Albutein

Description

ALBUTEIN 25% is a sterile, aqueous solution intended for single-dose intravenous administration, containing 25% human albumin (weight/volume). This product is derived from pooled human plasma obtained through a cold alcohol fractionation method. Each gram of protein in ALBUTEIN 25% is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate. The colloid osmotic effect of this solution is approximately five times greater than that of normal human plasma.

A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion, and the aluminum content does not exceed 200 micrograms per liter throughout the product's shelf life. The formulation is preservative-free and is manufactured from Source Plasma collected at FDA-approved plasmapheresis centers in the United States. Additionally, ALBUTEIN 25% undergoes a heating process at 60 °C for ten hours, which is effective in inactivating viruses.

Uses and Indications

This drug is indicated for the treatment of hypovolemia and is utilized in cardiopulmonary bypass procedures. It is also indicated for managing acute nephrosis and hypoalbuminemia. Additionally, this drug is indicated for the treatment of ovarian hyperstimulation syndrome and neonatal hyperbilirubinemia. It is effective in the management of adult respiratory distress syndrome (ARDS) and is recommended for the prevention of central volume depletion following paracentesis in patients with cirrhotic ascites.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For intravenous use only, the dosage and infusion rate should be tailored to meet the individual requirements of the patient.

Indications and Doses:

Hypovolemia:

• Adults: An initial dose of 25 g is recommended, which includes patients undergoing renal dialysis. For acute liver failure, an initial dose of 12 to 25 g is advised.

Cardiopulmonary Bypass Procedures:

• Adults: An initial dose of 25 g should be administered.

Acute Nephrosis:

• Adults: A dose of 25 g should be given in conjunction with a diuretic once daily for a duration of 7 to 10 days.

Hypoalbuminemia:

• Adults: A total dose of 50 to 75 g is indicated. For pre- and post-operative hypoproteinemia, the same dosage of 50 to 75 g is recommended. In burn therapy, after the first 24 hours, an initial dose of 25 g should be administered, with subsequent adjustments made to maintain a plasma protein concentration of 2.5 g per 100 mL. For third space protein loss due to infection, an initial dose of 50 to 100 g is suggested.

Ovarian Hyperstimulation Syndrome:

• Adults: A dose ranging from 50 g to 100 g should be infused over 4 hours, with the possibility of repeating the dose at intervals of 4 to 12 hours as necessary.

Neonatal Hyperbilirubinemia:

• Administer 1 g per kilogram of body weight prior to or during exchange transfusion.

Adult Respiratory Distress Syndrome (ARDS):

• Adults: An initial dose of 25 g should be infused over 30 minutes, with the option to repeat every 8 hours for up to 3 days if required.

Prevention of Central Volume Depletion After Paracentesis Due to Cirrhotic Ascites:

• Adults: Administer 8 g for every 1000 mL of ascitic fluid removed.

It is critical to avoid diluting the solution with sterile water for injection, as this may lead to hemolysis in recipients.

Contraindications

Use is contraindicated in patients with hypersensitivity to albumin preparations or any of the excipients. Additionally, the product should not be administered to individuals with severe anemia or cardiac failure when intravascular volume is normal or increased, due to the potential for exacerbating these conditions.

Warnings and Precautions

Suspicion of allergic or anaphylactic reactions necessitates the immediate discontinuation of the injection and the implementation of appropriate medical treatment. Healthcare professionals should remain vigilant for signs of such reactions during administration.

Hypervolemia may occur if the dosage and rate of infusion are not appropriately adjusted to the patient's volume status. Caution is advised in patients with conditions where hypervolemia and its consequences, or hemodilution, could pose a significant risk.

When administering concentrated albumin, it is essential to ensure that the patient is adequately hydrated. This precaution helps mitigate potential complications associated with the infusion.

Monitoring of electrolytes, coagulation, hematology parameters, and hemodynamic status is recommended during albumin administration. These parameters are critical for assessing the patient's response to treatment and for identifying any adverse effects promptly.

It is important to note that albumin should not be diluted with sterile water for injection, as this could compromise the integrity of the product.

As a derivative of human blood, albumin carries an extremely remote risk of transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD), despite effective donor screening and manufacturing processes. While there is a theoretical risk for the transmission of Creutzfeldt-Jakob disease (CJD), the actual risk is also considered extremely remote. To date, no cases of transmission of viral diseases, CJD, or vCJD have been identified for ALBUTEIN 25%.

Side Effects

Patients receiving treatment may experience a range of adverse reactions. Common adverse reactions include anaphylactoid type reactions, which necessitate careful monitoring during administration.

Serious side effects warrant immediate attention. In cases of suspected allergic or anaphylactic reactions, it is critical to discontinue the injection promptly and initiate appropriate medical treatment. Additionally, hypervolemia may occur if the dosage and rate of infusion are not properly adjusted to the patient's volume status. Caution is advised in patients with conditions where hypervolemia and its consequences, or hemodilution, could pose a significant risk. Severe anemia or cardiac failure may also occur, particularly in patients with normal or increased intravascular volume.

Hypersensitivity reactions have been noted in patients with a known hypersensitivity to albumin preparations or any of the excipients contained in the formulation.

