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Prescribing Information Indications and
Important Safety Information
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FLEXBUMIN® for your
top priorities:

Safety

GALAXY® shatterproof flexible plastic container: Eliminates safety concerns from glass breakage and spills1,2

Selected Important Risk Information

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.


1. Baxalta US Inc. FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution. Package insert. July 2017.
2. Baxalta US Inc. FLEXBUMIN 5%, Albumin (Human), USP, 5% Solution. Package insert. July 2017.

FLEXBUMIN® for your
top priorities:

Efficiency

FLEXBUMIN 25% (50mL) in cartons on a pharmacy shelf can potentially take up less than 1/2 the storage space compared to cartons of albumin in glass bottles of equal volume. FLEXBUMIN 5% (250mL) can potentially reduce more than half of the storage space compared to cartons of albumin in glass bottles of equal
volume 1,2*

*Calculations based on bottles of BUMINATE® 25% and 5% [Albumin (Human)] USP, 25% and 5% Solution

1. Data on file VV-MED-7220 - FLEX-006 Plastic vs. Glass Weights and Dimensions.

2. Data on file VV-MED-7463 - FLEX-016 GALAXY Storage Space Comparisons 2014.

FLEXBUMIN® for your
top priorities:

Sustainability

FLEXBUMIN 25% (100 mL) has a 28% lower carbon footprint and FLEXBUMIN 5% (250 mL) has a 46% lower carbon footprint when compared to albumin glass bottles of equal volume1*



*Global CO2 output calculations based on bottles of BUMINATE® 25% and 5% [Albumin (Human)] USP, 25% and 5% Solution

1. Data on file VV-MED-7406 - FLEX-009 Environmental Impact.

The first human albumin product in the
GALAXY® shatterproof flexible plastic container1,2

FLEXBUMIN® [Albumin (Human)], USP

Designed with safety, efficiency and
sustainability in mind for the demands
of the critical care setting



1. Baxalta US Inc. FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution. Package insert. July 2017.

2. Baxalta US Inc. FLEXBUMIN 5%, Albumin (Human), USP, 5% Solution. Package insert. July 2017.

See for yourself Request a sample of the FLEXBUMIN GALAXY container (sample bag will not contain albumin)

BACK

Important Safety Information

Please read below for Indications and Detailed Important Safety Information for FLEXBUMIN 25% AND 5%.

Indications and Important Safety Information for FLEXBUMIN 5% [Albumin (Human)], USP, 5% and FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solutions

Indications for FLEXBUMIN 5% and 25%

FLEXBUMIN 5% and 25% are indicated for hypovolemia, hypoalbuminemia due to general causes and burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime.

FLEXBUMIN 25% is also indicated for hypoalbuminemia due to adult respiratory distress syndrome (ARDS) and nephrosis, and for use in hemolytic disease of the newborn (HDN).

Limitations of use:

 Albumin is not indicated as an intravenous nutrient.

Important Safety Information

CONTRAINDICATIONS

  • Patients with a 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.

  • Patients with severe anemia or cardiac failure with normal or increased intravascular volume.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions:

 Hypersensitivity reactions (including anaphylactic reactions) have been observed. If hypersensitivity reaction is suspected, discontinue use 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 and ensure adequate substitution of other blood constituents are available (coagulation factors, platelets, and erythrocytes). Monitor electrolyte balance.

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 this can cause hemolysis in recipients.

Transmission of Infectious Agents:

 This product is made from human plasma and may contain infectious agents e.g., viruses and, theoretically, the variant Creutzfeldt-Jakob disease agent.

ADVERSE REACTIONS

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

CAUTION DURING ADMINISTRATION

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.

For full details please see the Prescribing Information for FLEXBUMIN 5% and FLEXBUMIN 25%.

© 2017 Shire US Inc., Lexington, MA 02421. All rights reserved. 1-800-828-2088

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

BUMINATE and FLEXBUMIN are registered trademarks of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.

Baxter and Galaxy are registered trademarks of Baxter International Inc.

S35104 10/17

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