Albuked

Description

Albumin (Human) 20%, USP (Albuked™ 20) is derived from large pools of human venous plasma through the Cohn cold ethanol fractionation process, with some fractionation potentially conducted by another licensed manufacturer. This product is prepared in compliance with the applicable U.S. Food and Drug Administration requirements.

Albuked 20 is a sterile solution containing 20% albumin in an aqueous diluent, stabilized with 0.016 M sodium caprylate and 0.016 M acetyltryptophan. The aluminum content does not exceed 200 µg/L, while the approximate sodium content is 145 mEq/L. The solution is characterized as 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 undergoes heat treatment at 60°C for 10 hours to mitigate the risk of hepatitis virus transmission. Furthermore, the manufacturing process has 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

This drug is indicated for the emergency treatment of hypovolemic shock. Albuked 20 is hyperoncotic and, upon intravenous infusion, expands plasma volume by an additional amount, three to four times the volume administered, by withdrawing fluid from interstitial spaces, provided the patient is normally hydrated interstitially or has interstitial edema.

In burn therapy, Albuked 20 is utilized during the first 24 hours post-thermal injury to restore depleted extracellular fluid volume through large volumes of crystalloids. Beyond 24 hours, it can be employed to maintain plasma colloid osmotic pressure.

Albuked 20 is also indicated for the treatment of hypoproteinemia with or without edema, particularly in cases of major surgery, sepsis, or in intensive care patients who may lose significant amounts of circulating albumin. In patients with Adult Respiratory Distress Syndrome (ARDS) exhibiting signs of hypoproteinemia with fluid volume overload, Albuked 20, in conjunction with a diuretic, may be beneficial.

For cardiopulmonary bypass, preoperative dilution of blood using albumin and crystalloid has been demonstrated to be safe and well-tolerated. In cases of acute liver failure, the administration of Albuked 20 may support plasma colloid osmotic pressure and bind excess plasma bilirubin during rapid loss of liver function.

Albuked 20 may be indicated prior to exchange transfusion in neonatal hemolytic disease to bind free bilirubin, thereby reducing the risk of kernicterus. It may also be required for the sequestration of protein-rich fluids in conditions such as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis, addressing reduced volume or oncotic activity.

In the context of erythrocyte resuspension, Albuked 20 may be necessary to prevent excessive hypoproteinemia during certain types of exchange transfusion or when using large volumes of previously frozen or washed red cells. Additionally, it may be helpful in managing edema in acute nephrosis when combined with a loop diuretic, particularly in patients unresponsive to cyclophosphamide or steroid therapy. Lastly, Albuked 20 may be valuable in treating shock or hypotension in patients undergoing renal dialysis.

Dosage and Administration

Albuked 20 should be administered exclusively 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 20 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 after 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 dosage for adults is between 50 to 75 g, while for children, the recommended dose is 25 g. Patients experiencing severe hypoproteinemia who continue to lose albumin may necessitate larger quantities. It is critical that the rate of administration of Albuked 20 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) 20%, USP (Albuked™ 20) 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 risk of CJD transmission is considered extremely remote and no cases have been documented, the potential for transmission of infectious agents remains. Measures such as screening plasma donors, testing for current viral infections, and employing virus inactivation or removal techniques have been implemented to mitigate these risks. However, the possibility of unknown infectious agents persisting in the product cannot be excluded. Healthcare providers should report any suspected infections that may have been transmitted through this product to Grifols Therapeutics LLC at 1-800-520-2807. Prior to prescribing or administering Albuked™ 20, physicians must discuss the associated risks and benefits with the patient.

In terms of administration, caution is advised when using diluents. The use of Sterile Water for Injection as a diluent for Albumin (Human), 20% can lead to severe hemolysis and acute renal failure. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.

Patients receiving Albuked™ 20 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 vigilant observation to identify and manage any severed blood vessels that may not have bled at lower blood pressure levels.

Side Effects

Adverse reactions associated with the use of albumin are generally rare, but may include allergic reactions such as urticaria, chills, fever, and changes in respiration, pulse, and blood pressure. These reactions can occur in patients receiving albumin therapy, particularly in cases of excessive administration leading to high plasma protein levels.

In clinical settings, it is important to note that products derived from human plasma may carry the risk of transmitting infectious agents, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob Disease (CJD). Although the risk of CJD transmission is considered extremely remote and no cases have been documented for albumin, the potential for transmission of infectious agents remains. This risk has been mitigated through rigorous screening of plasma donors, testing for current viral infections, and employing methods to inactivate or remove certain viruses. However, unknown infectious agents may still be present, and individuals receiving blood or plasma products may exhibit signs or symptoms of viral infections, particularly hepatitis C.

Additional adverse reactions may arise from the inappropriate use of diluents. Severe hemolysis and acute renal failure can occur if Sterile Water for Injection is used as a diluent for Albumin (Human), 20%. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. Careful monitoring of patients is essential to prevent circulatory overload, especially since albumin is hyperoncotic. In cases of dehydration, albumin should be administered with or followed by additional fluids. Furthermore, the rapid increase in blood pressure that may occur after administering a colloid with positive oncotic activity necessitates vigilant observation to identify and manage any severed blood vessels that may not have bled at lower blood pressure levels.

