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HepaGam B™
[Hepatitis B Immune Globulin Intravenous (Human)], Sterile Solution for Intravenous
or Intramuscular Injection Solvent/Detergent Treated and Filtered. >312 IU/mL
HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent- treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion- exchange column chromatography manufacturing method9,10. HepaGam B (hepatitis b immune globulin human) is formulated as a 5% (50 mg/mL) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 mL and 5 mL single dose vials. The product appears as a clear to opalescent liquid. It contains no preservatives and is intended for single use. HepaGam B (hepatitis b immune globulin human) may be administered intravenously or intramuscularly dependent upon indication [see INDICATIONS]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1 and HCV and found to be negative. An investigational NAT for HBV was performed on all Source Plasma used, and found to be negative; however, the significance of a negative result has not been established. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per mL.
The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV11. Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses12. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses.
The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 5. The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process's ability for viral clearance in general.
Table 5 - Virus Reduction Values Obtained Through Validation Studies8
| Enveloped | Enveloped | Non-Enveloped | |||||
| Genome | RNA | DNA | RNA | DNA | |||
| Virus | HIV-1 BVDV | PRV | HAV EMC | MMV PPV | |||
| Family | retro | flavi | herpes | picorna | parvo | ||
| Size (nm) | 80-100 50-70 | 120-200 | 25-30 | 30 | 20-25 | 18-24 | |
| Anion Exchange Chromatography (partitioning) | Not evaluated | 2.3 | n.e. | 3.4 | n.e. | ||
| 20N Filtration (size exclusion) | ≥ 4.7 | ≥ 3.5 | ≥ 5.6 a | n.e. | 4.8 | n.e. | 4.1 |
| Solvent/Detergent (inactivation) | ≥ 4.7 | ≥ 7.3 | ≥ 5.5 | Not evaluated | |||
| Total Reduction (log10) | ≥ 9.4 | ≥ 10.8 | ≥ 11.1 | 2.3 | 4.8 | 3.4 | 4.1 |
| Abbreviations: HIV-1: human immunodeficiency virus-1; relevant virus for human immunodeficiency virus-1 and model for HIV-2 BVDV: bovine viral diarrhea virus; model virus for hepatitis C virus (HCV) and West Nile virus (WNV) PRV: pseudorabies virus; model for large enveloped DNA viruses, including herpes HAV: human hepatitis A virus; relevant virus for HAV and model for small non-enveloped viruses in general EMC: encephalomyocarditis virus; model for HAV and for small non- enveloped viruses in general MMV: murine minute virus; model for human parvovirus B19 and for small non-enveloped viruses in general PPV: porcine parvovirus; model for human parvovirus B19 and for small non- enveloped viruses in general n.e.: not evaluated a The PRV was retained by the 0.1 µm pre-filter during the virus validation. Since manufacturing employs a 0.1 µm pre-filter before the 20N filter, the claim of ≥ 5.6 reduction is considered applicable. |
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The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 IU/mL. The measured potency of each lot is stamped on the vial label [see Dosage Forms and Strengths].
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of HepaGam B »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
REFERENCES
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of HepaGam B »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
9. Bowman JM, et al. WinRho: Rh immune globulin prepared by ion exchange for intravenous use. Canadian Med Assoc J 1980; 123:1121-5.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of HepaGam B »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
10. Friesen AD, et al. Column ion-exchange preparation and characterization of an Rh immune globulin (WinRho) for intravenous use. Journal Appl Biochem 1981; 3:164- 75.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of HepaGam B »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
11. 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 Hematol Blood Transfus 1989; 56:83-96.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of HepaGam B »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
12. Burnouf T. Value of virus filtration as method for improving the safety of plasma products. Vox Sang 1996; 70:235-6.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of HepaGam B »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
Last reviewed on RxList: 2/20/2009
This monograph has been modified to include the generic and brand name in many instances.
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