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 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. Notably, ALBUTEIN 25% is free from preservatives and is manufactured from Source Plasma collected at FDA-approved plasmapheresis centers in the United States. Additionally, the solution undergoes a heating process at 60 °C for ten hours, which is effective in inactivating viruses.

Uses and Indications

ALBUTEIN 25% is indicated for the treatment of hypovolemia, management during cardiopulmonary bypass procedures, and the treatment of acute nephrosis. It is also indicated for the correction of hypoalbuminemia, management of ovarian hyperstimulation syndrome, and treatment of neonatal hyperbilirubinemia. Additionally, ALBUTEIN 25% is indicated for the management of adult respiratory distress syndrome (ARDS) and for the prevention of central volume depletion following paracentesis in patients with cirrhotic ascites.

No teratogenic or nonteratogenic effects have been reported for ALBUTEIN 25%.

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.

• In cases of 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, a dose of 50 to 75 g is also recommended.

• In burn therapy, after the first 24 hours, an initial dose of 25 g should be given, 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 of 50 g to 100 g should be infused over 4 hours, with repeat doses at 4 to 12-hour intervals 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 necessary.

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 important to note that this product should not be diluted 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 and hematology parameters, as well as 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 product 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 may experience a range of adverse reactions associated with the use of this product. Common adverse reactions include anaphylactoid type reactions. In the event of suspected allergic or anaphylactic reactions, immediate discontinuation of the injection is required, along with the implementation of appropriate medical treatment.

Serious adverse reactions may arise in patients with hypersensitivity to albumin preparations or any of the excipients. Additionally, patients with severe anemia or cardiac failure, despite having normal or increased intravascular volume, should be closely monitored.

Hypervolemia is a potential concern if the dosage and rate of infusion are not appropriately adjusted to the patient's volume status. Caution is advised in patients where hypervolemia and its consequences, or hemodilution, could pose a special risk. When administering concentrated albumin, it is essential to ensure adequate hydration of the patient.

Monitoring of electrolytes, coagulation and hematology parameters, as well as hemodynamic status, is recommended during albumin administration. It is important to note that albumin is a derivative of human blood, and while effective donor screening and product manufacturing processes minimize risks, there remains an extremely remote risk of transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). Although there is a theoretical risk for the transmission of Creutzfeldt-Jakob disease (CJD), no cases of transmission of viral diseases, CJD, or vCJD have ever 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 signs of adverse reactions is recommended when administering ALBUTEIN 25% in a clinical setting.

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 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 should closely monitor geriatric patients for any adverse effects and consider appropriate dosage adjustments based on individual patient needs and responses.

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 is 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 regarding the use of ALBUTEIN 25% in lactating mothers to inform a drug-associated risk. It is currently unknown whether ALBUTEIN 25% is excreted in human milk. Caution should be exercised when administering ALBUTEIN 25% to a nursing mother.

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 patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 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 attention should be sought. 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, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 are advised 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).

The risk of transmission of infectious agents through ALBUTEIN 25% has been mitigated through several measures. These include the screening of plasma donors for prior exposure to specific viruses, testing of the donated plasma for certain viral agents, and the implementation of 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), increased blood pressure, raised venous pressure, or pulmonary edema.

Patients should also 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 several safety measures. These include 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.

Healthcare providers should encourage an open dialogue between the patient and physician regarding the risks and benefits of ALBUTEIN 25%. Additionally, in cases of dehydration, patients should be advised to receive additional fluids either with or immediately following the administration of ALBUTEIN 25%.

Storage and Handling

ALBUTEIN FlexBag 25% is supplied in a configuration that ensures optimal stability and efficacy. The product is stable for a duration of two years when stored at temperatures not exceeding 30 °C. It is imperative to protect the product from freezing to maintain its integrity. Additionally, the overwrap should remain intact until the product is ready for use to ensure proper storage conditions are upheld.

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)