NABI-HB SUMMARY
Hepatitis B Immune Globulin (Human), Nabi-HB, is a sterile solution of immunoglobulin (5 ± 1% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is processed using a modified Cohn 6 / Oncley 9 cold-alcohol fractionation process1,2 with two added viral reduction steps described below. Nabi-HB is formulated in 0.075 M sodium chloride, 0.15 M glycine, and 0.01% polysorbate 80, at pH 6.2. The product is supplied as a nonturbid sterile liquid in single dose vials and appears as clear to opalescent. It contains no preservative and is intended for single use by the intramuscular route only.
Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings:
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Acute Exposure to Blood Containing HBsAg
Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum.
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Perinatal Exposure of Infants Born to HBsAg-positive Mothers
Infants born to mothers positive for HBsAg with or without HBeAg12.
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Sexual Exposure to HBsAg-positive Persons
Sexual partners of HBsAg-positive persons. -
Household Exposure to Persons with Acute HBV Infection
Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other household contacts with an identifiable blood exposure to the index patient.
Nabi-HB is indicated for intramuscular use only.
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