Identification
- Summary
Albumin human is a purified form of human serum albumin used to replace lost albumin in patients with hypoalbuminemia, to treat hypovolemia and ascites, and as a part of some diagnostic imaging kits.
- Brand Names
- Albuked, Albuminex, Alburex, Alburx, Albutein, Flexbumin, Hizentra, Human Albumin Grifols, Kedbumin, Octalbin, Plasbumin, Plasmanate
- Generic Name
- Albumin human
- DrugBank Accession Number
- DB00062
- Background
Human serum albumin is the primary protein present in human blood plasma. The main function of albumin is to maintain the oncotic pressure of blood 2. It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). Albumin represents approximately 50% of the total protein content in healthy humans 5.
Human albumin is a small globular protein (molecular weight: 66.5 kDa), consisting of a single chain of 585 amino acids organized in three repeated homolog domains (sites I, II, and III). Each domain comprises two separate sub-domains (A and B) 5.
There are various preparations of albumin that are well established and widely available in the clinical setting 9, 10, 6.
Also known as Albuminex 5% or 25%, one brand of human serum albumin is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US 12. This is a biosimilar drug to existing human serum albumin and was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018 6.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Structure
- Protein Chemical Formula
- C2936H4624N786O889S41
- Protein Average Weight
- 66472.2 Da
- Sequences
> Human Serum Albumin Sequence MKWVTFISLLFLFSSAYSRGVFRRDAHKSEVAHRFKDLGEENFKALVLIAFAQYLQQCPF EDHVKLVNEVTEFAKTCVADESAENCDKSLHTLFGDKLCTVATLRETYGEMADCCAKQEP ERNECFLQHKDDNPNLPRLVRPEVDVMCTAFHDNEETFLKKYLYEIARRHPYFYAPELLF FAKRYKAAFTECCQAADKAACLLPKLDELRDEGKASSAKQRLKCASLQKFGERAFKAWAV ARLSQRFPKAEFAEVSKLVTDLTKVHTECCHGDLLECADDRADLAKYICENQDSISSKLK ECCEKPLLEKSHCIAEVENDEMPADLPSLAADFVESKDVCKNYAEAKDVFLGMFLYEYAR RHPDYSVVLLLRLAKTYETTLEKCCAAADPHECYAKVFDEFKPLVEEPQNLIKQNCELFE QLGEYKFQNALLVRYTKKVPQVSTPTLVEVSRNLGKVGSKCCKHPEAKRMPCAEDYLSVV LNQLCVLHEKTPVSDRVTKCCTESLVNRRPCFSALEVDETYVPKEFNAETFTFHADICTL SEKERQIKKQTALVELVKHKPKATKEQLKAVMDDFAAFVEKCCKADDKETCFAEEGKKLV AASQAALGL
Download FASTA Format- Synonyms
- Albumin (human)
- Albumin human
- Albumin, blood
- Albumin, human
- Albumin, human-kjda
- Human albumin
- Human serum albumin
- Serum albumin
Pharmacology
- Indication
Albuminex solution is indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass 12.
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Management of Acute liver failure •••••••••••• ••••••••• Management of Acute nephrosis •••••••••••• ••••••••• Management of Burns •••••••••••• ••••••••• Management of Hemolytic disease of the newborn •••••••••••• ••••••••• Treatment of Hypoalbuminemia •••••••••••• ••••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Serum albumin is a soluble, monomeric protein essential for maintaining and regulating the colloidal osmotic pressure of blood. It is utilized to increase the circulating plasma volume, which reduces hemoconcentration and blood viscosity. Albumin is also used as a transport protein that binds naturally occurring, therapeutic and toxic materials and drugs in the circulation 12.
Human albumin makes up over 50% the total protein in the plasma and represents about 10% of protein synthesis activity by the liver. Human Albumin 25% has a corresponding hyper-oncotic effect 13.
- Mechanism of action
The main function of albumin results from its contribution to plasma colloid oncotic pressure and transport function 13.
Albumin stabilizes circulating blood volume and carries hormones, enzymes, medicines, and toxins. Other physiological functions include antioxidant properties, free radical scavenging, in addition to maintenance capillary membrane integrity 13.
Exogenously administered albumin increases the oncotic pressure of the intravascular system, moving fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. The increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume while maintaining cardiac output in shock. In dehydrated patients, negligible effects exist on circulating blood volume. In addition to the above albumin replaces protein in patients with hypoproteinemia until the cause of the deficiency can be determined 8.
