Alburx

Description

ALBURX® 5 is a sterile aqueous solution for intravenous administration, containing a 5% 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 indicate 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 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. Notably, the solution is free from preservatives.

Uses and Indications

ALBURX® 5, Albumin (Human) 5% solution is indicated for the definitive treatment of major hemorrhage through the transfusion of red blood cells, aimed at restoring normal oxygen transport capacity of the blood. It may be utilized as an emergency measure to support blood volume when blood is not immediately available, thereby restoring cardiac output and alleviating circulatory failure associated with tissue anoxia.

In the immediate care of burned patients, ALBURX® 5 is employed to maintain adequate plasma volume and protein (colloid) content during the first 24 hours, in conjunction with large volumes of crystalloid solutions. For continued therapy beyond 24 hours, larger amounts of ALBURX® 5 are generally recommended.

This solution is also beneficial in the early management of shock related to acute hemorrhagic pancreatitis and peritonitis, as it aids in correcting blood volume deficits and providing sufficient fluid therapy. Additionally, ALBURX® 5 is suitable for addressing postoperative losses of circulating albumin resulting from intra-operative damage to capillary walls, particularly following radical dissections for malignant disease, colon and rectum surgeries, and major vascular procedures.

In cases of subacute or chronic hypoproteinemia, ALBURX® 5 may be indicated for the rapid correction of an oncotic deficit; however, it is not intended for the treatment of the chronic condition itself.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

ALBURX® 5, Albumin (Human) 5% solution, must be administered intravenously. Prior to administration, the venipuncture site should be free from infection or trauma and 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.

The solution is ready for use as contained in the bottle and may be administered without regard to the blood group of the recipient. For adult patients, the initial dose is typically 250 mL or 500 mL. The rate of infusion and total volume administered should be determined based on the patient's condition and response. In the absence of overt shock, a suitable infusion rate is generally 1–2 mL per minute. In cases of exsanguination, the capacity of the administration set is the only limiting factor.

For pediatric patients, a dose of 22 to 33 mL per kilogram of body weight is usually adequate. Close surveillance of the young patient is essential during administration. Treatment should always be guided by the hemodynamic response rather than relying solely on blood volume calculations or measurements.

Contraindications

The use of ALBURX® 5, Albumin (Human) 5% solution is contraindicated in patients with a history of an incompatibility reaction to albumin preparations. Additionally, ALBURX® 5 may be contraindicated in patients with cardiac failure or severe anemia due to the risk of acute circulatory overload.

Warnings and Precautions

ALBURX® 5, Albumin (Human) 5% 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 for prior exposure to specific viruses, testing for current infections, and employing inactivation and removal techniques such as alcohol fractionation and heat treatment (10 hours at 60ºC), the potential for disease transmission remains.

The theoretical risk of transmitting Creutzfeldt-Jakob Disease (CJD) is considered extremely remote, and to date, no cases of viral disease or CJD transmission have been documented in relation to Albumin (Human). However, it is important to acknowledge the possibility of unknown infectious agents being present in the product. Healthcare providers are urged to report any suspected infections that may have been transmitted by this product to the CSL Behring Pharmacovigilance Department at 1-866-915-6958.

Physicians are advised to engage in a thorough discussion with patients regarding the risks and benefits associated with the use of ALBURX® 5.

Administration of the solution must be conducted with caution. Turbid solutions are contraindicated and should not be used. Additionally, it is imperative that administration does not commence more than 4 hours after the introduction of the administration set to ensure patient safety and product efficacy.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Among the very rare non-septic incompatibility reactions, symptoms such as nausea, chills, fever, urticaria, headache, and hypotension have been reported. Additionally, severe allergic reactions, including anaphylactic shock, have been documented.

