Hepagam B Recall
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FDA Labeling Changes
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HepaGam B®, Hepatitis B Immune Globulin Intravenous (Human), is indicated for the prevention of hepatitis B recurrence following liver transplantation, in HbsAg-positive liver transplant patients.
HepaGam B should be administered intravenously for this indication.
HepaGam B is indicated for the treatment of acute exposure to blood containing HbsAg, perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAgpositive
persons and household exposure to persons with acute HBV infection in the following settings:
Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HbsAg-positive materials such as blood, plasma or serum1,2.
Perinatal Exposure of Infants Born to HbsAg-positive Mothers
Infants born to mothers positive for HbsAg with or without HbeAg1.
Sexual Exposure to HbsAg-positive Persons
Sexual partners of HbsAg-positive persons1,2.
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.
HepaGam B is indicated for intramuscular use only for these post-exposure prophylaxis indications.
There is currently no drug history available for this drug.
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 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 may be administered intravenously or intramuscularly dependent upon indication [see Indications and Usage (1.)]. 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 inprocess 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.
|Anion Exchange Chromatography(partitioning)||Not evaluated||2.3||n.e.||3.4||n.e.|
|20N Filtration(size exclusion)||≥ 4.7||≥ 3.5||≥ 5.6 *||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|
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.
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 (3.)].