Flexbumin

Description

FLEXBUMIN 5% is a sterile, nonpyrogenic preparation of albumin intended for intravenous administration. Each 100 mL of the solution contains 5 g of albumin, which has been adjusted to a physiological pH using sodium bicarbonate and/or sodium hydroxide. The formulation is stabilized with N-acetyltryptophan (0.004M) and sodium caprylate (0.004M), resulting in a sodium content of 145 ± 15 mEq/L.

This product is preservative-free and does not contain any coagulation factors typically found in fresh whole blood or plasma. FLEXBUMIN 5% appears as a transparent or slightly opalescent solution, which may exhibit a greenish tint and can range in color from pale straw to amber, while remaining clear of particulate matter.

Manufactured from human plasma, FLEXBUMIN 5% is produced through the modified Cohn-Oncley cold ethanol fractionation process, which involves a series of cold-ethanol precipitation, centrifugation, and/or filtration steps, followed by pasteurization of the final product at 60 ± 0.5°C for 10 to 11 hours. This method effectively purifies albumin and reduces viral load. Additionally, FLEXBUMIN 5% contains no blood group isoagglutinins, allowing for administration without consideration of the recipient's blood group.

Uses and Indications

FLEXBUMIN 5%, Albumin (Human) Solution is indicated for the treatment of hypovolemia and hypoalbuminemia, including conditions such as burns and during cardiopulmonary bypass surgery.

Limitations of use: This drug is not indicated for use as an intravenous nutrient.

Dosage and Administration

For intravenous use only. The dosage and rate of infusion should be adjusted based on the patient's clinical status. The maximum daily dose should not exceed 2 g of albumin per kg of body weight. For patients with normal blood volume, the infusion rate should not exceed 1 mL/min. It is important to note that the solution should not be diluted with Sterile Water for Injection.

In the case of hypovolemic shock, the recommended dosage is as follows: for infants and young children, administer 12 to 20 mL per kg of body weight. For older children and adults, an initial dose of 250 to 500 mL is recommended. If the response is inadequate, a repeat dose may be given after 15 to 30 minutes.

For hypoalbuminemia, the body albumin compartment should be calculated to be between 80 to 100 mL per kg of body weight. The daily dose must not exceed 2 g of albumin per kg of body weight.

In the management of burns, the dosage should be determined based on the patient's condition and their response to treatment after the first 24 hours.

Contraindications

Use is contraindicated in patients with a history of hypersensitivity reactions to albumin preparations or to any of the excipients, including N-acetyltryptophan and sodium caprylate, due to the risk of severe allergic reactions.

Additionally, the product should not be administered to individuals with severe anemia or cardiac failure when intravascular volume is normal or increased, as this may exacerbate the patient's condition.

Warnings and Precautions

Hypersensitivity reactions, including anaphylactic reactions, have been reported in patients receiving this product. If a hypersensitivity reaction is suspected, it is imperative to discontinue use immediately and implement appropriate standard medical treatment.

In situations where hypervolemia and/or hemodilution may occur, it is essential to adjust the dose and rate of infusion according to the patient's volume status. When administering large volumes, healthcare professionals should closely monitor hemodynamic parameters and ensure that adequate substitution of other blood constituents, such as coagulation factors, platelets, and erythrocytes, is available. Additionally, monitoring of electrolyte balance is recommended to prevent complications.

Post-administration, healthcare providers must closely monitor hemodynamic parameters for signs of cardiac or respiratory failure, renal failure, or increasing intracranial pressure. In trauma and postoperative surgery patients, it is particularly important to monitor blood pressure to detect any re-bleeding that may occur secondary to clot disruption.

It is critical to avoid diluting this product with Sterile Water for Injection, as this practice can lead to hemolysis in recipients.

This product is derived from human plasma and may contain infectious agents, including viruses, and theoretically, the variant Creutzfeldt-Jakob disease agent. Therefore, appropriate precautions should be taken when administering this product to minimize the risk of transmission of infectious agents.

Side Effects

Serious adverse reactions associated with the use of this product include hypersensitivity reactions, which may manifest as anaphylactic reactions. In cases where a hypersensitivity reaction is suspected, it is imperative to discontinue use and implement appropriate standard medical treatment. Additionally, pulmonary edema has been reported as a serious adverse reaction.

Patients with a history of hypersensitivity reactions to albumin preparations or to any of the excipients, such as N-acetyltryptophan and sodium caprylate, should be closely monitored. Other notable adverse reactions include severe anemia or cardiac failure, which may occur despite normal or increased intravascular volume. Furthermore, hypervolemia may arise if the dosage and rate of infusion exceed recommended levels.

Drug Interactions

No specific drug interactions have been identified in the available data.

However, it is advised to monitor certain laboratory parameters during treatment. When comparatively large volumes are replaced, coagulation and hematology parameters should be closely observed to ensure patient safety. Additionally, monitoring of electrolyte status is recommended to maintain electrolyte balance, which is crucial for overall health and effective treatment outcomes.

Biosimilarity

Flexbumin is the FDA‑licensed reference product against which biosimilar and interchangeable products are compared.

