HEPAGAM B (hepatitis b 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:

Aptevo BioTherapeutics LLC

INN (International Name):

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

Composition:

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU] in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following: including - acute exposure to HBsAg-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc), - perinatal exposure of infants born to HBsAg-positive mothers, - sexual exposure to HBsAg-positive persons, and - household exposure to persons with acute HBV infection. - Individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive HepaGam B. - Individuals who are deficient in IgA may have the potential to develop anti-IgA antibodies and have an anaphylactoid reaction. HepaGam B contains less than 40 micrograms per milliliter of IgA. - HepaGam B contains less than 40 micrograms per milliliter of IgA. - For postexposure prophylaxis indications, HepaGam B must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulat

Product summary:

NDC 70504-0052-2; a carton containing a 1.0 milliliter single dose vial (>312 IU per milliliter; measured potency of each lot is stamped on the vial label) and a package insert. NDC 70504-0051-2; a carton containing a 5.0 milliliter single dose vial (>312 IU per millileter; measure potency of each lot is stamped on the vial label) and a package insert. Store at 36 to 46 °F (2 to 8 °C). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HEPAGAM B- HEPATITIS B IMMUNE GLOBULIN (HUMAN) INJECTION, SOLUTION
APTEVO BIOTHERAPEUTICS 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 PER MILLILITER (MEASURED POTENCY
STAMPED ON THE VIAL LABEL)
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Dosage and Administration, Preparation (2.3) 1/2012
Warning and Precautions, Thrombotic events (5.7) 1/2012
Clinical Trials in Liver Transplant Patients (14.1) 1/2012
INDICATIONS AND USAGE
For Intravenous or Intramuscular Administration Only
Prevention of Hepatitis B recurrence following Liver Transplantation
in HBsAg-positive liver transplant patients (1.1).
Postexposure Prophylaxis (1.2) 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
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 per liter:
_REGULARLY MONITOR SERUM ANTI-HBS TO ALLOW FOR TREATMENT ADJUSTMENTS._
ANHEPATIC PHASE WEEK 1 POST-OPERATIVE WEEKS 2-12
PO ST-OPE RATIVE
MONTH 4 ONWARDS
First dose
Daily from Day 1-7
Every two weeks from Day 14 Monthly
POSTEXPOSURE PROPHYLAXIS (2.2)
HepaGam B must be administered intramuscularly only as directed below:
Acute Exposure to Blood
Containing HBsAg
0.06 milliliter
per kilogram
Administer as soon as possible after exposure and within 24 hours if
possible .
Perinatal Exposure of Infants Born
to HBsAg-positive Mothers
0.5 milliliter
Admi