Human Serum Albumin

Identification

Name
Human Serum Albumin
Accession Number
DB00062  (BTD00059, BTD00089, BTD00101, BIOD00059, BIOD00089, BIOD00101, DB00096, DB00064)
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
Description

Serum albumin is the main protein of human blood plasma. It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). The main function of albumin is to maintain the oncotic pressure of blood [2]. There are various preparations of albumin that are well established and widely available in the clinical setting [8], [9], [L310].

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 [11]. 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 [5].

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 microspheres, human
  • Albumin, blood
  • Albumin, human
  • Albumin, human-kjda
  • Human albumin
  • Microspheres of human albumin
  • Serum albumin
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AlbukedSolution.05 g/mLIntravenousKedrion Biopharma, Inc.1976-08-26Not applicableUs
AlbukedSolution10 g/50mLIntravenousKedrion Biopharma, Inc.1981-07-28Not applicableUs
AlbukedSolution10 g/50mLIntravenousKedrion Biopharma, Inc.1981-07-28Not applicableUs
AlbukedSolution2.5 g/50mLIntravenousKedrion Biopharma, Inc.1976-08-26Not applicableUs
AlbukedSolution5 g/20mLIntravenousKedrion Biopharma, Inc.1942-10-21Not applicableUs
AlbukedSolution5 g/20mLIntravenousKedrion Biopharma, Inc.1942-10-21Not applicableUs
Albumin (Human)Solution200 g/1000mLIntravenousOctapharma2006-10-17Not applicableUs
Albumin (Human)Solution200 g/1000mLIntravenousOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2006-10-17Not applicableUs
Albumin (Human)Solution50 g/1000mLIntravenousOctapharma2006-10-17Not applicableUs
Albumin (Human)Solution50 g/1000mLIntravenousOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2006-10-17Not applicableUs
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Albumin Human DiluentHuman Serum Albumin (.3 mg) + Sodium Chloride (9 mg)LiquidSubcutaneousOmega Laboratories Ltd1987-12-31Not applicableCanada
Optison Perflutren Protein-Type A MicrospheresHuman Serum Albumin (10MG/ML 0) + Perflutren (0.22MG/ML 0)Injection, solutionIntravenousGe Healthcare2002-01-02Not applicableUs
Sterile Diluent for Allergenic ExtractHuman Serum Albumin (.0003 mL/mL) + Phenol (.004 mL/mL)Injection, solutionIntradermal; SubcutaneousAntigen Laboratories, Inc.1974-03-23Not applicableUs
Categories
UNII
ZIF514RVZR
CAS number
9048-46-8

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 [11].

Associated Conditions
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 [11].

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 [12].

Mechanism of action

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 [12].

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 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 [7].

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 [12].

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 [11], [12].

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 [12].

Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life
Not Available
Clearance
Not Available
Toxicity

In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated [11].

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 [11].

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 [12].

