Immune Globulin Human

Identification

Name
Immune Globulin Human
Accession Number
DB00028  (BTD00091, BIOD00091)
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Polyclonal antibody (pAb)
Description

Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders.

Protein structure
Db00028
Protein chemical formula
C6332H9826N1692O1980S42
Protein average weight
142682.3 Da
Sequences
>IGG1
PSALTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHAGKAPKVIIYEVNKRPSGV
PDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYEGSDNFVFGTGTKVTVLGQPKANPTVT
LFPPSSEELQANKATEVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASS
YLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECSPLVLQESGPGLVKPSEALSLTCTV
SGDSINTILYYWSWIRQPPGKGLEWIGYIYYSGSTYGNPSLKSRVTISVNTSKNQFYSKL
SSVTAADTAVYYCARVPLVVNPWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGC
LVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNH
KPSNTKVDKRVAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYV
DGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKA
KGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLD
SDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL
>IgA2
ELVMTQSPSSLSASVGDRVNIACRASQGISSALAWYQQKPGKAPRLLIYDASNLESGVPS
RFSGSGSGTDFTLTISSLQPEDFAIYYCQQFNSYPLTFGGGTKVEIKRTVAAPSVFIFPP
SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT
LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGECQVKLLEQSGAEVKKPGASVKVSCKAS
GYSFTSYGLHWVRQAPGQRLEWMGWISAGTGNTKYSQKFRGRVTFTRDTSATTAYMGLSS
LRPEDTAVYYCARDPYGGGKSEFDYWGQGTLVTVSSASPTSPKVFPLSLDSTPQDGNVVV
ACLVQGFFPQEPLSVTWSESGQNVTARNFPPSQDASGDLYTTSSQLTLPATQCPDGKSVT
CHVKHYTNPSQDVTVPCPVPPPPPCCHPRLSLHRPALEDLLLGSEANLTCTLTGLRDASG
ATFTWTPSSGKSAVQGPPERDLCGCYSVSSVLPGCAQPWNHGETFTCTAAHPELKTPLTA
NITKSGNTFRPEVHLLPPPSEELALNELVTLTCLARGFSPKDVLVRWLQGSQELPREKYL
TWASRQEPSQGTTTFAVTSILRVAAEDWKKGDTFSCMVGHEALPLAFTQKTIDRLAGKPT
HVNVSVVMAEVDGTCY
Download FASTA Format
Synonyms
  • Human IGG
  • Human Immunoglobulin G
  • Human Normal Immunoglobulin
  • Immune globulin (human)
  • Immune Globulin Intravenous
  • Immune Globulin Subcutaneous
  • Immunoglobulin G (human)
  • Immunoglobulin G, Human
  • Intravenous Immunoglobulin
  • IVIg
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
BivigamInjection, solution1 g/10mLIntravenousKedrion Biopharma, Inc.2013-02-04Not applicableUs
BivigamInjection, solution10 g/100mLIntravenousBiotest2013-02-04Not applicableUs
BivigamInjection, solution5 g/50mLIntravenousBiotest2013-02-04Not applicableUs
Carimune NanofilteredInjection, powder, lyophilized, for solution6 g/1IntravenousCsl Behring Ag2009-02-10Not applicableUs
Carimune NanofilteredInjection, powder, lyophilized, for solution3 g/1IntravenousCsl Behring Ag2009-02-102016-11-22Us
Carimune NanofilteredInjection, powder, lyophilized, for solution12 g/1IntravenousCsl Behring Ag2009-02-10Not applicableUs
CuvitruInjection, solution1 g/5mLIntravenous; SubcutaneousBaxalta Canada Corporation2016-10-18Not applicableUs
CuvitruSolution200 mgSubcutaneousBaxalta Canada CorporationNot applicableNot applicableCanada
Flebogamma 10%Solution100 mgIntravenousInstituto Grifols, S.A.Not applicableNot applicableCanada
Flebogamma 5%Solution50 mgIntravenousInstituto Grifols, S.A.Not applicableNot applicableCanada
International/Other Brands
Civacir / Flebogamma (Instituto Grifols SA)
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
HyQviaImmune Globulin Human + HyaluronidaseKitBaxalta Canada Corporation2014-09-12Not applicableUs
HyqviaImmune Globulin Human + HyaluronidaseKitBaxalta Canada Corporation2014-09-12Not applicableUs
HyQviaImmune Globulin Human + HyaluronidaseKitBaxalta Canada Corporation2014-09-12Not applicableUs
HyQviaImmune Globulin Human + HyaluronidaseKitBaxalta Canada Corporation2014-09-12Not applicableUs
HyQviaImmune Globulin Human + HyaluronidaseKitBaxalta Canada Corporation2014-09-12Not applicableUs
Iveegam Immuno 5000mg (iv)Immune Globulin Human (5 g) + Water (100 ml)Kit; Liquid; Powder, for solutionIntravenousBaxter Ag1992-12-312008-12-23Canada
Categories
UNII
66Y330CJHS
CAS number
9007-83-4

