Nabi-HB^TM, 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 (needle stick, 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.¹²
• 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^TM is indicated for intramuscular use only.

DOSAGE AND ADMINISTRATION

This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to prevent transmission of infectious agents from one person to another. Any vial of Nabi HB^TM ,Hepatitis B Immune Globulin (Human), that has been entered should be used promptly. Do not reuse or save for future use.

This product contains no preservative; therefore, partially used vials should be discarded immediately.

Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to Hepatitis B Vaccine.¹¹

Acute Exposure to Blood Containing HBSAg

Table 2 summarizes prophylaxis for percutaneous (needle stick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure, as its value after seven days following exposure is unclear.¹² An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult the Hepatitis B Vaccine package insert for dosage information regarding the vaccine.

For persons who refuse Hepatitis B Vaccine or are known non-responders to vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given one month after the first dose.¹²

Table 2 Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure¹²

^*Hepatitis B Immune Globulin (Human) dose of 0.06 mL/kg IM.

^†Set manufacturers'recommendation for appropriate dose.

^‡Less than 10 mIU/mL anti-HBs by radioimmunoassay, sugatiue by enzyme immunoassay.

Prophylaxis of Infants Born to Mothers Who Are

Positive for HBsAg With or Without HBeAg. Table 3 contains the recommended schedule of hepatitis B prophylaxis for infants born to mothers that are either known to be positive for HBsAg or have not been screened. Infants born to mothers known to be HBsAg-positive should receive 0.5 mL Hepatitis B Immune Globulin (Human) after physiologic stabilization of the infant and preferably within 12 hours of birth. The Hepatitis B Vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently with the Hepatitis B Immune Globulin (Human), but at a different site. Subsequent doses of the vaccine should be administered in accordance with the recommendations of the manufacturer.

Women admitted for delivery, who were not screened for HBsAg during the prenatal period, should be tested. While test results are pending, the newborn infant should receive Hepatitis B Vaccine within 12 hours of birth (see manufacturers' recommendations for dose). If the mother is later found to be HBsAg-positive, the infant should receive 0.5 mL Hepatitis B Immune Globulin (Human) as soon as possible and within seven days of birth; however, the efficacy of Hepatitis B Immune Globulin (Human) administered after 48 hours of age is not known.^10,19 Testing for HBsAg and anti-HBs is recommended at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been protected.¹²

Table 3 Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus Infection19

^*See manufacturer's recommendations for appropriate dose.

^†0.5mL administered IM at a site different from that used for the vaccine.

^‡See ACIP recommendation.

Sexual Exposure to HBsAg-positive Persons

All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single dose of Hepatitis B Immune Globulin (Human) (0.06 mL/kg) and should begin the Hepatitis B Vaccine series, it not contraindicated, within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine with Hepatitis B Immune Globulin (Human) may improve the efficacy of post-exposure treatment. The vaccine has the added advantage of conferring long-lasting protection.¹⁹

Household Exposure to Persons With Acute HBV Infection

Prophylaxis of an infant less than 12 months of age with 0.5 mL Hepatitis B Immune Globulin (Human) and Hepatitis B Vaccine is indicated it the mother or primary caregiver has acute HBV infection. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive Hepatitis B Vaccine.¹⁹

HOW SUPPLIED

Nabi-HB^TM, Hepatitis B Immune Globulin (Human), is supplied as:

STORAGE

Refrigerate between 2 to 8°C (36 to 46°F). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.

REFERENCES

1. Bowman JM, et al: WinRho: Rh immune globulin prepared by ion exchange for intravenous use. Canadian Med Assoc J 1980; 123: 1121-1125.

2. Friesen AD, etal: Column ion-exchange preparation and characterization of an Rh immune globulin (WinRho) for intravenous use. Journal of Applied Biochem 1981; 3: 164-175.

3. Horowitz B: Investigations into the application of tri (n-butyl) phosphate/detergent mixtures to blood derivatives. Morgenthaler J (ed): Virus Inactivation in Plasma Products, Curr Stud Hemato/Blood Transfus 1989; 56: 83-96.

4. Bumouf T: Value of virus filtration as method for improving the safety of plasma products. VoxSang 1996; 70: 235-236.

5. Unpublished data on file, Viral Validation Study Reports, Cangene Corporation.

6. Grady GF, and Lee VA: Hepatitis B immune globulin-prevention of hepatitis from accidental exposure among medical personnel. N Engl J Med1975; 293: 1067-1070.

7. Seeff LB, etal.: Type B hepatitis after needlestick exposure: Prevention with hepatitis B immune globulin. Ann Int Med 1978; 88: 285-293.

8. Krugman S, and Giles JP: Viral hepatitis, type B (MS-2-strain). Further observations on natural history and prevention. N Engl J Med 1973; 288: 755-760.

9. Hoofnagle JH, etal.: Passive-active immunity from hepatitis B immuneglobulin. Ann lnt Med1979; 91: 813-818.

10.BeasleyRP, et al.: Efficacy of hepatitis B immuneglobulin for prevention of perinatal transmission of the hepatitis B virus carrier state: Final report of a randomized doubleblind, placebo-controlled trial. Hepatology 1983; 3: 135-141.

11.Szmuness W, et al.: Passive active immunisation against hepatitis B: Immunogenicity studies in adult Americans. Lancet 1981; 1: 575-577.

12.Centers for Disease Control: Recommendations for protection against viral hepatitis. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1985; 34(22): 31 3-335.

13.Shiraki Y, et al.: Hepatitis B surface antigen and chronic hepatitis in infants born to asymptomatic carrier mothers. Am J Dis Child 1977; 131: 644-647.

14.Beasley RP, etal.: The e antigen and vertical transmission of hepatitis B surface antigen. Am J Epidemiol 1977; 105: 94-98.

15.WongVCW, et al.: Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis B vaccine and hepatitis B immunoglobulin: Double blind randomized placebo-controlled study. Lancet 1984; 1: 921-926.

16.Poovorawan Y, et al.: Long term hepatitis B vaccine in infants born to hepatitis B e antigen positive mothers. Archives of Diseases in Childhood 1997; 77: F47-F51.

17.Stevens CE, et al.: Perinatal Hepatitis B virus transmission in the United States: Prevention by passive-active immunization. JAMA 1985; 253: 1740-1745.

18.Jhaveri R, et al.: High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive mothers. J Pediatr 1980; 97: 305-308.

19.Centers for Disease Control: Hepatitis B virus: A comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. Recommendations of the Immunization PracticesAdvisory Committee (ACIP). MMWR 1991; 40(1 3): 1-25.

20.Data on file, Nabi.

21.Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis B immunoglobulins after intramuscular application in man. Develop Biol Standard 1983; 54: 347.

22.Centers for Disease Control: General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1994; 1:6.

23.Ellis EF and Henney CS: Adverse reactions following administration of human gamma globulin. J Allerg 1969; 43: 45-54.

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