be administered using either the convenience of IM or the comfort of IV."
HDN is a serious and sometimes fatal disorder in which antibodies produced by a pregnant Rh-negative woman attack the red blood cells of her Rh-positive fetus. While it has no adverse effect on the mother, HDN can have serious consequences for her child, ranging from reversible conditions such as jaundice and anemia to severe results including brain damage, heart failure and death. The Rh factor is a protein on the surface of red blood cells. People who have the Rh factor are considered Rh-positive. People without it are Rh-negative.
Without treatment, if blood from an Rh-positive fetus "leaks" into the blood stream of its Rh-negative mother, the woman can have a reaction to the Rh factor on the blood cells and develop antibodies. These leaks -- called fetomaternal hemorrhages (FMH) -- can occur naturally, such as during birth or miscarriage, or through some type of medical procedure, such an amniocentesis. Serious trauma, such as a car accident or fall, can also cause hemorrhages between mother and child.
The formation of Rh antibodies, known as Rh sensitization, has no immediate consequences. However in subsequent pregnancies, the antibodies may attack the blood of the fetus, causing HDN.
Approximately 10 percent of all pregnancies in North America involve an Rh-negative mother. To prevent Rh sensitization, physicians prescribe a dose of Rhophylac® to Rh-negative women between 28-30 weeks of pregnancy. A second dose is given to the woman within 72 hours of giving birth if her baby is Rh-positive. Additional treatments may be necessary if a physician suspects the woman suffered a large FMH.
A person may also be sensitized by receiving Rh-positive blood during a transfusion. To prevent sensitization, physicians may prescribe multiple doses of Rhophylac®.
ZLB Bioplasma employs the novel ChromaPlus(TM) process in its plant in Bern, Switzerland, to produce Rhophylac®. This unique process utilizes patented ion-exchange chromatography, a gentle, highly specific method of isolating vital anti-Rh antibodies from U.S. hyperimmune plasma donations.
The ChromaPlus(TM) process also employs two steps dedicated to viral inactivation and elimination -- solvent detergent (S/D) treatment and nanofiltration. S/D treatment has been successfully used for more than 15 years to rapidly inactivate enveloped viruses that could be present in plasma-derived products. Nanofiltration is a relatively new viral elimination method that filters pathogens based on size. It can remove both enveloped and non-enveloped viruses that might be present. ZLB uses a 15 nm nanofilter, capable of removing models for the human Parvovirus B19, one of the smallest viruses known to man. Nanofiltration using a 15 nm filter has also demonstrated effectiveness in removing model Creutzfeldt-Jakob Disease agents.
Rhophylac®'s formulation has always been free of mercury-containing thimerosal or other preservatives. In addition, the product utilizes a latex-free syringe to eliminate the risk of reactions.
"Patient safety is our number one concern, especially when it involves the precious lives of infants," said Martin Rosendale, Senior Vice President and General Manager at ZLB Bioplasma Inc. "The thoroughness of our ChromaPlus(TM) process is representative of our commitment to our patients and the safety of blood plasma therapies."
ZLB Bioplasma's Rhophylac® has been marketed in Switzerland since 1996 and was introduced to other European markets in 2002.
Rhophylac® will be available for purchase in the U.S. in March 2004 in ready for use prefilled syringes containing 300 ug Rh0(D) immune globulin in 2 ml.
Rhophylac® is a highly purified, plasma-derived product comprised of Rh Immune Globulin Intravenous (Human), with the flexibility of IV or IM administration. Its primary indication is for the prevention of hemolytic disease of the fetus and newborn (HDN). Rhophylac is also indicated to prevent Rh sensitization after transfusion of Rh-positive blood type to Rh-negative patient.
About ZLB Bioplasma Inc.
ZLB Bioplasma Inc. is a major source of intravenous immunoglobulin (human) -- IGIV -- and other specialty plasma-derived products for the U.S. The company's focus is on helping the U.S. healthcare community improve the quality of life for patients by providing a steady supply of safe and effective immunology-based therapies and related services.
The products distributed by ZLB Bioplasma Inc. are developed and produced by ZLB Bioplasma AG (Bern, Switzerland). U.S. Food and Drug Administration (FDA)-licensed products to be used in the U.S. are produced exclusively from plasma from U.S. donors. ZLB Bioplasma AG, originally a laboratory of the Swiss Red Cross, has over 50 years of experience in plasma fractionation. The company developed the first intact IGIV product in 1979 and is the only manufacturer to offer an uninterrupted supply since that time.
ZLB Bioplasma is a wholly owned subsidiary of CSL Limited, a leading biotechnology and biopharmaceutical company founded in 1916 in Melbourne, Australia.
ZLB Bioplasma's products are available nationally through wholesalers, distributors and group purchasing organizations or direct from ZLB Bioplasma Inc. For more information, visit www.zlbusa.com or call 866-244-2ZLB (2952).
Note: For full prescribing information for Rhophylac®, go to www.zlbusa.com.
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Source: ZLB Bioplasma Inc.