Pharmacology

Indication

IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases.

Structured Indications
Not Available
Pharmacodynamics

Used as a replacement therapy in inherited humoral immunodeficiency disorders such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich Syndrome. The immunoglobulins target, bind and kill bacterial cells as well as viral particles. IgG is the monomeric immunoglobulin of which there are four subclasses (IgG1, IgG2, IgG3 and IgG4) in differing abundances (66%, 23%, 7% and 4%). IgAs represent about 15% of the immunoglobulins in the blood. These target inhaled or ingested pathogens.

Mechanism of action

IVIg interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface immunocompetent molecules. IVIg also impacts different effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Its main mechanism of actions are believed to be Fc-dependent and F(ab')2-dependent. IVIg competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and suppressing platelet depletion. IVIg contains a number of different antobodies, which prevent infection by attaching to the surface of invading pathogens and aiding in their disposal before they can infect cells. Antibodies remove pathogens via complement activation, agglutination or precipitation, pathogen receptor blocking, macrophage “tagging” or neutralization (via binding) of pathogen toxins. Intact IVIg and F(ab′)2 fragments of IVIg can also neutralize the activity of various autoantibodies. By triggering the production of interleukin-1 receptor antagonist, IVIg modulates of the production of cytokines and cytokine antagonists. It also prevents the generation of the C5b-9 membrane attack complex and subsequent complement-mediated tissue damage by binding active complement components.

TargetActionsOrganism
AHigh affinity immunoglobulin gamma Fc receptor I
antagonist
Human
AHigh affinity immunoglobulin gamma Fc receptor IB
antagonist
Human
ALow affinity immunoglobulin gamma Fc region receptor II-a
antagonist
Human
ALow affinity immunoglobulin gamma Fc region receptor II-b
antagonist
Human
ALow affinity immunoglobulin gamma Fc region receptor II-c
antagonist
Human
ALow affinity immunoglobulin gamma Fc region receptor III-A
antagonist
Human
ALow affinity immunoglobulin gamma Fc region receptor III-B
antagonist
Human
AComplement C3
binder
Human
AComplement C4-A
binder
Human
AComplement C4-B
binder
Human
AComplement C5
binder
Human
Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life

>20 hours (mammalian reticulocytes, in vitro).

Clearance
Not Available
Toxicity
Not Available
Affected organisms
  • Humans and other mammals
  • Bacteria and protozoa
  • Various viruses
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
DrugInteractionDrug group
BCG vaccineThe therapeutic efficacy of BCG vaccine can be decreased when used in combination with Immune Globulin Human.Investigational
Clostridium tetani toxoid antigen (formaldehyde inactivated)The therapeutic efficacy of Clostridium tetani toxoid antigen (formaldehyde inactivated) can be decreased when used in combination with Immune Globulin Human.Approved
Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)The therapeutic efficacy of Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) can be decreased when used in combination with Immune Globulin Human.Approved
G17DTThe therapeutic efficacy of G17DT can be decreased when used in combination with Immune Globulin Human.Investigational
GI-5005The therapeutic efficacy of GI-5005 can be decreased when used in combination with Immune Globulin Human.Investigational
INGN 201The therapeutic efficacy of INGN 201 can be decreased when used in combination with Immune Globulin Human.Investigational
INGN 225The therapeutic efficacy of INGN 225 can be decreased when used in combination with Immune Globulin Human.Investigational
Rabies virus inactivated antigen, AThe therapeutic efficacy of Rabies virus inactivated antigen, A can be decreased when used in combination with Immune Globulin Human.Approved
RindopepimutThe therapeutic efficacy of Rindopepimut can be decreased when used in combination with Immune Globulin Human.Investigational
Rotavirus VaccineThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Immune Globulin Human.Approved
Rubella virus vaccineThe therapeutic efficacy of Rubella virus vaccine can be decreased when used in combination with Immune Globulin Human.Approved
SRP 299The therapeutic efficacy of SRP 299 can be decreased when used in combination with Immune Globulin Human.Investigational
TecemotideThe therapeutic efficacy of Tecemotide can be decreased when used in combination with Immune Globulin Human.Investigational
TG4010The therapeutic efficacy of TG4010 can be decreased when used in combination with Immune Globulin Human.Investigational
Yellow fever vaccineThe therapeutic efficacy of Yellow fever vaccine can be decreased when used in combination with Immune Globulin Human.Approved
Zoster vaccineThe therapeutic efficacy of Zoster vaccine can be decreased when used in combination with Immune Globulin Human.Approved
Food Interactions
Not Available

