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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).
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).
Important Safety Information
Contraindications
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%.
The following information addresses central line-associated bloodstream infection (CLABSI) in general.
FLEXBUMIN® [Albumin (Human)] has not been evaluated in clinical studies for CLABSI risk reduction.
CLABSI is a common, serious healthcare problem that increases hospital lengths of stay and costs.1 A majority of the estimated 30,100 CLABSIs that occur in U.S. intensive care units (ICUs) and acute care institutions each year are preventable.2,3
CLABSIs increase healthcare costs and prolong hospital lengths of stay, impacting not only the direct cost of care but also healthcare worker productivity and patient quality of life.1 Estimated costs associated with CLABSIs in U.S. healthcare institutions vary across multiple reports based on a variety of factors, but are considered to be substantial.1,4,5
Prolonged lengths of stay have been reported in multiple analyses involving critically ill patients hospitalized in Argentina, Mexico, and the United States.6–8
The estimate is based on a systematic review of the literature to assess U.S. costs of CLABSI. Values have been weighted and adjusted to 2012 dollars.5
The estimate is based on a literature review of additional hospital costs due to hospital-acquired conditions. Additional costs were highest for CLABSI, compared with other infectious conditions.4
According to The Joint Commission, closed infusion systems are an additional intervention to help lower risk for contamination during initial setup and administration and may help further reduce the risk for CLABSI. The Joint Commission has defined open and closed systems as follows1:
IV fluid containers that require no external venting for the bag to empty are closed infusion systems.1
Glass bottles, semi-rigid plastic bottles, and burettes that must be vented to allow air to enter for the fluid to egress are open infusion systems.1
In a meta-analysis involving 15 ICUs, switching from open to closed system IV fluid containers was observed to significantly reduce the incidence of CLABSIs from 10.1 to 3.3 per 1,000 central line-days (p<0.001).9:
Study designThe study was a meta-analysis involving 15 ICUs in Argentina, Brazil, Italy, and Mexico that evaluated the rate of CLABSI in 2,237 adult patients (15,189 central line-days) treated during an 8-12-month open container period as well as 2,136 adult patients (13,456 central line-days) treated during a 6-12-month closed infusion container period.9
*Study was performed using VIAFLEX and VIAFLO containers by Baxter. The study did not include use of FLEXBUMIN or the GALAXY container.
Checklist for Prevention of Central Line-Associated Bloodstream Infections
Bundle of the INICC to Prevent Central and Peripheral Line-Related Bloodstream Infections
Prevention of Central Line-Associated Bloodstream Infections
Preventing Central Line-Associated Bloodstream Infections: A Global Challenge, A Global Perspective
References