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Hepatitis B immune globulin

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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
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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

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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.[citation needed]

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

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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.[citation needed]

Preparation

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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

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  • 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

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References

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  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): 919–921. doi:10.1002/jmv.20816. PMID 17516515. S2CID 41095427.
  3. ^ "HepaGam B (hepatitis b immune globulin intravenous- human injection". DailyMed. U.S. National Library of Medicine. 15 January 2019. Retrieved 14 July 2020.
  4. ^ a b "HepaGam B- human hepatitis b virus immune globulin injection". DailyMed. U.S. National Library of Medicine. 16 April 2020. Retrieved 14 July 2020.
  5. ^ a b "Nabi-HB (hepatitis b immune globulin- human liquid". DailyMed. U.S. National Library of Medicine. 22 July 2019. Retrieved 14 July 2020.
  6. ^ "Hepatitis B Immune Globulin (Intramuscular Route, Intravenous Route)". Mayo Clinic. Retrieved 3 June 2009.
  7. ^ a b Poinier AC, Romito K, Thompson EG, Flamm SL, eds. (11 November 2010). "Hepatitis B Immunoglobulin (HBIG)". BlueShield information. Archived from the original on 21 July 2011. Retrieved 3 June 2009.
  8. ^ Aguzzi A, Glatzel M (June 2006). "Prion infections, blood and transfusions". Nature Clinical Practice. Neurology. 2 (6): 321–329. doi:10.1038/ncpneuro0214. PMID 16932576. S2CID 25966682.
  9. ^ Centers for Disease Control (CDC) (June 1982). "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. PMID 6811846.
  10. ^ "Hepatitis B Immune Globulin (Human) Product description with dose schedule" (PDF). Bayer Corporation. March 2004. Archived from the original (PDF) on 11 May 2008. Retrieved 3 June 2009.
  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. U.S. National Library of Medicine. 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. 17 September 2018. Retrieved 14 July 2020.
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