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).

Benefits header bag

Trusted by Hospitals for
More Than 15 Years.

FLEXBUMIN 25% and 5% are delivered in the innovative GALAXY® container. Designed without extra packaging, the shatterproof FLEXBUMIN container helps maintain sterility during setup and administration and is designed with safety and efficiency in mind.1-3

*FLEXBUMIN 25% Solution was FDA approved on October 11, 2005.

Benefits header bag

Flexbumin.
Proven Sterility Without an Overwrap.

Delivered with no extra packaging, FLEXBUMIN in the GALAXY container is designed to maintain sterility during setup and administration.1-5

No Swabbing Required

FLEXBUMIN is designed to maintain sterility without swabbing the injection port.1-3

No Overwrap Needed

FLEXBUMIN is delivered in an innovative four-layer polymer container—which maintains sterility and stability without a protective overwrap.1-3,6

Sterile Closed Infusion System

Unlike glass bottles, which require venting that allows ambient hospital air to flow through the albumin solution (open system), the FLEXBUMIN GALAXY container is fully collapsible with self-sealing injection ports. The FLEXBUMIN GALAXY container connects with standard IV administration sets to form a sterile closed system.3,4*

*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 fluid from the secondary container is complete.

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Because the glass containers are a rigid system, you would need a vented system in order to allow free flow of the solution through the IV tubing. In comparison, the FLEXBUMIN packaging is collapsible and doesn't require venting, so it's easier to handle from a nursing perspective.

Michelle Dusing Wiest, PharmD, Pharmacy Services
Cincinnati, Ohio

Actual quoted individual not pictured.

Flexbumin.
Designed With Safety in Mind.

Delivered in a shatterproof, flexible container, FLEXBUMIN helps reduce risk in critical situations.1-3,7-8

Shatterproof Bag

FLEXBUMIN can be transported from the pharmacy to the medical floor without the risk of broken glass and a reduction in the chances of spilling.1-3

Reduces Risk in Critical Situations

The flexible FLEXBUMIN container connects to a standard administration set and can empty without venting or use of an infusion pump—reducing potential risks associated with additional steps, medication errors, or infusion pump error.1-5,9-11

Latex-free

The GALAXY container is free of latex, PVC, DEHP, and DEHA.7† There is no known risk of aluminum leaching from the container.8

†Polyvinyl chloride (PVC), diethylhexyl phthalate (DEHP), diethylhexyl adipate (DEHA).

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We frown on having any glass sent to the patient care areas strictly because of safety and the risk of breakage. From that standpoint, the FLEXBUMIN packaging is a benefit.

Diana Dorgan, Pharmacy Inventory Director,
Cincinnati, Ohio

Actual quoted individual not pictured.

Flexbumin.
Designed With Efficiency in Mind.

Lightweight and flexible, the FLEXBUMIN container helps enhance storage and setup efficiencies.1-3,12,13

Saves Shelf Space

FLEXBUMIN is smaller than glass bottles of equal volume, helping to save space on pharmacy shelves and in automated dispensing cabinets—making it possible for more human albumin to be on the medical floor in critical situations.12,13‡

Dispensing cabinets can hold at least 57% more FLEXBUMIN containers than ALBUMIN in glass bottles of equal volume13‡

‡Calculations were based on an Omnicell dispensing cabinet and comparison of FLEXBUMIN 25% 50 mL and 100 mL containers and FLEXBUMIN 5% 250 mL containers with containers of BUMINATE® [Albumin (Human)], USP, 5% and 25% Solutions in glass bottles of equal volume.

Fast, Simple Setup

The lightweight FLEXBUMIN container can be set up in three simple steps—helping to reduce time to administration in critical situations.1,2,12,14,15*

  1. Hang: Suspend from eyelet support

  2. Uncap: Remove plastic protection from outlet
  3. Connect: Attach standard administration set

Thoroughly inspect the flexible container for minute leaks, particulate matter, and discoloration prior to administration. Do not use the bag if the tip protector is damaged, detached, or missing.

*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 fluid from the secondary container is complete.

Reduced Waste

FLEXBUMIN is designed to reduce disposal volume and overall waste.1-3,6

  • Approximately 90% lighter than empty glass bottles of equal volume.14,16§

  • Room temperature storage for up to 2 years.3,6

§Calculations based on BUMINATE® [Albumin (Human)], USP, 5% and 25% Solutions in glass bottles of equal volume.