References

Synthesis Reference

Wolfgang Stephan, "Production of intravenously applicable native human immune globulin having a normal half-life." U.S. Patent US4082734, issued July, 1970.

US4082734
General References
  1. Bayry J, Fournier EM, Maddur MS, Vani J, Wootla B, Siberil S, Dimitrov JD, Lacroix-Desmazes S, Berdah M, Crabol Y, Oksenhendler E, Levy Y, Mouthon L, Sautes-Fridman C, Hermine O, Kaveri SV: Intravenous immunoglobulin induces proliferation and immunoglobulin synthesis from B cells of patients with common variable immunodeficiency: a mechanism underlying the beneficial effect of IVIg in primary immunodeficiencies. J Autoimmun. 2011 Feb;36(1):9-15. doi: 10.1016/j.jaut.2010.09.006. Epub 2010 Dec 9. [PubMed:20970960]
  2. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
  3. Stangel M, Pul R: Basic principles of intravenous immunoglobulin (IVIg) treatment. J Neurol. 2006 Sep;253 Suppl 5:V18-24. [PubMed:16998749]
  4. Emmi L, Chiarini F: The role of intravenous immunoglobulin therapy in autoimmune and inflammatory disorders. Neurol Sci. 2002 Apr;23 Suppl 1:S1-8. [PubMed:12032582]
External Links
UniProt
P01877
Genbank
J00221
PubChem Substance
46508774
PharmGKB
PA164754884
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
AHFS Codes
  • 80:04.00 — Serums

