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 a significant reduction of viral load as demonstrated in in vitro studies. However, it is noted that no method has been proven to completely eliminate viral infectivity from human plasma derivatives.

The formulation of ALBUMIN (HUMAN) 5% is characterized as a clear, slightly viscous liquid that may appear almost colorless or exhibit a slight yellow or green tint. The composition 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. This product is free from preservatives, and the packaging components are latex-free.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

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, depending on clinical judgment.

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 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 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 is 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 to ensure patient safety. Additionally, it is crucial to ensure adequate substitution of other blood constituents. Monitoring of coagulation status and hematocrit levels is recommended to prevent complications.

Hypotension has been documented in some cases. Continuous monitoring of hemodynamic performance is necessary to identify and manage any potential issues promptly.

It is important to note that this 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

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 progress to severe anaphylaxis, necessitating the immediate availability of epinephrine for the treatment of any acute hypersensitivity event.

In clinical observations, cardiovascular effects such as hypotension have been noted, and patients should be monitored for hemodynamic performance. Additionally, hypervolemia is a concern, particularly in patients at risk for this condition or hemodilution; infusion should be halted if signs of cardiovascular overload are present.

Electrolyte imbalances have also been reported, warranting regular monitoring of electrolyte status in patients receiving this treatment. Coagulation abnormalities may occur, and it is essential to ensure adequate substitution of other blood constituents while monitoring coagulation status and hematocrit levels.

Furthermore, as this product is derived from human plasma, there is a risk of infection from infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

It is important to note that 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 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) 5% in pregnant women to assess potential drug-associated risks. Animal reproduction studies have not been conducted with ALBUMIN (HUMAN) 5%, and therefore, it remains unknown whether this product can cause fetal harm or affect fertility when administered to a pregnant woman. Given the lack of data, ALBUMIN (HUMAN) 5% 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. Healthcare professionals should consider these background risks when evaluating the use of ALBUMIN (HUMAN) 5% in pregnant patients.

Lactation

There are no data available regarding the use of ALBUMIN (HUMAN) 5% in lactating mothers to assess any drug-associated risks. It is currently unknown whether ALBUMIN (HUMAN) 5% is excreted in human milk. Additionally, the effects of ALBUMIN (HUMAN) 5% on breastfed infants or on milk production remain undetermined.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Additionally, healthcare professionals should consider contacting a poison control center for further guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the amount and timing of the substance taken, 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

Adverse events reported in the postmarketing experience include allergic reactions such as skin rashes, hives, itching, breathing difficulties, coughing, nausea, vomiting, hypotension, and tachycardia. In cases of these symptoms, it is advised to discontinue the use of ALBUMIN (HUMAN) 5% immediately.

Patients are informed that ALBUMIN (HUMAN) 5% is derived from human plasma and may potentially contain infectious agents that could cause disease, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease (CJD). However, the risk of transmission of infectious agents has been mitigated through measures such as screening plasma donors for prior exposure to certain viruses, testing donated plasma for specific viral infections, and employing inactivation and/or removal processes for certain viruses during the manufacturing process.

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) 5%.

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 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).

It is important to reassure patients that the risk of transmitting an infectious agent 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 virus 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.

To ensure the integrity of the product, it must be stored protected from light. Freezing is not permitted, as it may compromise the quality of the albumin. Additionally, the product should not be used after the expiration date indicated on the packaging. It is also essential to refrain from using the product if it appears turbid, as this may indicate a loss of efficacy or safety.

Additional Clinical Information

Patients receiving ALBUMIN (HUMAN) 5% should have their hemodynamic performance monitored regularly. This monitoring may include assessments of arterial blood pressure and 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, administration routes, patient counseling, or postmarketing experiences.

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)