Plasbumin

Description

Albumin (Human) 5%, USP (Plasbumin®-5) 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-5 is a sterile 5% 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, and 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 contains no preservatives and is intended for intravenous administration.

Each vial of Plasbumin-5 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-5 is iso-oncotic with normal plasma and, upon 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 (Plasbumin-5). In cases where there is an oncotic deficit, Albumin (Human) 25%, USP (Plasbumin-25) may be preferred.

The use of albumin infusion may be required to support blood volume in patients undergoing removal of ascitic fluid due to cirrhosis, as this procedure may lead to changes in cardiovascular function and potentially result in hypovolemic shock.

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 Plasbumin-25 being preferred for this purpose.

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, characterized by rapid loss of liver function with or without coma, the administration of albumin may support both the colloid osmotic pressure of plasma and bind excess plasma bilirubin.

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

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Plasbumin-5 is to be administered exclusively via intravenous infusion. The volume and rate of administration should be tailored to the individual patient's response.

For neonates and infants, Plasbumin-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. This target is best achieved through the intravenous administration of Plasbumin, preferably in the form of Plasbumin-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

Plasbumin-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 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, and unknown infectious agents may also be present. Healthcare providers should report any suspected infections that may be linked to this product to Grifols Therapeutics LLC at 1-800-520-2807. Prior to prescribing or administering Plasbumin-5, physicians must discuss the associated risks and benefits with the patient.

Patients receiving Plasbumin-5 should be monitored closely to prevent circulatory overload. As Plasbumin-5 is iso-oncotic with normal plasma, it does not typically exacerbate tissue dehydration. If necessary, additional crystalloids should be administered 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 caused by hemodilution. It is important to recognize that hemodilution following albumin administration can persist for several hours in patients with reduced circulating blood volume, while it lasts for a shorter duration in those with normal blood volume. 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, changes in respiration, alterations in pulse, and fluctuations in blood pressure.

Plasbumin-5, which is derived from human plasma, carries warnings regarding the potential transmission of infectious agents, including viruses and, theoretically, 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 risk of transmitting infectious agents has been mitigated through rigorous screening of plasma donors for prior exposure to certain viruses, testing for current viral infections, and employing methods to inactivate or remove specific viruses. Nonetheless, there remains a possibility that unknown infectious agents may be present in these products. Patients receiving infusions of blood or plasma products should be monitored for signs and symptoms of viral infections, particularly hepatitis C. Any suspected infections believed to be transmitted by this product should be reported to Grifols Therapeutics LLC at 1-800-520-2807.

Certain contraindications exist for the use of albumin, particularly in patients with a history of congestive cardiac failure, renal insufficiency, or stabilized chronic anemia, as these individuals are at an increased risk of developing circulatory overload. Additionally, a documented history of allergic reaction to albumin serves as a specific contraindication for its use.

Drug Interactions

Plasbumin-5 demonstrates compatibility with various intravenous solutions and blood products. 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. Plasbumin-5 should not be combined with protein hydrolysates, amino acid solutions, or solutions containing alcohol. Mixing with these substances may lead to adverse effects or reduced efficacy of Plasbumin-5. Therefore, it is essential to adhere to these guidelines to ensure safe and effective use of the product.

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, particularly those aged 65 and older, may exhibit different physiological responses to treatment compared to younger individuals. In cases of shock, crystalloid solutions administered in volumes significantly greater than that of Plasbumin-5 may be effective for younger patients without preexisting conditions. However, geriatric patients, especially those with preexisting debilitating conditions or those whose shock is attributable to a medical disorder, may not tolerate hypoalbuminemia as effectively.

It is crucial to monitor elderly patients closely to mitigate the risk of circulatory overload. Certain individuals, such as those with a history of congestive cardiac failure, renal insufficiency, or stabilized chronic anemia, are particularly susceptible to this complication. Therefore, healthcare providers should adjust the volume and speed of administration based on the individual patient's response, taking into account the unique physiological considerations of older patients.

Pregnancy

Plasbumin-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, Plasbumin-5 should be prescribed to pregnant patients only if the benefits clearly outweigh the risks. Healthcare professionals are advised to carefully consider the necessity of treatment with Plasbumin-5 in this population.

Lactation

Plasbumin-5 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 Plasbumin-5 can cause harm to a breastfed infant or affect lactation.

Given the lack of information, Plasbumin-5 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific guidance.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Plasbumin-5. The potential for Plasbumin-5 to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, Plasbumin-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 elevated 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 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 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 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. 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. Providers should emphasize the importance of not beginning administration more than four hours after the container has been entered, and that any partially used vials must be discarded.

Providers should also advise patients against using vials that are cracked, previously entered, or damaged, as these conditions may allow for the entry of microorganisms. Continuous monitoring of patients is crucial to prevent the risk of circulatory overload. If necessary, appropriate additional crystalloids should be administered to maintain normal fluid balance.

In cases of hemorrhage, it is important to supplement the administration of albumin with the transfusion of whole blood to address the relative anemia associated with hemodilution. Providers should be aware that a rapid rise in blood pressure may occur following the administration of a colloid with positive oncotic activity, necessitating careful observation to identify and treat any severed blood vessels that may not have bled at lower blood pressure.

Providers should inform patients that animal reproduction studies have not been conducted with Plasbumin-5, and it is unknown whether it can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, Plasbumin-5 should only be given to pregnant women if clearly needed. Additionally, safety and effectiveness in the pediatric population have not been established.

While adverse reactions to albumin are rare, providers should make patients aware that such reactions may be allergic in nature or due to high plasma protein levels resulting from excessive albumin administration. Patients should be informed of potential allergic manifestations, which may include urticaria, chills, fever, and changes in respiration, pulse, and blood pressure.

Storage and Handling

Plasbumin-5 is supplied in rubber-stoppered vials with the following configurations: 50 mL, 250 mL, and 500 mL.

For optimal storage, Plasbumin-5 should be maintained at room temperature, not exceeding 30°C (86°F). It is imperative to avoid freezing the product. Additionally, the product should not be used after the expiration date indicated on the packaging.

Additional Clinical Information

Plasbumin-5 is administered intravenously, and it is essential for clinicians to ensure proper administration techniques are followed. Patients should engage in discussions with their healthcare providers regarding the potential risks and benefits associated with the use of this product to make informed decisions about their treatment.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)