Source: FDA, National Drug Code (US) Revision Year: 2020
Hepatitis B Immune Globulin (Human) provides passive immunization for individuals exposed to the hepatitis B virus (HBV) as evidenced by a reduction in the attack rate of hepatitis B following its use.(2-7) The administration of the usual recommended dose of this immune globulin generally results in a detectable level of circulating anti-HBs which persists for approximately 2 months or longer. The highest antibody (IgG) serum levels were seen in the following distribution of subjects studied: (8)
| DAY | % OF SUBJECTS |
|---|---|
| 3 | 38.9% |
| 7 | 41.7% |
| 14 | 11.1% |
| 21 | 8.3% |
Mean values for half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days.(8)
Cases of type B hepatitis are rarely seen following exposure to HBV in persons with preexisting anti-HBs. No confirmed instance of transmission of hepatitis B has been associated with this product.
In a clinical study, 12 healthy human adults receiving another hyperimmune immune globulin product, Rabies Immune Globulin (Human), HyperRAB, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period.
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