Identification

Summary

Hepatitis B immune globulin is an injection of immunoglobulin G (IgG) antibodies to prevent the development of chronic Hepatitis B infection.

Brand Names
Hepagam B, Hyperhep B, Nabi-HB
Generic Name
Hepatitis B immune globulin
DrugBank Accession Number
DB05276
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.

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

Indication

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

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Associated Conditions
Associated Therapies
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
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Toxicity

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.
AducanumabThe risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Aducanumab.
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.
AmivantamabThe risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Amivantamab.
AnifrolumabThe risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Anifrolumab.
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).
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Food Interactions
No interactions found.

Products

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dosage, form, labeller, route of administration, and marketing period.
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
H-bigLiquid1.5 unit / mLIntramuscularAbbott1988-12-311997-08-18Canada flag
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUS flag
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2018-06-20Not 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 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; IntravenousAptevo Biotherapeutics Llc2016-07-01Not applicableUS flag
HepaGam BInjection312 [iU]/1mLIntramuscular; IntravenousSaol Therapeutics Inc.2018-06-20Not applicableUS flag
HepaGam BInjection, solution312 [iU]/1mLIntramuscular; IntravenousCangene bioPharma Inc.2010-08-012018-02-28US flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
HEPATECT CP 50 IU 10 ML FLAKONHepatitis B immune globulin (50 iu/nl)InjectionIntravenousKANSUK LABORATUVARI SAN. VE TİC. A.Ş.2020-08-14Not applicableTurkey 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
Affected organisms
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. [Article]
PubChem Substance
347910055
RxNav
26744
ChEMBL
CHEMBL2108512
Wikipedia
Hepatitis_B_immune_globulin

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedPreventionLiver Transplantation / Viral Hepatitis B1
4CompletedPreventionViral Hepatitis B1
4CompletedSupportive CareViral Hepatitis B1
4RecruitingPreventionChronic Infection / Congenital Malformations / Fetal Malformation / Hepatitis B Virus Infection / Viral sepsis1
4Unknown StatusTreatmentLiver Transplantation / Viral Hepatitis B1
3CompletedPreventionHepatitis B Chronic Infection1
3CompletedPreventionLiver Transplantation / Viral Hepatitis B1
3CompletedPreventionViral Hepatitis B1
3WithdrawnTreatmentHepatitis B Chronic Infection1
2CompletedPreventionHepatitis B Chronic Infection2

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
LiquidIntramuscular1.5 unit / mL
Injection, solution
Injection, solutionIntravenous
InjectionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous50 mg/1mL
SolutionIntramuscular; Intravenous312 unit / mL
SolutionIntramuscular; Intravenous312 [iU]/1mL
Injection, solutionIntramuscular; Intravenous
SolutionParenteral
InjectionIntravenous
SolutionIntravenous50 iu/ml
Solution, concentrateIntravenous50 IU
LiquidIntramuscular
Injection200 IU/ml
Injection, solutionIntramuscular
InjectionIntramuscular220 [iU]/1mL
SolutionIntramuscular110 unit / 0.5 mL
SolutionIntramuscular220 unit / mL
InjectionIntramuscular16.5 %
Injection, solutionIntramuscular1000 UI/5ML
Injection, solutionIntramuscular600 UI/3ML
InjectionIntramuscular200 iu/ml
Injection, solutionIntramuscular200 IU/ml
Injection, solutionIntramuscular312 IU/ml
Injection, solutionIntramuscular180 U.I./1ML
Injection, solutionIntramuscular540 U.I./3ML
SolutionIntramuscular1000 IU
SolutionIntramuscular180 IU
Injection, powder, lyophilized, for solutionIntravenous
Injection, solutionIntramuscular1000 UI/3ML
Injection, solutionIntramuscular180 UI/1ML
Injection, solutionIntramuscular540 UI/3ML
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, solutionIntravenous1,000 I.U./4 ml
Injection, solutionIntravenous600 I.U./2.4 ml
Powder, for solutionIntravenous2500 UI/50ML
Powder, for solutionIntravenous500 U.I./10ML
Injection, powder, for solutionParenteral
Injection, solutionSubcutaneous500 UI
Injection, solutionSubcutaneous500 IU
InjectionSubcutaneous500 iu/ml
Injection, solutionIntravenous250 IU/ml
Solution400 IU/2ml
Injection, solution200 IU/ml
Injection2500 IU
Injection500 IU
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created at November 18, 2007 18:23 / Updated at October 04, 2022 23:16