Albuked

Description

Albumin (Human) 25%, USP (Albuked™ 25) is derived from large pools of human venous plasma through the Cohn cold ethanol fractionation process, with potential fractionation performed by another licensed manufacturer. This product is prepared in compliance with the applicable requirements established by the U.S. Food and Drug Administration.

Albuked 25 is a sterile solution containing 25% albumin in an aqueous diluent, stabilized with 0.02 M sodium caprylate and 0.02 M acetyltryptophan. The aluminum content does not exceed 200 µg/L, while the approximate sodium content is 145 mEq/L. The solution is clear, slightly viscous, and ranges in color from almost colorless to yellow, amber, or green. It is formulated without preservatives and is intended for intravenous administration.

Each vial of Albuked 25 undergoes heat treatment at 60°C for 10 hours to mitigate the risk of transmitting hepatitis viruses. The manufacturing process has also been evaluated for its effectiveness in reducing the infectivity of an experimental agent associated with transmissible spongiform encephalopathy (TSE), which serves as a model for variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD). The production steps from pooled plasma to effluent IV-1 have demonstrated a reduction in TSE infectivity of at least 7.0 logs, providing reasonable assurance that any low levels of vCJD/CJD agent infectivity present in the starting material would be effectively removed.

Uses and Indications

Albuked 25 is indicated for the emergency treatment of hypovolemic shock, where it acts as a hyperoncotic solution that expands plasma volume by three to four times the volume administered, contingent upon normal interstitial hydration or the presence of interstitial edema.

In burn therapy, Albuked 25 is utilized during the first 24 hours post-thermal injury to restore depleted extracellular fluid volume, and beyond this period, it serves to maintain plasma colloid osmotic pressure.

The drug is also indicated for the treatment of hypoproteinemia, with or without edema, particularly in patients undergoing major surgery, experiencing sepsis, or in intensive care settings where significant albumin loss may occur.

In cases of Adult Respiratory Distress Syndrome (ARDS), Albuked 25 may be administered alongside a diuretic when clinical signs indicate hypoproteinemia with fluid volume overload.

Albuked 25 is indicated for use in cardiopulmonary bypass procedures, where preoperative dilution of blood with albumin and crystalloid has demonstrated safety and tolerability.

In acute liver failure, the administration of Albuked 25 supports plasma colloid osmotic pressure and aids in binding excess plasma bilirubin.

For neonatal hemolytic disease, Albuked 25 may be indicated prior to exchange transfusion to bind free bilirubin, thereby reducing the risk of kernicterus.

The drug is also indicated for the sequestration of protein-rich fluids, addressing reduced volume or oncotic activity in conditions such as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis.

Albuked 25 may be required for erythrocyte resuspension to prevent excessive hypoproteinemia during certain exchange transfusions or when utilizing large volumes of previously frozen or washed red blood cells.

In the management of acute nephrosis, a regimen of a loop diuretic and 100 mL of Albuked 25, repeated daily for 7 to 10 days, may assist in controlling edema in patients unresponsive to cyclophosphamide or steroid therapy.

Additionally, Albuked 25 may be beneficial in treating shock or hypotension in patients undergoing renal dialysis.

No specific teratogenic or nonteratogenic effects have been noted in the provided data.

Dosage and Administration

Albuked 25 should always be administered by intravenous infusion. It may be given either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. In cases where sodium restriction is necessary, Albuked 25 should only be administered undiluted or diluted in a sodium-free carbohydrate solution, such as 5% Dextrose in Water.

For the treatment of hypovolemic shock, the volume administered and the speed of infusion must be tailored to the individual patient's response. Following a burn injury, typically beyond 24 hours, the objective is to maintain the plasma albumin concentration around 2.5 ± 0.5 g per 100 mL, corresponding to a plasma oncotic pressure of 20 mm Hg, which is equivalent to a total plasma protein concentration of 5.2 g per 100 mL.

The usual daily dose of albumin for adults ranges from 50 to 75 g, while for children, the recommended dose is 25 g. Patients experiencing severe hypoproteinemia who continue to lose albumin may require larger quantities. It is critical that the rate of administration of Albuked 25 does not exceed 2 mL per minute, as more rapid injection may lead to circulatory embarrassment and pulmonary edema.

Contraindications

Use is contraindicated in patients with a history of congestive cardiac failure, renal insufficiency, or stabilized chronic anemia due to the increased risk of developing circulatory overload. Additionally, individuals with a known allergic reaction to albumin should not use this product.

