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About Hepatitis B

Hepatitis B is a small, highly infectious, relatively resilient, double-shelled DNA virus that almost exclusively infects humans, and in some cases may even be capable of producing infection from environmental surfaces for more than 7 days at room temperature.1 

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Certain populations are at risk for hepatitis B exposure4:

  • Individuals exposed to blood containing hepatitis B surface antigen (HBsAg)
  • Infants born to HBsAg-positive mothers
  • Sex partners of HBsAg-positive persons
  • Individuals exposed to HBsAg-positive persons within their household

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Postexposure Prophylaxis for Hepatitis B

HyperHEP B contains high titers of hepatitis B antibodies for postexposure prophylaxis (PEP), providing rapid immune protection with detectable levels of antibodies that persist for approximately 2 months or longer. When used in combination with hepatitis B vaccine, a hepatitis B immune globulin such as HyperHEP B offers maximum postexposure immune protection.4-6 

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For individuals who have been exposed to hepatitis B, the Centers for Disease Control and Prevention (CDC) recommends PEP within approximately 24 hours.2,6 Learn more about the CDC recommendations.

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Prophylaxis Following Percutaneous or Permucosal Exposure4

Prophylaxis of Infants Born to HBsAg- and HBeAg-Positive Mothers4

Efficacy of prophylactic hepatitis B immune globulin (human) (HBIG) in infants at risk depends on administering HBIG on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery.

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Hepatitis B immune globulin (human) (0.5 mL) should be administered intramuscularly to the newborn infant after physiologic stabilization of the infant and preferably within 12 hours of birth. Hepatitis B immune globulin (human) efficacy decreases markedly if treatment is delayed beyond 48 hours.4

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Learn more about the Advisory Committee on Immunization Practices recommendations for infants born to HBV-infected mothers. 

Prophylaxis for Sexual Exposure to Hepatitis B4

For more information about PEP in specific indications, please see the full Prescribing Information.

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QUICK FACTS

  • It is estimated that between 800,000 and 1.4 million people in the United States are currently infected with hepatitis B1,2
  • If the mother is positive for both HBsAg and HBeAg, 70%–90% of infants will become infected in the absence of postexposure prophylaxis1
    • An estimated 25,000 infants are born to HBsAg-positive mothers each year in the US3
  • The hepatitis B virus is 50 to 100 times more infectious than HIV7
  • The virus is transmitted through contact with the blood or other body fluids of an infected person, not through casual contact1

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Learn more about other Hypermunes.

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Important Safety Information for HyperHEP B® (hepatitis B immune globulin [human])

HyperHEP B® (hepatitis B immune globulin [human]) is indicated for postexposure prophylaxis in the following situations: acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to an HBsAg-positive person, and household exposure to persons with acute HBV infection.

HyperHEP B should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Epinephrine should be available.

HyperHEP B should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Epinephrine should be available.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, hepatitis B immune globulin (human) should be given only if the expected benefits outweigh the risks.

Local pain and tenderness at the injection site, urticaria, and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immunoglobulin preparations. Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after hepatitis B immune globulin (human) administration.

HyperHEP B is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Please see full Prescribing Information for HyperHEP B.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


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References:

  1. Centers for Disease Control and Prevention. Hepatitis B. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:149-174.
  2. Centers for Disease Control and Prevention. Hepatitis B questions and answers for health professionals. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm#overview. Accessed June 27, 2019.
  3. Schillie S, Murphy TV, Fenlon N, et al. Update: Shortened interval for postvaccination serologic testing of infants born to Hepatitis B-infected mothers. MMWR Morb Mortal Wkly Rep. 2015;64(39):1118-1120.
  4. HyperHEP B® (hepatitis B immune globulin [human]) Prescribing Information. Grifols.
  5. Schillie S, Murphy TV, Sawyer M, et al. CDC guidance for evaluating health-care personnel for hepatitis B virus protection and for administering postexposure management. MMWR Recomm Rep. 2013;62(RR-10):1-19.
  6. U.S. Public Health Service. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2001;50(RR-11):1-52.
  7. World Health Organization. Hepatitis B. http://www.who.int/mediacentre/factsheets/fs204/en/. Accessed September 23, 2019.