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
0CompletedTreatmentCutaneous Lupus Erythematosus (CLE)1
0CompletedTreatmentRenal Failure, Chronic / Transplantation, Renal1
0Not Yet RecruitingTreatmentHaemolysis neonatal1
0RecruitingTreatmentDermatomyositis1
1Active Not RecruitingTreatmentKidney Failure,Chronic1
1CompletedTreatmentHealthy Volunteers1
1CompletedTreatmentMucocutaneous Lymph Node Syndrome1
1CompletedTreatmentMuscle Rigidity / Spasms / Stiff Man Syndrome1
1CompletedTreatmentTransplantation, Kidney1
1RecruitingTreatmentBK Virus / Isoantibodies / Transplantation, Kidney1
1RecruitingTreatmentSafety and Tolerability in Healthy Volunteers1
1RecruitingTreatmentSpinocerebellar Ataxias1
1TerminatedTreatmentPolyneuropathies1
1Unknown StatusTreatmentHeart Failure, Unspecified1
1WithdrawnTreatmentAnterior Segment Inflammation / Corneal Graft Failure / Corneal Neovascularization1
1WithdrawnTreatmentStroke, Ischemic1
1, 2CompletedTreatmentAnthrax1
1, 2CompletedTreatmentBiliary Atresia1
1, 2CompletedTreatmentEnd Stage Renal Disease (ESRD)1
1, 2CompletedTreatmentTransplant, Kidney1
1, 2Not Yet RecruitingTreatmentCongenital Immunodeficiency1
1, 2RecruitingTreatmentPain / Sickle Cell Disorders1
2Active Not RecruitingTreatmentMild Cognitive Impairment (MCI)1
2CompletedTreatmentAgammaglobulinemia / Hypogammaglobulinemia / Primary Immunodeficiency (PID)1
2CompletedTreatmentAlzheimer's Disease (AD)2
2CompletedTreatmentDemyelinating Diseases / Paraproteinemias1
2CompletedTreatmentEncephalitis, Japanese B1
2CompletedTreatmentFournier's Gangrene / Gas Gangrene / Necrotizing Fasciitis / Necrotizing Soft Tissue Infections1
2CompletedTreatmentIgG Deficiency / Infection NOS1
2CompletedTreatmentImmunologic Deficiency Syndromes1
2CompletedTreatmentMacular Degeneration1
2CompletedTreatmentMultifocal Motor Neuropathy (MMN)2
2CompletedTreatmentMultiple System Atrophy (MSA)1
2CompletedTreatmentNeuromyelitis Optica Spectrum Disorder1
2CompletedTreatmentPurpura, Thrombocytopenic, Idiopathic1
2CompletedTreatmentRelapsing Remitting Multiple Sclerosis (RRMS)1
2CompletedTreatmentRenal Failure1
2CompletedTreatmentSpinocerebellar Ataxias1
2CompletedTreatmentSpinocerebellar Degenerations1
2Enrolling by InvitationTreatmentMultifocal Motor Neuropathy (MMN)1
2Not Yet RecruitingTreatmentAutoimmune Encephalitis / Psychosis1
2Not Yet RecruitingTreatmentChronic Obstructive Pulmonary Disease (COPD)1
2Not Yet RecruitingTreatmentMild Cognitive Impairment (MCI)1
2RecruitingNot AvailableToxic Shock Syndrome1
2RecruitingOtherChronic Obstructive Pulmonary Disease (COPD)1
2RecruitingTreatmentAneurysm, Coronary / Mucocutaneous Lymph Node Syndrome1
2RecruitingTreatmentMyasthenia Gravis1
2RecruitingTreatmentRecurrent Implantation Failure (RIF)1
2RecruitingTreatmentRecurrent Pregnancy Losses1
2RecruitingTreatmentSmall Fibre Neuropathy1
2TerminatedTreatmentAntibody-mediated Rejection / Humoral Rejection1
2TerminatedTreatmentAutoimmune Diseases, Nervous System / Epilepsy, Cryptogenic / Epilepsy, Localization Related / Limbic Encephalitis / Seizures Disorders1
2TerminatedTreatmentEvidence of Liver Transplantation / Sequelae of Viral Hepatitis / Transplantation Infection1
2TerminatedTreatmentKidney Failure,Chronic1
2TerminatedTreatmentPemphigus Vulgaris (PV)1
