Nabi-HB® [Hepatitis B Immune Globulin (Human)] is a hyperimmune globulin that contains antibodies to hepatitis B surface antigen (anti-HBs).
Nabi-HB® is indicated for the treatment of acute exposure to blood containing hepatitis B surface antigen (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:
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.
Perinatal Exposure of Infants Born to HBsAg-positive Mothers
Infants born to mothers positive for HBsAg with or without HBeAg.
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.
Product Benefits
Hepatitis B Immune Globulin (Human) products provide passive immunization for individuals exposed to the hepatitis B virus as evidenced by a reduction in the attack rate by hepatitis B following use. Clinical studies conducted prior to 1983 with hepatitis B immune globulins similar to Nabi-HB indicate the advantage of simultaneous administration of hepatitis B Vaccine and hepatitis B Immune Globulin (Human).
Warnings
Nabi-HB is made from human plasma. Products made from human plasma may contain
infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD)
agent. Nabi-HB should not be given to persons who have had anaphylactic or severe systemic reactions to human globulin. Nabi-HB may cause anaphylactic reactions in individuals who are IgA deficient. (See full prescribing information)
For more information:
Biotest Pharmaceuticals Corporation
5800 Park of Commerce Blvd., N.W.
Boca Raton, FL 33487
