About Hepatitis B

Hepatitis B is a small, highly infectious, relatively resilient, double-stranded 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

Up to 2.2 million people in the United States

Are currently infected with hepatitis B1

An estimated 25,000 infants are born to HBsAg-positive mothers each year in the US3

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

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

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.

Prophylaxis Following Percutaneous or Permucosal Exposure4

Source

HBsAg-Positive
Unvaccinated
  1. Hepatitis B immune globulin (human)x1 immediately*
  2. Initiate HB Vaccine series†
Vaccinated
  1. Test exposed person for anti-HBs
  2. If inadequate antibody,‡ hepatitis B immune globulin (human)x1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later

Known Source (High Risk)
Unvaccinated
  1. Initiate HB Vaccine series
  2. Test source for HBsAg. If positive, hepatitis B immune globulin (human)×1
Vaccinated

Test source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give hepatitis B immune globulin (human)x1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later

Low Risk HBsAg-Positive
Unvaccinated

Initiate HB Vaccine series

Vaccinated

Nothing required

Unknown Source
Unvaccinated

Initiate HB Vaccine series within 7 days of exposure

Vaccinated

Nothing required

*Hepatitis B immune globulin (human), dose 0.06 mL/kg IM.
†HB Vaccine dose 20 μg IM for adults; 10 μg IM for infants or children under 10 years of age. First dose within 1 week; second and third doses 1 and 6 months later, respectively.
‡Less than 10 sample ratio units (SRU) by radioimmunoassay (RIA), negative by enzyme immunoassay (ElA).

*Hepatitis B immune globulin (human), dose 0.06 mL/kg IM.
†HB Vaccine dose 20 μg IM for adults; 10 μg IM for infants or children under 10 years of age. First dose within 1 week; second and third doses 1 and 6 months later, respectively.
‡Less than 10 sample ratio units (SRU) by radioimmunoassay (RIA), negative by enzyme immunoassay (ElA).
Source Unvaccinated Vaccinated

HBsAg-Positive
  1. Hepatitis B immune globulin (human)x1 immediately*
  2. Initiate HB Vaccine series†
  1. Test exposed person for anti-HBs
  2. If inadequate antibody,‡ hepatitis B immune globulin (human)x1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later

Known Source (High Risk)
  1. Initiate HB Vaccine series
  2. Test source for HBsAg. If positive, hepatitis B immune globulin (human)×1

Test source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give hepatitis B immune globulin (human)x1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later

Low Risk HBsAg-Positive

Initiate HB Vaccine series

Nothing required

Unknown Source

Initiate HB Vaccine series within 7 days of exposure

Nothing required

For persons who refuse hepatitis B vaccine, a second dose of hepatitis B immune globulin (human) should be given 1 month after the first dose.

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.

Administration

HBIG

0.5 mL given intramuscularly (IM)
Hepatitis B Vaccine

Hepatitis B vaccine should be administered IM in 3 doses of 0.5 mL of vaccine (10 μg) each

HBIG Hepatitis B Vaccine

0.5 mL given intramuscularly (IM)

Hepatitis B vaccine should be administered IM in 3 doses of 0.5 mL of vaccine (10 μg) each

Timing

HBIG

Newborn infant after physiologic stabilization and preferably within 12 hours of birth
Hepatitis B Vaccine
  • 1st dose should be given within 7 days of birth (may be given concurrently with HBIG but at a separate site)
  • 2nd dose should be given 1 month after the 1st
  • 3rd dose should be given 6 months after the 1st
HBIG Hepatitis B Vaccine

Newborn infant after physiologic stabilization and preferably within 12 hours of birth
  • 1st dose should be given within 7 days of birth (may be given concurrently with HBIG but at a separate site)
  • 2nd dose should be given 1 month after the 1st
  • 3rd dose should be given 6 months after the 1st

Contingencies

HBIG

HBIG efficacy decreases markedly if treatment is delayed beyond 48 hours
Hepatitis B Vaccine
  • If administration of 1st dose of hepatitis B vaccine is delayed up to 3 months, then repeat 0.5 mL dose of HBIG at month 3
  • If hepatitis B vaccine is refused, then repeat 0.5 mL dose of HBIG at months 3 and 6
HBIG Hepatitis B Vaccine

HBIG efficacy decreases markedly if treatment is delayed beyond 48 hours
  • If administration of 1st dose of hepatitis B vaccine is delayed up to 3 months, then repeat 0.5 mL dose of HBIG at month 3
  • If hepatitis B vaccine is refused, then repeat 0.5 mL dose of HBIG at months 3 and 6

Notes

HBIG

HBIG administered at birth should not interfere with oral polio and diphtheria-tetanus-pertussis vaccines administered at 2 months of age
Hepatitis B Vaccine

None

HBIG Hepatitis B Vaccine

HBIG administered at birth should not interfere with oral polio and diphtheria-tetanus-pertussis vaccines administered at 2 months of age

None

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

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

Prophylaxis for Sexual Exposure to Hepatitis B4

HBIG

Dose

Recommended Timing

Vaccine

Dose

Recommended Timing

0.06 mL/kg IM

Single dose within 14 days of last sexual contact

Vaccine

1.0 mL IM

First dose at time of HBIG treatment*

*The first dose can be administered at the same time as the HBIG dose but at a different site; subsequent doses should be administered as recommended for specific vaccine.

*The first dose can be administered at the same time as the HBIG dose but at a different site; subsequent doses should be administered as recommended for specific vaccine.
HBIG Vaccine

Dose

Recommended Timing

Dose

Recommended Timing

0.06 mL/kg IM

Single dose within 14 days of last sexual contact

1.0 mL IM

First dose at time of HBIG treatment*

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

Quick Facts

  • It is estimated that between 850,000 and 2.2 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

Have a question about
HyperHEP B (hepatitis B immune globulin [human])?

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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.

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.

References

  1. Centers for Disease Control and Prevention. Hepatitis B. In: Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 14th ed. Washington, DC. Public Health Foundation; 2021.
  2. Centers for Disease Control and Prevention. Hepatitis B Information. Frequently Asked Questions for Health Professionals. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm#overview. Accessed June 6, 2023.
  3. US Department of Health and Human Services. Viral Hepatitis: Hepatitis B Basic Information. https://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/hepatitis-b-basics/index.html. Reviewed March 31, 2023. Accessed February 1, 2024.
  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: How can I protect myself from hepatitis B? https://www.who.int/news-room/questions-and-answers/item/hepatitis-b-how-can-i-protect-myself. Accessed December 14, 2023.