FLEXBUMIN 5% and 25% are indicated for hypovolemia, hypoalbuminemia (burns), and cardiopulmonary bypass surgery. Albumin is not indicated as an intravenous nutrient.
 FLEXBUMIN 25% is also indicated for hypoalbuminemia due to Adult Respiratory Distress Syndrome (ARDS) and nephrosis, and for hemolytic disease of the newborn (HDN).

About Albumin header bag

About
Albumin

Albumin is an extensively used and studied plasma protein.1 In the United States, human albumin solutions have been manufactured from pooled human plasma and have been used therapeutically for more than 60 years.2,3

About Albumin header bag

Therapeutic Use of
5% and 25% Albumin Solutions

Therapeutic human albumin solutions are used for a broad range of clinical conditions, either in the 5% isotonic or 25% hypertonic solution.3-5 The key indication for albumin is the restoration and maintenance of circulating blood volume in situations such as trauma, surgery, blood loss, hypoalbuminemia, and burns.4,5

The degree and duration of volume expansion depends on a variety of factors such as patients’ clinical condition and initial circulatory volume, but the effect may be diminished with dehydration. The dose requirements are dependent on clinical factors such as the size of the patient, severity of trauma or illness, and continuing fluid and protein losses.6

Maintenance of adequate circulating volume is achieved by monitoring hemodynamic performance regularly; tests may include assessments of arterial blood pressure and pulse rate, central venous pressure, pulmonary artery wedge pressure, urine output, serum electrolytes, and hematocrit/hemoglobin levels.6

Icon 
In 2018, approximately

182 tons of albumin

were sold for medical use in the U.S., an increase of 3.4% from 2017.3

Isotonic 5% albumin solutions

  • Have an osmotic pressure almost identical to that of normal plasma7,8
  • Often are used for blood volume replacement3

Hypertonic 25% albumin solutions

  • Have an osmotic pressure greater than plasma7
  • Help increase fluid volume by drawing water out of the intercellular space8
  • Often used for blood volume expansion3

History of Albumin’s Clinical Use

The first formally documented clinical use of human albumin was following the attack on Pearl Harbor in December 1941.3,9,10 Seven patients who suffered burns in the attack were treated with human albumin and survived.3

Following this initial success, albumin was used to treat shock victims during the remainder of World War II. Afterward, it became the first protein available at industrial scale. Emergency physicians and first responders have come to rely on human albumin as a vital tool in response to trauma, burns, and shock in many critical care situations.3,9,10

Human albumin was first purified for clinical use by Dr. E. Cohn in the 1940s.11

Takeda’s Commitment to
Plasma-based Therapeutics

To meet growing demand for plasma-based therapeutics, Takeda is focused on optimizing our global manufacturing operation.12 As part of this effort, our new state-of-the-art plasma fractionation facility in Covington, GA, is expected to expand capacity by 3 million liters of plasma each year when fully functional—an ~30% increase.3,13

The facility received U.S. Food and Drug Administration (FDA) approval for production of one immune globulin product in June 2018 and albumin in March 2019.13,14

Collection and processing image

Our Focus on Safety Throughout Collection
and Processing

Takeda is committed to the highest standards of quality in plasma collection and processing and the manufacture of life-saving therapeutics from plasma.15

Takeda employs a series of key processes to support safety, beginning with the collection of human plasma from donors and continuing through production. Our processes have been certified by the Plasma Protein Therapeutics Association (PPTA) Quality Standards of Excellence, Assurance and Leadership (QSEAL) Voluntary Standard since 2001.16

Our Rigorous Approach
to Plasma Collection and Manufacturing

Takeda has the experience and the expertise to confidently manage the end-to-end challenges of developing complex, plasma-based therapeutics—from securing donations to delivering treatment.

Accurately predicting utilization for plasma-based therapeutics and meeting that demand can be a complicated process for manufacturers. At Takeda, we conduct rigorous analyses and manage multiple challenges that can impact albumin supply, including collections, manufacturing process, lead time, yield, and utilization of all plasma products.12,17,18

Collections

Takeda operates more than 100 state-of-the-art BioLife® plasma donation centers in the United States to help meet the growing need for plasma-based therapeutics.3

