Albuked

Description

Albumin (Human) 5%, USP (Albuked™ 5) 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 requirements set forth by the U.S. Food and Drug Administration.

Albuked 5 is formulated as a 5% sterile solution of albumin in an aqueous diluent, stabilized with 0.004 M sodium caprylate and 0.004 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.

To mitigate the risk of hepatitis virus transmission, each vial of Albuked 5 undergoes heat treatment at 60°C for 10 hours. 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 5 is iso-oncotic with normal plasma and, when administered via intravenous infusion, will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions primarily associated with a volume deficit, albumin is best administered as a 5% solution (Albuked 5). In cases where there is an oncotic deficit, Albumin (Human) 25%, USP (Albuked 25) may be preferred. The removal of ascitic fluid from patients with cirrhosis may lead to changes in cardiovascular function and potentially result in hypovolemic shock; in such instances, albumin infusion may be necessary to support blood volume.

In burn therapy, during the first 24 hours following thermal injury, large volumes of crystalloids are infused to restore depleted extracellular fluid volume. Beyond this period, albumin can be utilized to maintain plasma colloid osmotic pressure, with Albuked 25 being preferred for this purpose.

For cardiopulmonary bypass, the relatively small priming volume required with modern pumps allows for the safe and well-tolerated preoperative dilution of blood using albumin and crystalloid.

In cases of acute liver failure, characterized by rapid loss of liver function with or without coma, the administration of albumin may support the colloid osmotic pressure of plasma and assist in binding excess plasma bilirubin.

Albumin is also indicated for the sequestration of protein-rich fluids in conditions such as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The significant loss into the third space may necessitate treatment of reduced volume or oncotic activity through albumin infusion.

Limitations of use include the observation that in chronic nephrosis, infused albumin is promptly excreted by the kidneys without alleviating chronic edema or affecting the underlying renal lesion. It may be used occasionally for rapid “priming” diuresis in nephrosis. Additionally, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein-losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified. No specific teratogenic effects have been noted.

Dosage and Administration

Albuked 5 should be administered exclusively by intravenous infusion. The volume and rate of administration must be tailored to the individual patient's response.

For neonates and infants, Albuked 5 may be administered in larger volumes, with a recommended dosage of 10 to 20 mL/kg, which corresponds to 0.5 to 1.0 g of albumin per kg of body weight.

In cases of burn injury, typically after 24 hours post-injury, the objective is to maintain plasma albumin concentrations around 2.5 ± 0.5 g per 100 mL, alongside a plasma oncotic pressure of 20 mm Hg, which is equivalent to a total plasma protein concentration of 5.2 g per 100 mL. This target is optimally achieved through the intravenous administration of Albuked, preferably using Albuked 25.

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 history of allergic reactions to albumin should not use this product.

Warnings and Precautions

Albuked 5 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, it is important to note that no cases of viral disease or CJD transmission have been documented in relation to albumin. The risk of transmitting infectious agents has been mitigated through rigorous screening of plasma donors, testing for current viral infections, and employing methods to inactivate or remove certain viruses. However, despite these precautions, there remains a potential for disease transmission, including the possibility of unknown infectious agents. Healthcare providers should be vigilant for signs and symptoms of viral infections, particularly hepatitis C, in individuals receiving infusions of blood or plasma products. Any suspected infections believed to be transmitted by this product must be reported to Grifols Therapeutics LLC at 1-800-520-2807. Prior to prescribing or administering Albuked 5, physicians are advised to discuss the associated risks and benefits with the patient.

Patients receiving Albuked 5 should be monitored closely to prevent circulatory overload. As Albuked 5 is iso-oncotic with normal plasma, it is unlikely to exacerbate tissue dehydration; however, additional crystalloids may be necessary to maintain normal fluid balance. In cases of hemorrhage, the administration of albumin should be accompanied by whole blood transfusions to address the relative anemia resulting from hemodilution. It is important to recognize that hemodilution may persist for several hours following albumin administration in patients with reduced circulating blood volume, while in those with normal blood volume, the effects are typically shorter-lived. The potential for a rapid increase in blood pressure following the administration of a colloid with positive oncotic activity necessitates careful observation 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 either allergic in nature or due to elevated plasma protein levels resulting from excessive albumin administration. Allergic manifestations observed in patients include urticaria, chills, fever, and changes in respiration, pulse, and blood pressure.

