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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (H's) » Hepatitis B Immune Globulin (Human)


Hepatitis B Immune Globulin (Human), Nabi-HBTM, is a sterile solution of immunoglobulin (51% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is purified by an anion-exchange column chromatography method1,2 with two added viral reduction steps described below. The product is formulated in 0.075 M sodium chloride, 0.15 M glycine, and 0.01% polysorbate 80, pH6.25. It contains no preservative and is intended for single use by the intramuscular route only. The product appears as a clear to opalescent, nonturbid liquid.

The manufacturing steps are designed to reduce the risk of transmission of viral disease. The solvent/detergent treatment step, using tri-n-butyl phosphate and Triton X-100, is effective in inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). 3 Virus filtration, using a Plan ova35 nm Virus Filter, is effective in reducing some known enveloped and non-enveloped viruses. 4The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in the following table:

Table 1 Log Reduction of Test Viruses5

Test Virus

Model Virus: HIV HCV HBV Hepatitis A PVB19
Envelope/Genome: yes/RNA yes/RNA yes/DNA no/RNA no/DNA
Manufacturing Step          
dextran sulfate NT NT NT 3.32 <1
anion-exchange NT NT NT >3.52 >5.34
solvent/detergent >4.67 >7.43 >5.26 2.7 >5.81
virus filtration >6.02 >7.30 >677 4.25 >4.97
BVD = Bovine Viral Diarrhea PRV = Pseudorabies Virus Polio = Poliovirus
BPV= Bovine Panvovirus PVB19= Parvovirus B19 NT= not tested

The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. Each vial contains greater than 312 IU/mL anti-HBs. The potency of each vial of Nabi-HBTM exceeds the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (FDA). The U.S. reference has been tested by Nabi against the WHO standard and found to be equal to 208 IU/mL.

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