Albutein

Description

ALBUTEIN 5% is a sterile, aqueous solution intended for single-dose intravenous administration, containing 5% human albumin (weight/volume). This product is derived from pooled human plasma obtained through a cold alcohol fractionation method from venous blood. Each liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion and is osmotically and isotonically equivalent to an equal volume of normal human plasma.

The formulation is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The aluminum content is maintained at not more than 200 micrograms per liter throughout the product's shelf life, and it contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected at FDA-approved plasmapheresis centers in the United States and undergoes a heating process at 60 °C for ten hours, which is effective in inactivating viruses.

Uses and Indications

ALBUTEIN 5% is indicated for the treatment of hypovolemia, management during cardiopulmonary bypass procedures, correction of hypoalbuminemia, and facilitation of plasma exchange.

There are no teratogenic or nonteratogenic effects associated with ALBUTEIN 5%.

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:

• For adults, the initial dose is 20 g, which includes patients undergoing renal dialysis.

• In cases of acute liver failure, the initial dose ranges from 12 to 25 g.

Cardiopulmonary Bypass Procedures:

• For adults, an initial dose of 25 g is recommended.

Hypoalbuminemia:

• For adults, the dosage ranges from 50 to 75 g.

• In the context of pre- and post-operative hypoproteinemia, the same dosage of 50 to 75 g is advised.

• For 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.

• In cases of third space protein loss due to infection, an initial dose of 50 to 100 g is indicated.

Plasma Exchange:

• The required dose will depend on the volume of plasma removed during the procedure.

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

Contraindications

Use of this product is contraindicated in patients with hypersensitivity to albumin preparations or any of the excipients. Additionally, it 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.

Caution is advised regarding the potential for hypervolemia, particularly if the dosage and rate of infusion are not appropriately adjusted to the patient's volume status. This condition may pose special risks in patients with pre-existing conditions where hypervolemia and its consequences, or hemodilution, could be detrimental.

When administering albumin, it is essential to monitor electrolytes, coagulation and hematology parameters, as well as the patient's hemodynamic status. These monitoring parameters are critical to ensure patient safety and to mitigate any adverse effects associated with the treatment.

It is imperative to avoid diluting albumin with sterile water for injection, as this could compromise the integrity of the product.

As albumin is derived from human blood, it 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, if it exists, is also considered extremely remote. Notably, no cases of transmission of viral diseases, CJD, or vCJD have ever been identified for ALBUTEIN 5%.

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 any suspicion of allergic or anaphylactic reactions, immediate discontinuation of the injection is required, along with the implementation of appropriate medical treatment.

Serious adverse reactions may include hypervolemia, which can occur if the dosage and rate of infusion are not adjusted to the patient's volume status. Caution is advised in patients with conditions where hypervolemia and its consequences, or hemodilution, could pose a special risk.

Hypersensitivity reactions may occur in patients with known hypersensitivity to albumin preparations or any of the excipients contained in the formulation. Additionally, cardiovascular complications such as severe anemia or cardiac failure may arise, even in the presence of normal or increased intravascular volume.

It is important to note that albumin is a derivative of human blood. Although effective donor screening and product manufacturing processes are in place, there remains an extremely remote risk of transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). While there is a theoretical risk for the transmission of Creutzfeldt-Jakob disease (CJD), if such a risk exists, it is also considered extremely remote. Notably, no cases of transmission of viral diseases, CJD, or vCJD have ever been identified for ALBUTEIN 5%.

Drug Interactions

ALBUTEIN 5% 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 5% 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 5% in conjunction with other therapies.

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 versus 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 the individual patient's health status and needs is essential before initiating therapy in this demographic.

Pregnancy

There is no data available regarding the use of ALBUTEIN 5% in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ALBUTEIN 5%, and it remains unknown whether ALBUTEIN 5% can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, ALBUTEIN 5% 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 weigh the potential benefits against the unknown risks when considering the use of ALBUTEIN 5% in pregnant patients.

Lactation

There is no information regarding the presence of ALBUTEIN 5% in human milk, the effect on breastfed infants, or the effects on milk production.

The developmental and health benefits of breastfeeding should be considered alongside the clinical need for ALBUTEIN 5% in lactating mothers, as well as any potential adverse effects on the breastfed infant from ALBUTEIN 5%.

Renal Impairment

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

There is no data available regarding the use of ALBUTEIN 5% in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ALBUTEIN 5%, and it remains unknown whether ALBUTEIN 5% can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, ALBUTEIN 5% 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 specific non-teratogenic effects or nonclinical toxicology details are provided in the available data. Additionally, there are no details regarding animal pharmacology and toxicology.

Postmarketing Experience

Patients are advised that ALBUTEIN 5% 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 5% 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 5% about the associated risks and benefits of its use. It is essential for patients to understand the importance of reporting any signs and symptoms of concern to their physician immediately. These include allergic or anaphylactic reactions, cardiovascular overload characterized by headache, dyspnea, and jugular venous distention, as well as increased blood pressure, raised venous pressure, and pulmonary edema.

Patients should be made aware that ALBUTEIN 5% 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 5% has been mitigated by screening plasma donors for prior exposure to certain viruses, testing the donated plasma for specific viral agents, and implementing manufacturing steps designed to inactivate and/or remove certain viruses.

Healthcare providers should encourage a discussion between the patient and physician regarding the risks and benefits of ALBUTEIN 5%. For detailed information on dosage and directions for administration, patients should refer to the accompanying pamphlet. Additionally, patients must be advised not to use ALBUTEIN 5% 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 5% is supplied in single-use vials that are individually laser etched for identification. Each vial is designed for single use to ensure product integrity and safety.

For optimal storage, ALBUTEIN 5% 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 essential to protect the vials from freezing to preserve the efficacy and quality of the solution.

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)