U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Immune globulin human (Human immunoglobulin) is a mixture of IgG1 and other antibodies derived from healthy human plasma and used to strengthen the body's natural defense system (immune system) to reduce the risk of infection in people with weakened immune systems. Human immunoglobulin is used as replacement therapy for inherited humoral immunodeficiency disorders, such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich syndrome. Human immunoglobulin interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors, and several immunocompetent cell surface molecules. Human immunoglobulin also acts on various effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Human immune globulin competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and inhibiting platelet depletion. Human immunoglobulin contains a number of different antibodies that prevent infection by attaching pathogenic microorganisms to the surface and facilitating their removal before they can infect cells. Antibodies remove pathogens by activating complement, agglutination or precipitation, blocking the pathogen receptor, “tagging” macrophages, or neutralizing the pathogen toxins. Serious adverse reactions are observed during intravenous treatment in clinical studies of aseptic meningitis. The most common adverse reactions were headache, fatigue, hyperthermia, nausea, chills, severity, pain in the limbs, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, sore throat and throat, rash, myalgia, itching, and cardiac murmur. During clinical trials of subcutaneous treatment, no serious adverse reactions were observed.

Approval Year

Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
GAMMAGARD

Approved Use

GAMMAGARD LIQUID is an immune globulin infusion (human) indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. GAMMAGARD LIQUID is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy.

Launch Date

1.11490564E12

Sample Use Guides

Intravenous Administration: 300 to 600 mg/kg every 3 to 4 weeks based on clinical response Subcutaneous Administration: Initial Dose is 1.37 × previous intravenous dose divided by # of weeks between intravenous doses. Maintenance dose is based on clinical response
Route of Administration: Other
Substance Class Structurally Diverse
Created
by admin
on Sat Dec 16 01:39:33 UTC 2023
Edited
by admin
on Sat Dec 16 01:39:33 UTC 2023
Source Materials Class ORGANISM
Source Materials Type HUMAN
Source Materials Parent
Part BLOOD PLASMA
Fraction Material Type PROTEIN
Fraction Name IGG
Record UNII
66Y330CJHS
Record Status Validated (UNII)
Record Version
  • Download
Related Record Type
Name Type Language
HUMAN IMMUNOGLOBULIN G
Common Name English
HUMAN NORMAL IMMUNOGLOBULIN (IVIG) [EMA EPAR]
Common Name English
HUMAN NORMAL IMMUNOGLOBULIN [EMA EPAR]
Common Name English
HUMAN NORMAL IMMUNOGLOBULIN (IVIG)
EMA EPAR  
Common Name English
CSL787 NEBULIZED IG
Code English
BT-295
Common Name English
IMMUNOGLOBULIN G (HUMAN)
Common Name English
Immunoglobulin g human [WHO-DD]
Common Name English
FLEBOGAMMA DIF
Brand Name English
HYQVIA COMPONENT HUMAN IMMUNOGLOBULIN G
Common Name English
NORMAL IMMUNOGLOBULINS [MART.]
Common Name English
IVIG
Common Name English
HUMAN NORMAL IMMUNOGLOBULIN
EMA EPAR  
Common Name English
FLEBOGAMMADIF
Brand Name English
PRIVIGEN
Brand Name English
CSL787
Code English
KIOVIG
Brand Name English
IMMUNOGLOBULIN G, HUMAN
Common Name English
NPB-01
Code English
CSL-787
Code English
IGIV
Common Name English
HUMAN GAMMAGLOBULIN
Common Name English
HUMAN IGG
Common Name English
NEWGAM
Brand Name English
HUMAN NORMAL IMMUNOGLOBULIN [JAN]
Common Name English
Classification Tree Code System Code
FDA ORPHAN DRUG 152101
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 180503
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 564716
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 243307
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS PRIVIGEN (AUTHORIZED: GUILLAIN-BARRE SYNDROME)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
WHO-ATC J06BA02
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 176003
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 439914
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS PRIVIGEN (AUTHORIZED: PURPURA, THROMBOCYTOPENIC, IDIOPATHIC)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS FLEBOGAMMA DIF (AUTHORIZED: PURPURA, THROMBOCYTOPENIC, IDIOPATHIC)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 514315
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS KIOVIG (AUTHORIZED: MUCOCUTANEOUS LYMPH NODE SYNDROME)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
NCI_THESAURUS C307
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 219706
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 264208
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 335211
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EU-Orphan Drug EU/3/17/1866
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 70592
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS HYQVIA (AUTHORIZED: IMMUNOLOGIC DEFICIENCY SYNDROMES)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 224906
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
WHO-ATC J06BA01
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS PRIVIGEN (AUTHORIZED: MUCOCUTANEOUS LYMPH NODE SYNDROME)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS FLEBOGAMMA DIF (AUTHORIZED: MUCOCUTANEOUS LYMPH NODE SYNDROME)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
FDA ORPHAN DRUG 142901
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
NDF-RT N0000184165
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS KIOVIG (AUTHORIZED: PURPURA, THROMBOCYTOPENIC, IDIOPATHIC)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS FLEBOGAMMA DIF (AUTHORIZED: GUILLAIN-BARRE SYNDROME)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
WHO-ESSENTIAL MEDICINES LIST 11.2
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
EMA ASSESSMENT REPORTS KIOVIG (AUTHORIZED: GUILLAIN-BARRE SYNDROME)
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
Code System Code Type Description
RXCUI
1426680
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
FDA UNII
66Y330CJHS
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
CAS
308067-58-5
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
EVMPD
SUB127300
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
NDF-RT
N0000007920
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY Immunoglobulins [Chemical/Ingredient]
EVMPD
SUB20618
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
ALTERNATIVE
DAILYMED
66Y330CJHS
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
NDF-RT
N0000183365
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY Passively Acquired Immunity [PE]
NCI_THESAURUS
C80829
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
DRUG BANK
DB00028
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
NDF-RT
N0000184008
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY Antigen Neutralization [MoA]
EVMPD
SUB14196MIG
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
EVMPD
SUB12041MIG
Created by admin on Sat Dec 16 01:39:34 UTC 2023 , Edited by admin on Sat Dec 16 01:39:34 UTC 2023
PRIMARY
Related Record Type Details
SUB_CONCEPT->SUBSTANCE
SUB_CONCEPT->SUBSTANCE
SUB_CONCEPT->SUBSTANCE
SUB_CONCEPT->SUBSTANCE
SUB_CONCEPT->SUBSTANCE
SUB_CONCEPT->SUBSTANCE
SUB_CONCEPT->SUBSTANCE
SUB_CONCEPT->SUBSTANCE
Related Record Type Details
ACTIVE MOIETY