HEPAGAM B- human hepatitis b virus immune globulin injection, solution
Apotex Corporation
1 INDICATIONS AND USAGE
Prevention of Hepatitis B recurrence following Liver Transplantation
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.
Postexposure Prophylaxis
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 HBsAg?positive
persons and household exposure to persons with acute HBV infection in the following settings:
Acute Exposure to Blood Containing HBsAg
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 persons 1 ,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.
2 DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration; if these are seen, vials should not be used. During preparation, do not shake vials; avoid foaming.
Any vial of HepaGam B that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately.
Prevention of Hepatitis B recurrence following liver transplantation
For the prevention of hepatitis B recurrence following liver transplantation in HBsAg positive liver transplant patients, HepaGam B is administered intravenously according to a set dosing regimen designed to attain serum levels of antibodies to hepatitis B surface antigen (anti-HBs) greater than 500 IU/L3.
Based upon the HepaGam B clinical trial, patients should receive 20,000 IU/dose [see Clinical Trials in Liver Transplant Patients (14.1) ]. The volume of each 20,000 IU dose should be calculated from the measured potency of the particular lot of HepaGam B as stamped on the vial label.