This drug has thousands of endogenous and exogenous targets. Human albumin also binds and carries a plethora of hydrophobic molecules, such as endogenous (i.e., cholesterol, fatty acids, bilirubin, thyroxine) or exogenous substances (for example, drugs and toxins), transition metal ions, as well as gas (nitric oxide NO), with resulting implications for their solubilisation, transport, metabolism, and detoxification 5.
Target Actions Organism UNitric oxide binderHumans - Absorption
Not Available
- Volume of distribution
Albumin is distributed throughout the extracellular space and more than 60% of the body albumin pool is located in the extravascular fluid space 13.
In healthy adults, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion of albumin. There is considerable individual variation in the effect of albumin on plasma volume, however 12, 13.
In some patients, the plasma volume can remain elevated for several hours. In critically ill patients, however, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate that is difficult to predict 13.
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated 12.
The most common adverse reactions are rigors, hypotension, tachycardia with increased heart rate, fever, chills, nausea, vomiting, dyspnea and/or bronchospasm, skin rash/pruritus. Stop the infusion immediately if anaphylaxis, with or without shock is observed 12.
Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the volume status of the patient. When clinical signs of cardiovascular overload occur (headache, dyspnea, jugular venous distention, increased blood pressure), the infusion must be slowed or stopped immediately 13.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs Browse all" title="About SNP Mediated Effects/ADRs" id="snp-actions-info" class="drug-info-popup" href="javascript:void(0);">
- Not Available
Interactions
- Drug Interactions Learn More" title="About Drug Interactions" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.No interactions found.
- Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Albuked Solution 2.5 g/50mL Intravenous Kedrion Biopharma, Inc. 1976-08-26 Not applicable US 
Albuked Solution 5 g/20mL Intravenous Kedrion Biopharma, Inc. 1942-10-21 Not applicable US Albuked Solution 5 g/20mL Intravenous Kedrion Biopharma, Inc. 1942-10-21 2017-04-29 US Albuked Solution 10 g/50mL Intravenous Kedrion Biopharma, Inc. 1981-07-28 2017-04-29 US Albuked Solution .05 g/1mL Intravenous Kedrion Biopharma, Inc. 1976-08-26 2018-01-08 US - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Albumin Human Diluent Albumin human (.3 mg / mL) + Sodium chloride (9 mg / mL) Liquid Subcutaneous Omega Laboratories Ltd 1987-12-31 Not applicable Canada 
Macrotec Albumin human (10 mg/1) + Albumin Aggregated (1.5 mg/1) Injection, powder, lyophilized, for suspension Intravenous Bracco Diagnostics, Inc 1974-05-08 2008-04-20 US Sterile Diluent for Allergenic Extract Albumin human (0.0003 mL/1mL) + Phenol (0.004 mL/1mL) Injection, solution Intradermal; Subcutaneous Antigen Laboratories, Inc. 1974-03-23 Not applicable US Venomil Honey Bee Venom (12mcg) Albumin human (1.8 mL / vial) + Apis mellifera venom (12 mcg / vial) Kit; Liquid; Powder, for solution Intradermal Hollister Stier Laboratories Llc 1998-09-15 2005-09-02 Canada Venomil Wasp Venom Protein (12mcg) Albumin human (1.8 mL / vial) + Vespula vulgaris venom protein (12 mcg / vial) Kit; Powder, for solution Intradermal Hollister Stier Laboratories Llc 1998-09-15 2005-09-02 Canada - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image CEALB ALBUMIN %20 100 ML 1 ADET SISE Albumin human (20 %) Solution Intravenous CENTURION PHARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. 2016-11-29 Not applicable Turkey 
CEALB ALBUMIN %20 50 ML 10 GR Albumin human (20 %) Solution Intravenous CENTURION PHARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. 2015-09-29 Not applicable Turkey
Categories
- ATC Codes
- B05AA01 — Albumin
- Drug Categories
- Albumins
- Amino Acids, Peptides, and Proteins
- Blood and Blood Forming Organs
- Blood and Related Products
- Blood Derivatives
- Blood Proteins
- Blood Substitutes and Perfusion Solutions
- Blood Substitutes and Plasma Protein Fractions
- Cardiac Function
- Diluents
- Human Serum Albumin
- Increased Intravascular Volume
- Increased Oncotic Pressure
- Osmotic Activity
- Proteins
- Serum Albumin
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- ZIF514RVZR
- CAS number
- 9048-46-8
References
- Synthesis Reference
Robert A. Tenold, "Preparing essentially monomeric normal human serum albumin." U.S. Patent USRE0362590, issued July, 1976. Rene Fickat, Simon Benita, Francis Puisieux, "Preparation of biodegradable microcapsules based on serum albumin." U.S. Patent US4666641, issued June, 1958.