It is important to note that products derived from human plasma carry a risk of transmitting infectious agents, including viruses that can cause disease. Although the risk has been significantly mitigated through rigorous screening of plasma donors, testing for current virus infections, and employing inactivation and removal techniques such as alcohol fractionation and heat treatment, the potential for disease transmission remains. The theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) is considered extremely remote, and no cases of viral disease or CJD transmission have been identified for Albumin (Human). However, the possibility of unknown infectious agents being present cannot be entirely excluded.

Patients should also be monitored for circulatory overload, as acute pulmonary edema has been observed in 3 to 4 percent of patients who were resuscitated from severe shock. This condition is not specifically linked to any particular type of resuscitative fluid and is not necessarily attributed to circulatory overload. Special caution is advised for patients with stabilized chronic anemia or renal insufficiency.

Drug Interactions

ALBURX 5, an Albumin (Human) 5% solution, has specific compatibility considerations that must be adhered to in order to ensure safe and effective use.

Incompatibilities ALBURX 5 should not be mixed with protein hydrolysates, amino acid mixtures, or solutions containing alcohol. The presence of these substances may lead to adverse reactions or reduced efficacy of the albumin solution.

Compatibility The solution is compatible with whole blood or packed red cells, as well as standard electrolyte and carbohydrate solutions intended for intravenous administration. This compatibility allows for flexible use in clinical settings where albumin may be required alongside these other intravenous therapies.

Healthcare professionals are advised to follow these guidelines to avoid potential complications and to ensure optimal therapeutic outcomes when administering ALBURX 5.

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 typically require a dose of 22 to 33 mL per kilogram of body weight. Close surveillance of these young patients is essential during treatment.

It is important to note that treatment should be guided by the hemodynamic response rather than relying solely on blood volume calculations or measurements. This is particularly critical for pediatric patients with sepsis or severe multiple injuries, as they may require a circulating blood volume that exceeds predictions based on body weight.

Geriatric Use

Special caution is indicated in geriatric patients, particularly those aged 65 and older, who have stabilized chronic anemia or renal insufficiency. These conditions may necessitate careful monitoring and potential dose adjustments to ensure safety and efficacy.

In addition, adequate precautions should be taken against circulatory overload in elderly patients, as they may have reduced kidney function or increased sensitivity to side effects. It is essential for healthcare providers to assess renal function and consider the overall health status of geriatric patients when determining treatment plans. Regular monitoring and appropriate dose modifications may be required to mitigate risks associated with these factors.

Pregnancy

ALBURX® 5, Albumin (Human) 5% solution, has not been evaluated in animal reproduction studies, and the potential effects on fetal outcomes or reproduction capacity in humans are not well understood. It is currently unknown whether ALBURX® 5 can cause fetal harm when administered to pregnant patients. Therefore, ALBURX® 5 should be administered to pregnant women only if clearly needed, weighing the potential benefits against any unknown risks. Despite the lack of specific contraindications associated with reproduction, pregnancy, or fetal health, healthcare professionals should exercise caution and consider the individual circumstances of each patient when prescribing this medication.

Lactation

It is not known whether ALBURX® 5 is excreted in human breast milk or if it can cause harm to a breastfed infant. Therefore, caution should be exercised when administering ALBURX® 5 to lactating mothers. The decision to use ALBURX® 5 in breastfeeding women should be made only if clearly needed, considering the potential benefits and risks. There is no evidence indicating any contraindication to the use of ALBURX® 5 specifically associated with reproduction, pregnancy, or the fetus.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

Given the absence of detailed guidance, it is recommended that healthcare providers consult local poison control centers or relevant medical authorities for further assistance in managing potential overdosage situations. Continuous assessment of the patient's condition is essential to ensure appropriate interventions are implemented promptly.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with ALBURX 5, Albumin (Human) 5% solution. The potential for ALBURX 5 to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, ALBURX 5 should be administered to a pregnant woman only if clearly needed. However, there is no evidence indicating any contraindication to the use of ALBURX 5 specifically associated with reproduction, pregnancy, or the fetus.

