Plasbumin

Description

Albumin (Human) 25%, USP (Plasbumin®-25) is derived from large pools of human venous plasma through the Cohn cold ethanol fractionation process, with part of the 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.

Plasbumin-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 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.

To mitigate the risk of hepatitis virus transmission, each vial of Plasbumin-25 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. Plasbumin-25 is hyperoncotic and, when administered intravenously, expands plasma volume by three to four times the volume infused, provided the patient is normally hydrated or has interstitial edema. In cases of dehydration, additional crystalloids should be administered, or alternatively, Albumin (Human) 5%, USP (Plasbumin-5) should be used. Continuous monitoring of the patient’s hemodynamic response is essential, and precautions against circulatory overload must be observed. The total dose should not exceed approximately 2 g per kg body weight in the absence of active bleeding. While Plasbumin-5 is preferred for typical volume deficits, Plasbumin-25 may offer therapeutic advantages in oncotic deficits or prolonged shock.

Plasbumin-25 is also indicated for burn therapy. Although an optimal regimen for colloids, crystalloids, and water following extensive burns has not been established, large volumes of crystalloids are typically infused within the first 24 hours post-injury to restore extracellular fluid volume. Beyond this period, Plasbumin-25 can be utilized to maintain plasma colloid osmotic pressure.

In cases of hypoproteinemia with or without edema, particularly during major surgery, sepsis, or in intensive care patients, treatment with Plasbumin-25 may be beneficial due to significant albumin loss.

For patients with Adult Respiratory Distress Syndrome (ARDS), characterized by deficient oxygenation from pulmonary interstitial edema, Plasbumin-25 may be used alongside a diuretic when clinical signs indicate hypoproteinemia with fluid volume overload.

In the context of cardiopulmonary bypass, Plasbumin-25 can be safely used to dilute blood preoperatively, adjusting the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL.

In acute liver failure, where rapid loss of liver function occurs, the administration of albumin may support colloid osmotic pressure and bind excess plasma bilirubin.

Plasbumin-25 is indicated prior to exchange transfusion in neonatal hemolytic disease to bind free bilirubin and reduce the risk of kernicterus, with a recommended dosage of 1 g/kg body weight administered approximately one hour before the procedure. Caution is advised in hypervolemic infants.

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

In erythrocyte resuspension, Plasbumin-25 may be required to prevent excessive hypoproteinemia during certain exchange transfusions or when large volumes of previously frozen or washed red cells are used. Typically, 25 g of albumin per liter of erythrocytes is added immediately prior to transfusion.

For patients with acute nephrosis who do not respond to cyclophosphamide or steroid therapy, Plasbumin-25 may be administered daily for 7 to 10 days, in conjunction with a loop diuretic, to help control edema and improve responsiveness to steroid treatment.

Although not a standard part of renal dialysis regimens, Plasbumin-25 may be beneficial in treating shock or hypotension in these patients, with a typical volume of about 100 mL administered while carefully avoiding fluid overload.

Dosage and Administration

Plasbumin-25 must be administered exclusively by intravenous infusion. It can be given either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. In cases where sodium restriction is necessary, Plasbumin-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 of Plasbumin-25 administered and the infusion rate should 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 standard 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 does not exceed 2 mL per minute, as more rapid infusion 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 allergy to albumin should not use this product.

Warnings and Precautions

Plasbumin-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 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 potential for infectious agent transmission has been mitigated through rigorous screening of plasma donors, testing for current viral infections, and employing methods to inactivate or remove certain viruses. However, the possibility of disease transmission remains, including the risk of unknown infectious agents. Healthcare providers should report any suspected infections that may have been transmitted by this product to Grifols Therapeutics LLC at 1-800-520-2807. Prior to prescribing or administering Plasbumin-25, physicians must discuss the associated risks and benefits with the patient.

In terms of administration, caution is advised when using Sterile Water for Injection as a diluent for Albumin (Human), 25%. The inappropriate use of this diluent may lead to severe hemolysis and acute renal failure. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.

Patients receiving Plasbumin-25 should be monitored closely to prevent circulatory overload, as the product is hyperoncotic. In cases of dehydration, it is essential to administer albumin alongside or followed by 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 recognize that hemodilution may persist for several hours in patients with reduced circulating blood volume, while in those with normal blood volume, the effects are typically shorter-lived.

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 to albumin are rare, but may occur and can be classified as allergic in nature or due to elevated plasma protein levels resulting from excessive albumin administration. Allergic manifestations reported include urticaria, chills, fever, and changes in respiration, pulse, and blood pressure.