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

Interactions

Drug Interactions
No interactions found.
Food Interactions
Not Available

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. BLA APPROVAL [Link]
  6. ALBUMIN (HUMAN)- albumin human solution DailyMed [Link]
  7. PDR-Human Albumin [Link]
  8. Alburx [Link]
  9. Human Albumin [Link]
  10. Plasbumin [Link]
  11. Albuminex package insert [File]
  12. Albuminex 25 package insert [File]
  13. CSL Bhering Prescribing Information [File]
External Links
UniProt
P02768
Genbank
M12523
PubChem Substance
46509098
ChEMBL
CHEMBL1201451
PharmGKB
PA164743293
RxList
RxList Drug Page
Wikipedia
Serum_albumin
ATC Codes
V08DA01 — Microspheres of human 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
0RecruitingTreatmentHepatocellular,Carcinoma1
0WithdrawnDiagnosticRenal Cell Adenocarcinoma1
1CompletedDiagnosticAbdominal Trauma1
1CompletedDiagnosticNeoplasms, Abdominal / Pelvic Neoplasms1
1RecruitingTreatmentCardiomyopathy Due to Anthracyclines1
1TerminatedTreatmentPolyneuropathies1
1TerminatedTreatmentSubarachnoid Hemorrhage1
1, 2Active Not RecruitingDiagnosticVesico-Ureteral Reflux1
1, 2WithdrawnDiagnosticCoronary Artery Disease1
1, 2WithdrawnDiagnosticCrohn's Disease (CD)1
2Active Not RecruitingTreatmentIntermittent Claudication / Peripheral Artery Disease (PAD)1
2CompletedTreatmentAlpha 1-Antitrypsin Deficiency1
2CompletedTreatmentAlzheimer's Disease (AD)1
2CompletedTreatmentAmyotrophic Lateral Sclerosis (ALS)1
2CompletedTreatmentAnginal Pain / Chronic Ischemic Heart Disease / Ischaemic Cardiomyopathy / Symptomatic left ventricular ejection fraction ≤ 35% Chronic heart failure1
2CompletedTreatmentCommunity Acquired Pneumonia (CAP)1
2CompletedTreatmentMacular Degeneration1
2CompletedTreatmentRelapsing Remitting Multiple Sclerosis (RRMS)1
2CompletedTreatmentSymptomatic left ventricular ejection fraction ≤ 35% Chronic heart failure1
2RecruitingDiagnosticRenal Cell Adenocarcinoma1
2RecruitingTreatmentAmyotrophic Lateral Sclerosis (ALS)1
2RecruitingTreatmentChronic Myocardial Ischemia1
2TerminatedDiagnosticCarotid Artery Diseases1
2TerminatedTreatmentCardiopulmonary Bypass / Systemic Inflammatory Response Syndrome (SIRS)1
2, 3Active Not RecruitingTreatmentAllergic Rhinitis (AR)2
2, 3Active Not RecruitingTreatmentAlzheimer's Disease (AD)1
2, 3CompletedTreatmentAllergies / Asthma Bronchial / Rhinitis1
2, 3CompletedTreatmentFibrinogen Deficiency in Complex Cardiac Surgery1
2, 3TerminatedTreatmentGraft Versus Host Disease (GVHD)1
2, 3TerminatedTreatmentHypovolaemia1
2, 3Unknown StatusNot AvailableSevere Head Injury1
3CompletedTreatmentLiver Cirrhosis1
3CompletedTreatmentMultifocal Motor Neuropathy (MMN)1
3CompletedTreatmentPolyradiculoneuropathy, Chronic Inflammatory Demyelinating1
3CompletedTreatmentSecondary Recurrent Miscarriage1
3RecruitingTreatmentPostoperative Kidney Injury1
3TerminatedTreatmentAcute Ischemic Stroke (AIS)1
3TerminatedTreatmentAlzheimer's Disease (AD)1
3TerminatedTreatmentLiver Cirrhosis / Renal Failure / Sepsis1
3TerminatedTreatmentLung Injury, Acute (ALI) / Respiratory Distress Syndrome, Acute (ARDS)1
4Active Not RecruitingDiagnosticNonvalvular Atrial Fibrillation1
4CompletedNot AvailableEchocardiography1
4CompletedDiagnosticPulmonary Hypertension (PH)1
4CompletedPreventionHemorrhage1
4CompletedPreventionHepatic Encephalopathy1
4CompletedTreatmentCardiopulmonary Bypass / Surgery, Cardiac1
4CompletedTreatmentHeart; Dysfunction Postoperative, Cardiac Surgery1
4CompletedTreatmentHypoalbuminemia / Peptic Ulcer Bleeding1
4RecruitingDiagnosticTransplantation, Kidney1
4RecruitingPreventionAcute Kidney Injury (AKI)1
4RecruitingTreatmentAlpha-1 Anti-trypsin Deficiency / Chronic Obstructive Pulmonary Disease (COPD)1
4RecruitingTreatmentHepatic Encephalopathy / Liver Cirrhosis1
4RecruitingTreatmentHypoalbuminemia1
4RecruitingTreatmentHypoalbuminemia / Shock / Systemic Inflammatory Response Syndrome (SIRS)1
4TerminatedTreatmentSpontaneous Bacterial Peritonitis (SBP)1
4TerminatedTreatmentMinor burns1
4Unknown StatusTreatmentHemorrhage; Complicating Delivery, Coagulation Defect1
4Unknown StatusTreatmentSecond or Third Degree Burns1
Not AvailableActive Not RecruitingTreatmentAscites / Liver Cirrhosis1
Not AvailableCompletedScreeningCancer, Breast1
Not AvailableRecruitingNot AvailableHeart Transplantation1
Not AvailableRecruitingDiagnosticTransesophageal Echocardiography Contrast Agents1
Not AvailableRecruitingOtherEndothelial Dysfunction1
Not AvailableRecruitingTreatmentAortic Valve Disorder / Brain Injury / Coronary Heart Disease (CHD) / Renal Failure / Shock, Cardiogenic / Strokes1
Not AvailableRecruitingTreatmentHemodynamic Stability1
Not AvailableSuspendedDiagnosticAscites / Liver Cirrhosis1
Not AvailableTerminatedTreatmentLiver Cirrhosis1
Not AvailableTerminatedTreatmentSubarachnoid Hemorrhage1
Not AvailableUnknown StatusDiagnosticCoronary Artery Disease / Myocardial Perfusion Abnormalities1
Not AvailableWithdrawnDiagnosticCarotid Stenosis / Coronary Stenosis / Myocardial Reperfusion1
Not AvailableWithdrawnDiagnosticOvarian Hyperstimulation Syndrome1

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
SolutionIntravenous.05 g/mL
SolutionIntravenous2.5 g/50mL
SolutionIntravenous5 g/20mL
SolutionIntravenous200 g/1000mL
SolutionIntravenous250 g/1000mL
SolutionIntravenous50 g/1000mL
LiquidSubcutaneous
SolutionIntravenous20 g/100mL
SolutionIntravenous25 g/100mL
SolutionIntravenous25 g
SuspensionIntravenous5 %
SolutionIntravenous5 %
SolutionIntravenous12.5 g/250mL
Injection, solutionIntravenous10 g/50mL
Injection, solutionIntravenous12.5 g/250mL
Injection, solutionIntravenous.05 g/mL
Injection, solutionIntravenous.25 g/mL
LiquidIntradermal; Subcutaneous0.03 %
SolutionIntravenous.25 g/mL
SolutionIntravenous10 g/50mL
SolutionIntravenous12.5 g/50mL
SolutionIntravenous20 %
Injection, solutionIntravenous12.5 g/50mL
LiquidIntravenous25 %
SolutionIntravenous25 %
Injection, solutionIntravenous
SolutionIntravenous250 mg
SolutionIntravenous50 mg
Injection, solutionIntradermal; Subcutaneous
SolutionIntravenous0.03 %
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)
US5558094No1995-02-282012-02-28Us
US6723303No2001-04-202021-04-20Us

Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

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

Drug created on June 13, 2005 07:24 / Updated on July 18, 2018 17:36