Hepatitis B Immune Globulin

Identification

Name
Hepatitis B Immune Globulin
Accession Number
DB05276
Description

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.

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Polyclonal antibody (pAb)
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • HBIG
  • Hepatitis B Immune Globulin (Human)
  • Hepatitis B immune globulin human
  • Hepatitis B immunoglobulin (human)
  • Human hepatitis B immunoglobulin
  • Human hepatitis B virus immune globulin
  • Human hepatitis-B immunoglobulin

Pharmacology

Indication

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

Associated Conditions
Associated Therapies
Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
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Pharmacodynamics
Not Available
Mechanism of action

In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer.

TargetActionsOrganism
UHBsAgNot AvailableHBV
Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life
Not Available
Clearance
Not Available
Adverse Effects
Learn about our commercial Adverse Effects data.
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Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

Products

Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
H-bigLiquidIntramuscularAbbott1988-12-311997-08-18Canada
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2019-03-01Not applicableUs
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUs
HepaGam BSolution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUs
HepaGam BInjection, solution50 mg/1mLIntramuscular; IntravenousCangene BioPharma, LLC2010-08-012018-02-28Us
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2018-06-20Not applicableUs
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousApotex Corporation2008-12-012012-12-31Us
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2019-03-01Not applicableUs
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2018-06-20Not applicableUs
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousCangene bioPharma Inc.2010-08-012018-02-28Us
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Chemical Identifiers

UNII
XII270YC6M
CAS number
Not Available

References

General References
  1. Ghany MG, Ayola B, Villamil FG, Gish RG, Rojter S, Vierling JM, Lok AS: Hepatitis B virus S mutants in liver transplant recipients who were reinfected despite hepatitis B immune globulin prophylaxis. Hepatology. 1998 Jan;27(1):213-22. [PubMed:9425940]
PubChem Substance
347910055
RxNav
26744
ChEMBL
CHEMBL2108512
AHFS Codes
  • 80:04.00 — Serums

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedPreventionTransplantation, Liver / Viral Hepatitis B1
4CompletedPreventionViral Hepatitis B1
4CompletedSupportive CareViral Hepatitis B1
4Not Yet RecruitingTreatmentTransplantation, Liver / Viral Hepatitis B1
4RecruitingPreventionChronic Infection / Congenital Malformations / Fetal Malformation / Hepatitis B Infection / Viral sepsis1
3CompletedPreventionTransplantation, Liver / Viral Hepatitis B1
3CompletedPreventionViral Hepatitis B1
3WithdrawnTreatmentHepatitis B Chronic Infection1
2CompletedPreventionHepatitis B Chronic Infection2
2RecruitingTreatmentHepatitis B Chronic Infection1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
InjectionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous50 mg/1mL
SolutionIntramuscular; Intravenous312 [iU]/1mL
SolutionIntramuscular; Intravenous312 unit
LiquidIntramuscular
InjectionIntramuscular220 [iU]/1mL
SolutionIntramuscular220 unit
Injection, solutionIntramuscular312 IU/ml
InjectionIntramuscular1560 [iU]/5mL
InjectionIntramuscular312 [iU]/1mL
LiquidIntramuscular1560 [iU]/5mL
LiquidIntramuscular312 [iU]/1mL
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Targets

Kind
Protein
Organism
HBV
Pharmacological action
Unknown
General Function
Not Available
Specific Function
Not Available
Gene Name
S gene
Uniprot ID
Q69600
Uniprot Name
HBsAg
Molecular Weight
25420.905 Da

Drug created on November 18, 2007 11:23 / Updated on August 10, 2020 08:11

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