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 Therapies
- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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.
Target Actions Organism UHBsAg Not Available HBV - 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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Hepatitis B immune globulin. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Hepatitis B immune globulin. Aducanumab The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Aducanumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Hepatitis B immune globulin. Alirocumab The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Alirocumab. Amivantamab The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Anifrolumab. Ansuvimab The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Ansuvimab. Anthrax immune globulin human The 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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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image H-big Liquid 1.5 unit / mL Intramuscular Abbott 1988-12-31 1997-08-18 Canada 
HepaGam B Solution 312 [iU]/1mL Intramuscular; Intravenous Aptevo Biotherapeutics Llc 2016-07-01 Not applicable US 
HepaGam B Injection, solution 50 mg/1mL Intramuscular; Intravenous Cangene BioPharma, LLC 2010-08-01 2018-02-28 US HepaGam B Injection 312 [iU]/1mL Intramuscular; Intravenous Saol Therapeutics Inc. 2018-06-20 Not applicable US HepaGam B Injection 312 [iU]/1mL Intramuscular; Intravenous Saol Therapeutics Inc. 2019-03-01 Not applicable US HepaGam B Injection, solution 312 [iU]/1mL Intramuscular; Intravenous Apotex Corporation 2008-12-01 2012-12-31 US HepaGam B Solution 312 [iU]/1mL Intramuscular; Intravenous Aptevo Biotherapeutics Llc 2016-07-01 Not applicable US HepaGam B Injection, solution 312 [iU]/1mL Intramuscular; Intravenous Cangene bioPharma Inc. 2010-08-01 2018-02-28 US HepaGam B Injection, solution 312 [iU]/1mL Intramuscular; Intravenous Aptevo Biotherapeutics Llc 2016-07-01 Not applicable US HepaGam B Injection 312 [iU]/1mL Intramuscular; Intravenous Saol Therapeutics Inc. 2018-06-20 Not applicable US - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image HEPATECT CP 50 IU 10 ML FLAKON Hepatitis B immune globulin (50 iu/nl) Injection Intravenous KANSUK LABORATUVARI SAN. VE TİC. A.Ş. 2020-08-14 Not applicable Turkey 
Categories
- ATC Codes
- J06BB04 — Hepatitis b immunoglobulin
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Antiinfectives for Systemic Use
- Blood Proteins
- Globulins
- Human Immunoglobulin
- Immune Sera and Immunoglobulins
- Immunization, Passive
- Immunoglobulins
- Immunoproteins
- Passively Acquired Immunity
- Proteins
- Serum
- Serum Globulins
- Specific Immunoglobulins
- Virus Neutralization
- 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
- 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]
- External Links
- PubChem Substance
- 347910055
- 26744
- ChEMBL
- CHEMBL2108512
- Wikipedia
- Hepatitis_B_immune_globulin
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Prevention Liver Transplantation / Viral Hepatitis B 1 4 Completed Prevention Viral Hepatitis B 1 4 Completed Supportive Care Viral Hepatitis B 1 4 Recruiting Prevention Chronic Infection / Congenital Malformations / Fetal Malformation / Hepatitis B Virus Infection / Viral sepsis 1 4 Unknown Status Treatment Liver Transplantation / Viral Hepatitis B 1 3 Completed Prevention Hepatitis B Chronic Infection 1 3 Completed Prevention Liver Transplantation / Viral Hepatitis B 1 3 Completed Prevention Viral Hepatitis B 1 3 Withdrawn Treatment Hepatitis B Chronic Infection 1 2 Completed Prevention Hepatitis B Chronic Infection 2
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Liquid Intramuscular 1.5 unit / mL Injection, solution Injection, solution Intravenous Injection Intramuscular; Intravenous 312 [iU]/1mL Injection, solution Intramuscular; Intravenous 312 [iU]/1mL Injection, solution Intramuscular; Intravenous 50 mg/1mL Solution Intramuscular; Intravenous 312 unit / mL Solution Intramuscular; Intravenous 312 [iU]/1mL Injection, solution Intramuscular; Intravenous Solution Parenteral Injection Intravenous Solution Intravenous 50 iu/ml Solution, concentrate Intravenous 50 IU Liquid Intramuscular Injection 200 IU/ml Injection, solution Intramuscular Injection Intramuscular 220 [iU]/1mL Solution Intramuscular 110 unit / 0.5 mL Solution Intramuscular 220 unit / mL Injection Intramuscular 16.5 % Injection, solution Intramuscular 1000 UI/5ML Injection, solution Intramuscular 600 UI/3ML Injection Intramuscular 200 iu/ml Injection, solution Intramuscular 200 IU/ml Injection, solution Intramuscular 312 IU/ml Injection, solution Intramuscular 180 U.I./1ML Injection, solution Intramuscular 540 U.I./3ML Solution Intramuscular 1000 IU Solution Intramuscular 180 IU Injection, powder, lyophilized, for solution Intravenous Injection, solution Intramuscular 1000 UI/3ML Injection, solution Intramuscular 180 UI/1ML Injection, solution Intramuscular 540 UI/3ML Injection, solution Intravenous 50 UI/ML Powder, for solution Intravenous 50 UI/ML Injection Intramuscular 1560 [iU]/5mL Injection Intramuscular 312 [iU]/1mL Liquid Intramuscular 1560 [iU]/5mL Liquid Intramuscular 312 [iU]/1mL Injection, solution Parenteral 50 IU/mL Injection, solution Intravenous 250 I.U./ml Injection, solution Intravenous 1,000 I.U./4 ml Injection, solution Intravenous 600 I.U./2.4 ml Powder, for solution Intravenous 2500 UI/50ML Powder, for solution Intravenous 500 U.I./10ML Injection, powder, for solution Parenteral Injection, solution Subcutaneous 500 IU Injection, solution Subcutaneous 500 UI Injection Subcutaneous 500 iu/ml Injection, solution Intravenous 250 IU/ml Solution 400 IU/2ml Injection, solution 200 IU/ml Injection 2500 IU Injection 500 IU - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
Drug created at November 18, 2007 18:23 / Updated at December 01, 2022 23:18