Icon 
In 2019, Takeda collected an estimated

8.4 million liters

of plasma in the United States.3

References

  1. Bertolini J, Goss N, Curling J. Production of Plasma Proteins For Therapeutic Use. Hoboken, NJ: John Wiley & Sons; 2013.
  2. Center for Biologic Evaluation and Research. List of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations to date. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM412398.pdf. Accessed September 17, 2020.
  3. Marketing Research Bureau. The Plasma Proteins Market in the United States 2019. Published July 2020.
  4. FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution [prescribing information]. Lexington, MA: Baxalta. July 2017.
  5. FLEXBUMIN 5% [Albumin (Human)], USP, 5% Solution [prescribing information]. Lexington, MA: Baxalta. July 2017.
  6. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Core SmPC for Human Albumin Solution. EMA/CHMP/BPWP/494462/2011/Rev.3. London, 26 July 2018.
  7. Liumbruno G, Bennardello F, Lattanzio A, Piccoli P, Rossettias G. Recommendations for the use of albumin and immunoglobulins. Blood Transfus. 2009;7(3):216-234.
  8. Crawford A, Harris H. I.V. fluids: What nurses need to know. Nursing. 2011;41(5):30-38.
  9. Myburgh JA and Mythen MG. Resuscitation fluids. N Engl J Med. 2013;369:2462-2463.
  10. Kendrick DB, Medical Department United States Army. Blood program in World War II. http://history.amedd.army.mil/booksdocs/wwii/blood/default.htm. Accessed September 17, 2020.
  11. Cohn EJ, Oncley JL, Strong LE et al. Chemical, clinical, and immunological studies on the products of human plasma fractionation. I. The characterization of the protein fractions of human plasma. J Clin Invest. 1944;23:417-432.
  12. Berman K. Plasma fractionation: the challenge of keeping pace with global IG demand. http://www.igliving.com/magazine/articles/IGL_2018-08_AR_Plasma-Fractionation-The-Chellenge-of-Keeping-Pace-with-Global-IG-Demand.pdf. Published August 2018. Accessed September 17, 2020.
  13. Data on file. Takeda. June 21, 2018.
  14. Takeda. Takeda receives U.S. FDA approval to manufacture Albumin at new plasma manufacturing facility near Covington, Georgia. https://www.takeda.com/en-us/newsroom/news-releases/2019/takeda-receives-u.s.-fda-approval-to-manufacture-flexbumin/. Published March 18, 2019. Accessed February 6, 2020.
  15. Data on file VV-MED-7520—FLEX-020 BioLife Press Kit 2012.
  16. Plasma Protein Therapeutic Association. Quality Standards of Excellence, Assurance and Leadership (QSEAL) Program Certification Program. 2010.
  17. U.S. Department of Health and Human Services. Analysis of supply, distribution, demand, and access issues associated with immune globulin intravenous (IGIV), final report. https://aspe.hhs.gov/pdf-report/analysis-supply-distribution-demand-and-access-issues-associated-immune-globulin-intravenous-igiv. Published February 1, 2007. Accessed September 17, 2020.
  18. Rhodes RT. Immune globulin: controlling supply and demand. BioSupply Trends. 2015(Winter):14-18.

Indications and Limitation of Use

FLEXBUMIN [Albumin (Human)] 5% and 25% are indicated for hypovolemia, hypoalbuminemia (burns), and cardiopulmonary bypass surgery. Albumin is not indicated as an intravenous nutrient.
 FLEXBUMIN 25% is also indicated for hypoalbuminemia due to Adult Respiratory Distress Syndrome (ARDS) and nephrosis, and for hemolytic disease of the newborn (HDN).

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Important Safety Information

Contraindications

  • History of hypersensitivity reaction to albumin preparations or to any of the excipients (N-acetyltryptophan and sodium caprylate). Reactions have included anaphylactic shock, anaphylactic
 reaction, or hypersensitivity/allergic reactions.
  • 
Severe anemia or cardiac failure with normal or increased intravascular volume.

Warnings and Precautions

Hypersensitivity Reactions: Have been observed (including anaphylactic reactions). If hypersensitivity reaction is suspected, discontinue administration immediately and implement appropriate standard medical treatment.

Hypervolemia/Hemodilution: Under conditions where hypervolemia and/or hemodilution may occur, adjust the dose and rate of infusion to the patient’s volume status. When administering large volumes, monitor hemodynamic parameters. Ensure adequate substitution of other blood constituents and monitor electrolyte balance. Discontinue administration at the first clinical signs of cardiovascular overload.

Hemodynamics: Closely monitor hemodynamic parameters after administration for evidence of cardiac or respiratory failure, renal failure, or increasing intracranial pressure.

Blood Pressure: Monitor blood pressure in trauma patients and postoperative surgery patients in order to detect re-bleeding secondary to clot disruption.

Hemolysis: Do not dilute with Sterile Water for Injection, as there is potential risk of fatal hemolysis and acute renal failure in recipients.

Transmission of Infectious Agents: Because FLEXBUMIN 5% and 25% are made from human plasma, they may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No cases of transmission of viral diseases, Creutzfeldt-Jakob disease (CJD) or variant Creutzfeldt-Jakob disease (vCJD) have ever been identified.

Adverse Reactions

The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema.

Administration 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 click for Full Prescribing Information for FLEXBUMIN 5% and FLEXBUMIN 25%.