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 the product 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. ALBUMIN (HUMAN) 25% is formulated without 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 experiencing hypovolemia and hypoalbuminemia. This drug is also indicated for the prevention of central volume depletion following paracentesis in patients with cirrhotic ascites, as well as for the management of ovarian hyperstimulation syndrome (OHSS), adult respiratory distress syndrome (ARDS), acute nephrosis, and 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 with a known hypersensitivity to albumin preparations, any ingredient in the formulation, or components of the container. This precaution is essential to prevent potential allergic reactions or adverse effects associated with these substances.

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.

Caution is advised when administering this product to patients who are at risk of hypervolemia or hemodilution. Infusion should be discontinued if any signs of cardiovascular overload are observed.

Electrolyte imbalances have been noted; therefore, regular monitoring of electrolyte status is essential. Additionally, it is crucial to ensure adequate substitution of other blood constituents. Coagulation status and hematocrit levels should be closely monitored to prevent complications.

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

It is important to note that the solution should not be diluted with sterile water for injection, as this may compromise its efficacy and safety.

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. Appropriate precautions should be taken to mitigate these risks.

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 with an incidence of 5% or greater. 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.

Serious adverse reactions may include hypervolemia, which necessitates caution in patients at risk for this condition or hemodilution. Infusion should be stopped if signs of cardiovascular overload occur. Additionally, patients may experience electrolyte imbalances, and it is recommended to monitor electrolyte status closely. Coagulation abnormalities have been noted, highlighting the importance of ensuring adequate substitution of other blood constituents and monitoring coagulation status and hematocrit levels.

Hypotension has been reported, necessitating careful monitoring of hemodynamic performance. Furthermore, there is an inherent risk of infection from human plasma, as this product is derived from human plasma and may contain infectious agents, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease.

Contraindications for this product 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. As a result, the potential for drug interactions remains undefined. Healthcare professionals are advised to exercise caution and consider monitoring 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 deemed necessary. Caution is advised due to the lack of comprehensive studies evaluating 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 is recommended to ensure appropriate management of any emerging side effects or complications in this population.

Pregnancy

There are no data available regarding the use of ALBUMIN (HUMAN) 25% in pregnant women to assess potential drug-associated risks. Animal reproduction studies have not been conducted with ALBUMIN (HUMAN) 25%, and it remains unknown whether this product can cause fetal harm or affect fertility when administered to a pregnant woman. Therefore, ALBUMIN (HUMAN) 25% should be administered to pregnant patients 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.

Lactation

There are no data available regarding the use of ALBUMIN (HUMAN) 25% in lactating mothers to determine whether it is excreted in human milk. Consequently, it is not known if ALBUMIN (HUMAN) 25% can cause harm to a breastfed infant or affect milk production.

ALBUMIN (HUMAN) 25% should be administered to lactating mothers only if clearly needed, weighing the potential benefits against any unknown risks to the nursing infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in terms of 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis and other hypersensitivity reactions. Additionally, cases of renal dysfunction, including acute kidney injury, have been documented in the postmarketing setting.

Reports have also indicated instances of transfusion-related acute lung injury (TRALI) associated with the use of Albumin (Human). Furthermore, there have been observations of circulatory overload, particularly in patients with compromised cardiac function. Rare reports of the transmission of infectious agents, including viral infections, have been noted, despite the implementation of measures aimed at reducing such risks.

Patient Counseling

Healthcare providers should inform patients that this product is typically administered in a hospital setting. It is essential to discuss the potential risks and benefits associated with the use of Albumin (Human) 25%.

Patients should be advised to discontinue the treatment immediately if they experience any allergic symptoms, which may include skin rashes, hives, itching, breathing difficulties, coughing, nausea, vomiting, a fall in blood pressure, or an increased heart rate.

Additionally, healthcare providers must inform patients that ALBUMIN (HUMAN) 25% is derived from human plasma and may contain infectious agents that could potentially cause disease, such as viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease (CJD).

It is important to reassure patients that the risk of transmitting an infectious agent through ALBUMIN (HUMAN) 25% has been mitigated by screening plasma donors for prior exposure to certain viruses, testing the donated plasma for specific virus 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 effective storage and handling. The product may be stored for a period of 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 protect the product from light during storage to maintain its integrity.

Freezing of ALBUMIN (HUMAN) 25% is strictly prohibited, as it may compromise the quality of the product. Additionally, the product should not be used after the expiration date indicated on the packaging. Users must also ensure that the solution is clear and free from turbidity before administration, as a turbid solution is not suitable for use.

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 USA Inc. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)