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).

Contact your Takeda account representative,
or call Takeda at 800-423-2090 to learn more.

FLEXBUMIN 5% and 25% concentrations are available in a shatterproof container, with no extra packaging. FLEXBUMIN is designed with sterility, safety features, and efficiency in mind.1-4

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*Supplied as a single-dose GALAXY® polymer container.

FLEXBUMIN 5%

[Albumin (Human)] USP, 5% Solution

FLEXBUMIN 25%

[Albumin (Human)] USP, 25% Solution

Volume

 250 mL 50 mL 100 mL

Grams

 12.5 g* 12.5 g* 25 g*

Equivalent Units

 1 1 2

Bags per carton

 10 24 12

Container Dimensions

 12 x 6 x 6.25 in 12 x 6 x 2.5 in 12 x 6 x 2.5 in

Shipping Weight

 7 lb 4.2 lb 4.2 lb

Carton NDC

 0944-0495-05 0944-0493-01 0944-0493-02

References

  1. FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution [prescribing information]. Lexington, MA: Baxalta. July 2017.
  2. FLEXBUMIN 5% [Albumin (Human)], USP, 5% Solution [prescribing information]. Lexington, MA: Baxalta. July 2017.
  3. Data on file. VV-MED-7455—FLEX-013 FLEXBUMIN biologics license application.
  4. Data on file. GALAXY storage space comparisons. Baxter Healthcare Corporation.

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%.