Postexposure Prophylaxis for Hepatitis B

The Centers for Disease Control and Prevention (CDC) estimates that between 800,000 and 1.4 million people in the United States are currently infected with hepatitis B. Stop the threat with HyperHEP B® S/D (hepatitis B immune globulin [human]).1

For more information, recommendations, and guidelines concerning hepatitis B, visit the CDC Advisory Committee on Immunization Practices (ACIP).

Vaccines can take weeks to build efficacy but can protect for years.2 HyperHEP B S/D provides immediate protection. This allows the vaccine the time needed to establish active immunity in high-risk situations, such as1:

  • Patients exposed to blood containing hepatitis B surface antigen (HBsAg)
  • Perinatal exposure of infants born to HBsAg-positive and/or hepatitis B envelope antigen–positive mothers1
  • Sexual exposure to an HBsAg-positive person
  • Household exposure to persons with acute HBV

Immediate Protection

HyperHEP B S/D contains high titers of hepatitis B antibodies for postexposure prophylaxis, providing rapid immune protection with detectable levels of antibodies that persist for approximately 2 months or longer. When used in combination with a vaccine, a hepatitis B immune globulin such as HyperHEP B S/D offers maximum postexposure immune protection.1,3

According to the CDC, immune globulins like HyperHep S/D, when used in combination with a vaccine can prevent the spread of hepatitis B by at as much as 75%.4

Safety Is a Priority3

  • HyperHEP B S/D is mercury (thimerosal) free and latex free
  • HyperHEP B S/D has Food and Drug Administration (FDA) labeling for removal of pathogenic prions that may cause transmissible spongiform encephalopathies in humans
    • Studies of the HyperHEP S/D manufacturing process demonstrated that TSE clearance is achieved during the Pooled Plasma to Effluent III Fraction Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed
  • HyperHEP B S/D offers tamper-evident packaging and incorporates
    UltraSafe® Needle Guards to help protect the healthcare professional from needlestick injuries
  • Because HyperHEP B S/D is made from human plasma, it may carry a risk of transmitting 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

Dosing Recommendations3

HyperHEP Dosing Recommendations

Product Information3

HyperHEP Product Information
Important Safety Information for HyperHEP B® S/D (hepatitis B immune globulin [human])

HyperHEP® B S/D (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 S/D 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 S/D 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 HyperHEP S/D full Prescribing Information for complete prescribing details.

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 (CDC). Epidemiology and prevention of vaccine-preventable diseases. CDC website. http://www.cdc.gov/vaccines/pubs/pinkbook/hepb.html. Updated August 6, 2015. Accessed April 7, 2016.
  2. Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occup Med (Lond). 2007;57(8):552-556.
  3. HyperHEP B® S/D (hepatitis B immune globulin [human]) prescribing information. Research Triangle Park, NC: Grifols Therapeutics Inc. September 2012.
  4. U.S. Public Health Service. Updated US 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):1-542.