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
  • 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

Pharmacology
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Indication

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

Associated Conditions
Associated Therapies
Contraindications & Blackbox Warnings
Contraindications
Contraindications & Blackbox Warnings
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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
Medicalerrors
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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.
DrugInteraction
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Hepatitis B Immune Globulin.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Hepatitis B Immune Globulin.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Hepatitis B Immune Globulin.
AlirocumabThe risk or severity of adverse effects can be increased when Hepatitis B Immune Globulin is combined with Alirocumab.
AnsuvimabThe risk or severity of adverse effects can be increased when Hepatitis B Immune Globulin is combined with Ansuvimab.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Hepatitis B Immune Globulin is combined with Anthrax immune globulin human.
Antilymphocyte immunoglobulin (horse)The risk or severity of adverse effects can be increased when Hepatitis B Immune Globulin is combined with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Hepatitis B Immune Globulin.
Asfotase alfaThe risk or severity of adverse effects can be increased when Hepatitis B Immune Globulin is combined with Asfotase alfa.
AtezolizumabThe risk or severity of adverse effects can be increased when Hepatitis B Immune Globulin is combined with Atezolizumab.
Interactions
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Food Interactions
Not Available

Products

Products
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
H-bigLiquidIntramuscularAbbott1988-12-311997-08-18Canada flag
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUS flag
HepaGam BInjection, solution50 mg/1mLIntramuscular; IntravenousCangene BioPharma, LLC2010-08-012018-02-28US flag
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousApotex Corporation2008-12-012012-12-31US flag
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2018-06-20Not applicableUS flag
HepaGam BSolution312 unitIntramuscular; IntravenousSaol Therapeutics Research Limited2007-08-13Not applicableCanada flag
HepaGam BSolution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUS flag
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2019-03-01Not applicableUS flag
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousCangene bioPharma Inc.2010-08-012018-02-28US flag
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousApotex Corporation2008-12-012012-12-31US flag

Categories

ATC Codes
J06BB04 — Hepatitis b immunoglobulin
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
Wikipedia
Hepatitis_B_immune_globulin
AHFS Codes
  • 80:04.00 — Serums

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedPreventionTransplantation, Liver / Viral Hepatitis B1
4CompletedPreventionViral Hepatitis B1
4CompletedSupportive CareViral Hepatitis B1
4RecruitingPreventionChronic Infection / Congenital Malformations / Fetal Malformation / Hepatitis B Infection / Viral sepsis1
4Unknown StatusTreatmentTransplantation, Liver / Viral Hepatitis B1
3CompletedPreventionHepatitis B Chronic Infection1
3CompletedPreventionTransplantation, Liver / Viral Hepatitis B1
3CompletedPreventionViral Hepatitis B1
3WithdrawnTreatmentHepatitis B Chronic Infection1
2CompletedPreventionHepatitis B Chronic Infection2

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solution180 U.I.
Injection, solution540 U.I.
Injection, solutionIntravenous100 U.I.
Injection, solutionIntravenous500 U.I.
Injection, solutionIntramuscular200 IU/ml
Injection, solutionIntramuscular100 IU/0.5ml
InjectionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous50 mg/1mL
SolutionIntramuscular; Intravenous312 [iU]/1mL
SolutionIntramuscular; Intravenous312 unit
Injection, solutionIntramuscular; Intravenous1560 iu/5ml
Injection, solutionIntramuscular; Intravenous312 iu/1ml
Injection, solutionIntravenous100 UI/2ML
Injection, solutionIntravenous2000 U.I./40ML
Injection, solutionIntravenous500 UI/10ML
SolutionParenteral50 IU/ml
InjectionIntravenous50 iu/nl
Solution, concentrateIntravenous50 IU
LiquidIntramuscular
Injection200 IU/ml
InjectionIntravenous1000 iu/5ml
InjectionIntravenous200 iu/1ml
Injection, solutionIntravenous100 IU/mL
Injection, solutionIntramuscular400 UI/2ML
InjectionIntramuscular220 [iU]/1mL
Injection, solutionIntramuscular220 IU/ml
SolutionIntramuscular
Injection, solutionIntramuscular1000 UI/5ML
Injection, solutionIntramuscular600 UI/3ML
Injection, solutionIntramuscular312 IU/ml
Injection, solutionIntramuscular1000 UI/3ML
Injection, solutionIntramuscular180 U.I./1ML
Injection, solutionIntramuscular540 U.I./3ML
SolutionIntramuscular1000 IU
SolutionIntramuscular180 IU
Injection, powder, lyophilized, for solutionIntravenous5000 iu/100ml
Injection, solutionIntravenous50 UI/ML
Powder, for solutionIntravenous50 UI/ML
InjectionIntramuscular1560 [iU]/5mL
InjectionIntramuscular312 [iU]/1mL
LiquidIntramuscular1560 [iU]/5mL
LiquidIntramuscular312 [iU]/1mL
Injection, solutionParenteral50 IU/mL
Injection, solutionIntravenous250 I.U./ML
Injection, solutionIntramuscular180 UI/1ML
Injection, solutionIntramuscular540 UI/3ML
Powder, for solutionIntravenous2500 UI/50ML
Powder, for solutionIntravenous500 U.I./10ML
Injection, powder, for solutionParenteral50 IU/ml
Injection, solutionSubcutaneous500 UI
Injection, solutionSubcutaneous500 IU
Injection, solutionIntravenous
Solution
Injection, solution
Injection
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 18:23 / Updated on February 24, 2021 23:07