MedPath

Hepatitis B immune globulin

Generic Name
Hepatitis B immune globulin
Brand Names
Hepagam B, Hyperhep B, Nabi-HB, Zutectra
Drug Type
Biotech
Unique Ingredient Identifier
XII270YC6M

Overview

Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus.

Background

Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus.

Indication

Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications.

Associated Conditions

  • Reactivation of hepatitis B virus infection

FDA Approved Products

HepaGam B
Manufacturer:Saol Therapeutics Inc.
Route:INTRAVENOUS, INTRAMUSCULAR
Strength:312 [iU] in 1 mL
Approved: 2019/01/15
NDC:70257-051
HepaGam B
Manufacturer:Saol Therapeutics Inc.
Route:INTRAVENOUS, INTRAMUSCULAR
Strength:312 [iU] in 1 mL
Approved: 2020/04/16
NDC:70257-053
Nabi-HB
Manufacturer:ADMA Biologics, Inc.
Route:INTRAMUSCULAR
Strength:312 [iU] in 1 mL
Approved: 2022/11/22
NDC:69800-4202
Nabi-HB
Manufacturer:ADMA Biologics, Inc.
Route:INTRAMUSCULAR
Strength:1560 [iU] in 5 mL
Approved: 2022/11/22
NDC:69800-4203
HepaGam B
Manufacturer:Saol Therapeutics Inc.
Route:INTRAVENOUS, INTRAMUSCULAR
Strength:312 [iU] in 1 mL
Approved: 2020/04/16
NDC:70257-054

Singapore Approved Products

HyperHEP B Pre-filled Syringe 1mL
Manufacturer:Grifols Therapeutics LLC
Form:INJECTION
Strength:15-18%
Online:Yes
Approved: 2008/07/15
Approval:SIN13491P
HEPATECT CP SOLUTION FOR INFUSION 50 IU/ML
Manufacturer:Biotest AG
Form:INFUSION, SOLUTION
Strength:50 iu/ml
Online:Yes
Approved: 2014/10/24
Approval:SIN14652P
HyperHEP B INJECTION
Manufacturer:Grifols Therapeutics LLC
Form:INJECTION
Strength:15 - 18%
Online:Yes
Approved: 1998/03/07
Approval:SIN09669P
HyperHEP B Pre-filled Syringe 0.5mL
Manufacturer:Grifols Therapeutics LLC
Form:INJECTION
Strength:15-18%
Online:Yes
Approved: 2008/07/15
Approval:SIN13490P

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