Hepatitis B immune globulin

Hepatitis B immune globulin
Names
Trade namesHepaGam B, Nabi-HB, Zutectra, others
Clinical data
Drug classAntibodies[1]
Main usesPrevent hepatitis B[1]
Side effectsPain at the site of injection, headache, nausea, lightheadedness, fever[1]
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Pregnancy
category
  • AU: Exempt[2]
  • US: C (Risk not ruled out)[2]
    Routes of
    use    		Intramuscular, intravenous
    Onset of actionImmediate[3]
    Duration of action3 to 6 months[3]
    External links
    AHFS/Drugs.comMonograph
    Legal
    Legal status

    Hepatitis B immunoglobulin (HBIG) is a medication used to prevent hepatitis B following exposure.[1] This includes in newborns following birth to a women who is hepatitis B positive, following liver transplant in someone with hepatitis B, and following exposure in those who are not immune.[1] It may be given by injection into a vein or muscle.[1] Hepatitis B vaccine may be given at the same time, but at a different site on the body.[4][5]

    Common side effects include pain at the site of injection, headache, nausea, lightheadedness, and fever.[1] Other side effects may include allergic reactions.[1] It can be used in pregnancy when required.[1] It is antibodies directed against hepatitis B surface antigen (anti-HBs).[1]

    Hepatitis B immunoglobulin come into medical use in 1974.[3] It is available as a generic medication.[4] In the United Kingdom 500 units costs the NHS about £500 as of 2021.[4] In the United States it costs about 830 USD for 5 ml.[6] It is made from human plasma.[1]

    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.[7] 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.[8] As with all blood-derived products, the transmission of prions is possible as a residual risk.

    HBIG should be given within 14 days of exposure to the hepatitis B virus.[8] 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]

    Protection lasts for 3 to 6 months.[3]

    Dosage

    In the United Kingdom it is generally given as a dose of 500 units for prevention.[4]

    In the United States it is often given at a dose of 0.06 mL/kg for prevention.[1]

    Side effects

    Pregnancy

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

    Society and culture

    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)[11][12]
    • HyperHEP B (US market; intramuscular preparation)[13]
    • Nabi-HB[14][15]
    • Nabi-HB NovaPlus
    • Zutectra (EU)[16]

    See also

    References

    1. 1 2 3 4 5 6 7 8 9 10 11 12 "Hepatitis B Immune Globulin Monograph for Professionals". Drugs.com. Archived from the original on 24 August 2019. Retrieved 9 December 2021.
    2. 1 2 "Hepatitis b immune globulin Use During Pregnancy". Drugs.com. 3 August 2020. Archived from the original on 21 October 2020. Retrieved 13 September 2020.
    3. 1 2 3 4 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.
    4. 1 2 3 4 "14. Vaccines". British National Formulary (BNF) (82 ed.). London: BMJ Group and the Pharmaceutical Press. September 2021 – March 2022. pp. 1343–1346. ISBN 978-0-85711-413-6.{{cite book}}: CS1 maint: date format (link)
    5. ↑ Richman, Douglas D.; Whitley, Richard J.; Hayden, Frederick G. (10 July 2020). Clinical Virology. John Wiley & Sons. p. 365. ISBN 978-1-55581-943-9. Archived from the original on 11 December 2021. Retrieved 10 December 2021.
    6. ↑ "Hepatitis B Immune Globulin Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 10 December 2021.
    7. ↑ Mayo Clinic Archived 2019-08-24 at the Wayback Machine Retrieved 2009-06-03
    8. 1 2 BlueShield information Archived 2011-07-08 at the Wayback Machine Retrieved 2009-06-03
    9. ↑ CDC recommendation for postexposure prophylaxis of hepatitis B Archived 2020-10-20 at the Wayback Machine 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- human hepatitis b virus immune globulin injection". DailyMed. 16 April 2020. Archived from the original on 24 March 2021. Retrieved 14 July 2020.
    12. ↑ "HepaGam B". U.S. Food and Drug Administration (FDA). 4 April 2017. Archived from the original on 8 August 2020. Retrieved 14 July 2020.
    13. ↑ "HyperHEP B S/D (hepatitis b immune globulin- human injection". DailyMed. 22 January 2020. Archived from the original on 24 March 2021. Retrieved 14 July 2020.
    14. ↑ "Nabi-HB (hepatitis b immune globulin- human liquid". DailyMed. 22 July 2019. Archived from the original on 24 March 2021. Retrieved 14 July 2020.
    15. ↑ "Nabi-HB". U.S. Food and Drug Administration (FDA). 4 April 2017. Archived from the original on 28 September 2020. Retrieved 14 July 2020.
    16. ↑ "Zutectra EPAR". European Medicines Agency. Archived from the original on 12 November 2020. Retrieved 14 July 2020.
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