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Brand Name :
Engerix-B, Recombivax HB
Synonyms :
Hepatitis B Vaccine (Recombinant)
Class :
Vaccine, Inactivated (Viral), Recombinant
Brand Name :
Engerix-B, Recombivax HB
Synonyms :
Hepatitis B Vaccine (Recombinant)
Class :
Vaccine, Inactivated (Viral), Recombinant
Dosage Forms & Strengths
Suspension
10 mcg/ml
20 mcg/ml
40 mcg/ml
Dosage Forms & Strengths
Suspension
5 mcg/0.5 ml
10 mcg/0.5 ml
Refer to adult dosing
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).
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
None
Contraindication/Caution:
Contraindication:
Caution:
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
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
Administration
The Hepatitis B Vaccine (Recombinant) is administered through intramuscular injection.
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.
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