Frequently Asked Questions

  1. What is the recommended infusion rate for the administration of albumin?

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    The usual dosage of albumin is patient-specific and dependent upon many factors. Please refer to the dosage and administration information for FLEXBUMIN 25% [Albumin (Human)], 25% Solution, BUMINATE 5% [Albumin (Human)], 5% Solution and BUMINATE 25% [Albumin (Human)], 25% Solution. The infusion rate should be adjusted according to the response observed in the individual patient. 1,2,3

    FLEXBUMIN and BUMINATE 25% must be administered intravenously at a rate not to exceed 1 mL/min to patients with normal blood volume. More rapid administration might cause circulatory overload and pulmonary edema. 1,2

  2. What is the risk of viral transmission with albumin treatment?

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    Although the risk of viral transmission with albumin treatment cannot be completely eliminated, steps taken during the collection of plasma and processing minimize the risk. First, source plasma donations are only accepted from repeat donors who do not demonstrate high risk behavior. Repeat donors have been noted to have lower rates of viral infection than do those donating for the first time. Second, donated blood is tested for serologic viral markers. Third, plasma fractionators hold all donations for 60 days in order to detect seroconversion of HIV, HBV and HCV in recently infected donors. Finally, albumin undergoes heat pasteurization to inactivate viruses.1,2,3

    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.

  3. What is the half-life of albumin?

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    The half-life of albumin is 15 to 20 days with a turnover of approximately 15 g per day.1,2,3

  4. Can albumin 25% be diluted to a 5% solution?

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    Yes, albumin 25% can be diluted with either normal saline or dextrose 5% to produce an albumin 5% solution. Sterile water for injection should not be used as a diluent due to the potential for hemolysis and renal failure.1,2,4,5

  5. Can albumin 25% be diluted with sterile water?

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    No, sterile water should not be used to dilute albumin. Normal saline or dextrose 5% are appropriate diluents for albumin 25%. When diluted with sterile water, the resulting albumin solution is severely hypotonic. Infusion of hypotonic Albumin solutions prepared in this manner has been reported to lead to hemolysis in at least four patients, one of which was fatal. Hemolysis and renal insufficiency due to infusion of a hypotonic albumin solution were listed as contributory causes of death in this patient.1,2,4,5

  6. What is salt-poor albumin?

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    Salt-poor albumin is a historical term for albumin 25% that is no longer applicable but persists in the medical community. The term came about to distinguish normal albumin preparations from high-salt albumin solutions used by the military. The military products contained 300 mEq/L of sodium in order to maintain stability in warm environments. High-salt albumin preparations were abandoned soon after they were introduced upon the discovery of stabilizers that are still used today. To achieve acceptable tonicity, all albumin products manufactured after February 28, 1978 are required by law to contain physiologic amounts of sodium, 130 to 160 mEq/L.6

    The sodium content in FLEXBUMIN 25% [Albumin(Human)], 25% Solution and BUMINATE 5% and 25% [Albumin(Human)], 5% and 25% Solutions is 145 ± 15 mEq/L.1,2,3

  7. In what concentration and size is FLEXBUMIN 25% [Albumin (Human)], 25% Solution available? Are BUMINATE 5% [Albumin (Human)], 5% Solution and BUMINATE 25% [Albumin (Human)], 25% Solution being discontinued?

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    FLEXBUMIN is available in 25% 50 mL and 25% 100 mL.  For these sizes and concentrations, the BUMINATE in glass vials have been discontinued. However, BUMINATE 5% 250 mL, 5% 500 mL, and 25% 20 mL will continue to be made available in glass vials.

  8. Does the FLEXBUMIN 25% GALAXY container contain PVC, DEHA or DEHP?

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    No, the GALAXY container system does not contain PVC or the phthalate plasticizers DEHA or DEHP which are commonly used in PVC.7

  9. Can FLEXBUMIN 25% [Albumin (Human)], 25% Solution optimize space utilization in automated medication storage devices such as the PYXIS system?

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    Yes, FLEXBUMIN 25% takes up 60% less space than glass bottles on shelves 9* and helps optimize storage in PYXIS units.

    *Based on comparison with BUMINATE 25% [Albumin (Human)]

    Point of Care Medication Dispensing Devices

    The PYXIS MEDSTATION is the leading automated dispensing system supporting decentralized medication management.  It is an automated medication cabinet. The PYXIS MEDSTATION features include8:

    • Barcode scanning to help ensure accurate medication dispensing
    • Features to prevent loading of the wrong medication
    • Active alerts to provide an added safety precaution for high risk medications

  10. Is FLEXBUMIN 25% [Albumin (Human)], 25% Solution eligible for Medicare reimbursement?

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    Yes, FLEXBUMIN is eligible for the same reimbursement as all other albumin products.

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).

Please see Important Risk Information for FLEXBUMIN 25% and Full Prescribing Information.

BUMINATE 5% [Albumin (Human)], USP, 5% Solution

BUMINATE 5% [Albumin (Human)], USP, 5% Solution is indicated for Hypovolemia, Hypoalbuminemia due to general causes and burns, and use during or prior to cardiopulmonary bypass surgery.

Please see Important Risk Information for BUMINATE 5% and Full Prescribing Information.

BUMINATE 25% [Albumin (Human)], USP, 25% Solution

Buminate 25% [Albumin (Human)], USP, 25% Solution is indicated for Hypovolemia, Hypoalbuminemia due to general causes, burns, adult respiratory distress syndrome (ARDS), and nephrosis, for use during or prior to cardiopulmonary bypass surgery, and Hemolytic disease of the newborn (HDN).

Please see Important Risk Information for BUMINATE 25% and Full Prescribing Information.

  1. FLEXBUMIN 25% [Albumin (Human)], 25% Solution [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; September 2009.
  2. BUMINATE 25% [Albumin (Human)] [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; September 2009.
  3. BUMINATE 5% [Albumin (Human)] [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; September 2009.
  4. Pierce LR, Gaines A, Varricchio F, Epstein J, Trissel LA. Hemolysis and renal failure associated with use of sterile water for injection to dilute 25% human albumin solution. American Journal of Health-System Pharmacy. 1998; 55:1057-1070.
  5. Forte FJ, Caravone D, Coyne MJ. Albumin dilution as a cause of hemolysis during plasmapheresis. American Journal of Health-System Pharmacy. 1995; 52:207.
  6.  Finlayson JS. The birth and demise of "salt-poor" albumin. American Journal of Hospital Pharmacy. 1978; 35:898-900.
  7. GALAXY Container Components. Data on file. Baxter Healthcare Corporation.
  8. Pyxis® MedStation® System.  Carefusion website. http://www.carefusion.com/products-and-services/products-services-categories/medication-management/pyxis-medstation-system.aspx. Accessed May 25, 2011.
  9. Storage and Space Comparison. Data on file. Baxter Healthcare Corporation.

FLEXBUMIN
[Albumin (Human)]

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The first and only formulation of human albumin available in a flexible container.
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SAFETY PROFILE

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Albumin has been used as a therapeutic agent for over 50 years.
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