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Brand Name :
Heplisav-B
Synonyms :
Hepatitis B Vaccine (Recombinant [Adjuvanted])
Class :
Vaccine, Inactivated (Viral), Recombinant
Brand Name :
Heplisav-B
Synonyms :
Hepatitis B Vaccine (Recombinant [Adjuvanted])
Class :
Vaccine, Inactivated (Viral), Recombinant
Dosage Forms & Strengths
Solution
20 mcg/0.5 ml
Administer dose of 0.5 ml intramuscularly given as a series of two dose minimum one month interval between doses
Not advised
Refer to adult dosing
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.
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
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
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
Administration
The Hepatitis B Vaccine (Recombinant [Adjuvanted]) is typically administered as an intramuscular injection.
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.
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