Nabi-HB® [Hepatitis B Immune Globulin (Human)]
Nabi-HB 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.
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).
Nabi-HB Important Safety Information
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB®, Hepatitis B Immune Globulin (Human), or any other human immune globulin. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions.
In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB should be given only if the expected benefits outweigh the potential risks.
Nabi-HB is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Nabi-HB, Hepatitis B Immune Globulin (Human), must be administered only intramuscularly for post-exposure prophylaxis.
Vaccination with live virus vaccines (e.g., MMR) should be deferred until approximately three months after administration of Nabi-HB.
The most common adverse reactions associated with Nabi-HB in clinical trials were erythema and ache at the injection site, and systemic reactions such as headache, myalgia, malaise, nausea, and vomiting. No anaphylactic reactions with Nabi-HB have been reported.
Please see the Full Prescribing Information for Nabi-HB Hepatitis B Immune Globulin (Human)
For additional information, please call
(toll free) 1-800-458-4244
Biotest Pharmaceuticals Corporation
5800 Park of Commerce Blvd., N.W.
Boca Raton, FL 33487