Albumin (human)

Description

ALBUMIN (HUMAN) 20% 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 a significant reduction of viral infectivity as demonstrated in in vitro studies. However, no method has been proven to completely eliminate viral infectivity from human plasma derivatives.

The formulation of ALBUMIN (HUMAN) 20% is characterized as a clear, slightly viscous liquid that may appear almost colorless or exhibit a slight yellow or green tint. The composition includes 200 g of protein, with at least 96% being 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 product is free from preservatives, and the packaging components are latex-free.

Uses and Indications

ALBUMIN (HUMAN) 20% 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)

This drug does not exhibit teratogenic or nonteratogenic effects.

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.

For the management of hypovolemia, the recommended dosage is as follows: adults should receive 25 g, while children under 13 years of age should be administered between 1.25 g to 2.5 g. In cases of hypoalbuminemia, adults may be treated with a dosage ranging from 50 g to 75 g.

To prevent volume depletion following paracentesis, adults should receive 8 g for every 1,000 mL of ascitic fluid removed. For ovarian hyperstimulation syndrome, adults may be given 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.

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

For the management 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 hypersensitivity to albumin preparations, any ingredient in the formulation, or components of the container. This is due to the potential for severe allergic reactions in susceptible patients.

Warnings and Precautions

Hypersensitivity or allergic reactions, including severe anaphylaxis, have been reported in patients receiving this product. 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. Infusion should be discontinued if any signs of cardiovascular overload are observed (5.2).

Electrolyte imbalances have been noted in some patients. Therefore, regular monitoring of electrolyte status is essential to ensure patient safety (5.3).

Adequate substitution of other blood constituents must be ensured during treatment. Additionally, it is crucial to monitor coagulation status and hematocrit levels to prevent complications (5.4).

Instances of hypotension have been documented. Continuous monitoring of hemodynamic performance is recommended to manage any potential drops in blood pressure 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 risk (5.7).

Side Effects

Adverse reactions associated with this product include a range of hypersensitivity and allergic reactions, with anaphylactoid type reactions occurring in 5% or more of patients. These reactions may escalate to severe anaphylaxis, necessitating immediate availability of epinephrine for the treatment of any acute hypersensitivity event.

Cardiovascular effects have been noted, including hypotension, which requires careful monitoring of hemodynamic performance. Additionally, caution is advised in patients at risk of hypervolemia or hemodilution, as hypervolemia may occur. Infusion should be halted if signs of cardiovascular overload are observed.

Electrolyte imbalances have also been reported, highlighting the importance of monitoring electrolyte status during treatment. Furthermore, it is essential to ensure adequate substitution of other blood constituents, as alterations in coagulation status and hematocrit may arise.

This product is derived from human plasma and carries the potential risk of transmitting infectious agents, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease.

It is critical to avoid use in individuals who exhibit hypersensitivity 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) 20% in pediatric patients, including premature infants, are very limited. The product should be administered to children only when clinically necessary, taking into consideration the lack of extensive safety and efficacy data in this population. Caution is advised when considering treatment with ALBUMIN (HUMAN) 20% in pediatric patients.

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 patients. 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

Pregnant patients should be aware that ALBUMIN (HUMAN) 20% 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) 20%, and there is insufficient data to determine whether it can cause fetal harm when administered to a pregnant woman or affect reproductive capacity.

ALBUMIN (HUMAN) 20% should be administered to pregnant women only if clearly necessary. Additionally, the effects of ALBUMIN (HUMAN) 20% during labor and delivery are not well understood, and it should also be given during these times only if necessary. Healthcare professionals should weigh the potential benefits against the risks when considering the use of this product in pregnant patients.

Lactation

It is not known whether ALBUMIN (HUMAN) 20% 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) 20% 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 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 non-clinical toxicology studies with ALBUMIN (HUMAN) 20% have been conducted. Human Albumin is a normal constituent of human plasma and functions similarly to physiological albumin.

Postmarketing Experience

Postmarketing experience has revealed several adverse reactions reported voluntarily or through surveillance programs. Allergic reactions, including anaphylaxis, have been documented. Additionally, other adverse reactions such as fever, chills, and hypotension have been reported. There have also been instances of transmission of infectious agents, including viral infections, 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) 20%.

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 should explain to patients that ALBUMIN (HUMAN) 20% 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 infectious agents through ALBUMIN (HUMAN) 20% has been minimized. 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) 20% is supplied in a configuration that allows for effective storage and handling. It 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. Freezing is not permitted, as it may compromise the integrity of the solution. The product should not be used after the expiration date indicated on the packaging. Additionally, ALBUMIN (HUMAN) 20% must not be used if the solution appears turbid.

For reference, the National Drug Code (NDC) numbers associated with this product should be consulted for specific packaging details.

Additional Clinical Information

Patients receiving ALBUMIN (HUMAN) 20% 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) 20% 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 transmission for 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)