Hepatitis B Vaccine (Recombinant)
Identification
- Summary
Hepatitis B Vaccine (Recombinant) is a solution of Hepatitis B surface antigen used to immunize patients against Hepatitis B.
- Brand Names
- Engerix-B, Heplisav-B, Pediarix, Recombivax, Twinrix, Vaxelis
- Generic Name
- Hepatitis B Vaccine (Recombinant)
- DrugBank Accession Number
- DB11627
- Background
Hepatitis B Vaccine is an ingredient in the EMA-withdrawn product Quintanrix. It is marketed in Canada as Engerix B. It is also a part of Twinrix (Hep A/Hep B vaccine) available also in Canada. The hepatitis B virus induces a severe form of viral hepatitis. Other causative agents are hepatitis A virus, and the non-A, non-B hepatitis viruses. Hepatitis D virus, a defective virus requiring the “keeper function” of the hepatitis B virus, occurs either as a co-infection or super-infection in a HBsAg carrier.
Transmission of the virus occurs through percutaneous contact with contaminated blood, serum or plasma. Infection may also occur by the exposure of mucous surfaces, or intact or damaged skin to other body fluids such as saliva, mucosal secretions and semen.
There is no specific treatment for hepatitis. The incubation period may be as long as 6 months, followed by a very complex clinical course of an acute or chronic nature, often leading to hospitalization.
Viral hepatitis caused by hepatitis B virus is a major worldwide health problem, though the incidence and epidemiology vary widely among geographical areas and population subgroups.
In Canada, the United States and Northern Europe, 4% to 6% of the population are infected during their lifetime (mostly young adults); between 5% and 10% of infections lead to persistent viremia (carrier state). Certain population subgroups in these areas, however, are at high risk (see Indications and Clinical Use).
In Asia, infection often occurs early in life, leading to a hepatitis B marker prevalence of more than 70% in the general population and a carrier rate of up to 20%.
It is estimated that the reservoir of persistent hepatitis B surface antigen carriers amounts to 350 million people worldwide. Carriers are at a high risk of developing chronic liver disease which may lead to cirrhosis or primary hepatocellular carcinoma. A significant reduction in the incidence of hepatocellular carcinoma has been observed in children aged 6 to14 years following a nationwide hepatitis B vaccination in Taiwan. This resulted from a significant decline in the prevalence of hepatitis B antigen, the persistence of which is an essential factor in the development of hepatocellular carcinoma.
Vaccination against hepatitis B is expected in the long term to reduce the overall incidence of both hepatitis B and the chronic complications such as chronic active hepatitis and cirrhosis.
- Type
- Biotech
- Groups
- Approved, Withdrawn
- Biologic Classification
- Vaccines
Inactivated / Recombinant - Synonyms
- HBSAG
- Hepatitis B antigen
- Hepatitis B surface antigen
- Hepatitis B Surface Antigen (rDNA)
- Hepatitis B surface antigen (recombinant)
- Hepatitis B surface antigen vaccine
- Hepatitis B surface antigens
- Hepatitis B Vaccine
- Hepatitis B virus hbsag surface protein antigen
- Hepatitis-B surface antigen
Pharmacology
- Indication
Active immunization against hepatitis B virus infection.
The vaccine will not protect against infection caused by hepatitis A and non-A non-B hepatitis viruses. As hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection or carrier state, it can be expected that hepatitis D will also be prevented by vaccination with hepatitis B virus vaccine.
The vaccine can be administered at any age from birth onwards. It may be used to start a primary course of vaccination or as a booster dose. It may also be used to complete a primary course of vaccination started with plasma-derived or yeast-derived vaccines or as a booster dose in subjects who have previously received a primary course of vaccination with plasma-derived or yeast-derived vaccines.
In areas of low prevalence of hepatitis B, vaccination is strongly recommended in subjects who are at increased risk of infection. These include the following groups:
- Health professionals: physicians and surgeons; oral surgeons and dentists; nurses, dental nurses, dental hygienists, podiatrists; IV teams and operating room personnel; paramedical personnel in close contact with patients; staff in hemodialysis, nephrology, hepatology, hematology and oncology units; laboratory personnel handling blood and other clinical specimens; blood bank and plasma fractionation workers; pathologists and morgue attendants; cleaning staff who handle waste in hospitals; emergency and first aid workers; ambulance staff; dental, medical and nursing students.
- Patients: patients receiving frequent blood transfusion or clotting factor concentrates, such as those in oncology units and those with thalassemia, sickle-cell anemia, cirrhosis, hemophilia, etc.; patients on hemodialysis; patients with type 2 diabetes.
- Personnel and residents of institutions: persons with frequent and/or close contacts with high-risk groups; prisoners and prison staff; residents and staff of institutions for the developmentally challenged (those who are in contact with aggressive biting residents being at highest risk).
- Persons at increased risk due to their sexual practices: males having sexual contact with other males; others with multiple sexual partners or with a recent history of sexually transmitted disease.
- Persons who use injectable drugs illicitly.