2Unknown StatusPreventionHypogammaglobulinemia / Transplantation, Lung1
2Unknown StatusTreatmentCancer of Colon / Malignant Melanoma / Urologic Cancer1
2Unknown StatusTreatmentEnd Stage Renal Disease (ESRD)1
2Unknown StatusTreatmentPain, Neuropathic1
2Unknown StatusTreatmentPediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections1
2WithdrawnTreatmentRejection, Transplant / Transplantation, Kidney1
2WithdrawnTreatmentSystemic Lupus Erythematosus (SLE)1
2, 3Active Not RecruitingTreatmentAlzheimer's Disease (AD)1
2, 3CompletedPreventionAutoantibody-Associated Heart Block / Congenital Heart Block / Neonatal Lupus1
2, 3CompletedPreventionInfant, Low Birth Weight / Infant, Small for Gestational Age / Infants, Premature / Newborn Infants / Sepsis1
2, 3CompletedTreatmentAutoimmune Autonomic Ganglionopathy (AAG)1
2, 3CompletedTreatmentEnd Stage Renal Disease (ESRD)1
2, 3CompletedTreatmentPost-Polio Syndrome1
2, 3CompletedTreatmentPrimary Immunodeficiency (PID)1
2, 3CompletedTreatmentPrimary Immunodeficiency Diseases (PID)1
2, 3CompletedTreatmentPrimary Immunodeficiency Diseases (PID) / Primary Immunodeficiency Diseases(PIDD)1
2, 3CompletedTreatmentPrimary Immunodeficiency Disorders1
2, 3RecruitingTreatmentAlloimmune Thrombocytopenia / Fetal Alloimmune Thrombocytopenia1
2, 3RecruitingTreatmentLangerhans Cell Histiocytosis (LCH)1
2, 3RecruitingTreatmentSecondary Immune Deficiency1
3Active Not RecruitingTreatmentInflammation, Brain1
3CompletedNot AvailablePrimary Antibody Deficiency1
3CompletedPreventionHepatitis C Infection / Hepatitis, Viral, Human / Hepatocellular,Carcinoma / Liver Cirrhosis / Viruses1
3CompletedPreventionNeonatal Sepsis1
3CompletedTreatmentAcute Myocardial Infarction (AMI)1
3CompletedTreatmentAgammaglobulinemia / Common Variable Immunodeficiency / Immunologic Deficiency Syndromes / Severe Combined Immunodeficiency / Wiskott-Aldrich Syndrome (WAS)1
3CompletedTreatmentAlzheimer's Disease (AD)1
3CompletedTreatmentAutoimmune Diseases / Mental Disorders Diagnosed in Childhood / Schizophrenic Disorders1
3CompletedTreatmentAutosomal Recessive Agammaglobulinemia / Bruton's agammaglobulinemia / Common Variable Immunodeficiency1
3CompletedTreatmentBruton's agammaglobulinemia / Common Variable Immunodeficiency / Hyper-IgM Syndrome / Primary Immune Deficiency Disorders (PIDD)1
3CompletedTreatmentChronic Idiopathic Thrombocytopenic Purpura1
3CompletedTreatmentChronic Inflammatory Demyelinating Polyneuropathy (CIDP)2
3CompletedTreatmentChronic Inflammatory Demyelinating Polyneuropathy (CIDP) / Polyradiculoneuropathy1
3CompletedTreatmentCommon Variable Hypogammaglobulinemia / Congenital Immunodeficiency / Hypogammaglobulinemia / Immunodeficiency With Hyper-IgM / Wiskott-Aldrich Syndrome (WAS) / X-linked Hypogammaglobulinemia1
3CompletedTreatmentEnd-Stage Renal Disease (ESRD) / Transplantation, Kidney1
3CompletedTreatmentIdiopathic Thrombocytopenic Purpura (ITP)1
3CompletedTreatmentImmune Thrombocytopenic Purpura ( ITP )3
3CompletedTreatmentImmune Thrombocytopenic Purpura ( ITP ) / Kawasaki Syndrome / Primary Immunodeficiency Disorders1
3CompletedTreatmentMucocutaneous Lymph Node Syndrome2
3CompletedTreatmentMultifocal Motor Neuropathy (MMN)1
3CompletedTreatmentPolyradiculoneuropathy, Chronic Inflammatory Demyelinating1
