Albumin (human)

Description

ALBUMIN (HUMAN) 25% is a sterile liquid preparation of albumin derived from large pools of human plasma, sourced exclusively from FDA-approved blood establishments. The product is manufactured through a process of cold ethanol fractionation, followed by ultra- and diafiltration. This process includes final container pasteurization and additional bulk pasteurization at 60 ± 0.5°C for 10 to 11 hours, which contributes to significant viral reduction as demonstrated in in vitro studies. However, it is important to note that no procedure has been proven to completely eliminate viral infectivity from human plasma derivatives.

The appearance of ALBUMIN (HUMAN) 25% is a clear, slightly viscous liquid that is nearly colorless or may exhibit a slight yellow or green tint. The composition of ALBUMIN (HUMAN) 25% includes 250 g of protein, of which at least 96% is human albumin, along with sodium (130 – 160 mmol), potassium (≤ 2 mmol), N-acetyl-DL-tryptophan (0.064 - 0.096 mmol/g protein), caprylic acid (0.064 - 0.096 mmol/g protein), and water for injection to a total volume of 1000 ml. This formulation contains no preservatives, and all packaging components are latex-free.

Uses and Indications

ALBUMIN (HUMAN) 25% is indicated for the restoration and maintenance of circulating blood volume in patients with the following conditions:

• Hypovolemia

• Hypoalbuminemia

• Prevention of central volume depletion following paracentesis due to cirrhotic ascites

• Ovarian hyperstimulation syndrome (OHSS)

• Adult respiratory distress syndrome (ARDS)

• Acute nephrosis

• Hemolytic disease of the newborn (HDN)

There are no teratogenic or nonteratogenic effects associated with ALBUMIN (HUMAN) 25%.

Dosage and Administration

Intravenous administration is the only approved route for this medication. The daily dose must not exceed 2 g per kg of body weight.

In cases of hypovolemia, the recommended dosage is as follows: for adults, administer 25 g; for children under 13 years of age, the dosage ranges from 2.5 g to 1.25 g. For hypoalbuminemia, adults should receive a dosage between 50 g and 75 g.

To prevent volume depletion following paracentesis, adults should be given 8 g for every 1,000 mL of ascitic fluid removed. In the management of ovarian hyperstimulation syndrome, adults may receive 50 g to 100 g over a period of 4 hours, with the option to repeat the dose at intervals of 4 to 12 hours as necessary.

For adult respiratory distress syndrome, a dosage of 25 g should be administered over 30 minutes, with the possibility of repeating the dose every 8 hours for up to 3 days if required. In cases of acute nephrosis, adults should receive 25 g in conjunction with a diuretic once daily for a duration of 7 to 10 days.

For the treatment of hemolytic disease of the newborn, the recommended dosage is 1 g per kilogram of body weight, administered prior to or during the exchange transfusion.

It is critical to avoid diluting the medication with sterile water for injection, as this may lead to hemolysis in recipients. If large volumes exceeding 1,500 mL are to be administered, the product should be warmed to room temperature prior to use. Each bottle is intended for single use only.

Contraindications

Use is contraindicated in individuals who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container. This precaution is necessary to prevent potential allergic reactions or adverse effects associated with hypersensitivity.

Warnings and Precautions

Hypersensitivity or allergic reactions, including severe anaphylaxis, have been reported in some patients. It is imperative that epinephrine be readily available for immediate administration in the event of an acute hypersensitivity reaction (5.1).

Caution is advised when administering this product to patients who are at risk of hypervolemia or hemodilution. In such cases, the infusion should be discontinued if any signs of cardiovascular overload are observed (5.2).

Electrolyte imbalances have been noted; therefore, regular monitoring of electrolyte status is essential to ensure patient safety (5.3). Additionally, it is crucial to ensure adequate substitution of other blood constituents. Monitoring of coagulation status and hematocrit levels is recommended to prevent complications (5.4).

Hypotension has been documented as a potential adverse effect. Continuous monitoring of hemodynamic performance is necessary to manage this risk effectively (5.5).

This product is derived from human plasma and may carry the risk of transmitting infectious agents, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease. Healthcare professionals should remain vigilant regarding this potential risk (5.7).

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. The most common adverse reactions include anaphylactoid type reactions, which occur in 5% or more of patients. Hypersensitivity or allergic reactions have also been observed and may progress to severe anaphylaxis; therefore, it is essential that epinephrine be readily available to treat any acute hypersensitivity reaction.

In addition to allergic reactions, other adverse reactions include hypervolemia, which should be approached with caution in patients at risk of cardiovascular overload or hemodilution. Infusion should be stopped if signs of cardiovascular overload occur. Electrolyte imbalances have been noted, necessitating regular monitoring of electrolyte status. Furthermore, it is important to ensure adequate substitution of other blood constituents, as monitoring of coagulation status and hematocrit is advised.

