Nabi-HB

CLINICAL PHARMACOLOGY

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 of hepatitis B following use6-9.

Clinical studies10,11 conducted prior to 1983 with hepatitis B immune globulins similar to Nabi-HB (hepatitis b vaccine recombinant) indicate the advantage of simultaneous administration of hepatitis B vaccine and Hepatitis B Immune Globulin (Human). The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) advises that the combination prophylaxis be provided in certain instances of exposure based upon the increased efficacy found with that regimen in neonates12. Cases of hepatitis B are rarely seen following exposure to HBV in persons with preexisting anti-HBs. However, no prospective studies have been performed on the efficacy of concurrent hepatitis B vaccine and Hepatitis B Immune Globulin (Human) administration following parenteral exposure, mucous membrane contact, or oral ingestion in adults.

Infants born to HBsAg-positive mothers are at risk of being infected with HBV and becoming chronic carriers13. The risk is especially great if the mother is also HBeAg-positive14. Studies conducted with hepatitis B immune globulins similar to Nabi-HB (hepatitis b vaccine recombinant) indicated that for an infant with peri-natal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85-98% effective in preventing development of the HBV carrier state15-17. Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have a 70-90% efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has 50% efficacy18.

Since infants have close contact with primary caregivers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection19.

Sexual partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. A single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within two weeks of the last sexual exposure to a person with acute hepatitis B19.

Pharmacokinetics

Pharmacokinetics trials20 of Nabi-HB, Hepatitis B Immune Globulin (Human), given intramuscularly to 50 healthy volunteers demonstrated pharmacokinetic parameters similar to those reported by Scheiermann and Kuwert21. The half-life for Nabi-HB (hepatitis b vaccine recombinant) was 23.1 ± 5.5 days. The clearance rate was 0.35 ± 0.12 L/day and the volume of distribution was 11.2 ± 3.4 L.

Maximum concentration of Nabi-HB (hepatitis b vaccine recombinant) was reached in 6.5 ±4.3 days. The maximum concentration of anti-HBs and the area under the time-concentration curve achieved by Nabi-HB (hepatitis b vaccine recombinant) were bio-equivalent to that of another licensed Hepatitis B Immune Globulin (Human) when compared in the same pharmacokinetics trial. Comparability of pharmacokinetics between Nabi-HB (hepatitis b vaccine recombinant) and a commercially available hepatitis B immunoglobulin indicate that similar efficacy of Nabi-HB (hepatitis b vaccine recombinant) should be inferred.

REFERENCES

6. Grady GF, and Lee VA: Hepatitis B immune globulin - prevention of hepatitis from accidental exposure among medical personnel. N Engl J Med 1975; 293:1067-1070.

7. Seeff LB, et al.: Type B hepatitis after needle-stick 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, et al.: Passive - active immunity from hepatitis B immune globulin. Ann Int Med 1979; 91:813-818.

10. Beasley RP, et al.: Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: Final report of a randomized double-blind, 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):313-335.

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, et al.: The e antigen and vertical transmission of hepatitis B surface antigen. Am J Epidemiol 1977; 105:94-98.

15. Wong VCW, 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 Practices Advisory Committee (ACIP). MMWR 1991; 40(13):1-25.

20. Data on file, Nabi® Biopharmaceuticals

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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