USRE0362590- General References
- Zunszain PA, Ghuman J, Komatsu T, Tsuchida E, Curry S: Crystal structural analysis of human serum albumin complexed with hemin and fatty acid. BMC Struct Biol. 2003 Jul 7;3:6. Epub 2003 Jul 7. [Article]
- Moman RN, Bhimji SS: Albumin . [Article]
- Neumann E, Frei E, Funk D, Becker MD, Schrenk HH, Muller-Ladner U, Fiehn C: Native albumin for targeted drug delivery. Expert Opin Drug Deliv. 2010 Aug;7(8):915-25. doi: 10.1517/17425247.2010.498474. [Article]
- Schussler GC: The thyroxine-binding proteins. Thyroid. 2000 Feb;10(2):141-9. doi: 10.1089/thy.2000.10.141. [Article]
- Caraceni P, Tufoni M, Bonavita ME: Clinical use of albumin. Blood Transfus. 2013 Sep;11 Suppl 4:s18-25. doi: 10.2450/2013.005s. [Article]
- BLA APPROVAL [Link]
- ALBUMIN (HUMAN)- albumin human solution DailyMed [Link]
- PDR-Human Albumin [Link]
- Alburx [Link]
- Human Albumin [Link]
- Plasbumin [Link]
- Albuminex package insert [File]
- Albuminex 25 package insert [File]
- CSL Bhering Prescribing Information [File]
- External Links
- UniProt
- P02768
- Genbank
- M12523
- PubChem Substance
- 46509098
- 828529
- ChEMBL
- CHEMBL1201451
- PharmGKB
- PA164743293
- RxList
- RxList Drug Page
- Wikipedia
- Serum_albumin
- FDA label
- Download (265 KB)
- MSDS
- Download (122 KB)
Clinical Trials
- Clinical Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">
Phase Status Purpose Conditions Count 4 Completed Basic Science Rabies 1 4 Completed Other Carcinoma / Hepatocellular Carcinoma / Neoplasms, Hepatic 1 4 Completed Prevention Coronary Artery Occlusive Disease(CAOD) 1 4 Completed Prevention Fluid Over-load / Hypotension During Dialysis 1 4 Completed Prevention Gastrointestinal Hemorrhage / Hepatic Encephalopathy (HE) / Hyponatremia / Kidney Failure / Sepsis 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- ALK-Abello Inc.
- Alpha Therapeutic Corp.
- Alpine Biologics Inc.
- American Red Cross
- Baxter International Inc.
- CSL Behring LLC
- Grifols SA
- Massbiologics
- Octapharma USA
- Sanofi-Aventis Inc.
- Talecris Biotherapeutics
- Dosage Forms
Form Route Strength Injection, solution Parenteral 200 g/L Injection, solution Parenteral 50 g/L Solution Intravenous 200 mg/100mL Solution Parenteral 200 g/l Solution Parenteral 50 g/l Injection, solution Intravenous 50 mg/ml Injection, solution Intravenous; Parenteral 200 MG/ML Injection, solution Intravenous; Parenteral 50 MG/ML Solution Intravenous .05 g/1mL Injection, solution Intravenous 200 mg/ml Injection Intravenous Injection, solution, concentrate Intravenous 200 g/L Solution Intravenous 200 g/1000mL Solution Intravenous 250 g/1000mL Solution Intravenous 50 g/1000mL Liquid Subcutaneous Injection, solution Parenteral 25 G/100ML Solution Intravenous 10 g Solution Parenteral 10 g Solution, concentrate Intravenous 20 g Solution Intravenous 25.000 g Injection, solution Parenteral 200 MG/ML Injection, solution 200 G/L Injection, solution 50 G/L Injection, solution Injection, solution Intravenous 2.5 G/50ML Injection Intravenous 20 % Injection Intravenous 5 % Solution Intravenous 20 g/100mL Solution Intravenous 25 g / 100 mL Solution Intravenous 25 g/100mL Solution Intravenous 0.05 g/1mL Solution Parenteral 20.000 g Suspension Intravenous 5 % Solution Parenteral 250 g/l Solution Parenteral 40 g/l Injection, solution Intravenous 50 g/1000ml Solution Intravenous 5.000 g Injection, solution Parenteral 20 % Injection, solution Parenteral 25 % Injection, solution Parenteral 5 % Solution Intravenous 5 % Solution Parenteral 20 % Solution Intravenous 25 g Solution Intravenous 25000000 g/L Solution Parenteral 5 % Solution Intravenous 