Hepatitis B Vaccine

Table of contents

  • Brand Names
  • Drug Combinations
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Drug Interactions
  • Dosage

Brand Names

Europe

Austria: Fendrix, HBvaxPRO; Belgium: Engerix-B, Fendrix, HBvaxPRO; Bulgaria: Engerix-B; Cyprus: Engerix-B; Czech Republic: Fendrix, HBvaxPRO; Denmark: Engerix-B; Estonia: Engerix-B, Fendrix, HBvaxPRO; Finland: Engerix-B; France: Engerix-B, HBvaxPRO; Germany: Engerix-B, Fendrix, HB-Vax, HBvaxPRO, HepB-RIX; Greece: Engerix-B, Fendrix, HBvaxPRO; Hungary: HBvaxPRO; Ireland: Engerix-B, Fendrix; Italy: Engerix-B, Fendrix, HBvaxPRO; Latvia: Fendrix, HBvaxPRO; Lithuania: Engerix-B; Malta: Engerix B; Netherlands: Engerix-B, Fendrix, HBvaxPRO; Poland: Engerix-B, Euvax B, Fendrix, H-B-Vax II, HBvaxPRO, Hepavax-Gene TF; Portugal: Engerix-B, Fendrix, HBvaxPRO; Romania: Engerix-B, Euvax B, Fendrix, HBvaxPRO, Hepavax-Gene TF; Slovakia: Engerix-B, Euvax B, Fendrix, HBvaxPRO; Spain: Engerix B, Fendrix, HbvaxPRO; Sweden: Engerix-B, Fendrix, HBvaxPRO; UK: Engerix-B, Fendrix, HBvaxPRO.

North America

Canada: Engerix-B, Recombivax HB; USA: Engerix-B, Recombivax HB.

Latin America

Argentina: AGB-AGB Pediátrico, Biovac HB, Engerix-B, HBvaxPRO, Hepativax, Supervax, Vacuna Antihepatitis B AGB; Brazil: Vacina contra Hepatite B, Vacina R-DNA contra Hepatite B; Mexico: Engerix-B, H-B-Vax II, Heberbiovac HB, Probivac-B.

Asia

Japan: Adsorbed hepatitis B vaccine, Bimmugen, Heptavax-II.

Drug combinations

Hepatitis B Vaccine and Haemophilus influenzae type b Conjugate Vaccine

Hepatitis B Vaccine and Hepatitis A Vaccine

Hepatitis B Vaccine, Bordetella pertussis, Diphtheria Toxoid, and Tetanus Toxoid

Hepatitis B Vaccine, Bordetella pertussis, Haemophilus influenzae type b, Diphtheria Toxoid, and Tetanus Toxoid

Hepatitis B Vaccine, Bordetella pertussis, Diphtheria Toxoid, Haemophilus influenzae type b, Poliovirus types I, II and III, and Tetanus Toxoid

Chemistry

Pharmacologic Category

Serums, Toxoids, and Vaccines; Vaccines. (ATC-Code: J07BC01).

Mechanism of action

Recombinant hepatitis B vaccine is a noninfectious subunit viral vaccine, which confers active immunity via formation of antihepatitis B antibodies.

Therapeutic use

Hepatitis B vaccine (recombinant) is used for primary immunization against hepatitis B virus (HBV) infection and to stimulate active immunity to HBV in risk of potential exposure to HBV or hepatitis B surface antigen-positive (HB~s~Ag-positive) materials (e.g. blood, plasma, serum).

Pregnancy and lactiation implications

Reproduction studies not conducted. There is no apparent risk to fetus when hepatitis B vaccine is administered during pregnancy. Use with caution during lactation.

Unlabeled use

Contraindications

Hypersensitivity to yeast, hepatitis B vaccine, or any component of the formulation.

Warnings and precautions

Anaphylactoid/hypersensitivity reactions. Use with caution in decreased cardiopulmonary function. Unrecognized hepatitis B infection may be present. Use with caution in multiple sclerosis. Use with caution in severely immunocompromised patients (e.g. patients receiving chemo/radiation therapy or other immunosuppressive therapy (including high-dose corticosteroids)). Patients >65 years may have lower response rates. Packaging may contain natural latex rubber.

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