Human albumin (Solution) Instructions for Use

ATC Code

B05AA01 (Albumin)

Active Substance

Human albumin (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Plasma substitute. Human albumin preparation

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

In quantitative terms, Human albumin represents more than half of the total plasma protein, accounting for approximately 10% of the liver’s protein-synthesizing activity.

Human albumin has a corresponding hyperoncotic effect. The most important physiological functions of albumin are associated with its contribution to the regulation of blood oncotic pressure, as well as with its transport function. Albumin stabilizes the volume of circulating blood and serves as a carrier for hormones, enzymes, medicinal products, and toxins.

Pharmacokinetics

Normally, the total exchangeable albumin pool is 4-5 g/kg of body weight, with 40-45% located intravascularly and 55-60% in the tissues. In conditions such as severe burns or septic shock, increased capillary permeability alters the kinetics of albumin and can cause its abnormal distribution. Normally, the average T_1/2 of albumin is about 19 days. The balance between albumin synthesis and breakdown is usually maintained by a feedback mechanism. The elimination process occurs primarily intracellularly under the action of lysosomal proteases.

In healthy individuals, less than 10% of intravenously administered albumin leaves the intravascular space within the first 2 hours. There is significant individual variability in the effect of albumin infusion on plasma volume. In some patients, blood plasma volume may remain increased for several hours. However, in critically ill patients, albumin can leave the vascular bed in significant amounts and at an unpredictable rate.

Preclinical safety data

Human albumin is a natural component of human plasma and acts similarly to physiological albumin.

Single-dose toxicity studies in animals are of little significance and do not allow for the assessment of toxic or lethal doses or the dose-effect relationship.

Repeated-dose toxicity studies in animals are not feasible due to the formation of antibodies to the heterologous protein.

To date, there is no information regarding the embryonic and fetal toxicity, carcinogenic, and mutagenic effects of human albumin. Animal studies have also revealed no signs of acute toxicity.

Indications

Restoration and maintenance of circulating blood volume in cases of volume deficiency and when the use of colloids is appropriate, including Human albumin may be used in the following clinical conditions

• Shock – for emergency therapy in cases of shock and other similar conditions requiring urgent restoration of circulating blood volume;
• Burns – albumin either in an isotonic solution or in a dextrose solution to prevent severe hemoconcentration and maintain the required electrolyte balance;
• Hypoproteinemia with or without edema – in clinical situations usually associated with low blood plasma protein concentration leading to a decrease in circulating blood volume;
• Hypoalbuminemia – when albumin deficiency is a consequence of insufficient synthesis, excessive catabolism, loss due to burns or trauma, or due to redistribution within the body.

ICD codes

Dosage Regimen

Solution

The dose of the administered Human albumin solution is determined individually. When administering Human albumin, hemodynamic parameters and the patient’s breathing should be monitored to prevent pulmonary edema. Additionally, the patient’s neurological status should be monitored to prevent increased intracranial pressure.

The Human albumin solution should be administered intravenously. The Human albumin solution should not be mixed with other medicinal products, including whole blood and blood components; however, it can be used as an adjunctive agent if medically appropriate.

The Human albumin solution must not be diluted with water for injections, as this may cause hemolysis in patients. The Human albumin solution must not be mixed with protein hydrolysates or solutions containing alcohol, as such combinations may lead to protein precipitation.

Do not add other medicinal products.

If the dose and rate of administration are not adjusted according to the solution concentration and the patient’s clinical status, the administration of Human albumin may lead to hypervolemia.

In patients receiving Human albumin, hemodynamic parameters must be monitored to prevent the occurrence of hypervolemia and overload of the cardiovascular system.

Adverse Reactions

Adverse reactions from clinical studies

There are no data on adverse reactions in controlled clinical studies of Human albumin.

Adverse reactions reported during the post-marketing period

During the post-marketing period, reports of the following adverse reactions have been received. These reactions are listed by system organ class (SOC) using preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA) in descending order of severity.

Immune system disorders anaphylactic shock, anaphylactic reactions, hypersensitivity/allergic reactions.

Nervous system disorders headache.

Cardiac and vascular disorders when it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be decided; tachycardia, decreased blood pressure, flushing.

Respiratory, thoracic and mediastinal disorders dyspnea.

Gastrointestinal disorders vomiting, nausea, dysgeusia.

Skin and subcutaneous tissue disorders urticaria, rash, pruritus.