200 g Solution Intravenous 12.5 g/50mL Solution Intravenous 12.5 g/250mL Solution Intravenous 250 g/L Solution Intravenous 50 g/l Injection, solution Intravenous 10 g/50mL Injection, solution Intravenous 12.5 g/250mL Solution Intravenous 0.2 g Solution Intravenous 250 mg Injection, solution Intravenous 25 % Solution Intravenous 50 mg Injection, solution Intravenous 5 % Injection Intravenous 10.0 g/50ml Injection Intravenous 12.5 g/50ml Injection Intravenous 12.5 g/250ml Injection Intravenous 200 g/1000ml Solution Intravenous 200 mg Injection, solution Intravenous 0.2 g/1mL Injection, solution Intravenous 0.25 g/1mL Liquid Intradermal; Subcutaneous 0.03 % Injection, solution Intravenous 0.05 g/1mL Solution Intravenous 0.20 g/1mL Solution Intravenous 0.25 g/1mL Solution Intravenous 20.000 g Solution Intravenous 20 g Injection, solution Intravenous 20 g/100mL Injection, solution Intravenous 20 % Injection, solution Intravenous 25 g/100mL Solution Parenteral 5.000 g Solution Intravenous 200 mg/ml Solution Intravenous 0.2 g/ml Solution Intravenous 20 % Injection, solution Intravenous 20 %/50ml Solution Parenteral Solution Intravenous drip 200 g/L Injection, solution Intravenous 12.5 g/50mL Solution Parenteral 10.000 g Injection, powder, lyophilized, for suspension Intravenous Injection, powder, lyophilized, for suspension Intravenous 2 mg Kit 2.5 mg Injection, powder, lyophilized, for solution Intravenous; Subcutaneous 1 mg Kit 500 Mikrogramm Injection, powder, lyophilized, for suspension Subcutaneous Kit 0.5 mg Liquid Intravenous 25 % Solution Intravenous Solution Intravenous 5.00 g Solution Intravenous 25 % Injection, solution Parenteral 250 G/L Solution Intravenous 10 g/50mL Solution Intravenous 2.5 g/50mL Solution Intravenous 5 g/20mL Solution Intravenous 250 mg / mL Injection Intravenous 5 g/20ml Solution Intravenous 50 mg / mL Liquid Intravenous 50 mg / mL Kit 2 mg Injection, solution Intravenous Injection, powder, lyophilized, for solution Subcutaneous 0.5 mg Injection Intravenous; Subcutaneous 1 mg Injection, solution Intravenous 0.2 g/mL Solution Intravenous 20.0000 mg Injection, solution Intradermal; Subcutaneous Solution Subcutaneous 0.03 % Injection, solution Intravenous; Parenteral 20 % Injection, solution Parenteral 20 G/100ML Injection, solution Parenteral 5 G/100ML Solution Intravenous 200 g/l Solution Intravenous 1000000 g Injection, solution Parenteral Injection, solution Intravenous Kit; liquid; powder, for solution Intradermal Kit; powder, for solution Intradermal Injection Intravenous 20 % w/v Injection Intravenous 4.5 % w/v Injection, solution Intravenous 4.5 % - Prices
Unit description Cost Unit Buminate 25% iv solution 2.22USD ml Albumin 25% iv solution 1.97USD ml Albutein 25% vial 1.32USD ml Buminate 5% iv solution 0.44USD ml Albutein 5% iv solution 0.43USD ml Albumin (human) 5% iv solution 0.3USD ml DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US5558094 No 1996-09-24 2012-02-28 US US6723303 No 2004-04-20 2021-04-20 US
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
References
- Caraceni P, Tufoni M, Bonavita ME: Clinical use of albumin. Blood Transfus. 2013 Sep;11 Suppl 4:s18-25. doi: 10.2450/2013.005s. [Article]
- Ishima Y, Kragh-Hansen U, Maruyama T, Otagiri M: Albumin as a nitric oxide-traffic protein: characterization, biochemistry and possible future therapeutic applications. Drug Metab Pharmacokinet. 2009;24(4):308-17. [Article]
- Lee P, Wu X: Review: modifications of human serum albumin and their binding effect. Curr Pharm Des. 2015;21(14):1862-5. [Article]
Drug created at June 13, 2005 13:24 / Updated at February 20, 2024 23:54