Hepatitis B immune globulin

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]

Hepatitis B immune globulin
Clinical data
Trade namesHepaGam B, Nabi-HB, Zutectra, others
AHFS/Drugs.comMonograph
Pregnancy
category
Routes of
administration		Intramuscular injection, intravenous
ATC code
Legal status
Legal status
Identifiers
DrugBank
ChemSpider
  • none
UNII
ChEMBL
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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
  • Bayhep B
  • HepaGam B (US market; intravenous preparation)[4][11]
  • HyperHEP B (US market; intramuscular preparation)[12]
  • Nabi-HB[5][13]
  • Nabi-HB NovaPlus
  • Zutectra (EU)[14]

See also

References
  1. "Hepatitis b immune globulin Use During Pregnancy". Drugs.com. 3 August 2020. Retrieved 13 September 2020.
  2. Zuckerman JN (July 2007). "Review: hepatitis B immune globulin for prevention of hepatitis B infection". Journal of Medical Virology. 79 (7): 919–21. doi:10.1002/jmv.20816. PMID 17516515.
  3. "HepaGam B (hepatitis b immune globulin intravenous- human injection". DailyMed. 15 January 2019. Retrieved 14 July 2020.
  4. "HepaGam B- human hepatitis b virus immune globulin injection". DailyMed. 16 April 2020. Retrieved 14 July 2020.
  5. "Nabi-HB (hepatitis b immune globulin- human liquid". DailyMed. 22 July 2019. Retrieved 14 July 2020.
  6. Mayo Clinic Retrieved 2009-06-03
  7. BlueShield information Retrieved 2009-06-03
  8. Aguzzi, Adriano; Glatzel, Markus (June 2006). "Prion infections, blood and transfusions". Nature Clinical Practice Neurology. 2 (6): 321–329. doi:10.1038/ncpneuro0214. ISSN 1745-8358.
  9. CDC recommendation for postexposure prophylaxis of hepatitis B Retrieved 2009-06-03
  10. Product description with dose schedule Archived 2008-05-11 at the Wayback Machine Retrieved 2009-06-03
  11. "HepaGam B". U.S. Food and Drug Administration (FDA). 4 April 2017. Retrieved 14 July 2020.
  12. "HyperHEP B S/D (hepatitis b immune globulin- human injection". DailyMed. 22 January 2020. Retrieved 14 July 2020.
  13. "Nabi-HB". U.S. Food and Drug Administration (FDA). 4 April 2017. Retrieved 14 July 2020.
  14. "Zutectra EPAR". European Medicines Agency. Retrieved 14 July 2020.
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