Hepatitis B immune globulin explained

Verifiedfields:changed
Verifiedrevid:450879755
Tradename:HepaGam B, Nabi-HB, Zutectra, others
Pregnancy Au Comment:Exempt[1]
Legal Us:Rx-only
Legal Eu:Rx-only
Routes Of Administration:Intramuscular injection, intravenous
Atc Prefix:J06
Atc Suffix:BB04
Drugbank:DB05276
Chemspiderid:none
Unii:XII270YC6M
Chembl:2108512

Hepatitis B immunoglobulin (HBIG) is a human immunoglobulin that is used to prevent the development of hepatitis B[2] and is used for the treatment of acute exposure to HBsAg.[3] [4] [5]

Medical uses

HBIG is indicated as a postexposure prophylaxis for people at risk to develop hepatitis B because they have been recently exposed to body fluids of individuals who have hepatitis B. This includes babies of mothers with hepatitis B, sexual partners, healthcare workers, police and fire workers, and morticians.[6] It provides a temporarily induced immunity by the transfer of immunoglobulins.

HBIG is given by either intramuscular (IM) or intravenous (IV) route, depending on the preparation. Side effects include allergic reactions, back pain, general feeling of discomfort, headaches, muscle pain, nausea, and pain or bleeding at the injection site. Allergy to human immunoglobulin is a contraindication. HIV has never been transmitted by HBIG.[7] As with all blood-derived products, the transmission of prions is possible as a residual risk.[8]

Concomitant vaccination

HBIG should be given within 14 days of exposure to the hepatitis B virus.[7] The half-life of HBIG is about 3 weeks. In lieu of a booster administration of HBIG, a hepatitis B vaccination is initiated at the time of the initial HBIG administration, thus providing long term protection.[9]

HBIG is classified as pregnancy category C substance by the U.S. Food and Drug Administration.

Preparation

HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus.[10]

Brand names

See also

External links

Notes and References

  1. Web site: Hepatitis b immune globulin Use During Pregnancy . Drugs.com . 3 August 2020 . 13 September 2020.
  2. Zuckerman JN . Review: hepatitis B immune globulin for prevention of hepatitis B infection . Journal of Medical Virology . 79 . 7 . 919–921 . July 2007 . 17516515 . 10.1002/jmv.20816 . 41095427 .
  3. Web site: HepaGam B (hepatitis b immune globulin intravenous- human injection . DailyMed . U.S. National Library of Medicine . 15 January 2019 . 14 July 2020.
  4. Web site: HepaGam B- human hepatitis b virus immune globulin injection . DailyMed . U.S. National Library of Medicine . 16 April 2020 . 14 July 2020.
  5. Web site: Nabi-HB (hepatitis b immune globulin- human liquid . DailyMed . U.S. National Library of Medicine . 22 July 2019 . 14 July 2020.
  6. Web site: Hepatitis B Immune Globulin (Intramuscular Route, Intravenous Route) . Mayo Clinic . 3 June 2009 .
  7. Web site: Poinier AC, Romito K, Thompson EG, Flamm SL . Hepatitis B Immunoglobulin (HBIG) . https://web.archive.org/web/20110721041831/https://www.blueshieldca.com/hw/articles/hw_article.jsp?articleId=HWHW40221&fromCategoryId=9&_requestid=814778 . 21 July 2011 . BlueShield information . 3 June 2009 . 11 November 2010 .
  8. Aguzzi A, Glatzel M . Prion infections, blood and transfusions . Nature Clinical Practice. Neurology . 2 . 6 . 321–329 . June 2006 . 16932576 . 10.1038/ncpneuro0214 . 25966682 .
  9. ((Centers for Disease Control (CDC))) . Recommendation of the Immunization Practices Advisory Committee (ACIP). Inactivated hepatitis B virus vaccine . MMWR. Morbidity and Mortality Weekly Report . 31 . 24 . 317–22, 327–8 . June 1982 . 6811846 .
  10. Web site: Hepatitis B Immune Globulin (Human) Product description with dose schedule . Bayer Corporation . March 2004 . https://web.archive.org/web/20080511184159/http://www.talecris-pi.info/inserts/BayHepB.pdf . 11 May 2008 . 3 June 2009 .
  11. Web site: HepaGam B . U.S. Food and Drug Administration (FDA) . 4 April 2017 . 14 July 2020.
  12. Web site: HyperHEP B S/D (hepatitis b immune globulin- human injection . DailyMed . U.S. National Library of Medicine . 22 January 2020 . 14 July 2020.
  13. Web site: Nabi-HB . U.S. Food and Drug Administration (FDA) . 4 April 2017 . 14 July 2020.
  14. Web site: Zutectra EPAR . European Medicines Agency . 17 September 2018 . 14 July 2020.

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