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We use a fair amount of albumin and stock about 10 to 12 bags of albumin in our automatic dispensing cabinets in the surgical ICU. We are always fighting for space in those cabinets. With FLEXBUMIN we have more space for other medications.

Kevin Box, Pharm D, Clinical Pharmacy
San Diego, California

Actual quoted individual not pictured.

Flexbumin.
Designed With Environmental Sustainability in Mind.

Delivered in a lightweight, flexible container, FLEXBUMIN helps reduce environmental impacts throughout the product lifecycle.1-3,12,14,17,18§

Lower Carbon Footprint

The FLEXBUMIN container uses less energy during production, transport, and disposal, helping to reduce overall CO2 emissions compared to albumin in glass.16-18§

§Calculations based on BUMINATE® [Albumin (Human)], USP, 5% and 25% Solutions in glass bottles of equal volume.

Lighter Disposal Weight

Empty containers of FLEXBUMIN are approximately 90% lighter than empty glass bottles of equal volume, helping to reduce waste and lower the carbon footprint.16,17§

Safe End-of-life Disposal

Internal container film is composed of PVDC to allow disposal without creation of harmful residues, such as dioxins, when incinerated according to established industry standards.3,19¶

¶Polyvinylidene dichloride (PVDC).

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Certified by the Carbon Trust.
Flexbumin 25% and 5% Containers Are Certified by the Carbon Trust for Reduction in Co2 Emissions.20

References

  1. FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution [prescribing information]. Lexington, MA: Baxalta.
  2. FLEXBUMIN 5% [Albumin (Human)], USP, 5% Solution [prescribing information]. Lexington, MA: Baxalta.
  3. Data on file. VV-MED-7455—FLEX-013 FLEXBUMIN biologics license application.
  4. Maki DG, Rosenthal VD, Salomao R, Franzetti F, Rangel-Frausto MS. Impact of switching from an open to a closed infusion system on rates of central line-associated bloodstream infection: a meta-analysis of time-sequence cohort studies in 4 countries. Infect Control Hosp Epidemiol. 2011;32(1):50-58.
  5. The Joint Commission. Preventing Central Line-Associated Bloodstream Infections: A Global Challenge, A Global Perspective. https://www.jointcommission.org/-/media/tjc/documents/resources/hai/clabsi_monographpdf.pdf. Accessed September 17, 2020.
  6. Data on file. VV-MED-7218—FLEX-004 Albumin stability summary and conclusion.
  7. Data on file. VV-MED-7449—Certificate of non-use: concerned chemicals for environment.
  8. Data on file. VV-MED-7449—FLEX-012 Analysis of aluminum levels in FLEXBUMIN during stability.
  9. Kruer RM, Jarrell AS, Latif A. Reducing medication errors in critical care: a multimodal approach. Clin Pharmacol. 2014;6:117-126.
  10. van der Sluijs AF, van Slobbe-Bijlsma ER, Goossens A, Vlaar AP, Dongelmans DA. Reducing errors in the administration of medication with infusion pumps in the intensive care department: A lean approach. SAGE Open Med. 2019;7:2050312118822629.
  11. U.S. Food and Drug Administration. Safety Considerations for Product Design to Minimize Medication Errors. Guidance for Industry. https://www.fda.gov/files/drugs/published/Safety-Considerations-for-Product-Design-to-Minimize-Medication-Errors-Guidance-for-Industry.pdf. Accessed September 17, 2020.
  12. Data on file VV-MED-7220—FLEX-006 Plastic vs. glass weights and dimensions.
  13. Data on file. GALAXY storage space comparisons.
  14. Data on file. No. 68128FR. GALAXY 250 mL weight comparisons.
  15. Data on file. FLEXBUMIN time and motion study. March 17, 2010.
  16. Data on file. VV-MED-7242—FLEX-008 FLEXBUMIN GALAXY container disposal cost.
  17. Deloitte Consulting. Final results for albumin packaged as FLEXBUMIN and BUMINATE. October 2012.
  18. Data on file. FLEXBUMIN lifecycle assessment. 2009.
  19. DOW. Saran PVDC Resins & Films and the Environment, DOW Form No. 190-00500-0305. March 2005.
  20. The Carbon Trust Re-Certification. January 30, 2019.

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%.