Alburx

Description

ALBURX® 25 is a sterile aqueous solution for intravenous administration, containing a 25% concentration of albumin derived from human blood. The solution is characterized by its clear and slightly viscous appearance, which may range from almost colorless to yellow, amber, or green.

This product is prepared from the plasma of US donors through a manufacturing process that includes alcohol fractionation, followed by a heat treatment at 60°C for 10 hours to inactivate potential infectious agents. Validation studies have demonstrated that this process effectively eliminates both enveloped and non-enveloped viruses.

The formulation includes 0.14 M (3.2 mg/mL) sodium, with aluminum content not exceeding 200 mcg/L and potassium content limited to ≤ 0.002 M. To ensure stability, the solution is supplemented with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. Notably, the solution is free from preservatives.

Uses and Indications

ALBURX® 25, Albumin (Human) 25% solution, is indicated for the expansion of plasma volume in patients experiencing acute volume deficit, provided that interstitial water is available for inflow through capillary walls. This product is also indicated for the treatment of hypoproteinemia resulting from various etiologies, including but not limited to protein-calorie malnutrition, defective absorption due to gastrointestinal disorders, impaired albumin synthesis in chronic hepatic failure, increased protein catabolism associated with postoperative states or sepsis, and abnormal renal losses of albumin in chronic kidney disease.

ALBURX® 25 is appropriate for use in the following clinical scenarios:

• Shock

• Burns

• Adult Respiratory Distress Syndrome

• Cardiopulmonary Bypass

• Pre- and postoperative hypoproteinemia

• Third space problems of infectious origin

• Acute liver failure

• Acute nephrosis

• Ascites

• Red cell resuspension media

• Renal dialysis

• Hemolytic disease of the newborn

There are no teratogenic or nonteratogenic effects associated with ALBURX® 25.

Dosage and Administration

ALBURX® 25, Albumin (Human) 25% solution, must be administered intravenously. Prior to administration, the venipuncture site should be free from infection and trauma, and it should be prepared using standard aseptic techniques.

The solution is compatible with whole blood, packed red cells, and standard electrolyte and carbohydrate solutions intended for intravenous use. However, it should not be mixed with protein hydrolysates, amino acid mixtures, or solutions containing alcohol.

Dosage of ALBURX® 25 should be determined based on the principles outlined in the section on INDICATIONS AND USAGE, while always considering the individual patient's situation. For the treatment of a volume deficit, the total dose should not exceed 2 g per kg body weight in the absence of active hemorrhage.

To correct an oncotic deficit, the required dose in grams of protein can be estimated by calculating the difference between the desired and actual total serum protein (TSP) level, multiplied by the plasma volume (approximately 40 mL/kg) and then multiplied by 2.

For binding free serum bilirubin in severely hemolytic infants, the appropriate dose is 1 g/kg body weight, which should be administered approximately one hour prior to the exchange transfusion.

Contraindications

The use of ALBURX® 25, Albumin (Human) 25% solution is contraindicated in individuals with a history of an incompatibility reaction to Albumin (Human). This contraindication is based on the potential for severe adverse reactions in patients with prior sensitivity to the product.

Warnings and Precautions

ALBURX® 25, Albumin (Human) 25% solution is derived from human plasma, which carries inherent risks associated with infectious agents, including viruses that may cause disease. Although the risk of transmission has been significantly mitigated through rigorous screening of plasma donors, testing for current viral infections, and employing inactivation and removal techniques such as alcohol fractionation and heat treatment (10 hours at 60°C), the potential for disease transmission remains. The theoretical risk of Creutzfeldt-Jakob Disease (CJD) transmission is considered extremely remote, and no cases of viral disease or CJD transmission have been documented with Albumin (Human). However, the possibility of unknown infectious agents cannot be excluded. Healthcare providers are encouraged to report any suspected infections potentially linked to this product to the CSL Behring Pharmacovigilance Department at 1-866-915-6958. It is imperative that physicians discuss the associated risks and benefits of ALBURX® 25 with their patients prior to administration.

Administration of ALBURX® 25 should only be conducted with clear solutions; turbid solutions are contraindicated and must not be used. Furthermore, the administration set should not be introduced more than 4 hours prior to the start of administration to ensure product integrity. Any partially used bottles of ALBURX® 25 must be discarded to prevent contamination and ensure patient safety.