Hypotension has been observed in some patients, warranting careful monitoring of hemodynamic performance. Additionally, as this product is derived from human plasma, there is a potential risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Contraindications include individuals who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container.

Drug Interactions

No drug interaction studies have been conducted for this medication. Therefore, the potential for drug interactions remains undefined. It is advisable for healthcare professionals to exercise caution and monitor patients for any unexpected effects when this medication is used in conjunction with other therapies.

Biosimilarity

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

Pediatric Use

Data on the use of ALBUMIN (HUMAN) 25% in pediatric patients, including premature infants, are very limited. The product should be administered to children only when clinically necessary. Caution is advised due to the lack of comprehensive studies supporting its safety and efficacy in this population.

Geriatric Use

Clinical studies did not include a sufficient number of subjects aged 65 and older to determine whether elderly patients respond differently from younger subjects. Therefore, the safety and efficacy of this medication in geriatric patients have not been established.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, considering the potential for altered pharmacokinetics and increased sensitivity to adverse effects. Close monitoring of these patients is recommended to ensure appropriate therapeutic outcomes and to mitigate any risks associated with treatment.

Pregnancy

Pregnant patients should be aware that ALBUMIN (HUMAN) 25% is classified as Pregnancy Category C. This classification indicates that risk to the fetus cannot be ruled out. Animal reproduction studies have not been conducted with ALBUMIN (HUMAN) 25%, and there is insufficient data to determine whether it can cause fetal harm or affect reproductive capacity when administered to pregnant women.

ALBUMIN (HUMAN) 25% should only be administered to pregnant women if it is deemed necessary. Similarly, its use during labor or delivery should also be limited to situations where it is essential, as the potential effects on fetal outcomes and reproductive capacity remain unknown. Healthcare professionals are advised to weigh the benefits against the potential risks when considering the use of this product in pregnant patients.

Lactation

It is not known whether ALBUMIN (HUMAN) 25% is excreted in human milk. Therefore, it should be administered to nursing mothers only if necessary. Given that many drugs are excreted in human milk, caution should be exercised when ALBUMIN (HUMAN) 25% is administered to a lactating woman.

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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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

No nonclinical toxicology studies have been conducted with ALBUMIN (HUMAN) 25%. Human Albumin is a normal constituent of human plasma and functions similarly to physiological albumin.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of Albumin (Human). Reports of allergic reactions, including anaphylaxis and other hypersensitivity reactions, have been documented. Additionally, cases of renal impairment and acute kidney injury have been observed in the postmarketing setting. There have also been reports of transfusion-related acute lung injury (TRALI) linked to the use of Albumin (Human). Furthermore, instances of circulatory overload have been noted in patients receiving this product.

Patient Counseling

Healthcare providers should inform patients receiving Albumin (Human) 25% about the potential risks and benefits associated with its use. It is essential to discuss the importance of monitoring for allergic reactions, advising patients to discontinue the treatment immediately if they experience any symptoms such as skin rashes, hives, itching, breathing difficulties, coughing, nausea, vomiting, a fall in blood pressure, or an increased heart rate.

Patients should be made aware that Albumin (Human) 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).

Additionally, healthcare providers should reassure patients that the risk of transmitting infectious agents through Albumin (Human) 25% has been mitigated. This has been achieved through rigorous screening of plasma donors for prior exposure to certain viruses, testing the donated plasma for specific viral infections, and employing methods to inactivate and/or remove certain viruses during the manufacturing process.

Storage and Handling

ALBUMIN (HUMAN) 25% is supplied in a configuration that allows for storage for up to 36 months at temperatures ranging from +2°C to +25°C (36°F to 77°F) from the date of manufacture. It is essential to store the product protected from light to maintain its integrity.

Freezing of the product is strictly prohibited, as it may compromise its quality. Additionally, the product should not be used after the expiration date indicated on the packaging. Users must also ensure that the solution is clear; do not use if the product appears turbid.

Additional Clinical Information

Patients receiving ALBUMIN (HUMAN) 25% should undergo regular monitoring of hemodynamic performance. This includes assessments of arterial blood pressure, pulse rate, central venous pressure, pulmonary artery occlusion pressure, urine output, electrolytes, and hematocrit/hemoglobin levels.

As a derivative of human plasma, ALBUMIN (HUMAN) 25% carries an extremely remote risk of transmitting viral diseases, attributed to effective donor screening and manufacturing processes. The theoretical risk of transmission of Creutzfeldt-Jakob Disease (CJD) is also considered extremely remote, with no reported cases of viral disease or CJD transmission associated with this product.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Albumin (human) as submitted by Octapharma Pharmazeutika Produktionsgesellschaft m. b. H.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)