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Prescribing Information Indications and
Important Safety Information

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FLEXBUMIN^® 25%
[Albumin (Human)],
USP, 25% Solution
FLEXBUMIN 5%
[Albumin (Human)],
USP, 5% Solution

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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%.

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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