Formula & Concentration

Hepatitis B Immune Globulin (Human)

Manufacturer

Grifols USA, LLC

Indications

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 materials such as blood, plasma or serum. For inadvertent percutaneous exposure, a regimen of two doses of Hepatitis B Immune Globulin (Human), one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this setting.
Perinatal Exposure of Infants Born to HBsAg-positive Mothers
Infants born to HBsAg-positive mothers are at risk of being infected with hepatitis B virus and becoming chronic carriers.5,8-10 This risk is especially great if the mother is HBeAg-positive.11-13 For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85%–95% effective in preventing development of the HBV carrier state.8,14 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) alone has only 50% efficacy.8,15
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.8
Household Exposure to Persons with Acute HBV Infection
Since infants have close contact with primary care-givers and they 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 caregiver has acute HBV infection.8 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.16 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.16 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.16

Product Options

Package Size NDC Presentation
1 mL 13533-0636-01 Vial

Shelf Life & Storage

Store at 2–8°C (36–46°F). Do not freeze. Do not use after expiration date

HYPERHEP B

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