In addition to these reactions, it is important to note that Plasbumin-25 is derived from human plasma, which carries a theoretical risk of transmitting infectious agents, including viruses and the Creutzfeldt-Jakob Disease (CJD) agent. Although the risk of CJD transmission is considered extremely remote, no cases of viral disease or CJD transmission have been identified in relation to albumin. The risk of infectious agent transmission has been mitigated through rigorous screening of plasma donors, testing for current viral infections, and employing methods to inactivate or remove certain viruses. However, the potential for disease transmission remains, and unknown infectious agents may also be present. Healthcare providers are advised to report any infections suspected to be transmitted by this product to Grifols Therapeutics LLC at 1-800-520-2807.

Furthermore, when administering hyperoncotic protein solutions like albumin, there is a risk of severe hemolysis and acute renal failure if Sterile Water for Injection is improperly used as a diluent. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water, and adherence to these guidelines is crucial to minimize the risk of adverse effects.

Drug Interactions

Plasbumin-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 Plasbumin-25 with protein hydrolysates, amino acid solutions, or solutions containing alcohol.

Healthcare professionals should ensure that Plasbumin-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 Plasbumin-25 alongside other intravenous solutions.

Biosimilarity

Plasbumin 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 Plasbumin (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, which necessitates careful monitoring during administration. Due to potential reductions in kidney function and the associated risk of circulatory overload, dosage adjustments may be required for this population.

Special precautions should be taken when administering Plasbumin-25 to geriatric patients, particularly those with a history of congestive cardiac failure or renal insufficiency, as these individuals are at a heightened risk for developing circulatory overload.

It is essential for the physician to thoroughly assess the risks and benefits of albumin administration in elderly patients, especially in those with comorbid conditions. This careful evaluation is critical to ensure patient safety and optimal therapeutic outcomes.

Pregnancy

Plasbumin-25 has not been studied 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, Plasbumin-25 should be administered to pregnant patients only if the potential benefits clearly outweigh any potential risks. Healthcare professionals are advised to carefully consider the necessity of treatment with Plasbumin-25 in this population.

Lactation

There are no available data from animal reproduction studies regarding Plasbumin-25. The effects of Plasbumin-25 on lactating mothers and breastfed infants have not been established. It is also unknown whether Plasbumin-25 can be excreted in human breast milk or if it can cause harm to a nursing infant.

Plasbumin-25 should be administered to lactating mothers only if clearly needed, taking into consideration the potential risks and benefits.

Renal Impairment

Patients with renal impairment should be closely monitored when administering Albumin (Human), 25%, 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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Plasbumin-25. Therefore, it is not known whether Plasbumin-25 can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Plasbumin-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 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 administration are infrequent. Reported 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.

The theoretical risk of transmission of Creutzfeldt-Jakob disease (CJD) is regarded as extremely low, with no documented cases of viral disease or CJD transmission linked to albumin. However, individuals receiving infusions of blood or plasma products may exhibit signs and/or symptoms of certain viral infections, particularly hepatitis C. It is recommended that any infections suspected by a physician to be transmitted by this product 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 to emphasize the importance of monitoring patients closely to prevent the potential for circulatory overload, particularly in cases of dehydration, where albumin should be administered alongside or followed by additional fluids.

Patients should be informed about the possibility of developing signs and/or symptoms of viral infections, such as hepatitis C, following infusions of blood or plasma products. Healthcare providers are responsible for reporting any suspected infections that may have been transmitted by this product to Grifols Therapeutics LLC at 1-800-520-2807.

It is critical to ensure that solutions which have been frozen are not used, and that the product is not 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 microbial contamination.

Prior to administration, parenteral drug products should be visually inspected for particulate matter and discoloration, whenever the solution and container allow for such inspection. Healthcare providers should instruct patients to always swab the stopper top with a suitable antiseptic immediately before entering the vial.

Finally, healthcare providers should be aware that a rapid rise in blood pressure may occur following the administration of a colloid with positive oncotic activity. Careful observation is necessary to detect and manage any severed blood vessels that may not have bled at lower blood pressure levels.

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 is not permitted, as it may compromise the integrity of the product. Additionally, it is imperative to adhere to the expiration date, as the product should not be used after this date to ensure safety and efficacy.

Additional Clinical Information

Plasbumin-25 is administered intravenously. Clinicians are advised to engage in discussions with patients regarding the risks and benefits associated with this product. It is important to exercise caution in cases of dehydration, as albumin should be administered with or followed by the addition of fluids to ensure patient safety.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Plasbumin as submitted by GRIFOLS USA, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)