3CompletedTreatmentPrimary Immune Deficiency (PID)3
3CompletedTreatmentPrimary Immune Deficiency Disorders (PIDD)1
3CompletedTreatmentPrimary Immune Deficiency Disorders (PIDD) / Primary Immunodeficiency Disorders1
3CompletedTreatmentPrimary Immunodeficiency (PID)1
3CompletedTreatmentPrimary Immunodeficiency Diseases (PID)2
3CompletedTreatmentSecondary Recurrent Miscarriage1
3CompletedTreatmentStevens Johnson Syndrome / Toxic Epidermal Necrolysis1
3RecruitingPreventionPrimary Immunodeficiency Diseases (PID)1
3RecruitingSupportive CareImmune Thrombocytopenic Purpura ( ITP )1
3RecruitingTreatmentAutoimmune Epilepsy1
3RecruitingTreatmentChronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy1
3RecruitingTreatmentCongenital Immunodeficiency1
3RecruitingTreatmentDermatomyositis1
3RecruitingTreatmentImmune Thrombocytopenia1
3RecruitingTreatmentInfluenza A Virus Infection / Influenza B1
3RecruitingTreatmentMucocutaneous Lymph Node Syndrome1
3RecruitingTreatmentMyasthenia Gravis1
3RecruitingTreatmentPolyradiculoneuropathy, Chronic Inflammatory Demyelinating2
3TerminatedTreatmentAlzheimer's Disease (AD)2
3TerminatedTreatmentImmunologic Deficiency Syndromes1
3TerminatedTreatmentNeuromyelitis Optica / Transverse Myelitis1
3Unknown StatusTreatmentComplex Regional Pain Syndrome Type 11
4Active Not RecruitingPreventionPrimary Immune Deficiency (PID) / Secondary Immune Deficiency1
4Active Not RecruitingTreatmentAsperger's Disorder / Autism, Early Infantile / Autistic Disorder / PDD / Pervasive Developmental Disorder NOS1
4CompletedPreventionBruton's agammaglobulinemia / Common Variable Immunodeficiency / Hyper-IgM Syndrome / Primary Immune Deficiency Disorders (PIDD) / Wiskott-Aldrich Syndrome (WAS)1
4CompletedTreatmentAgammaglobulinemia / Common Variable Immunodeficiency1
4CompletedTreatmentCongenital Immunodeficiency1
4CompletedTreatmentErythroblastosis, Fetal / Hyperbilirubinemia1
4CompletedTreatmentImmune Thrombocytopenic Purpura ( ITP )1
4CompletedTreatmentMyasthenia Gravid1
4CompletedTreatmentPrimary or Secondary Antibody Deficiency (PAD or SAD)1
4Not Yet RecruitingTreatmentInfection caused by staphylococci / Streptococcal Infections1
4RecruitingOtherHumoral Immune Response1
4RecruitingTreatmentChronic Inflammatory Demyelinating Polyneuropathy (CIDP) / Diabetes Mellitus (DM) / Peripheral Neuropathy1
4RecruitingTreatmentCongenital Immunodeficiency2
4RecruitingTreatmentPrimary Immunodeficiency Diseases (PID)1
4TerminatedTreatmentClostridium Difficile-Associated Diarrhea (CDAD)1
4TerminatedTreatmentHIV-associated Myelopathy1
Not AvailableActive Not RecruitingTreatmentDiffuse Systemic Sclerosis / Sclerosis, Progressive Systemic1
Not AvailableCompletedNot AvailablePediatric Heart Transplant Recipients / Pediatric Heart Transplantation1
Not AvailableCompletedNot AvailablePrimary Immune Deficiency (PID)1
Not AvailableCompletedTreatmentCongenital Heart Disease (CHD) / Hypogammaglobulinemia1
Not AvailableCompletedTreatmentInfections After Lung Transplant1
Not AvailableCompletedTreatmentMiller Fisher Syndrome1
Not AvailableCompletedTreatmentNovel 2009 Influenza A (H1N1) Infection1
Not AvailableCompletedTreatmentPost Streptococcal Movement Disorder / Sydenham Chorea1
Not AvailableNot Yet RecruitingTreatmentMultifocal Motor Neuropathy (MMN)1