Warnings and Precautions

Albumin (Human) 25%, USP (Albuked™ 25) is derived from human plasma, which carries inherent risks associated with infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent. Although the theoretical risk of CJD transmission is considered extremely remote and no cases have been documented, it is essential to acknowledge that products made from human plasma can potentially transmit infectious diseases. Measures have been implemented to mitigate these risks, including screening plasma donors and testing for certain viral infections, as well as inactivating or removing specific viruses. However, the possibility of transmission of unknown infectious agents remains. Healthcare providers should report any suspected infections that may be attributed to this product to Grifols Therapeutics LLC at 1-800-520-2807. Prior to prescribing or administering this product, physicians must discuss the associated risks and benefits with the patient.

In terms of administration, caution is advised when using hyperoncotic protein solutions like Albuked 25, particularly regarding the choice of diluent. The use of Sterile Water for Injection as a diluent may lead to severe hemolysis and acute renal failure. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.

Patients receiving Albuked 25 should be closely monitored to prevent circulatory overload, as the product is hyperoncotic. In cases of dehydration, albumin administration must be accompanied by or followed with additional fluids. In situations involving hemorrhage, the administration of albumin should be complemented with whole blood transfusions to address the relative anemia caused by hemodilution. It is important to note that hemodilution effects can persist for several hours in patients with reduced circulating blood volume, while those with normal blood volume may experience a shorter duration of hemodilution.

Furthermore, the potential for a rapid increase in blood pressure following the administration of a colloid with positive oncotic activity necessitates careful observation. This vigilance is crucial to identify and manage any severed blood vessels that may not have bled at lower blood pressure levels.

Side Effects

Adverse reactions to albumin are rare, but may occur and can be classified as allergic reactions or reactions due to high plasma protein levels resulting from excessive albumin administration.

Allergic Reactions: Patients may experience urticaria, chills, fever, and changes in respiration, pulse, and blood pressure.

In addition to allergic reactions, there are important considerations regarding the use of albumin (Human) 25%, USP (Albuked™ 25), which is derived from human plasma. Products made from human plasma may contain infectious agents, including viruses, and theoretically, the agent responsible for Creutzfeldt-Jakob Disease (CJD). However, the risk of CJD transmission is considered extremely remote, and no cases of viral disease or CJD transmission have been identified in relation to albumin. The risk of transmitting infectious agents has been mitigated through screening plasma donors, testing for current viral infections, and employing methods to inactivate or remove certain viruses. Despite these precautions, there remains a potential risk for disease transmission, including the possibility of unknown infectious agents. Healthcare providers should report any suspected infections that may be attributed to this product to Grifols Therapeutics LLC at 1-800-520-2807.

Additional adverse reactions or important notes include the potential for severe hemolysis and acute renal failure if Sterile Water for Injection is improperly used as a diluent for albumin. Acceptable diluents are 0.9% Sodium Chloride or 5% Dextrose in Water. Patients should be monitored closely to prevent circulatory overload, as Albuked 25 is hyperoncotic. In cases of dehydration, albumin administration must be accompanied by or followed with additional fluids. Furthermore, in the event of hemorrhage, the administration of albumin should be complemented with whole blood transfusions to address the relative anemia associated with hemodilution. Careful observation is also necessary following the administration of a colloid with positive oncotic activity, as a rapid rise in blood pressure may occur, necessitating the detection and treatment of any severed blood vessels that may not have bled at lower blood pressure levels.

Drug Interactions

Albuked 25 is compatible with whole blood, packed red cells, and standard carbohydrate and electrolyte solutions intended for intravenous use. However, it is contraindicated to mix Albuked 25 with protein hydrolysates, amino acid solutions, or solutions containing alcohol.

Healthcare professionals should ensure that Albuked 25 is administered in accordance with these compatibility guidelines to avoid potential adverse effects associated with inappropriate mixtures. Monitoring for any signs of incompatibility is advised when administering Albuked 25 with other intravenous solutions.

Biosimilarity

Albuked 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 Albuked (albumin (human)) originator presentations. Columns show Packaging, Form, and Strength.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established. Therefore, caution is advised when considering the use of this medication in children, infants, and adolescents. Further studies are necessary to determine appropriate dosing and potential outcomes in these age groups.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of albumin (Human) 25%, USP (Albuked™ 25). Caution is advised when administering Albuked 25 to this population due to the potential for reduced kidney function, which is more prevalent among geriatric patients.

Dosage adjustments may be necessary for elderly patients, particularly those with compromised renal function. It is crucial to assess renal status prior to and during treatment to ensure appropriate dosing.

