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FDA Approves Baxter's FLEXBUMIN 5%, First and Only 5% Human Albumin Solution in a Flexible Container

Unique Flexible Container Offers Enhanced Safety, Efficiency, and Sustainability Features

DEERFIELD, Ill., AUGUST 4, 2014 - Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug Administration (FDA) has approved FLEXBUMIN® [Albumin (Human)], USP, 5% Solution. FLEXBUMIN 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery.

This approval expands Baxter's FLEXBUMIN product portfolio to include both 5% in a 250 mL solution and 25% in 50 and 100 mL solutions. FLEXBUMIN is the first and only preparation of human albumin to be packaged in a flexible plastic container. The new FLEXBUMIN 5% solution will be available to U.S. customers later this year.

The FLEXBUMIN flexible, shatterproof container offers unique safety features for hospitals by eliminating risk of glass breakage and affords the ability to infuse without a vented administration set. In addition, FLEXBUMIN 5% solution provides efficiency features for healthcare professionals through its streamlined three-step administration process, lighter weight and reduced space requirements compared to glass containers of equal volume, making it more compatible with hospital inventory storage systems.

"Human albumin is essential for hospitals in providing care to surgical, trauma and other critically ill patients," said Ron Lloyd, head of Baxter's BioTherapeutics business. "Our customers value the benefits of having this treatment available in a flexible container that more efficiently meets their needs for reduced waste and improved safety."

FLEXBUMIN uses Baxter's GALAXY® flexible container, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature. The GALAXY container, which employs barrier technology and a continuous aseptic filling process, has been used in the United States for more than 16 years to package pharmaceutical products. The flexible infusion system allows for simple administration steps with a non-vented administration set.

Compared with glass bottles of equal volume, shipping containers for FLEXBUMIN 5% contain approximately 45% less packaging materials and empty containers are 95% lighter, resulting in less waste.

About FLEXBUMIN 5%
FLEXBUMIN 5% [Albumin (Human)] 5% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration.

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

Important Risk Information for FLEXBUMIN 5% [Albumin (Human)] 5% Solution

  • FLEXBUMIN 5% is contraindicated in patients with a history of allergic reactions to human albumin and any of the excipients, severe anemia, and heart failure.
  • Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered.
  • Do not dilute with Sterile Water for injection as this can cause hemolysis. There exists a risk of potentially fatal hemolysis and acute renal failure from the use of Sterile Water for Injection as a diluent for Albumin (Human). Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.
  • FLEXBUMIN 5% is made from human blood. It carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD) and theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD).
  • FLEXBUMIN 5% must be administered intravenously. FLEXBUMIN 5% should be administered slowly (5 to 10 mL/min) to avoid too rapid a rise in the blood pressure. More rapid administration can cause circulatory overload and pulmonary edema.
  • Monitor blood pressure in trauma patients and postoperative patients resuscitated with FLEXBUMIN 5% in order to detect rebleeding secondary to clot disruption.
  • In post marketing experience anaphylactic shock, anaphylactic reaction, hypersensitivity/allergic reactions, headache, dysgeusia, myocardial infarction, atrial fibrillation, tachycardia, hypotension, flushing, pulmonary edema, dyspnea, vomiting, nausea, urticaria, rash, pruritus, pyrexia and chills have been reported.


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 visit www.baxter.com/downloads/healthcare_professionals/
products/Flexbumin_5_PI.pdf
for the full Prescribing Information for FLEXBUMIN 5%.

About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.