Not AvailableRecruitingNot AvailableChronic Inflammatory Demyelinating Polyneuropathy (CIDP)1
Not AvailableRecruitingNot AvailableCongenital Immunodeficiency / Secondary Immune Deficiency1
Not AvailableRecruitingNot AvailableExposure During Pregnancy1
Not AvailableRecruitingNot AvailablePrimary Immune Deficiency Disorders (PIDD)2
Not AvailableRecruitingNot AvailablePrimary Immunodeficiency Diseases (PID)1
Not AvailableRecruitingOtherAuto Immune Disorders / Psychosis / Schizophrenic Disorders1
Not AvailableRecruitingOtherChronic Inflammatory Demyelinating Polyneuropathy (CIDP)1
Not AvailableRecruitingTreatmentAutoimmune Diseases / Clarkson Syndrome / Muscular Autoimmune Disorders / Polyradiculoneuropathy, Chronic Inflammatory Demyelinating1
Not AvailableTerminatedTreatmentMyasthenia Gravis1
Not AvailableUnknown StatusTreatmentPrimary Immunodeficiency Disorders1
Not AvailableWithdrawnTreatmentPeritonitis / Postoperative Complications1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Dosage forms
FormRouteStrength
Injection, solutionIntravenous1 g/10mL
Injection, solutionIntravenous10 g/100mL
Injection, solutionIntravenous5 g/50mL
Injection, powder, lyophilized, for solutionIntravenous12 g/1
Injection, powder, lyophilized, for solutionIntravenous3 g/1
Injection, powder, lyophilized, for solutionIntravenous6 g/1
Injection, solutionIntravenous; Subcutaneous1 g/5mL
Injection, solutionIntravenous.05 g/mL
Injection, solutionIntravenous100 mg/ml
Injection, solutionIntravenous50 mg/ml
LiquidIntramuscular16.5 %
InjectionIntramuscular.165 g/mL
SolutionIntramuscular18 %
SolutionIntravenous50 mg
Injection, solutionIntravenous; Subcutaneous100 mg/mL
Kit
Powder, for solutionIntravenous10 g
Powder, for solutionIntravenous2.5 g
Powder, for solutionIntravenous5 g
Powder, for solutionIntravenous0.5 g
InjectionIntravenous10 g/100mL
SolutionIntravenous5 g/100mL
SolutionIntravenous5 g/50mL
LiquidIntramuscular165 mg
SolutionIntravenous; Subcutaneous10 g
Injection, solutionSubcutaneous200 mg/ml
LiquidSubcutaneous.2 g/mL
SolutionSubcutaneous200 mg
SolutionIntramuscular1500 unit
Injection, solutionSubcutaneous100 mg/ml
Kit
LiquidIntravenous50 mg
SolutionIntravenous10 g
SolutionIntravenous5 g
Kit; liquid; powder, for solutionIntravenous
SolutionIntravenous100 mg
SolutionIntravenous100 mg/mL
SolutionIntravenous50 mg/mL
LiquidIntravenous10 g/100mL
LiquidIntravenous20 g/200mL
LiquidIntravenous40 g/400mL
LiquidIntravenous5 g/50mL
SolutionIntravenous10 %
SolutionIntravenous120 g
SolutionSubcutaneous160 mg/mL
SolutionSubcutaneous160 mg
LiquidIntramuscular; Intravenous1500 [iU]/mL
LiquidIntramuscular; Intravenous15000 [iU]/mL
LiquidIntramuscular; Intravenous2500 [iU]/mL
LiquidIntramuscular; Intravenous5000 [iU]/mL
LiquidIntramuscular; Intravenous600 [iU]/mL
Prices
Unit descriptionCostUnit
Hypertet s-d 250 unit syringe324.23USD syringe
Hyperrab s-d vial224.07USD ml
Nabi-hb vial176.34USD ml
Hyperhep b s-d vial165.04USD ml
Hizentra 1 gram/5 ml vial30.24USD ml
Hizentra 2 gram/10 ml vial30.24USD ml
Hizentra 4 gram/20 ml vial30.24USD ml
Gamastan s-d vial24.44USD ml
Gammagard liquid 10% vial13.79USD ml
Gamunex 10% vial11.6USD ml
Immune globulin vial9.34USD ml
Flebogamma 5% vial4.84USD ml
Flebogamma dif 5% vial4.84USD ml
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Not Available

