Immunoglobulin therapy

Immunoglobulin therapy
Clinical data
Trade namesFlebogamma, Gammagard, Hizentra, others
Other namesnormal human immunoglobulin (HNIG), human normal immunoglobulin (HNIG)
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		Intravenous, intramuscular, subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
UNII

Immunoglobulin therapy is the use of a mixture of antibodies (normal human immunoglobulin) to treat several health conditions.[13][14] 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.[13] Depending on the formulation it can be given by injection into muscle, a vein, or under the skin.[13] The effects last a few weeks.[14]

Common side effects include pain at the site of injection, muscle pain, and allergic reactions.[13] Other severe side effects include kidney problems, anaphylaxis, blood clots, and red blood cell breakdown.[13] Use is not recommended in people with some types of IgA deficiency.[13] Use appears to be relatively safe during pregnancy.[13] Human immunoglobulin is made from human blood plasma.[13] It contains antibodies against many viruses.[14]

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.[15] It is on the World Health Organization's List of Essential Medicines.[16][17] Each formulation of the product is somewhat different.[14] A number of specific immunoglobulin formulations are also available including for hepatitis B, rabies, tetanus, varicella infection, and Rh positive blood exposure.[14]

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  2. ^ "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.
  3. ^ "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.
  4. ^ "Regulatory Decision Summary - Xembify". Health Canada. 23 October 2014. Archived from the original on 7 June 2022. Retrieved 7 June 2022.
  5. ^ "Summary Basis of Decision - HyQvia". Health Canada. 23 October 2014. Archived from the original on 5 August 2024. Retrieved 6 August 2022.
  6. ^ "Immune system health". Health Canada. 9 May 2018. Archived from the original on 19 January 2022. Retrieved 13 April 2024.
  7. ^ "Drug and medical device highlights 2018: Helping you maintain and improve your health". Health Canada. 14 October 2020. Archived from the original on 17 April 2024. Retrieved 17 April 2024.
  8. ^ Cite error: The named reference Asceniv FDA label was invoked but never defined (see the help page).
  9. ^ Cite error: The named reference Bivigam FDA label was invoked but never defined (see the help page).
  10. ^ Cite error: The named reference Gamunex-C FDA label was invoked but never defined (see the help page).
  11. ^ Cite error: The named reference Alyglo FDA label was invoked but never defined (see the help page).
  12. ^ Cite error: The named reference HyQvia EPAR was invoked but never defined (see the help page).
  13. ^ a b c d e f g h "Immune Globulin". The American Society of Health-System Pharmacists. Archived from the original on 9 January 2017. Retrieved 8 January 2017.
  14. ^ a b c d e British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. pp. 867–71. ISBN 9780857111562.
  15. ^ 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.
  16. ^ 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.
  17. ^ 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.