The first and only formulation of human albumin available
in a flexible container.
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Safety Profile
Millions of doses of human albumin have been administered during more than 50 years of widespread clinical use without a confirmed report of viral transmission of hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency viruses type 1 and 2 (HIV) to date.1
Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. Based on effective donor screening and product manufacturing processes, albumin carries an extremely remote risk for transmission of viral diseases. 2
Although the risk of viral transmission with albumin therapy cannot be completely eliminated, steps taken during the collection of source plasma and processing minimize the risk. First, source plasma donations are only accepted from repeat donors who do not demonstrate high risk behavior.2 Albumin is manufactured from human plasma by the Modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product. This process accomplishes both purification of albumin and reduction of viruses.2
FLEXBUMIN 25% is made from pooled human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
FLEXBUMIN 25% [Albumin (Human)]
FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. FLEXBUMIN 25% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns, adult respiratory distress syndrome (ARDS), and nephrosis, and for use during or prior to cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN).
Important Risk Information for FLEXBUMIN 25%
FLEXBUMIN 25% is contraindicated in patients with cardiac failure, in patients with severe anemia and in patients with a history of allergic reactions to human albumin.
Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered.
Do not use Sterile Water for Injection as a diluent. There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent for FLEXBUMIN 25%. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.
FLEXBUMIN 25% is made from pooled human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt–Jakob disease (CJD) agent.
FLEXBUMIN 25% must be administered intravenously at a rate not to exceed 1ml/min to patients with normal blood volume, due to the risk of developing circulatory overload and pulmonary edema.
When 25% albumin is infused, a rise in blood pressure necessitates careful observation to detect and treat severed blood vessels that may not have bled at a lower blood pressure.
Adverse reactions to FLEXBUMIN 25% are extremely rare, although nausea, fever, chills or urticaria may occasionally occur.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.
Please see Preparation for Administration for FLEXBUMIN 25% in the Prescribing Information.
Please review the FLEXBUMIN 25% [Albumin (Human)] Prescribing Information for full prescribing details.
Please see detailed Important Risk Information for BUMINATE 5% and Full Prescribing Information.
Please see detailed Important Risk Information for BUMINATE 25% and Full Prescribing Information.
- Tabor E. The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1. Transfusion. 1999;39:1160-1168.
- FLEXBUMIN Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; September 2009.