Drug Interactions

Albuked 20 is compatible with whole blood, packed red cells, and standard carbohydrate and electrolyte solutions intended for intravenous use. This compatibility allows for its use in conjunction with these blood products and solutions without concern for adverse interactions.

However, Albuked 20 should not be mixed with protein hydrolysates, amino acid solutions, or solutions containing alcohol. The combination of Albuked 20 with these substances may lead to undesirable effects and is therefore contraindicated. It is essential to adhere to these guidelines to ensure patient safety and the efficacy of the treatment.

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 effects of albumin. Therefore, caution is advised when administering albumin to this population, particularly due to the potential for reduced kidney function and the associated risk of circulatory overload.

Dosage adjustments may be necessary for geriatric patients, especially those with comorbid conditions that could impact fluid balance and kidney function. It is essential to closely monitor the hemodynamic response in elderly patients receiving albumin therapy to ensure safety and efficacy.

Pregnancy

Albuked 20 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 20 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 20 in this population and to discuss potential risks with patients of childbearing potential.

Lactation

Albuked 20 has not been studied in animal reproduction, and there is no available data regarding its excretion in human breast milk. Consequently, it is unknown whether Albuked 20 can cause harm to a breastfed infant or affect lactation.

Given the lack of information, Albuked 20 should be administered to lactating mothers only if clearly needed, weighing the potential benefits against any unknown risks to the nursing infant.

Renal Impairment

Patients with renal impairment should be closely monitored when administering Albumin (Human), 20%, particularly when using diluents. The use of Sterile Water for Injection as a diluent is contraindicated, as it may lead to severe hemolysis and acute renal failure, especially when administered in large volumes. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. It is essential to ensure that appropriate diluents are used to mitigate the risk of adverse renal outcomes in this patient population.

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 outlined 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

Severe hemolysis and acute renal failure may occur as a consequence of the inappropriate use of Sterile Water for Injection as a diluent for Albumin (Human), 20%. To mitigate the risk of overdosage, it is essential to utilize only acceptable diluents, which include 0.9% Sodium Chloride or 5% Dextrose in Water.

It is critical to ensure that solutions have not been frozen prior to use, as frozen solutions should not be administered. Additionally, any solution that appears turbid must be discarded, as this indicates potential contamination or degradation.

Healthcare professionals should adhere to strict guidelines regarding the timing of administration. Administration should not commence more than 4 hours after the container has been entered to minimize the risk of microbial contamination. Furthermore, any partially used vials must be discarded to prevent the risk of infection or compromised efficacy.

Vials that are cracked, previously entered, or otherwise damaged should not be utilized, as such conditions may allow for the entry of microorganisms, posing a significant risk to patient safety. It is important to note that Albuked 20 contains no preservative, which underscores the necessity for careful handling and adherence to these guidelines to prevent overdosage and ensure patient safety.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Albuked 20. Consequently, it is not known whether Albuked 20 can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Therefore, Albuked 20 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 may result from high plasma protein levels due to excessive albumin administration. Allergic manifestations can include urticaria, chills, fever, and alterations in respiration, pulse, and blood pressure.

Postmarketing Experience

Adverse reactions associated with albumin are infrequently reported. These 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 low, and no cases of viral disease or CJD transmission have been identified in relation to albumin.

The risk of transmitting infectious agents through these products has been mitigated by implementing measures such as screening plasma donors for prior exposure to specific viruses, testing for current viral infections, and employing methods to inactivate or remove certain viruses. Despite these precautions, there remains a potential for disease transmission, and unknown infectious agents may still be present in these products.

Patients receiving infusions of blood or plasma products may exhibit signs and/or symptoms of viral infections, particularly hepatitis C. Any infections suspected by healthcare providers 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. It is essential to emphasize the importance of hydration; in cases of dehydration, albumin must be administered alongside or followed by the addition of fluids to ensure patient safety.

Providers should instruct patients not to use the product if it appears turbid, as this may indicate contamination or degradation. Additionally, it is critical to inform patients that administration should not commence more than four hours after the container has been entered to maintain product integrity.

Any unused portion of the product must be discarded properly, and patients should be made aware of this requirement. Furthermore, if the shrink band is absent or shows any signs of tampering, patients should be advised not to use the product and to notify Grifols Therapeutics LLC immediately to ensure their safety and compliance with product guidelines.

Storage and Handling

Albuked 20 is supplied in rubber-stoppered vials, available in two configurations: 50 mL and 100 mL.

For optimal storage, it is essential to keep the product at room temperature, not exceeding 30°C (86°F). Freezing the product is strictly prohibited. Additionally, it is important to refrain from using Albuked 20 after the expiration date to ensure safety and efficacy.

Additional Clinical Information

Albuked 20 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 and efficacy of treatment.

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)