Patients receiving Albuked 5, which is derived from human plasma, should be informed of the potential risks associated with such products. Although the theoretical risk for transmission of infectious agents, including viruses and the Creutzfeldt-Jakob Disease (CJD) agent, is considered extremely remote, it remains a concern. No cases of transmission of viral diseases or CJD have been identified in relation to albumin. The risk of transmitting infectious agents has been mitigated through measures such as screening plasma donors for prior exposure to certain viruses, testing for current virus infections, and employing methods to inactivate or remove specific viruses. However, it is important to note that unknown infectious agents may still be present in these products. Healthcare providers should report any infections suspected to be transmitted by this product to Grifols Therapeutics LLC at 1-800-520-2807.

In addition to allergic reactions, careful monitoring of patients is essential to prevent circulatory overload, particularly in those with a history of congestive cardiac failure, renal insufficiency, or stabilized chronic anemia, who are at increased risk. Furthermore, a history of allergic reaction to albumin serves as a specific contraindication for its use.

Drug Interactions

Albuked 5 demonstrates compatibility with various blood products and intravenous solutions. It is suitable for use with whole blood and packed red cells, as well as standard carbohydrate and electrolyte solutions intended for intravenous administration.

However, caution is advised regarding specific mixtures. Albuked 5 should not be combined with protein hydrolysates or amino acid solutions, as these combinations may lead to undesirable interactions. Additionally, it is contraindicated to mix Albuked 5 with solutions containing alcohol, which could compromise the efficacy and safety of the treatment.

Healthcare professionals should ensure that Albuked 5 is administered in accordance with these compatibility guidelines to optimize therapeutic outcomes and minimize potential risks.

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. In neonates or infants, Albuked 5 may be administered in large amounts, with a recommended dose of 10 to 20 mL/kg, which is equivalent to 0.5 to 1.0 g of albumin per kg of body weight.

Geriatric Use

Elderly patients, particularly those aged 65 and older, may exhibit increased sensitivity to hypoalbuminemia, especially if they have preexisting debilitating conditions or if the shock is attributable to a medical disorder. In cases where the state of shock has persisted for an extended period prior to the initiation of active therapy, these patients may have a diminished tolerance to hypoalbuminemia.

Healthcare providers should exercise caution when treating geriatric patients under these circumstances. Close monitoring of albumin levels and overall clinical status is recommended to ensure appropriate management and to mitigate potential complications associated with hypoalbuminemia in this vulnerable population.

Pregnancy

Albuked 5 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 5 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 5 in this population and to discuss potential risks with patients of childbearing potential.

Lactation

It is not known whether Albuked 5 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 5 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 Albuked 5 in breastfeeding women.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Albuked 5. Consequently, it is not known whether Albuked 5 can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Therefore, Albuked 5 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 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 albumin administration. Allergic manifestations noted include urticaria, chills, fever, and alterations in respiration, pulse, and blood pressure.

It is recommended that physicians engage in discussions regarding the risks and benefits of albumin with patients prior to prescribing or administering the product.

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 theoretical risk of CJD transmission is considered extremely remote, and no cases of viral disease or CJD transmission have been documented in relation to albumin.

Patients receiving infusions of blood or plasma products may exhibit signs and/or symptoms indicative of certain viral infections, particularly hepatitis C. Any infections suspected by a physician 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 the use of this product. It is essential to inform patients that solutions which have been frozen should not be used, and that 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 to ensure safety.

Providers should advise patients against using vials that are cracked, previously entered, or damaged, as these conditions may allow for the entry of microorganisms. It is important to note that Albuked 5 contains no preservative, which necessitates careful handling.

Patients should be monitored closely to prevent the risk of circulatory overload. If required, appropriate additional crystalloids should be administered to maintain normal fluid balance. In cases of hemorrhage, the administration of albumin should be accompanied by the transfusion of whole blood to address the relative anemia associated with hemodilution.

Healthcare providers should also inform patients about the potential for a rapid rise in blood pressure following the administration of a colloid with positive oncotic activity. This necessitates careful observation to detect and manage any severed blood vessels that may not have bled at lower blood pressure levels.

It is crucial to communicate that animal reproduction studies have not been conducted with Albuked 5, and it remains unknown whether the product can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, Albuked 5 should only be given to pregnant women if clearly needed.

Providers should also make patients aware that the safety and effectiveness of Albuked 5 in the pediatric population have not been established. While adverse reactions to albumin are rare, it is important to inform patients that such reactions may be allergic in nature or due to elevated plasma protein levels from excessive albumin administration. Allergic manifestations can include urticaria, chills, fever, and changes in respiration, pulse, and blood pressure.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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 product integrity and efficacy.

Additional Clinical Information

Albuked 5 is to be administered exclusively via intravenous infusion. Clinicians are advised to engage in discussions with patients regarding the potential risks and benefits associated with the use of this product. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)