Albumin human

Identification

Name
Albumin human
Accession Number
DB00062
Description

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
Db00062
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.

Associated Conditions
Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
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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.

TargetActionsOrganism
UNitric oxide
binder
Humans
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
Learn about our commercial Adverse Effects data.
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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.

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
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
Not Available

Products

Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AlbukedSolution10 g/50mLIntravenousKedrion Biopharma, Inc.1981-07-282017-04-29US flag
AlbukedSolution5 g/20mLIntravenousKedrion Biopharma, Inc.1942-10-21Not applicableUS flag
AlbukedSolution.05 g/1mLIntravenousKedrion Biopharma, Inc.1976-08-262018-01-08US flag
AlbukedSolution2.5 g/50mLIntravenousKedrion Biopharma, Inc.1976-08-26Not applicableUS flag
AlbukedSolution10 g/50mLIntravenousKedrion Biopharma, Inc.1981-07-28Not applicableUS flag
AlbukedSolution5 g/20mLIntravenousKedrion Biopharma, Inc.1942-10-212017-04-29US flag
Albumin (Human)Solution250 g/1000mLIntravenousOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2006-10-17Not applicableUS flag
Albumin (Human)Solution50 g/1000mLIntravenousOctapharma USA Inc2006-10-17Not applicableUS flag
Albumin (Human)Solution50 g/1000mLIntravenousOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2006-10-17Not applicableUS flag
Albumin (Human)Solution200 g/1000mLIntravenousOctapharma USA Inc2006-10-17Not applicableUS flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Albumin Human DiluentAlbumin human (.3 mg) + Sodium chloride (9 mg)LiquidSubcutaneousOmega Laboratories Ltd1987-12-31Not applicableCanada flag
MacrotecAlbumin human (10 mg/1) + Albumin Aggregated (1.5 mg/1)Injection, powder, lyophilized, for suspensionIntravenousBracco Diagnostics, Inc1974-05-082008-04-20US flag
Sterile Diluent for Allergenic ExtractAlbumin human (0.0003 mL/1mL) + Phenol (0.004 mL/1mL)Injection, solutionIntradermal; SubcutaneousAntigen Laboratories, Inc.1974-03-23Not applicableUS flag

