What Is Flexbumin and how is it used?
Flexbumin (albumin human injection, solution) is an albumin solution indicated for low blood volume (hypovolemia), hypoalbuminemia: burns, and cardiopulmonary bypass surgery.
What are side effects of Flexbumin?
Side effects of Flexbumin are rare and may include:
- hypersensitivity reaction (including anaphylactic reaction) and
- fluid in the lungs (pulmonary edema)
For intravenous use
FLEXBUMIN 5% is a sterile, nonpyrogenic preparation of albumin in single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.004M) and sodium caprylate (0.004M). The sodium content is 145 ± 15 mEq/L. FLEXBUMIN 5% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 5% is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color and is clear of particulate matter.
FLEXBUMIN 5% 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 at 60 ± 0.5°C for 10 - 11 hours. This process accomplishes both purification of albumin and reduction of viruses.
In vitro studies demonstrate that the manufacturing process for FLEXBUMIN 5% provides for effective viral reduction. These viral reduction studies, summarized in Table 2, demonstrate viral clearance during the manufacturing process for FLEXBUMIN 5%.
These studies indicate that specific steps in the manufacturing of FLEXBUMIN 5% are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation by fractionation and by heating steps is different, the overall manufacturing process of FLEXBUMIN 5% is effective in reducing viral load.
Table 2 Summary of Viral Reduction Factor for Each Virus and Processing Step*
|Process Step||Viral Reduction Factor (log10)|
|Processing of Fraction I+II+III/II +III supernatant to Fraction IV4 Cuno 70C filtrate†||>4.9||>4.8||>5.7||>5.5||>4.5||3.0|
|Mean Cumulative Reduction Factor, log10||>12.7||>11.3||>5.7||>12.9||>7.7||4.6|
|* Human immunodeficiency virus, type 1 (HIV-1) both as a target virus and model for HIV-2 and other lipid-enveloped RNA viruses; bovine viral diarrhea virus (BVDV), a model for lipid-enveloped RNA viruses, such as hepatitis C virus (HCV); West Nile Virus (WNV), a target virus and model for other similar lipid-enveloped RNA viruses; pseudorabies virus (PRV), a model for other lipid-enveloped DNA viruses such as hepatitis B virus (HBV); mice minute virus (MMV), models for non-enveloped DNA viruses such as human parvovirus B1910; and hepatitis A virus (HAV), a target virus and a model for other non-enveloped RNA viruses.|
† Other Albumin fractionation process steps (processing of cryo-poor plasma to Fraction I+II+III/II+III supernatant and processing of Fraction V suspension to Cuno 90LP filtrate) showed virus reduction capacity in in-vitro viral clearance studies. These process steps also contribute to the overall viral clearance effectiveness of the manufacturing process. However, since the mechanism of virus removal is similar to that of this particular process step, the viral inactivation data from other steps were not used in the calculation of the Mean Cumulative Reduction Factor.
‡ n.d. not determined
§ Recent scientific data suggests that the actual human parvovirus B19 (B19V) is far more effectively inactivated by pasteurization than indicated by model virus data.10
The likelihood of the presence of viable hepatitis viruses has been minimized by testing the plasma at three stages for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1,2,3 FLEXBUMIN 5% contains no blood group isoagglutinins, thereby permitting its administration without regard to the recipient's blood group.
1. Cai K, Gierman T, Hotta J, et al: Ensuring the Biologic Safety of Plasma-Derived Therapeutic Proteins. Biodrugs 2005; 19 (2): 79-96.
2. Gerety R, Aronson D: Plasma derivatives and viral hepatitis. Transfusion 1982; 22 (5): 347- 351.
3. Burnouf T, Padilla A: Current strategies to prevent transmission of prions by human plasma derivatives. Transfusion Clinique et Biologique 2006; 13: 320-328.
10. Blümel J, Schmidt I, Willkommen H, et al: Inactivation of parvovirus B19 during pasteurization of human serum albumin. Transfusion 2002; 42: 1011-1018.