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
Condition | Modality | Targets | Highest Phase | Product |
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Primary | GAMMAGARD Approved UseGAMMAGARD 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 Date2005 |
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
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Classification Tree | Code System | Code | ||
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FDA ORPHAN DRUG |
152101
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FDA ORPHAN DRUG |
180503
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FDA ORPHAN DRUG |
564716
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FDA ORPHAN DRUG |
243307
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admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
PRIVIGEN (AUTHORIZED: GUILLAIN-BARRE SYNDROME)
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admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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WHO-ATC |
J06BA02
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FDA ORPHAN DRUG |
176003
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admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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FDA ORPHAN DRUG |
439914
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
PRIVIGEN (AUTHORIZED: PURPURA, THROMBOCYTOPENIC, IDIOPATHIC)
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admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
FLEBOGAMMA DIF (AUTHORIZED: PURPURA, THROMBOCYTOPENIC, IDIOPATHIC)
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admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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FDA ORPHAN DRUG |
514315
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
KIOVIG (AUTHORIZED: MUCOCUTANEOUS LYMPH NODE SYNDROME)
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admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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NCI_THESAURUS |
C307
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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FDA ORPHAN DRUG |
219706
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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FDA ORPHAN DRUG |
264208
Created by
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FDA ORPHAN DRUG |
335211
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EU-Orphan Drug |
EU/3/17/1866
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FDA ORPHAN DRUG |
70592
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admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
HYQVIA (AUTHORIZED: IMMUNOLOGIC DEFICIENCY SYNDROMES)
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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FDA ORPHAN DRUG |
224906
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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WHO-ATC |
J06BA01
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
PRIVIGEN (AUTHORIZED: MUCOCUTANEOUS LYMPH NODE SYNDROME)
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
FLEBOGAMMA DIF (AUTHORIZED: MUCOCUTANEOUS LYMPH NODE SYNDROME)
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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FDA ORPHAN DRUG |
142901
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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NDF-RT |
N0000184165
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
KIOVIG (AUTHORIZED: PURPURA, THROMBOCYTOPENIC, IDIOPATHIC)
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
FLEBOGAMMA DIF (AUTHORIZED: GUILLAIN-BARRE SYNDROME)
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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WHO-ESSENTIAL MEDICINES LIST |
11.2
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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EMA ASSESSMENT REPORTS |
KIOVIG (AUTHORIZED: GUILLAIN-BARRE SYNDROME)
Created by
admin on Sat Dec 16 01:39:34 GMT 2023 , Edited by admin on Sat Dec 16 01:39:34 GMT 2023
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Code System | Code | Type | Description | ||
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1426680
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PRIMARY | |||
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66Y330CJHS
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PRIMARY | |||
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308067-58-5
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PRIMARY | |||
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SUB127300
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N0000007920
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PRIMARY | Immunoglobulins [Chemical/Ingredient] | ||
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SUB20618
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ALTERNATIVE | |||
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66Y330CJHS
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PRIMARY | |||
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N0000183365
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PRIMARY | Passively Acquired Immunity [PE] | ||
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C80829
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PRIMARY | |||
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DB00028
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PRIMARY | |||
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N0000184008
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PRIMARY | Antigen Neutralization [MoA] | ||
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SUB14196MIG
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PRIMARY | |||
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SUB12041MIG
Created by
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PRIMARY |
ACTIVE MOIETY