Albumin (human)

Description

ALBUMIN (HUMAN) 5% 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) 5% 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 50 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) 5% is free from preservatives, and the components used in its packaging are latex-free.

Uses and Indications

ALBUMIN (HUMAN) 5% is indicated for the restoration and maintenance of circulating blood volume in patients experiencing hypovolemia, hypoalbuminemia, and for the prevention of central volume depletion following paracentesis due to cirrhotic ascites.

There are no known teratogenic or nonteratogenic effects associated with ALBUMIN (HUMAN) 5%.

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, a single dose of 25 g is indicated. For pediatric patients under 13 years of age, the dosage should range from 1.25 g to 2.5 g, depending on the clinical scenario.

For hypoalbuminemia, adults should receive a dosage between 50 g and 75 g.

To prevent volume depletion following paracentesis, adults should be administered 8 g for every 1,000 mL of ascitic fluid that is removed.

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 and should not be reused.

Contraindications

Use is contraindicated in individuals with hypersensitivity to albumin preparations, any ingredient in the formulation, or components of the container. This precaution is essential to prevent potential allergic reactions.

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. 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. Coagulation status and hematocrit levels should be closely monitored 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

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 effects include hypervolemia, which necessitates 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, and monitoring of electrolyte status is recommended. 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.

This product is contraindicated in 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. Clinicians are advised to exercise caution and consider individual patient factors when prescribing this medication alongside other therapies. Monitoring for any unexpected clinical effects is recommended, particularly in patients receiving multiple medications.

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) 5% in pediatric patients, including premature infants, are very limited. The product should be administered to pediatric patients only when clinically necessary. Caution is advised due to the lack of comprehensive studies 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

Pregnant patients should be aware that ALBUMIN (HUMAN) 5% 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) 5%, 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) 5% should be administered to pregnant women only if necessary, weighing the potential benefits against any possible risks. Similarly, its use during labor or delivery should also be limited to situations where it is deemed essential, as the effects on fetal outcomes and reproductive capacity in this context remain unknown.

Lactation

It is not known whether ALBUMIN (HUMAN) 5% 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) 5% 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 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) 5%. Human Albumin is a normal constituent of human plasma and functions similarly to physiological albumin.

Postmarketing Experience

Patients are advised that ALBUMIN (HUMAN) 5% 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). The risk of transmission of infectious agents through ALBUMIN (HUMAN) 5% has been mitigated by implementing measures such as screening plasma donors for prior exposure to specific viruses, testing the donated plasma for certain viral infections, and employing processes to inactivate and/or remove certain viruses during the manufacturing process.

Patient Counseling

Patients should be informed that this product is typically administered in a hospital setting. Healthcare providers are encouraged to discuss the potential risks and benefits associated with the use of Albumin (Human) 5% with their patients.

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.

It is important to inform patients that ALBUMIN (HUMAN) 5% 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).

Healthcare providers should reassure patients that the risk of transmitting infectious agents through ALBUMIN (HUMAN) 5% has been minimized. This has been achieved through measures such as screening plasma donors for prior exposure to certain viruses, testing the donated plasma for specific viral infections, and employing processes to inactivate and/or remove certain viruses during the manufacturing process.

Storage and Handling

ALBUMIN (HUMAN) 5% 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 store the product protected from light to maintain its integrity. Freezing is not permitted, as it may compromise the quality of the albumin. The product should not be used after the expiration date indicated on the packaging. Additionally, if the solution appears turbid, it should not be used.

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) 5% should have their hemodynamic performance monitored regularly. This monitoring may include assessments of arterial blood pressure, pulse rate, central venous pressure, pulmonary artery occlusion pressure, urine output, electrolytes, and hematocrit/hemoglobin levels to ensure safety and efficacy during treatment.

No further information is available regarding abuse, route, method, frequency of administration, patient counseling, or postmarketing experience.

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)