Hepatitis B Immune Globulin

Identification

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Name
Hepatitis B Immune Globulin
Accession Number
DB05276
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Polyclonal antibody (pAb)
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.

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
  • Human hepatitis B immunoglobulin
  • Human hepatitis B virus immune globulin
  • Human hepatitis-B immunoglobulin
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
H-bigLiquid1.5 unitIntramuscularAbbott1988-12-311997-08-18Canada
HepaGam BSolution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUs
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousApotex Corporation2008-12-012012-12-31Us
HepaGam BSolution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUs
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousCangene Bio Pharma2010-08-01Not applicableUs
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUs
HepaGam BInjection, solution50 mg/1mLIntramuscular; IntravenousCangene BioPharma, LLC2010-08-01Not applicableUs
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousCangene Bio Pharma2010-08-01Not applicableUs
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2019-03-01Not applicableUs
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUs
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
UNII
XII270YC6M
CAS number
Not Available

Pharmacology

Indication

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

Associated Conditions
Associated Therapies
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
Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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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
Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
Not Available
Food Interactions
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]
External Links
PubChem Substance
347910055
ChEMBL
CHEMBL2108512
AHFS Codes
  • 80:04.00 — Serums

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1RecruitingOtherHealthy Volunteers1
1, 2CompletedPreventionHepatitis B Virus (HBV) Associated Liver Disease / Hepatitis B Virus Associated Liver Disease1
2CompletedPreventionHepatitis B Chronic Infection1
2RecruitingTreatmentHepatitis B Chronic Infection1
2TerminatedPreventionTransplantation, Liver / Viral Hepatitis B1
3CompletedPreventionTransplantation, Liver / Viral Hepatitis B1
3CompletedPreventionViral Hepatitis B1
3WithdrawnTreatmentHepatitis B Chronic Infection1
4CompletedPreventionTransplantation, Liver / Viral Hepatitis B1
4CompletedPreventionViral Hepatitis B1
Not AvailableCompletedNot AvailableAcute fulminant liver failure / Hepatocellular,Carcinoma / Liver Cirrhosis / Viral Hepatitis B1
Not AvailableCompletedPreventionHBV1
Not AvailableCompletedPreventionHepatitis B Chronic Infection1
Not AvailableRecruitingNot AvailableHepatitis B Chronic Infection1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
LiquidIntramuscular1.5 unit
InjectionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous50 mg/1mL
SolutionIntramuscular; Intravenous312 unit
SolutionIntramuscular; Intravenous312 [iU]/1mL
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

Taxonomy

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

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 19, 2019 02:13