General disorders and administration site conditions pyrexia, chills.

Contraindications

• Allergic reactions to albumin or any of the excipients.

Human albumin solutions must not be diluted with water for injections, as this may cause hemolysis in recipients. There is a risk of hemolysis with potentially fatal outcomes, as well as a risk of acute renal failure due to the unacceptable use of sterile water for injections to dilute Human albumin.

With cautionHuman albumin should be used in conditions where hypervolemia and its consequences or hemodilution may pose a particular risk to the patient. Examples of such conditions are: decompensated heart failure, hypertension, varicose veins, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and post-renal failure.

Use in Pregnancy and Lactation

There are no data on the use of Human albumin in pregnant women and during lactation. Before prescribing the drug in each specific case, physicians should carefully assess the potential risks and benefits of using Human albumin.

Use in Renal Impairment

With cautionHuman albumin should be used in conditions where hypervolemia and its consequences or hemodilution may pose a particular risk to the patient. Examples of such conditions are: renal and post-renal failure.

Pediatric Use

The safety and efficacy of the Human albumin solution in pediatric patients have not been established; however, no additional risks of using this drug in children, other than the risks existing in its use in adults, have been identified.

Special Precautions

Allergic reactions/anaphylactic shock

Any suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the drug administration. In case of shock development, standard anti-shock therapy should be applied.

Since this drug is manufactured from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. This also applies to unknown or new viruses and other pathogens.

The risk of transmitting infectious agents is reduced by screening plasma donors for possible past exposure to certain viruses, testing for the presence of certain current viral infections, and by inactivating and/or removing certain viruses. The measures taken are considered effective for enveloped viruses such as HIV, hepatitis B virus, hepatitis C virus, as well as for non-enveloped viruses such as hepatitis A virus and parvovirus B19. It is strongly recommended that each time Human albumin is administered to a patient, the name and batch number of the drug be recorded to establish a link between the patient and the drug batch.

Hemodynamics

Do not administer without careful monitoring of hemodynamic parameters; monitor for the development of symptoms of cardiac or respiratory failure, renal failure, or increased intracranial pressure.

Hypervolemia/hemodilution

Human albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution may pose a particular risk to the patient. Examples of such conditions are: decompensated heart failure, hypertension, varicose veins, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and post-renal failure. The infusion rate should be adjusted according to the solution concentration and the patient’s hemodynamic parameters. Rapid administration may lead to circulatory overload and pulmonary edema. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein distension) or increased blood pressure, increased central venous pressure, and pulmonary edema, the administration of the drug should be immediately discontinued.

Use in pediatric practice

The safety and efficacy of the Human albumin solution in pediatric patients have not been established; however, no additional risks of using this drug in children, other than the risks existing in its use in adults, have been identified.

Large volumes

When replacing relatively large volumes, coagulation parameters and hematocrit levels must be monitored. Adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and red blood cells) must be ensured. Hemodynamic parameters must be strictly monitored.

Electrolyte status

When administering Human albumin, the patient’s electrolyte status should be monitored, and necessary measures should be taken to restore and maintain electrolyte balance.

Blood pressure

Increased blood pressure following the infusion of Human albumin necessitates careful monitoring of the patient after trauma or surgery to detect and treat damaged vessels that may not have bled at lower blood pressure.

Use, handling, and disposal

The Human albumin solution should not be mixed with other medicinal products, including whole blood and blood components; however, it can be used as an adjunctive agent if medically appropriate.

Do not use if the solution is cloudy or the vial seal is damaged. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. If leaks are found, the product must be discarded.

There is a risk of hemolysis with potentially fatal consequences, as well as a risk of acute renal failure when using sterile water for injections to dilute human albumin with a concentration of 20% and higher. Recommended solvents include 0.9% sodium chloride solution or 5% dextrose solution in water.

Effect on ability to drive and use machines

There are no data on the effect of Human albumin on the ability to drive a car and operate other machinery.

Overdose

Significant overdose and increased rate of administration may lead to hypervolemia.

Drug Interactions

Studies of the interaction of Human albumin with other medicinal products have not been conducted (unknown due to the lack of relevant data in clinical studies, medical literature, and safety reports).

Storage Conditions

Store the drug at a temperature between 2°C (35.6°F) and 25°C (77°F). Do not freeze. Keep out of the reach of children.

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.