FDA Approves Flexbumin Albumin Solution
DEERFIELD, Ill., October 17, 2005 -- Baxter Healthcare Corporation announced today that the U. S. Food and Drug Administration (FDA) has approved Flexbumin(TM) [Albumin (Human)] 25% Solution, the first preparation of human albumin to be packaged in a flexible container. The company plans to launch Flexbumin by early 2006.
Baxter's current Buminate [Albumin (Human)] 25% Solution, packaged in glass bottles, has been used in hospitals throughout the country for more than 50 years in patients undergoing cardiopulmonary bypass surgery and in patients suffering from shock, blood loss and severe burns.
Flexbumin has the same indications and provides the same stability as albumin in glass bottles, but provides improved convenience for healthcare professionals as its flexible packaging provides less risk of breakage and is more compatible with hospital inventory storage systems. The flexible containers are lighter and require less space, which may ultimately save hospitals money on disposal.
"Through the development of Flexbumin, we have leveraged our enhanced packaging technology to create a more convenient container for albumin that meets the changing needs of our customers," said Larry Guiheen, president of Baxter's BioScience business in North America. "We will continue to look at different ways to leverage our core competencies for further product innovation."
Historically, albumin has been packaged in glass bottles as a result of technical requirements related to manufacturing, including inertness, sturdiness and a high water vapor and oxygen barrier that no single plastic material has been able to fulfill.
"Our pharmacy and nursing staff will appreciate the additional handling safety benefits and convenience associated with the flexible containers over our current use of glass albumin vials, including the decreased risk of breakage, improved product storage and a significant reduction in our volume of hazardous waste material," said Larry Ligeski, manager of pharmacy purchasing and distribution, University of Michigan Hospitals and Health Centers. "In addition, Flexbumin will make it easier for our hospital to comply with industry standards."
Flexbumin uses Baxter's Galaxy(R) flexible container system, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature. GALAXY, which employs barrier technology and a continuous aseptic filling process, has been used in the United States for more than 16 years to package pharmaceutical products.
Flexbumin has the same indications and provides the same stability as Buminate, and can be stored for up to two years at room temperature. The solution will be available in both 50 mL and 100 mL flexible containers. All components of Flexbumin are latex-free.
Flexbumin is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Flexbumin is indicated in hypovolemia, hypoalbuminemia due to inadequate reproduction, excessive catabolism, hemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.
Flexbumin is contraindicated in patients with a history of allergic reactions to albumin, in severely anemic patients, and in patients with cardiac failure.
Flexbumin is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, that can cause disease.
The potential risks and benefits of albumin should be weighed against those of alternative therapies for all patients for whom albumin administration is being considered.
For more information, please visit www.baxter.com
Posted: October 2005