Hepatitis B immune globulin

Hepatitis B immunoglobulin (HBIG) is a human immunoglobulin that is used to prevent the development of hepatitis B and is used for the treatment of acute exposure to HBsAg.[1][2][3]

Hepatitis B immune globulin
Clinical data
Trade namesHepaGam B, Nabi-HB, Zutectra, others
AHFS/Drugs.comMonograph
Pregnancy
category
  • US: C (Risk not ruled out)
    Routes of
    administration    		Intramuscular injection, intravenous
    ATC code
    Legal status
    Legal status
    Identifiers
    DrugBank
    ChemSpider
    • none
    UNII
    ChEMBL
     NY (what is this?)  (verify)

    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.[4] 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.[5] As with all blood-derived products, the transmission of prions is possible as a residual risk.

    Concomitant vaccination

    HBIG should be given within 14 days of exposure to the hepatitis B virus.[5] 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.[6]

    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.[7]

    Brand names
    • Bayhep B
    • HepaGam B (US market; intravenous preparation)[2][8]
    • HyperHEP B (US market; intramuscular preparation)[9]
    • Nabi-HB[3][10]
    • Nabi-HB NovaPlus
    • Zutectra (EU)[11]

    See also

    References
    1. "HepaGam B (hepatitis b immune globulin intravenous- human injection". DailyMed. 15 January 2019. Retrieved 14 July 2020.
    2. "HepaGam B- human hepatitis b virus immune globulin injection". DailyMed. 16 April 2020. Retrieved 14 July 2020.
    3. "Nabi-HB (hepatitis b immune globulin- human liquid". DailyMed. 22 July 2019. Retrieved 14 July 2020.
    4. Mayo Clinic Retrieved 2009-06-03
    5. BlueShield information Retrieved 2009-06-03
    6. CDC recommendation for postexposure prophylaxis of hepatitis B Retrieved 2009-06-03
    7. Product description with dose schedule Archived 2008-05-11 at the Wayback Machine Retrieved 2009-06-03
    8. "HepaGam B". U.S. Food and Drug Administration (FDA). 4 April 2017. Retrieved 14 July 2020.
    9. "HyperHEP B S/D (hepatitis b immune globulin- human injection". DailyMed. 22 January 2020. Retrieved 14 July 2020.
    10. "Nabi-HB". U.S. Food and Drug Administration (FDA). 4 April 2017. Retrieved 14 July 2020.
    11. "Zutectra EPAR". European Medicines Agency. Retrieved 14 July 2020.
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