Hepatitis B Vaccine (Recombinant)

Action and Spectrum

Actions and Spectrum 

The Hepatitis B Vaccine (Recombinant) works by triggering the immune system to produce protective antibodies against the Hepatitis B virus. The vaccine contains recombinant viral surface proteins, known as the hepatitis B surface antigen (HBsAg).

Drug Interaction

Adverse Reaction

Frequency not defined  

Drowsiness, fatigue  

Flushing, hypotension 

Body pain, chills  

Irritability, malaise 

Headache, insomnia  

Skin rash, urticaria 

Abdominal pain, anorexia 

Diarrhea, dyspepsia  

Paresthesia, tingling sensation, vertigo 

Decreased appetite 

Diaphoresis  

Nausea, stomach cramps 

Dysuria 

Rhinitis, upper respiratory tract infection 

Lymphadenopathy 

Angioedema 

Bruising at injection site 

Erythema at injection site  

Influenza 

Induration at injection site  

injection site nodule 

Neck pain, neck stiffness 

Arthralgia, back pain, myalgia 

Shoulder pain, weakness 

Cough, pharyngitis 

Post marketing report  

Anaphylactoid reaction 

Febrile seizures  

Abnormal hepatic function tests  

Herpes zoster 

Petechiae, purpura  

Arthritis  

Thrombocytopenia, tinnitus 

Transverse myelitis, uveitis 

Bell’s palsy, brain disease 

Agitation, alopecia 

Radiculopathy, seizure, serum sickness-like reaction 

Stevens-Johnson syndrome 

Anaphylaxis, apnea 

bronchospasm 

Syncope, systemic lupus erythematosus, tachycardia 

Vasculitis, visual disturbance 

Black Box Warning

Black Box Warning 

None

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• If a person has a severe allergic reaction to a previous dose of the Hepatitis B vaccine or any of its components should be contraindicated.  

Caution: 

• The Hepatitis B Vaccine (Recombinant) contains yeast-derived products. If an individual has a severe allergy to yeast, they should not receive the vaccine. 
• Individuals who have a history of Guillain-Barré Syndrome (GBS) should take caution.

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  

The vaccine is based on hepatitis B surface antigen (HBsAg) generated by yeast cells using recombinant DNA methods.  

The part of the hepatitis B gene that codes for HBsAg is cloned into yeast, which is then grown to create hepatitis B vaccine.  

Pharmacodynamics 

The differentiated plasma cells secrete large amounts of specific antibodies, known as anti-HBs antibodies.  

These antibodies are highly specific to the HBsAg present in the vaccine. They circulate in the bloodstream, providing humoral immunity against the Hepatitis B virus. 

Pharmacokinetics 

ADME is not fully understood

Adminstartion

Administration 

The Hepatitis B Vaccine (Recombinant) is administered through intramuscular injection.

Patient Information Leaflet

Patient information leaflet 

Generic Name: Hepatitis B Vaccine (Recombinant) 

Why do we use Hepatitis B Vaccine (Recombinant)? 

The essential use of the Hepatitis B Vaccine (Recombinant) is for the prevention of Hepatitis B virus (HBV) infection.   

The Hepatitis B vaccine is recommended for all infants shortly after birth, typically within the first 24 hours.   

Administering this vaccine at birth helps provide early protection for babies born to mothers who are Hepatitis B positive.