Plasbumin

Description

Albumin (Human) 20%, USP (Plasbumin®-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 requirements set forth by the U.S. Food and Drug Administration.

Plasbumin-20 is a sterile 20% solution of 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 of Plasbumin-20 undergoes heat treatment at 60°C for 10 hours to mitigate the risk of transmitting hepatitis viruses. 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-20 is hyperoncotic and, when administered intravenously, can expand plasma volume by three to four times the volume infused, provided the patient is normally hydrated interstitially or has interstitial edema. In cases of dehydration, additional crystalloids should be administered, or alternatively, Albumin (Human) 5%, USP (Plasbumin-5) should be utilized.

Plasbumin-20 is also indicated for the removal of ascitic fluid in patients with cirrhosis, where it may be necessary to support blood volume to prevent changes in cardiovascular function and potential hypovolemic shock.

In burn therapy, Plasbumin-20 can be used beyond the first 24 hours post-thermal injury to maintain plasma colloid osmotic pressure after large volumes of crystalloids have been infused to restore extracellular fluid volume.

The drug is indicated for the treatment of hypoproteinemia with or without edema, particularly in patients undergoing major surgery, sepsis, or those in intensive care who may experience significant loss of circulating albumin.

In cases of Adult Respiratory Distress Syndrome (ARDS), Plasbumin-20, in conjunction with a diuretic, may be beneficial when clinical signs indicate hypoproteinemia with fluid volume overload.

Plasbumin-20 is indicated for preoperative dilution of blood during cardiopulmonary bypass, as this practice has been shown to be safe and well-tolerated.

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

For neonatal hemolytic disease, Plasbumin-20 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 in conditions such as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis, where an infusion of albumin may be necessary to address reduced volume or oncotic activity.

In the context of erythrocyte resuspension, albumin may be required to prevent excessive hypoproteinemia during certain exchange transfusions or when large volumes of previously frozen or washed red cells are used.

For patients with acute nephrosis, a loop diuretic combined with 100 mL of Plasbumin-20, repeated daily for 7 to 10 days, may assist in controlling edema in those who do not respond to cyclophosphamide or steroid therapy.

Lastly, Plasbumin-20 may be valuable in treating shock or hypotension in patients undergoing renal dialysis.

Dosage and Administration

Plasbumin-20 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-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 of Plasbumin-20 administered and the infusion speed 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 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 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-20 is derived from human plasma, which carries inherent risks associated with infectious agents, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob Disease (CJD). 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 products. 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 blood or plasma product infusions. 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 Plasbumin-20, physicians are advised to engage in a thorough discussion with patients regarding the associated risks and benefits of the treatment.

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

It is critical to adhere to specific handling guidelines: solutions that have been frozen must not be used, and the product should not be administered if turbid. Administration should commence no later than 4 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. Notably, Albumin (Human) 20%, USP (Plasbumin®-20) does not contain any preservatives.

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.

Plasbumin-20, derived from human plasma, 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 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. Nonetheless, there remains a possibility that unknown infectious agents may be present in such products. Patients receiving infusions of blood or plasma products should be aware that they may develop signs or symptoms of viral infections, particularly hepatitis C. Any infections suspected to be transmitted by this product should be reported to Grifols Therapeutics LLC at 1-800-520-2807.

It is essential for healthcare providers to monitor patients closely to prevent circulatory overload, particularly in those with a history of congestive cardiac failure, renal insufficiency, or stabilized chronic anemia, as these individuals are at increased risk. In cases of hemorrhage, the administration of albumin should be accompanied by whole blood transfusions to address the relative anemia associated with hemodilution. Additionally, the rapid increase in blood pressure that may occur 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. A history of allergic reactions to albumin serves as a specific contraindication for its use.

Drug Interactions

Plasbumin-20 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-20 with protein hydrolysates, amino acid solutions, or solutions containing alcohol.

Healthcare professionals should ensure that Plasbumin-20 is administered in accordance with these compatibility guidelines to avoid potential adverse interactions. Monitoring for any signs of incompatibility is advised when administering Plasbumin-20 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, the use of this medication in children, infants, and adolescents should be approached with caution until further data is available.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of Plasbumin-20. Therefore, caution is advised when administering this medication to geriatric patients, particularly due to the potential for reduced kidney function commonly observed in this population.

Dosage adjustments may be necessary for elderly patients, especially those with compromised renal function, to ensure safety and efficacy. Additionally, close monitoring for signs of circulatory overload is recommended, as elderly patients may be at a higher risk for this complication. It is essential for healthcare providers to consider these factors when treating geriatric patients with Plasbumin-20 to optimize therapeutic outcomes and minimize adverse effects.

Pregnancy

Plasbumin-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, Plasbumin-20 should be administered to pregnant patients only if the benefits clearly outweigh the risks. Healthcare professionals are advised to consider the necessity of treatment with Plasbumin-20 in this population and to weigh the potential risks to fetal outcomes against the clinical need for the medication.

Lactation

There are no available data on the excretion of Plasbumin-20 in human breast milk, nor have animal reproduction studies been conducted to assess its effects on lactation. Consequently, it is unknown whether Plasbumin-20 can cause harm to a breastfed infant or affect milk production in lactating mothers.

Plasbumin-20 should be administered to lactating mothers only if clearly needed, taking into consideration the potential risks and benefits. Healthcare professionals are advised to monitor breastfed infants for any adverse effects if Plasbumin-20 is administered to a nursing mother.

Renal Impairment

Patients with renal impairment should be closely monitored when receiving Albumin (Human), 20%, particularly due to the risk of severe hemolysis and acute renal failure associated with the inappropriate use of diluents. It is essential 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 crucial 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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Plasbumin-20. Therefore, it is not known whether Plasbumin-20 can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Plasbumin-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 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. Allergic manifestations observed 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 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. 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 for patients to understand the potential implications of treatment.

Caution should be exercised in patients who are dehydrated; albumin must be administered with or followed by the addition of fluids to mitigate risks. Continuous monitoring of patients is crucial to prevent the possibility of circulatory overload, particularly in individuals with a history of congestive cardiac failure, renal insufficiency, or stabilized chronic anemia, as they are at an increased risk.

Patients should be informed about the potential for developing signs and/or symptoms of viral infections, such as hepatitis C, following infusions of blood or plasma products. Any suspected infections that may have been transmitted through this product should be reported to Grifols Therapeutics LLC at 1-800-520-2807.

It is important to instruct 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. Vials that are cracked, previously entered, or damaged should also be avoided, as these conditions may allow for the entry of microorganisms. Additionally, a history of allergic reactions to albumin constitutes a specific contraindication for its use.

Storage and Handling

The product is available in 50 mL and 100 mL rubber-stoppered vials. It should be stored at room temperature, not exceeding 30°C (86°F). Freezing is not permitted, and the product must not be used after the expiration date.

Additional Clinical Information

Plasbumin-20 is 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 Plasbumin as submitted by GRIFOLS USA, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)