Additionally, careful monitoring for signs of circulatory overload is essential in elderly patients, as they may be at a higher risk for this complication. Regular evaluation of fluid status and cardiovascular function is recommended to mitigate potential adverse effects.

Pregnancy

Albuked 25 has not been evaluated in animal reproduction studies, and there is a lack of data regarding its potential to cause fetal harm or impact reproductive capacity when administered to pregnant women. Therefore, Albuked 25 should be prescribed to pregnant patients only if the benefits clearly outweigh the risks. Healthcare professionals are advised to consider the necessity of treatment with Albuked 25 in this population and to discuss potential risks with patients of childbearing potential.

Lactation

It is not known whether Albuked 25 is excreted in human breast milk or if it can cause harm to a breastfed infant. Due to the lack of data regarding its effects on lactating mothers and breastfed infants, Albuked 25 should be administered to a lactating mother only if clearly needed. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in breastfeeding women.

Renal Impairment

Patients with renal impairment should be closely monitored when receiving Albumin (Human), 25%, particularly due to the risk of severe hemolysis and acute renal failure associated with the inappropriate use of diluents. It is crucial to avoid using Sterile Water for Injection as a diluent; instead, acceptable alternatives include 0.9% Sodium Chloride or 5% Dextrose in Water. Careful consideration of these diluent options is essential to mitigate potential complications in patients with reduced kidney function.

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 considered as part of standard clinical practice.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Albuked 25. Therefore, it is not known whether Albuked 25 can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Albuked 25 should be administered to a pregnant woman only if clearly needed.

Adverse reactions to albumin are rare. Such reactions may be allergic in nature or due to elevated plasma protein levels resulting from excessive albumin administration. Allergic manifestations may include urticaria, chills, fever, and changes in respiration, pulse, and blood pressure.

Postmarketing Experience

Adverse reactions associated with albumin are infrequently reported. Such reactions may be of an allergic nature or arise from elevated plasma protein levels due to excessive administration of albumin. Documented allergic manifestations include urticaria, chills, fever, and alterations in respiration, pulse, and blood pressure.

Products derived from human plasma have the potential to contain infectious agents, including viruses, and theoretically, the agent responsible for Creutzfeldt-Jakob Disease (CJD). However, the risk of CJD transmission is considered extremely remote, and no cases of viral disease or CJD transmission have been identified in relation to albumin.

Patients receiving infusions of blood or plasma products may exhibit signs and/or symptoms indicative of viral infections, particularly hepatitis C. Any infections suspected by a healthcare provider to be transmitted by this product should be reported to Grifols Therapeutics LLC at 1-800-520-2807.

Patient Counseling

Healthcare providers should engage in a thorough discussion with patients regarding the risks and benefits associated with this product prior to prescribing or administering it. It is essential for patients to understand that in cases of dehydration, albumin must be administered alongside or followed by the addition of fluids to ensure safety and efficacy.

Patients should be closely monitored to prevent the risk of circulatory overload, which can occur during treatment. Additionally, it is important to inform patients that individuals receiving infusions of blood or plasma products may exhibit signs and/or symptoms of viral infections, particularly hepatitis C. Any suspected infections that may have been transmitted through this product should be reported to Grifols Therapeutics LLC at 1-800-520-2807.

Providers should also instruct patients on the proper handling of the product. Solutions that have been frozen should not be used, and the product must not be administered if it appears turbid. Administration should not commence more than four hours after the container has been entered, and any partially used vials must be discarded. Vials that are cracked, previously entered, or damaged should also be discarded to prevent the risk of contamination, as Albuked 25 contains no preservative.

It is crucial to communicate to patients that various factors beyond the control of the healthcare provider may affect the efficacy of this product or lead to adverse effects. These factors include improper storage and handling after the product leaves the provider's control, as well as individual patient differences in diagnosis, dosage, and method of administration. Therefore, adherence to proper storage guidelines and careful following of administration instructions is vital for patient safety and treatment success.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that the temperature does not exceed 30°C (86°F). Freezing of the product is strictly prohibited. Additionally, it is imperative to refrain from using the product after the expiration date. Proper adherence to these storage and handling guidelines is essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Albuked 25 must be administered intravenously. Clinicians are advised to engage in discussions with patients regarding the risks and benefits associated with this product. In cases of dehydration, it is essential that albumin is administered alongside or followed by the addition of fluids to ensure patient safety.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Albuked as submitted by KEDRION BIOPHARMA, INC.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)