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HyperHEP B® S/D [Hepatitis B Immune Globulin (Human)]
postexposure prophylaxis for hepatitis B

HyperHEP B® S/D Postexposure Prophylaxis for Hepatitis B

Hepatitis B Quick Facts

  • Approximately 350 million people around the world are chronically infected with HBV, and an estimated 620,000 of these people die each year from HBV complications1
  • The Centers for Disease Control and Prevention (CDC) estimates that there are nearly 1.4 million people in the United States who are currently infected with hepatitis B1
  • According to the World Health Organization (WHO), when used in combination with a vaccine, a hepatitis B immune globulin such as HyperHEP B S/D can prevent the spread of hepatitis B by 85%-95%2
  • The hepatitis B virus is 50-100 times more infectious than HIV3

HyperHEP B Quick Facts

  • HyperHEP B S/D is mercury (thimerosal) free and latex free4
  • Only HyperHEP B S/D has FDA labeling for removal of pathogenic prions that may cause TSEs* in humans
  • HyperHEP B S/D offers tamper-evident packaging and incorporates UltraSafe® Needle Guards to help protect the healthcare professional from needle-stick injuries4
  • 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 longer4,5
  • Convenient prefilled syringes and vials for single-use IM injection only4

HyperHEP B S/D IMPORTANT SAFETY INFORMATION

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. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.

For full Prescribing Information, click here.

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.

*Human TSEs (transmissible spongiform encephalopathies) are a group of neurodegenerative diseases related to mad cow disease.

References:

  1. Weinbaum CM, Williams I, Mast EE, et al; Centers for Disease Control and Prevention. Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. MMWR. 2008;57(RR-08):1-20.

  2. World Health Organization. Guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. http://www.who.int/occupational_health/activities/5pepguid.pdf. Accessed June 17, 2009.

  3. World Health Organization. Hepatitis B key facts. http://www.who.int/mediacentre/factsheets/fs204/en/print.html. Accessed June 17, 2009.

  4. HyperHEP B S/D [package insert]. Research Triangle Park, NC: Talecris Biotherapeutics; 2007.

  5. Centers for Disease Control and Prevention. Principles of vaccination. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac-508.pdf. Accessed June 17, 2009.