Albumin Preparation Approved for Critical Conditions

The FDA has approved a new dosage strength of Flexbumin (albumin [human]) to treat hypovolemia and other critical conditions, drugmaker Baxter International, Inc, announced yesterday.

Flexbumin 5% is a sterile, nonpyrogenic, single-dose albumin preparation that is indicated for intravenous administration in patients with hypovolemia, hypoalbuminemia due to general causes, and burns, as well as those undergoing cardiopulmonary bypass surgery. The treatment is currently available as a 25% solution packaged in 50- and 100-ml containers, and the new 5% strength in a 250-ml container will be available in the United States later this year.

According to a statement from Baxter, Flexbumin is “the first and only preparation of human albumin to be packaged in a flexible plastic container,” which “eliminat(es) risk of glass breakage and affords the ability to infuse without a vented administration set.” Additionally, the solution’s flexible, shatterproof containers weigh 95% less and use approximately 45% less packing materials than glass containers of equal volume, “making (them) more compatible with hospital inventory storage systems,” the company said.

“Human albumin is essential for hospitals in providing care to surgical, trauma and other critically ill patients,” Ron Lloyd, head of Baxter’s BioTherapeutics unit, said in the statement. “Our customers value the benefits of having this treatment available in a flexible container that more efficiently meets their needs for reduced waste and improved safety.”

Baxter warned that Flexbumin 5% is contraindicated in patients with a history of allergic reactions to human albumin, severe anemia, and heart failure. Since the solution is derived from human blood, the company cautioned that it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD), as well as a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD). In addition, administering the solution more rapidly than 5-10 ml/min can cause circulatory overload and pulmonary edema.