No specific non-teratogenic effects or nonclinical toxicology details are available in the provided data. Additionally, there are no specific animal pharmacology and toxicology details mentioned.

Postmarketing Experience

The use of ALBURX 5, Albumin (Human) 5% solution is contraindicated in patients with a history of incompatibility reactions to such preparations. Additionally, it may be contraindicated in individuals with cardiac failure or severe anemia due to the risk of acute circulatory overload.

Postmarketing surveillance has indicated that products derived from human plasma may contain infectious agents, including viruses that can cause disease. Although the risk of transmitting infectious agents has been significantly reduced through measures such as screening plasma donors, testing for current virus infections, and employing inactivation and removal techniques (including alcohol fractionation and heat treatment at 60ºC for 10 hours), the potential for disease transmission remains. The theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) is considered extremely remote, and no cases of viral disease or CJD transmission have been identified in relation to Albumin (Human). However, the possibility of unknown infectious agents being present cannot be excluded.

Healthcare providers are encouraged to report any infections that they suspect may have been transmitted by this product to the CSL Behring Pharmacovigilance Department at 1-866-915-6958.

In rare instances, non-septic incompatibility reactions, including nausea, chills, fever, urticaria, headache, and hypotension, have been observed following the administration of albumin-containing preparations. Severe allergic reactions, such as anaphylactic shock, have also been reported.

Patient Counseling

Healthcare providers should inform patients that ALBURX 5, Albumin (Human) 5% solution is derived from human plasma, which may contain infectious agents, including viruses that can cause disease. Although the risk of transmitting infectious agents has been significantly minimized through rigorous screening of plasma donors, testing for current virus infections, and employing virus inactivation and removal techniques, there remains a potential risk 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 reported with Albumin (Human). Patients should be made aware that unknown infectious agents may still be present in the product. Any suspected infections that may have been transmitted by this product should be reported to CSL Behring Pharmacovigilance Department at 1-866-915-6958.

It is essential for the physician to discuss the risks and benefits of ALBURX 5 with the patient prior to administration. Patients should be advised that turbid solutions must not be used and that administration should not commence more than 4 hours after the introduction of the administration set.

Healthcare providers should take adequate precautions against circulatory overload, as acute pulmonary edema can occur in 3 to 4 percent of patients resuscitated from severe shock. This condition is not necessarily linked to a specific type of resuscitative fluid or solely due to circulatory overload. Providers are encouraged to perform pulmonary auscultation and, if feasible, measure central venous pressure. Special caution is warranted for patients with stabilized chronic anemia or renal insufficiency.

Providers should also inform patients that animal reproduction studies have not been conducted with ALBURX 5, and it is unknown whether the product can cause fetal harm or affect reproductive capacity when administered to pregnant women. ALBURX 5 should only be given to pregnant women if clearly needed, although there is no evidence of contraindications related to reproduction, pregnancy, or fetal health.

Finally, healthcare providers should ensure that an intravenous infusion set suitable for the infusion of blood and blood products is used during administration.

Storage and Handling

ALBURX® 5, Albumin (Human) 5% solution is supplied in a configuration that ensures optimal preservation of its properties. It is essential to store this product at a temperature not exceeding 30°C (86°F) to maintain its efficacy and safety.

Healthcare professionals are advised to monitor the storage conditions closely and ensure that the product is not used after the expiration date indicated on the label. Proper adherence to these storage guidelines is crucial for the integrity of the solution.

Additional Clinical Information

ALBURX 5, Albumin (Human) 5% solution is administered intravenously, with an initial dose of 250 or 500 mL for adults, typically infused at a rate of 1–2 mL per minute in the absence of overt shock. For pediatric patients, a dose of 22 to 33 mL per kilogram of body weight is generally considered adequate.

Clinicians are advised to counsel patients on the risks and benefits associated with this product. It is important to note that turbid solutions must not be used, and administration should not commence more than 4 hours after the introduction of the administration set.

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)