HEPAGAM B hepatitis immune globulin (human) injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN (UNII: XII270YC6M) (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN - UNII:XII270YC6M)

Available from:

Cangene BioPharma, LLC

INN (International Name):

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

Composition:

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 50 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HEPAGAM B- HEPATITIS B IMMUNE GLOBULIN (HUMAN) INJECTION, SOLUTION
CANGENE BIOPHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPAGAM B SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR HEPAGAM B
.
HEPAGAM B
[HEPATITIS B IMMUNE GLOBULIN INTRAVENOUS (HUMAN)],
STERILE SOLUTION FOR INTRAVENOUS OR INTRAMUSCULAR INJECTION
SOLVENT/DETERGENT TREATED AND FILTERED. >312
IU/ML (MEASURED POTENCY STAMPED ON THE VIAL LABEL)
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Indications and Usage, Prevention of Hepatitis B recurrence following
Liver Transplantation ( 1.1) 4/2007
Dosage and Administration, Prevention of Hepatitis B recurrence
following Liver Transplantation ( 2.1) 4/2007
INDICATIONS AND USAGE
Prevention of Hepatitis B recurrence following Liver Transplantation
in HBsAg-positive liver transplant patients ( 1.1).
Postexposure Prophylaxis in the following settings:
Acute Exposure to Blood Containing HBsAg
Perinatal Exposure of Infants Born to HBsAg-positive Mothers
Sexual Exposure to HBsAg-positive Persons
Household Exposure to Persons with Acute HBV Infection ( 1.2)
DOSAGE AND ADMINISTRATION
PREVENTION OF HEPATITIS B RECURRENCE FOLLOWING LIVER TRANSPLANTATION (
2.1)
HepaGam B is administered intravenously at doses of 20,000 IU
(calculated from the measured potency stamped on the
vial label) according to the following regimen to attain serum
anti-HBs > 500 IU/L:
ANHEPATIC PHASE
WEEK 1 POST-
OPE RATIVE
WEEKS 2-12 POST-OPERATIVE
MONTH 4 ONWARDS
First dose
Daily from Day 1-7
Every two weeks from Day 14
Monthly
_Regularly monitor serum anti-HBs to allow for treatment adjustments _
POSTEXPOSURE PROPHYLAXIS ( 2.2)
HepaGam B must be administered intramuscularly only as directed below:
Acute Exposure to Blood
Containing HBsAg
0.06 mL/kg
Administer as soon as possible after exposure and within 24
hours if possible
Perinatal Exposure of Infants
Born to HBsAg-positive
Mothe rs
0.5mL
Administer after physiologic stabilization of the infant