- Travellers to areas of high endemicity and their close contacts.
- Household contacts of any of the above groups and of patients with acute or chronic hepatitis B infection.
- Infants born of HBsAg-positive mothers.
- Chronic Liver Disease (CLD): subjects with chronic liver disease; subjects at risk of developing CLD (e.g. Hepatitis C virus carriers, persons who abuse alcohol).
- Others: police; fire fighters; armed forces personnel; morticians and embalmers; those who through their work or personal lifestyle may be exposed to the hepatitis B virus.
- In areas of both low and high prevalence, vaccination should be offered to all young children and neonates at risk, as well as to adult high risk groups.
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- Contraindications & Blackbox Warnings
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- Pharmacodynamics
ENGERIX-B induces specific humoral antibodies against the surface antigen of hepatitis B virus (anti-HBs antibodies). An anti-HBs antibody titre above 10 IU/l correlates with protection to HBV infection.
- Mechanism of action
ENGERIX®-B induces specific humoral antibodies against HBsAg (anti-HBs antibodies). It is generally accepted that an anti-HBs titre greater than 10 IU/L correlates with protection against hepatitis B virus infection. More than 90% of healthy adults, children and neonates developed protective anti-HBs titres one month after completing a primary vaccination schedule of ENGERIX®-B (hepatitis B vaccine (recombinant)).
- Absorption
Vaccine is intended for intramuscular injection. Evaluation of pharmacokinetic properties is not required for vaccines.
- Volume of distribution
Evaluation of pharmacokinetic properties is not required for vaccines.
- Protein binding
Evaluation of pharmacokinetic properties is not required for vaccines.
- Metabolism
Evaluation of pharmacokinetic properties is not required for vaccines.
- Route of elimination
Evaluation of pharmacokinetic properties is not required for vaccines.
- Half-life
Evaluation of pharmacokinetic properties is not required for vaccines.
- Clearance
Evaluation of pharmacokinetic properties is not required for vaccines.
- Adverse Effects
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- Toxicity
Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
- 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 softwareAbatacept The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Abatacept. Adalimumab The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Adalimumab. Aldesleukin The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Aldesleukin. Alefacept The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Alefacept. Alemtuzumab The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Alemtuzumab. Altretamine The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Altretamine. Amsacrine The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Amsacrine. Anakinra The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Anakinra. Anifrolumab The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Anifrolumab. Antilymphocyte immunoglobulin (horse) The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Antilymphocyte immunoglobulin (horse). Identify potential medication risksEasily compare up to 40 drugs with our drug interaction checker.Get severity rating, description, and management advice.Learn more - Food Interactions
- 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.
- Product Ingredients
Ingredient UNII CAS InChI Key Hepatitis B virus subtype ADW HBSAG surface protein antigen XL4HLC6JH6 Not Available Not applicable Hepatitis B virus subtype ADW2 HBSAG surface protein antigen 9GCJ1L5D1P 351186-51-1 Not applicable - Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Engerix-B Suspension 10 mcg / 0.5 mL Intramuscular Glaxosmithkline Inc 2008-07-25 2020-04-01 Canada Engerix-B Injection, suspension 10 ug/0.5mL Intramuscular A-S Medication Solutions 2007-04-25 Not applicable US Engerix-B Injection, suspension 10 ug/0.5mL Intramuscular GlaxoSmithKline Biologicals SA 2007-04-25 Not applicable US Engerix-B Suspension 20 mcg / 1 mL Intramuscular Glaxosmithkline Inc 1991-12-31 2020-05-26 Canada Engerix-B Injection, suspension 20 ug/1mL Intramuscular A-S Medication Solutions 2007-03-28 Not applicable US Engerix-B Injection, suspension 20 ug/1mL Intramuscular Physicians Total Care, Inc. 2002-08-05 2012-06-30 US Engerix-B Suspension 20 mcg / 1 mL Intramuscular Glaxosmithkline Inc 2019-11-15 Not applicable Canada Engerix-B Injection, suspension 20 ug/1mL Intramuscular GlaxoSmithKline Biologicals SA 2007-03-28 Not applicable US Engerix-B Suspension 10 mcg / 0.5 mL Intramuscular Glaxosmithkline Inc 2019-10-07 Not applicable Canada Engerix-B Injection, suspension 20 ug/1mL Intramuscular Dispensing Solutions, Inc. 2009-05-28 Not applicable US - Mixture Products
- Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image EUVAX-B 0,5 ML FLAKON, 1 ADET Hepatitis B Vaccine (Recombinant) (20 μg/ml) Injection Intramuscular BERK İLAÇ İTHALAT VE PAZARLAMA A.Ş 2020-08-14 Not applicable Turkey EUVAX-B 1 ML FLAKON, 1 ADET Hepatitis B Vaccine (Recombinant) (20 μg/ml) Injection Intramuscular BERK İLAÇ İTHALAT VE PAZARLAMA A.Ş 2020-08-14 Not applicable Turkey
Categories
- ATC Codes
- J07CA08 — Haemophilus influenzae b and hepatitis b
- Drug Categories
- Actively Acquired Immunity
- Amino Acids, Peptides, and Proteins
- Antigens
- Antigens, Viral
- Antiinfectives for Systemic Use
- Bacterial and viral vaccines, combined
- Biological Factors
- Biological Products
- Cancer immunotherapy
- Complex Mixtures
- Hepatitis Antigens
- Hepatitis B Antigens
- Hepatitis B Surface Antigens
- Hepatitis B Surface Antigens, drug effects
- Hepatitis B Vaccines
- Immunotherapy
- Inactivated Hepatitis B Virus Vaccine
- Proteins
- Vaccines
- Viral Hepatitis Vaccines
- Viral Proteins
- Viral Vaccines
- Classification
- Not classified
- Affected organisms
- Hepatitis B virus
Chemical Identifiers
- UNII
- IFJ010MNE4
- CAS number
- Not Available
References
- General References
- External Links
- PubChem Substance
- 347911220
- 797752
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Hepatitis_B_vaccine
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Prevention Haemophilus Influenzae Type b (Hib) Infection 1 4 Active Not Recruiting Prevention Healthcare Worker, Hepatitis B Vaccine, Nonresponder 1 4 Completed Not Available Viral Hepatitis B 1 4 Completed Basic Science Immunization; Infection / Viral Hepatitis B 1 4 Completed Basic Science Viral Hepatitis B 1 4 Completed Health Services Research Healthy Subjects (HS) 1 4 Completed Prevention Acellular Pertussis / Diphtheria / Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines / Haemophilus Influenzae Serotype b (Hib) / Poliomyelitis / Tetanus / Viral Hepatitis B 1 4 Completed Prevention Acellular Pertussis / Diphtheria / Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines / Poliomyelitis / Tetanus 1 4 Completed Prevention Acellular Pertussis / Diphtheria / Poliomyelitis / Tetanus / Viral Hepatitis B 1 4 Completed Prevention Apnea / Apnoea neonatal / Infants, Premature 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, suspension 10 mcg/0.5ml Suspension Intramuscular 10.000 mcg Injection, suspension Intramuscular Injection, suspension Intramuscular 10 MICROGRAMMI Injection, suspension Intramuscular; Subcutaneous 10 mcg/0.5mL Injection, suspension Intramuscular; Subcutaneous 20 mcg/mL Injection Intramuscular 20 mcg/1ml Injection, suspension Intramuscular 10 ug/0.5mL Injection, suspension Intramuscular 20 ug/1mL Suspension Intramuscular 10 mcg / 0.5 mL Suspension Intramuscular 20 mcg / 1 mL Suspension Intramuscular 20 MCG Suspension Intramuscular Suspension Intramuscular 10 MCG/ML Injection, suspension Intramuscular 10 mcg/0.5ml Injection, suspension Parenteral Injection, suspension Intramuscular 20 mcg/ml Suspension Intramuscular 20 mcg/1ml Suspension Intramuscular 10 mcg/0.5ml Injection Intramuscular 10 mcg/0.5ml Suspension Intramuscular 20 cg Injection Intramuscular 20 μg/ml Injection Intramuscular 20 MCG/1.0ML Injection, suspension Intramuscular 20 mcg/0.5ml Suspension Intramuscular 20 µg Suspension Intramuscular 10 µg Injection, suspension Intramuscular 10 MCG/ML Injection, suspension Intramuscular 10 μg/ml Injection, suspension Intramuscular 40 MCG/ML Injection, suspension Intramuscular 40 μg/ml Injection, suspension Intramuscular 5 mcg/0.5mL Injection, suspension Intramuscular 5 μg/0.5ml Injection, suspension Intramuscular; Subcutaneous 10 mcg/mL Injection, suspension Intramuscular; Subcutaneous 5 mcg/0.5mL Suspension Intramuscular 10 µg/ml Injection Intramuscular 10 MCG/ML Injection Intramuscular 40 MCG/ML Injection Intramuscular 5 mcg/0.5ml Suspension Intramuscular 5 mcg/0.5ml Injection, solution Intramuscular 20 mcg Injection, solution Intramuscular 20 ug/0.5mL Injection, solution Intramuscular Injection Suspension Intramuscular Injection, powder, for suspension Intramuscular Injection Intramuscular Injection, suspension Intramuscular 10 ug/1mL Injection, suspension Intramuscular; Subcutaneous 10 ug/1mL Injection, suspension Intramuscular; Subcutaneous 40 ug/1mL Injection, suspension Intramuscular; Subcutaneous 5 ug/0.5mL Suspension Intramuscular 10 mcg / mL Suspension Intramuscular 40 mcg / mL Solution Intramuscular 40 mcg / mL Solution Intramuscular 10 mcg / mL Injection Intramuscular Injection; injection, suspension Intramuscular 20 mcg/mL Injection, suspension 10 mcg/1ml - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at October 17, 2016 21:25 / Updated at December 04, 2023 14:27