Healthcare professionals should also be aware of the risks associated with the use of inappropriate diluents. The use of sterile water for injection as a diluent for ALBURX® 25 poses a risk of potentially fatal hemolysis and acute renal failure. Acceptable diluents include 0.9% sodium chloride or 5% dextrose in water, and adherence to these guidelines is essential for safe administration.

Side Effects

Patients receiving ALBURX® 25, Albumin (Human) 25% solution may experience a range of adverse reactions. Among these, non-septic incompatibility reactions have been reported, albeit very rarely. These reactions can include nausea, chills, fever, urticaria, headache, and hypotension.

Severe allergic reactions, such as anaphylactic shock, have also been documented in some cases.

It is important to note the associated risks outlined in the warnings. There is a risk of bacterial contamination, which may lead to post-infusion septicemia if the container is damaged or if the rubber cap is punctured. Additionally, the inappropriate use of sterile water for injection as a diluent for ALBURX® 25 can result in potentially fatal hemolysis and acute renal failure. Acceptable diluents include 0.9% sodium chloride or 5% dextrose in water.

Patients with a history of incompatibility reactions to Albumin (Human) should not receive this product, as it is contraindicated in such individuals.

Drug Interactions

ALBURX 25, Albumin (Human) 25% solution has specific drug interactions and considerations that healthcare professionals should be aware of to ensure safe and effective use.

Drug Interactions and Considerations

ALBURX 25 should not be mixed with protein hydrolysates, amino acid mixtures, or solutions containing alcohol, as these combinations may lead to adverse effects or reduced efficacy.

In patients with acute nephrosis who do not respond to cyclophosphamide or steroid therapy, the combination of 100 mL of 20–25% Albumin (Human) solution with an appropriate diuretic may be beneficial in eliciting a therapeutic response.

The use of ALBURX 25 for resuspending red blood cells is indicated only in exceptional circumstances, such as specific types of exchange transfusions or when administering very large volumes of erythrocyte concentrates and frozen or washed red cells.

For patients undergoing long-term hemodialysis, ALBURX 25 may be necessary to address a volume or oncotic deficit, highlighting its role in managing fluid balance in this population.

In cases of hemolytic disease of the newborn, ALBURX 25 can be utilized to bind and detoxify free serum bilirubin while awaiting an exchange transfusion.

Healthcare providers should closely monitor patients receiving ALBURX 25 for signs of circulatory overload, particularly in those with chronic anemia, congestive heart failure, or renal insufficiency, as these conditions may increase the risk of adverse effects.

Biosimilarity

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

Pediatric Use

Pediatric patients requiring treatment with ALBURX 25, Albumin (Human) 25% solution for the binding of free serum bilirubin in cases of severe hemolysis should receive a dosage of 1 g/kg body weight. This dose is to be administered approximately one hour prior to the exchange transfusion. Caution is advised when treating hypervolemic infants to avoid potential complications.

Geriatric Use

Elderly patients, particularly those aged 65 and older, require special caution when treated with ALBURX 25, Albumin (Human) 25% solution. This population may present with stabilized chronic anemia, congestive heart failure, and renal insufficiency, conditions that necessitate careful monitoring and consideration of potential risks.

For patients undergoing long-term hemodialysis, ALBURX 25 may be indicated for the treatment of a volume or oncotic deficit. It is essential that the initial dose does not exceed 100 mL of a 20–25% solution. Due to the heightened sensitivity of geriatric patients to circulatory overload, close observation for signs of this condition is imperative following administration. Adjustments to dosing and vigilant monitoring are critical to ensure the safety and efficacy of treatment in this vulnerable population.

Pregnancy

Animal reproduction studies have not been conducted with ALBURX® 25, Albumin (Human) 25% solution. Therefore, it is not known whether ALBURX® 25 can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. ALBURX® 25 should be given to a pregnant woman only if clearly needed. However, there is no evidence for any contraindication to the use of ALBURX® 25 specifically associated with reproduction, pregnancy, or the fetus. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of ALBURX® 25 in pregnant patients.

Lactation

It is not known whether ALBURX® 25 is excreted in human breast milk or if it can cause harm to a breastfed infant. Therefore, caution should be exercised when administering ALBURX® 25 to lactating mothers.