Categories

Drug Categories
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

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
  1. 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. [PubMed:12846933]
  2. Moman RN, Bhimji SS: Albumin . [PubMed:29083605]
  3. 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. [PubMed:20586704]
  4. Schussler GC: The thyroxine-binding proteins. Thyroid. 2000 Feb;10(2):141-9. doi: 10.1089/thy.2000.10.141. [PubMed:10718550]
  5. Caraceni P, Tufoni M, Bonavita ME: Clinical use of albumin. Blood Transfus. 2013 Sep;11 Suppl 4:s18-25. doi: 10.2450/2013.005s. [PubMed:24333308]
  6. BLA APPROVAL [Link]
  7. ALBUMIN (HUMAN)- albumin human solution DailyMed [Link]
  8. PDR-Human Albumin [Link]
  9. Alburx [Link]
  10. Human Albumin [Link]
  11. Plasbumin [Link]
  12. Albuminex package insert [File]
  13. Albuminex 25 package insert [File]
  14. CSL Bhering Prescribing Information [File]
UniProt
P02768
Genbank
M12523
PubChem Substance
46509098
RxNav
828529
ChEMBL
CHEMBL1201451
PharmGKB
PA164743293
RxList
RxList Drug Page
Wikipedia
Serum_albumin
AHFS Codes
  • 16:00.00 — Blood Derivatives
  • 36:18.00 — Cardiac Function
  • 40:50.00* — Diluents
FDA label
Download (265 KB)
MSDS
Download (122 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentHypoalbuminemia1
4CompletedPreventionGastrointestinal Bleeding / Hepatic Encephalopathy (HE) / Hyponatremia / Renal Failure / Sepsis1
4CompletedPreventionHemorrhage1
4CompletedPreventionHepatic Encephalopathy (HE)1
4CompletedTreatmentAscites / Liver Cirrhosis2
4CompletedTreatmentCardiopulmonary Bypass / Surgery, Cardiac1
4CompletedTreatmentHeart; Dysfunction Postoperative, Cardiac Surgery1
4CompletedTreatmentHypoalbuminemia / Peptic Ulcer Bleeding1
4RecruitingTreatmentFluid Overload / Liver Cirrhosis / Volume Overload1
4RecruitingTreatmentHypoalbuminemia / Shock / Systemic Inflammatory Response Syndrome (SIRS)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
FormRouteStrength
SolutionIntravenous200 mg/100mL
SolutionParenteral200 g/l
SolutionParenteral50 g/l
Injection, solutionIntravenous50 mg/ml
Injection, solutionIntravenous; Parenteral200 MG/ML
Injection, solutionIntravenous; Parenteral50 MG/ML
SolutionIntravenous.05 g/1mL
Injection, solutionIntravenous200 mg/ml
Injection
SolutionIntravenous200 g/1000mL
SolutionIntravenous250 g/1000mL
SolutionIntravenous50 g/1000mL
LiquidSubcutaneous
Injection, solutionParenteral50 G/L
Injection, solutionParenteral25 G/100ML
Injection, solutionParenteral200 MG/ML
SolutionIntravenous20 g/100mL
SolutionIntravenous25 g/100mL
SolutionIntravenous0.05 g/1mL
SuspensionIntravenous
Injection, solutionIntravenous25 %
Injection, solutionIntravenous5 %
InjectionIntravenous
SolutionParenteral250 g/l
SolutionParenteral40 g/l
Injection, solutionParenteral20 %
Injection, solutionParenteral25 %
Injection, solutionParenteral5 %
SolutionParenteral20 %
SolutionIntravenous25 g
SolutionIntravenous250 g/L
SolutionParenteral5 %
SolutionIntravenous200 g
SolutionIntravenous12.5 g/250mL
SolutionIntravenous12.5 g/50mL
Injection, solutionIntravenous10 g/50mL
Injection, solutionIntravenous12.5 g/250mL
Injection, solutionIntravenous5 g/100mL
SolutionIntravenous0.2 g
InjectionIntravenous200 g/1000ml
SolutionIntravenous200 mg
Injection, solutionIntravenous0.2 g/1mL
Injection, solutionIntravenous0.25 g/1mL
Injection, solutionIntravenous25 g/100mL
SolutionIntravenous20 %
LiquidIntradermal; Subcutaneous
Injection, solutionIntravenous0.05 g/1mL
SolutionIntravenous0.20 g/1mL
SolutionIntravenous0.25 g/1mL
SolutionIntravenous20 g
Injection, solutionIntravenous20 %
Injection, solutionIntravenous12.5 g/50mL
Injection, powder, lyophilized, for suspensionIntravenous
Injection, powder, lyophilized, for suspensionIntravenous2 mg
Injection, powder, lyophilized, for solutionIntravenous; Subcutaneous1 mg
Kit500 Mikrogramm
Kit0.5 mg
LiquidIntravenous
Injection, solutionParenteral200 G/L
Injection, solutionParenteral250 G/L
SolutionIntravenous10 g/50mL
SolutionIntravenous2.5 g/50mL
SolutionIntravenous5 g/20mL
Injection, solutionIntravenous0.2 g/ml
Injection, solutionIntravenous0.25 g/ml
SolutionIntravenous
Injection, powder, lyophilized, for solutionSubcutaneous0.5 mg
Injection, solutionIntradermal; Subcutaneous
Injection, solutionIntravenous; Parenteral20 %
Injection, solutionParenteral20 G/100ML
Injection, solutionParenteral5 G/100ML
SolutionIntravenous25 %
SolutionIntravenous5 %
Injection, solutionIntravenous20 g/100ml
SolutionIntravenous10 g
InjectionIntravenous20 %
Solution
Prices
Unit descriptionCostUnit
Buminate 25% iv solution2.22USD ml
Albumin 25% iv solution1.97USD ml
Albutein 25% vial1.32USD ml
Buminate 5% iv solution0.44USD ml
Albutein 5% iv solution0.43USD ml
Albumin (human) 5% iv solution0.3USD ml
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US5558094No1996-09-242012-02-28US flag
US6723303No2004-04-202021-04-20US flag
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

    Learn more

Properties

State
Solid
Experimental Properties
Not Available

Targets

Kind
Small molecule
Organism
Humans
Pharmacological action
Unknown
Actions
Binder
References
  1. Caraceni P, Tufoni M, Bonavita ME: Clinical use of albumin. Blood Transfus. 2013 Sep;11 Suppl 4:s18-25. doi: 10.2450/2013.005s. [PubMed:24333308]
  2. 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. [PubMed:19745558]
  3. Lee P, Wu X: Review: modifications of human serum albumin and their binding effect. Curr Pharm Des. 2015;21(14):1862-5. [PubMed:25732553]

Drug created on June 13, 2005 07:24 / Updated on October 25, 2020 12:45

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