Hepatitis B Vaccine (Recombinant [Adjuvanted])

Action and Spectrum

Actions and Spectrum 

The vaccine contains a synthetic version of the HBsAg protein. It is produced using recombinant DNA technology. This vaccine contains an adjuvant, which is a substance that enhances the immune response to the HBsAg. Adjuvants can stimulate a more robust and long-lasting immune reaction, leading to better protection.

Drug Interaction

Adverse Reaction

Frequency defined  

>10% 

Headache  

Fatigue  

Pain at injection site 

1-10% 

Malaise 

Erythema at injection site 

Swelling at injection site  

Myalgia  

Fever 

Post marketing Report   

Hypersensitivity reaction 

Dizziness  

Gastrointestinal signs and symptoms 

Anaphylaxis 

Paresthesia 

Black Box Warning

Black Box Warning 

None

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Individuals who have a known severe allergic reaction to a previous dose of the Hepatitis B vaccine or any of its components should be contraindicated.  

Caution: 

• Caution should be taken in individuals with bleeding disorders or those on anticoagulant medications.  
• Individuals who have a history of Guillain-Barré Syndrome (GBS) should take caution.  
• Individuals who have a severe allergic reaction to yeast should not receive take vaccine. 

Pregnancy / Lactation

Pregnancy consideration: 

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 

Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology  

A noninfectious viral vaccination, recombinant (adjuvanted) hepatitis B vaccine gives active immunity through the production of anti-hepatitis B antibodies. The vaccine contains a recombinant form of the Hepatitis B surface antigen (HBsAg). 

Pharmacodynamics 

This vaccine is adjuvanted hence, it contains an additional substance (adjuvant) designed to enhance the immune response.  

Adjuvants are included in vaccines to improve the body’s response to the antigen and promote a stronger, more robust, and longer-lasting immune reaction. 

Pharmacokinetics 

ADME not fully understood

Adminstartion

Administration 

The Hepatitis B Vaccine (Recombinant [Adjuvanted]) is typically administered as an intramuscular injection.

Patient Information Leaflet

Patient information leaflet 

Generic Name: Hepatitis B Vaccine (Recombinant [Adjuvanted]) 

Why do we use Hepatitis B Vaccine (Recombinant [Adjuvanted])? 

The Hepatitis B Vaccine (Recombinant [Adjuvanted]) is primarily used to prevent Hepatitis B infection, which is caused by the Hepatitis B virus (HBV). Catch-up vaccination is recommended for individuals who did not receive the Hepatitis B Vaccine during infancy or childhood.