This information is not for clinical use. These highlights do not include all the information needed to use Nabi-hb safely and effectively. Before taking Nabi-hb please consult with your doctor. See full prescribing information for Nabi-hb.

Indications And Usage

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: 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 HBeAg12. 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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Dosage And Administration

Table 2 Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure 12 Exposed Person
Source Unvaccinated Vaccinated
HBsAg-positive 1. Hepatitis B Immune Globulin (Human) X1 immediately 2. Initiate HB Vaccine series 1. Test exposed person for anti-HBs 2. If inadequate antibody, Hepatitis B immune Globulin (Human) X 1 immediately plus either HB Vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later
Known Source - High Risk for HBsAG-Positive 1. Initiate HB Vaccine series 2. Test source for HBsAG. If positive, Hepatitis B Immune Globulin (Human)1 X 1. Test source for HBsAG only if exposed is vaccine nonresponder; if source is HBsAG-Positive, Give Hepatitis B Immune Globulin (Human) 1 X immediately plus either HB vaccine booster dose or second dose of Hepatitis B immune Globulin (Human) one month later.
Known Source - Low Risk for HBsAG - Positive Initiate HB Vaccine series Nothing Required
Unknown Source Initiate HB vaccine series Nothing Required

Contraindications

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. Nabi-HB contains not more than 40 micrograms per mL IgA. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions. The physician must weigh the potential benefit of treatment with Nabi-HB against the potential for hypersensitivity reactions.

Adverse Reactions

Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials20. The number of patients with reactions related to the administration of Nabi-HB included local reactions such as erythema 6 (12percent) and ache 2 (4percent) at the injection site, as well as systemic reactions such as headache 7 (14percent), myalgia 5 (10percent), malaise 3 (6percent), nausea 2 (4percent), and vomiting 1 (2percent). The majority (92percent) of reactions were reported as mild. The following adverse events were reported in the pharmacokinetics trials and were considered probably related to Nabi-HB: elevated alkaline phosphatase 2 (4percent), ecchymosis 1 (2percent), joint stiffness 1 (2percent), elevated AST 1 (2percent), decreased WBC 1 (2percent), and elevated creatinine 1 (2percent). All adverse events were mild in intensity. There were no serious adverse events. No anaphylactic reactions with Nabi-HB have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins23.

Drug Interactions

Drug Interactions Vaccination with live virus vaccines should be deferred until approximately three months after administration of Nabi-HB, Hepatitis B Immune Globulin (Human). It may be necessary to revaccinate persons who received Nabi-HB shortly after live virus vaccination. There are no available data on concomitant use of Nabi-HB and other drugs; therefore, Nabi- HB should not be mixed with other drugs.