It is important to note that albumin is derived from human blood. Although effective donor screening and manufacturing processes minimize risks, there remains an extremely remote possibility of transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). The theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) exists, but if such a risk is present, it is also considered extremely remote. To date, no cases of transmission of viral diseases, CJD, or vCJD have been identified for ALBUTEIN 25%.

Drug Interactions

ALBUTEIN 25% should not be mixed with other medicinal products due to the potential for adverse interactions. This precaution is critical to ensure the safety and efficacy of the treatment. It is advised that healthcare professionals administer ALBUTEIN 25% as a standalone product to avoid any complications that may arise from mixing with other medications. Monitoring for any unexpected reactions is recommended when administering ALBUTEIN 25% in conjunction with other therapies, although it should not be combined directly with other medicinal products.

Biosimilarity

Albutein 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 Albutein (albumin (human)) originator presentations. Columns show Packaging, Form, and Strength.

Pediatric Use

Pediatric patients should only be treated with this medication if clearly needed, as there are no available human or animal data to support its use in this population. Caution is advised when considering treatment options for children, infants, and adolescents.

Geriatric Use

Elderly patients should be prescribed this medication with caution, as there are no available human or animal data to support its safety and efficacy in this population. It is recommended that this medication be used only when clearly needed, taking into consideration the potential risks and benefits.

Healthcare providers are advised to closely monitor geriatric patients for any adverse effects or complications that may arise during treatment. Given the lack of specific data, careful assessment of each elderly patient's overall health status and concurrent medications is essential to ensure safe and effective use.

Pregnancy

There is no data available regarding the use of ALBUTEIN 25% in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ALBUTEIN 25%, and it remains unknown whether ALBUTEIN 25% can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, ALBUTEIN 25% should be administered to a pregnant woman only if clearly needed.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Healthcare professionals should consider these background risks when evaluating the potential benefits and risks of ALBUTEIN 25% in pregnant patients.

Lactation

There is no data available regarding the use of ALBUTEIN 25% in nursing mothers to inform a drug-associated risk. It is not known whether ALBUTEIN 25% can be excreted in human milk. Therefore, caution should be exercised when ALBUTEIN 25% is administered to a lactating mother.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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, as the lack of detailed overdosage data does not preclude the possibility of adverse effects. Symptoms may vary 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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the situation. Documentation of the incident and any interventions performed is crucial for ongoing patient care and future reference.

Nonclinical Toxicology

There is no data available regarding the use of ALBUTEIN 25% in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ALBUTEIN 25%, and it remains unknown whether ALBUTEIN 25% can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, ALBUTEIN 25% should be administered to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

No cases of transmission of viral diseases, including Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD), have ever been identified in relation to ALBUTEIN 25%.

No specific nonclinical toxicology data or animal pharmacology and toxicology data have been provided in the insert.

Postmarketing Experience

Patients treated with ALBUTEIN 25% are advised of the associated risks and benefits of its use. They should be instructed to promptly report any signs and symptoms indicative of allergic or anaphylactic reactions, as well as symptoms of cardiovascular overload, which may include headache, dyspnea, and jugular venous distention. Additionally, patients should be aware of the potential for increased blood pressure, raised venous pressure, and pulmonary edema.

ALBUTEIN 25% is derived from human plasma and may contain infectious agents that could lead to disease, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease (CJD). The risk of transmission of infectious agents through ALBUTEIN 25% has been mitigated by screening plasma donors for prior exposure to specific viruses, testing the donated plasma for certain viral agents, and implementing manufacturing processes designed to inactivate and/or remove certain viruses.

Patient Counseling

Healthcare providers should inform patients being treated with ALBUTEIN 25% about the associated risks and benefits of its use. It is essential for patients to understand the importance of promptly reporting any signs and symptoms that may indicate adverse reactions. Specifically, patients should be advised to immediately notify their physician if they experience allergic or anaphylactic reactions, cardiovascular overload (which may present as headache, dyspnea, or jugular venous distention), or symptoms such as increased blood pressure, raised venous pressure, and pulmonary edema.

Patients should be made aware that ALBUTEIN 25% is derived from human plasma and may contain infectious agents that could potentially cause disease, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease (CJD). However, it is important to communicate that the risk of transmitting an infectious agent through ALBUTEIN 25% has been mitigated by screening plasma donors for prior exposure to certain viruses, testing the donated plasma for specific viral agents, and implementing manufacturing processes designed to inactivate and/or remove certain viruses.

The healthcare provider and the patient should engage in a thorough discussion regarding the risks and benefits of using this product. In cases of dehydration, it is recommended that additional fluids be administered with or immediately following the administration of ALBUTEIN 25%.

Patients must be instructed not to use ALBUTEIN 25% if the solution appears turbid and to refrain from beginning administration more than four hours after the container has been entered.

Storage and Handling

ALBUTEIN 25% is supplied in single-use vials that are individually laser etched for identification. Each vial is designed for one-time use to ensure product integrity and safety.

For optimal storage, ALBUTEIN 25% should be maintained at a temperature not exceeding 30 °C. The product is stable for a period of three years under these conditions. It is crucial to protect ALBUTEIN 25% from freezing to preserve its efficacy and quality.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

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

View full prescribing information (PDF)