FDA approves Flexbumin
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.
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.
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.
Source: Baxter Healthcare Corporation