Packaging & NDC

The table below lists all NDC Code configurations of Flexbumin (albumin human) originator presentations. Columns show Packaging, Form, and Strength.

Pediatric Use

The safety of albumin solutions has been established in pediatric patients when dosed appropriately according to body weight. However, the safety of FLEXBUMIN 5% specifically has not been evaluated in studies conducted by the sponsor involving pediatric populations. Caution is advised when considering the use of FLEXBUMIN 5% in children, as the absence of dedicated pediatric studies limits the understanding of its safety profile in this demographic.

Geriatric Use

Elderly patients may have different pharmacokinetic and pharmacodynamic responses to medications compared to younger populations. However, there is currently no available human or animal data specifically addressing the use of this medication in geriatric patients.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, considering the potential for altered drug metabolism and increased sensitivity to adverse effects. Close monitoring of these patients is recommended to ensure safety and efficacy. Additionally, any dosage adjustments should be made judiciously, taking into account the individual patient's health status and concurrent medications.

Pregnancy

There are no available human or animal data to indicate the presence or absence of drug-associated risk with FLEXBUMIN 5% during pregnancy. Consequently, it is not known whether FLEXBUMIN 5% can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Healthcare professionals should weigh the potential benefits against the unknown risks when considering the use of FLEXBUMIN 5% in pregnant patients. Caution is advised, and alternative treatments should be considered when appropriate.

Lactation

There are no available human or animal data to indicate the presence or absence of drug-associated risk related to FLEXBUMIN 5%. It is currently unknown whether FLEXBUMIN 5% is excreted in human milk. Therefore, healthcare professionals should exercise caution when administering this medication to lactating mothers. The potential effects on breastfed infants remain undetermined.

Renal Impairment

Patients with renal impairment should be closely monitored for hemodynamic parameters following administration. This monitoring is essential to detect any evidence of cardiac or respiratory failure, renal failure, or increasing intracranial pressure. Adjustments to dosing may be necessary based on the patient's renal function, and healthcare professionals should remain vigilant in assessing these parameters to ensure patient safety.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In cases of overdosage, hypervolemia may occur as a result of excessive dosage or an accelerated rate of infusion. Healthcare professionals should be vigilant in monitoring patients for signs and symptoms associated with fluid overload, which may include hypertension, edema, and respiratory distress.

Management of overdosage should focus on the prompt identification of hypervolemia. If symptoms are observed, it is recommended to reduce the infusion rate or discontinue the administration of the medication. Additionally, supportive measures such as diuretics may be employed to alleviate fluid retention and restore hemodynamic stability.

Continuous assessment of the patient's clinical status is essential to ensure appropriate intervention and to mitigate potential complications arising from overdosage.

Nonclinical Toxicology

No human or animal data are available to indicate the presence or absence of drug-associated risk regarding teratogenic effects. It is not known whether FLEXBUMIN 5% can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity.

Similarly, there are no human or animal data available to assess the presence or absence of drug-associated risk concerning non-teratogenic effects. It remains unclear whether FLEXBUMIN 5% is excreted in human milk.

No specific nonclinical toxicology data or animal pharmacology and toxicology data have been provided.

Postmarketing Experience

Postmarketing experience has identified several important considerations regarding FLEXBUMIN 5%. Patients should be informed of the early signs of hypersensitivity reactions, which may include hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, hypotension, and anaphylaxis.

FLEXBUMIN 5% is derived from human plasma and may contain infectious agents that can lead to disease, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease (CJD). The risk of transmitting infectious agents through FLEXBUMIN 5% has been mitigated through measures such as screening plasma donors, testing donated plasma for specific viral infections, and employing a manufacturing process that has been shown to inactivate and/or remove certain viruses.

Symptoms indicative of a potential viral infection following administration may include headache, fever, nausea, vomiting, weakness, malaise, diarrhea, or jaundice, particularly in cases of hepatitis.

Patient Counseling

Healthcare providers should inform patients about the early signs of hypersensitivity reactions associated with FLEXBUMIN 5%. Patients should be advised to recognize symptoms such as hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. It is crucial for patients to understand the importance of seeking immediate medical attention if they experience any of these symptoms.

Patients should also be made aware that FLEXBUMIN 5% is derived from human plasma, which may contain infectious agents capable of causing disease, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease (CJD). Healthcare providers should explain that while the risk of transmitting infectious agents through FLEXBUMIN 5% has been minimized, it is not entirely eliminated. This risk has been reduced through careful screening of plasma donors, testing of donated plasma for specific viral infections, and employing manufacturing processes that have been shown to inactivate and/or remove certain viruses.

Additionally, healthcare providers should educate patients about the potential symptoms of a viral infection that may arise following administration of FLEXBUMIN 5%. These symptoms can include headache, fever, nausea, vomiting, weakness, malaise, diarrhea, and, in cases of hepatitis, jaundice. Patients should be encouraged to report any such symptoms to their healthcare provider promptly.

Storage and Handling

FLEXBUMIN 5% is supplied in a single-dose plastic container. It is essential to store this product at room temperature, ensuring that the temperature does not exceed 25°C (77°F). Additionally, the product must be protected from freezing to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Flexbumin as submitted by Takeda Pharmaceuticals America, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)