It has been suggested that this article should be split into a new article titled normal human immunoglobulin. (discuss) (December 2020)
Immunoglobulin therapy
Clinical data
Trade names
Flebogamma, Gammagard, Hizentra, others
Other names
normal human immunoglobulin (HNIG), human normal immunoglobulin (HNIG)
AHFS/Drugs.com
Monograph
License data
US DailyMed: Immune globulin
Pregnancy category
AU: Exempt[1]
Routes of administration
Intravenous, intramuscular, subcutaneous
ATC code
J06BA (WHO)
Legal status
Legal status
AU: S4 (Prescription only)[1][2][3]
CA: ℞-only[4][5][6][7]
US: ℞-only[8][9][10][11]
EU: Rx-only
In general: ℞ (Prescription only)
Identifiers
CAS Number
9007-83-4
ChemSpider
none
UNII
66Y330CJHS
Immunoglobulin therapy is the use of a mixture of antibodies (normal human immunoglobulin or NHIG) to treat several health conditions.[12][13] These conditions include primary immunodeficiency, immune thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy, Kawasaki disease, certain cases of HIV/AIDS and measles, Guillain–Barré syndrome, and certain other infections when a more specific immunoglobulin is not available.[12] Depending on the formulation it can be given by injection into muscle, a vein, or under the skin.[12] The effects last a few weeks.[13]
Common side effects include pain at the site of injection, muscle pain, and allergic reactions.[12] Other severe side effects include kidney problems, anaphylaxis, blood clots, and red blood cell breakdown.[12] Use is not recommended in people with some types of IgA deficiency.[12] Use appears to be relatively safe during pregnancy.[12] Human immunoglobulin is made from human blood plasma.[12] It contains antibodies against many viruses.[13]
Human immunoglobulin therapy first occurred in the 1930s and a formulation for injection into a vein was approved for medical use in the United States in 1981.[14] It is on the World Health Organization's List of Essential Medicines.[15][16] Each formulation of the product is somewhat different.[13] A number of specific immunoglobulin formulations are also available including for hepatitis B, rabies, tetanus, varicella infection, and Rh positive blood exposure.[13]
^ ab"Xembify APMDS". Therapeutic Goods Administration (TGA). 15 July 2022. Archived from the original on 14 July 2022. Retrieved 17 July 2022.
^"Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
^"Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
^"Regulatory Decision Summary - Xembify". Health Canada. 23 October 2014. Archived from the original on 7 June 2022. Retrieved 7 June 2022.
^"Summary Basis of Decision - HyQvia". Health Canada. 23 October 2014. Retrieved 6 August 2022.
^"Immune system health". Health Canada. 9 May 2018. Retrieved 13 April 2024.
^"Drug and medical device highlights 2018: Helping you maintain and improve your health". Health Canada. 14 October 2020. Retrieved 17 April 2024.
^Cite error: The named reference Asceniv FDA label was invoked but never defined (see the help page).
^Cite error: The named reference Bivigam FDA label was invoked but never defined (see the help page).
^Cite error: The named reference Gamunex-C FDA label was invoked but never defined (see the help page).
^Cite error: The named reference Alyglo FDA label was invoked but never defined (see the help page).
^ abcdefgh"Immune Globulin". The American Society of Health-System Pharmacists. Archived from the original on 9 January 2017. Retrieved 8 January 2017.
^ abcdeBritish national formulary : BNF 69 (69 ed.). British Medical Association. 2015. pp. 867–71. ISBN 9780857111562.
^Etzioni A, Ochs HD (2014). Primary Immunodeficiency Disorders: A Historic and Scientific Perspective. Academic Press. pp. 283–84. ISBN 9780124115545. Archived from the original on 9 January 2017.
^World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
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