ALBURX® 25 should be given to a lactating mother only if clearly needed, as there is no evidence for any contraindication to its use specifically associated with reproduction, pregnancy, or the fetus. Further studies may be necessary to fully understand the implications of ALBURX® 25 use during lactation.

Renal Impairment

Patients with renal impairment may be at increased risk of potentially fatal hemolysis and acute renal failure if sterile water for injection is used as a diluent for ALBURX® 25, Albumin (Human) 25% solution. It is essential to use acceptable diluents, such as 0.9% sodium chloride or 5% dextrose in water, to mitigate these risks. Healthcare professionals should exercise caution and ensure appropriate diluent selection when administering this product to 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 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, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with ALBURX 25, Albumin (Human) 25% solution. The potential for ALBURX 25 to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, ALBURX 25 should be administered to a pregnant woman only if clearly needed. However, there is no evidence indicating any contraindication to the use of ALBURX 25 specifically associated with reproduction, pregnancy, or the fetus.

No specific non-teratogenic effects or additional nonclinical toxicology details have been provided. Furthermore, there are no specific animal pharmacology and toxicology details available in the current data.

Postmarketing Experience

Products derived from human plasma may contain infectious agents, including viruses, that can lead to disease. The risk of transmitting such infectious agents has been significantly minimized through rigorous screening of plasma donors for prior exposure to specific viruses, testing for current virus infections, and employing inactivation and/or removal techniques, such as alcohol fractionation and heat treatment at 60°C for 10 hours in the final container. Despite these precautions, there remains a potential for disease transmission. The theoretical risk of Creutzfeldt-Jakob Disease (CJD) transmission is considered extremely remote, and no cases of viral disease or CJD transmission have been documented for Albumin (Human). However, the possibility of unknown infectious agents being present in these products cannot be excluded. Any infections suspected by a physician to be transmitted by this product should be reported to the CSL Behring Pharmacovigilance Department at 1-866-915-6958. Physicians are advised to discuss the associated risks and benefits of this product with their patients.

Although rare, non-septic incompatibility reactions have been reported following the administration of albumin-containing preparations. These reactions may include nausea, chills, fever, urticaria, headache, and hypotension. A favorable response has been noted with the intravenous administration of 50 to 100 mg of prednisolone. Additionally, severe allergic reactions, including anaphylactic shock, have been documented.

Patient Counseling

Healthcare providers should discuss the risks and benefits of ALBURX 25, Albumin (Human) 25% solution with patients, emphasizing that it is derived from human plasma and may contain infectious agents. Providers should inform patients to report any infections they suspect may be transmitted by this product to the CSL Behring Pharmacovigilance Department at 1-866-915-6958.

It is essential to use an intravenous infusion set that is appropriate for the administration of blood and blood products. Providers should instruct patients that turbid solutions must not be used and that administration should not commence more than 4 hours after the introduction of the administration set. Additionally, any partially used bottles should be discarded to ensure safety.

Healthcare providers should take adequate precautions against circulatory overload, which may involve pulmonary auscultation or X-ray, as well as monitoring central venous or pulmonary artery wedge pressure. Special caution is advised for patients with stabilized chronic anemia, congestive heart failure, and renal insufficiency.

When considering the administration of ALBURX 25 to pregnant women, providers should only proceed if clearly necessary, as animal reproduction studies have not been conducted, and the potential for fetal harm or effects on reproductive capacity remain unknown.

Finally, providers should instruct patients to visually inspect parenteral drug products for particulate matter and discoloration prior to administration, ensuring that solutions that are turbid or contain particulate matter are not used.

Storage and Handling

ALBURX® 25, Albumin (Human) 25% solution is supplied in a configuration that includes NDC numbers relevant to its packaging. This product must be stored at a temperature not exceeding 30°C (86°F) to maintain its efficacy and safety.

Healthcare professionals are advised to ensure that the solution is not used after the expiration date indicated on the label, as this may compromise the product's integrity and effectiveness. Proper storage and adherence to these guidelines are essential for optimal product performance.

Additional Clinical Information

The effect of ALBURX 25 infusion on serum protein levels should be monitored through laboratory analysis. This product, an Albumin (Human) 25% solution, is administered intravenously. Clinicians are advised to engage in discussions with patients regarding the potential risks and benefits associated with the use of ALBURX 25.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Alburx as submitted by CSL Behring AG. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)