Properties

State
Liquid
Experimental Properties
PropertyValueSource
melting point (°C)61 °C (FAB fragment), 71 °C (whole mAb)Vermeer, A.W.P. & Norde, W., Biophys. J. 78:394-404 (2000)
hydrophobicity-0.331Not Available
isoelectric point8.13Not 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

Targets

Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Antagonist
General Function
Receptor signaling protein activity
Specific Function
High affinity receptor for the Fc region of immunoglobulins gamma. Functions in both innate and adaptive immune responses.
Gene Name
FCGR1A
Uniprot ID
P12314
Uniprot Name
High affinity immunoglobulin gamma Fc receptor I
Molecular Weight
42631.525 Da
References
  1. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
  2. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  3. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Antagonist
General Function
Immunoglobulin receptor activity
Specific Function
May bind to the Fc region of immunoglobulins gamma with a low affinity compared to FCGR1A. May function in the humoral immune response.
Gene Name
FCGR1B
Uniprot ID
Q92637
Uniprot Name
High affinity immunoglobulin gamma Fc receptor IB
Molecular Weight
32231.795 Da
References
  1. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
  2. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  3. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Antagonist
General Function
Not Available
Specific Function
Binds to the Fc region of immunoglobulins gamma. Low affinity receptor. By binding to IgG it initiates cellular responses against pathogens and soluble antigens. Promotes phagocytosis of opsonized ...
Gene Name
FCGR2A
Uniprot ID
P12318
Uniprot Name
Low affinity immunoglobulin gamma Fc region receptor II-a
Molecular Weight
35000.42 Da
References
  1. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
  2. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  3. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Antagonist
General Function
Not Available
Specific Function
Receptor for the Fc region of complexed or aggregated immunoglobulins gamma. Low affinity receptor. Involved in a variety of effector and regulatory functions such as phagocytosis of immune complex...
Gene Name
FCGR2B
Uniprot ID
P31994
Uniprot Name
Low affinity immunoglobulin gamma Fc region receptor II-b
Molecular Weight
34043.355 Da
References
  1. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
  2. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  3. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Antagonist
General Function
Transmembrane signaling receptor activity
Specific Function
Receptor for the Fc region of complexed immunoglobulins gamma. Low affinity receptor. Involved in a variety of effector and regulatory functions such as phagocytosis of immune complexes and modulat...
Gene Name
FCGR2C
Uniprot ID
P31995
Uniprot Name
Low affinity immunoglobulin gamma Fc region receptor II-c
Molecular Weight
35577.96 Da
References
  1. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
  2. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  3. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Antagonist
General Function
Not Available
Specific Function
Receptor for the Fc region of IgG. Binds complexed or aggregated IgG and also monomeric IgG. Mediates antibody-dependent cellular cytotoxicity (ADCC) and other antibody-dependent responses, such as...
Gene Name
FCGR3A
Uniprot ID
P08637
Uniprot Name
Low affinity immunoglobulin gamma Fc region receptor III-A
Molecular Weight
29088.895 Da
References
  1. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
  2. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  3. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Antagonist
General Function
Not Available
Specific Function
Receptor for the Fc region of immunoglobulins gamma. Low affinity receptor. Binds complexed or aggregated IgG and also monomeric IgG. Contrary to III-A, is not capable to mediate antibody-dependent...
Gene Name
FCGR3B
Uniprot ID
O75015
Uniprot Name
Low affinity immunoglobulin gamma Fc region receptor III-B
Molecular Weight
26215.64 Da
References
  1. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
  2. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  3. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Binder
General Function
Receptor binding
Specific Function
C3 plays a central role in the activation of the complement system. Its processing by C3 convertase is the central reaction in both classical and alternative complement pathways. After activation C...
Gene Name
C3
Uniprot ID
P01024
Uniprot Name
Complement C3
Molecular Weight
187146.73 Da
References
  1. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  2. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
  3. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Binder
General Function
Endopeptidase inhibitor activity
Specific Function
Non-enzymatic component of C3 and C5 convertases and thus essential for the propagation of the classical complement pathway. Covalently binds to immunoglobulins and immune complexes and enhances th...
Gene Name
C4A
Uniprot ID
P0C0L4
Uniprot Name
Complement C4-A
Molecular Weight
192783.805 Da
References
  1. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  2. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
  3. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Binder
General Function
Non-enzymatic component of the C3 and C5 convertases and thus essential for the propagation of the classical complement pathway. Covalently binds to immunoglobulins and immune complexes and enhances the solubilization of immune aggregates and the clearance of IC through CR1 on erythrocytes. C4A isotype is responsible for effective binding to form amide bonds with immune aggregates or protein antigens, while C4B isotype catalyzes the transacylation of the thioester carbonyl group to form ester bonds with carbohydrate antigens.
Specific Function
Carbohydrate binding
Gene Name
C4B
Uniprot ID
P0C0L5
Uniprot Name
Complement C4-B
Molecular Weight
192749.785 Da
References
  1. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  2. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
  3. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Binder
General Function
Receptor binding
Specific Function
Activation of C5 by a C5 convertase initiates the spontaneous assembly of the late complement components, C5-C9, into the membrane attack complex. C5b has a transient binding site for C6. The C5b-C...
Gene Name
C5
Uniprot ID
P01031
Uniprot Name
Complement C5
Molecular Weight
188303.705 Da
References
  1. Baerenwaldt A, Biburger M, Nimmerjahn F: Mechanisms of action of intravenous immunoglobulins. Expert Rev Clin Immunol. 2010 May;6(3):425-34. doi: 10.1586/eci.10.9. [PubMed:20441428]
  2. Negi VS, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, Lacroix-Desmazes S, Bayry J, Kaveri SV: Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol. 2007 May;27(3):233-45. Epub 2007 Mar 11. [PubMed:17351760]
  3. Siberil S, Elluru S, Graff-Dubois S, Negi VS, Delignat S, Mouthon L, Lacroix-Desmazes S, Kazatchkine MD, Bayry J, Kaveri SV: Intravenous immunoglobulins in autoimmune and inflammatory diseases: a mechanistic perspective. Ann N Y Acad Sci. 2007 Sep;1110:497-506. [PubMed:17911465]

Drug created on June 13, 2005 07:24 / Updated on November 13, 2017 21:49