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).
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
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
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
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
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
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
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).
Important Safety Information