HyperHEP B™

Manufacturer: Talecris Biotherapeutics
Generic Name: Hepatitis B Immune Globulin (Human) Solvent / Detergent

Indications: Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B Immune vaccine will provide both short-and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice. HyperHEP B s/D is indicated for post-exposure prophylaxis in the following situations:

Acute Exposure to Blood Containing HBsAg: After either parenteral exposure, e.g., by accidental "needlestick" or direct mucous membrane contact (accidental splash) , or oral ingestion (pipetting accident) involving HBsAg-positive. For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B effective in preventing development of the HBV carrier state. Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have 70% -90% efficacy, while a single dose of Hepatitis B immune Globulin (Human) alones has only 50% efficacy.

Sexual Exposure to an HBsAg-positive Person: Sex partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. For sexual exposure to a person with acute hepatitis B, a single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within 2 weeks of last sexual exposure.

Household Exposure to Persons with Acute HBV Infection: Since infants have close contact with primary care-givers and the have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and Hepatitis B vaccine is indicated if the mother or primary care-giver has acute HBV infection.

Administration of Hepatitis B Immune Globulin (Human) either preceding or concomitant with the commencement of active immunization with Hepatitis B Vaccine provides for more rapid achievement of protective levels of Hepatitis B antibody, than when the vaccine alone is administered. Rapid achievement of protective levels of antibody to hepatitis B virus may be desirable in certain clinical situations, as in cases of accidental inoculations with contaminated medical instruments. Administration of Hepatitis B immune Globulin (human) either 1 month preceding or at the time of commencement of a program of active vaccination with Hepatitis B Vaccine has been shown not to interfere with the active immune response to the vaccine.

HyperHEP™ B Product Insert

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