Hepatitis B vaccine


Generic Medicine Info
Indications and Dosage
Intramuscular
Active immunisation against hepatitis B
Adult: Primary immunisation: As recombinant HBsAg vaccine 18-19 years 10 mcg/0.5 mL for 3 doses given at 0, 1, and 6 months; ≥20 years 20 mcg/mL for 3 doses given at 0, 1, and 6 months. An accelerated immunisation schedule given at 0, 1, 2, and 12 months may be followed. As recombinant, adjuvanted HBsAg vaccine: 20 mcg/0.5 mL for 2 doses given at least 1 month apart. Dosage and vaccination schedule recommendations may vary according to individual products and between countries (refer to specific product or official country guidelines).
Child: Primary immunisation: As recombinant HBsAg vaccine: Infants Born to HBsAg-negative mothers: 10 mcg/0.5 mL given within 24 hours of birth for the 1st dose, then given at 1-2 months of age for the 2nd dose, and at 6-18 months of age for 3rd dose; if birthweight is <2 kg, give the initial dose at 30 days of chronological age or at hospital discharge (whichever is 1st). Born to HBsAg-positive mothers: 1st dose: 10 mcg/0.5 mL given within the 1st 12 hours of life (regardless of birth weight) and administered simultaneously with hepatitis B immunoglobulin at a separate inj site; 2nd dose: Birthweight <2 kg: 10 mcg/0.5 mL given at 1 month of age; ≥2 kg: 10 mcg/0.5 mL given at 1-2 months of age; 3rd dose: Birthweight <2 kg: 10 mcg/0.5 mL given at 2-3 months of age; ≥2 kg: 10 mcg/0.5 mL given at 6 months of age; 4th dose: Birthweight <2 kg: 10 mcg/0.5 mL given at least 6 months of age (24 weeks). Born to mothers with unknown HBsAg status: Follow the vaccination schedule of those born to HBsAg-positive mothers, then once maternal status is determined follow the applicable vaccination schedule. ≤17 years 10 mcg/0.5 mL for 3 doses given at 0, 1, and 6 months. An accelerated immunisation schedule given at 0, 1, 2, and 12 months may be followed. Dosage and vaccination schedule recommendations may vary according to individual products and between countries (refer to specific product or official country guidelines).
Neonate: Primary immunisation: As recombinant HBsAg vaccine: Born to HBsAg-negative mothers: Birthweight <2 kg: 10 mcg/0.5 mL given at 30 days of chronological age or at hospital discharge (whichever is 1st); ≥2 kg: 10 mcg/0.5 mL given within 24 hours of birth for the 1st dose. Born to HBsAg-positive mothers: 1st dose: 10 mcg/0.5 mL given within the 1st 12 hours of life (regardless of birth weight) and administered simultaneously with hepatitis B immunoglobulin at a separate inj site; 2nd dose: Birthweight <2 kg: 10 mcg/0.5 mL given at 1 month of age; ≥2 kg: 10 mcg/0.5 mL given at 1-2 months of age; 3rd dose: Birthweight <2 kg: 10 mcg/0.5 mL given at 2-3 months of age; ≥2 kg: 10 mcg/0.5 mL given at 6 months of age; 4th dose: Birthweight <2 kg: 10 mcg/0.5 mL given at least 6 months of age (24 weeks). Born to mothers with unknown HBsAg status: Follow the vaccination schedule of those born to HBsAg-positive mothers, then once maternal status is determined follow the applicable vaccination schedule. Dosage and vaccination schedule recommendations may vary according to individual products and between countries (refer to specific product or official country guidelines).
Renal Impairment
As recombinant HBsAg vaccine: Haemodialysis patient: 40 mcg/2 mL given at 0, 1, 2, and 6 months. Dosage and vaccination schedule recommendations may vary according to individual products and between countries (refer to specific product or official country guidelines).
Contraindications
Hypersensitivity.
Special Precautions
Patient with bleeding disorders (including thrombocytopenia), multiple sclerosis. Immunocompromised patients (e.g. patients receiving chemotherapy, radiation, or immunosuppressant therapy). This vaccine may be available in multiple formulations which may contain different HBsAg concentrations; certain formulations may be specifically used only for neonates, children, or adults, refer to specific product guidelines prior to administration. Defer vaccine administration in patients with moderate or severe acute illness (with or without fever). Renal impairment. Neonates, children, and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Shoulder injury (e.g. shoulder bursitis or tendinopathy) due to vaccine administration; syncope, bleeding or haematoma (in patients with bleeding disorders); exacerbation of multiple sclerosis, anaphylactoid and/or hypersensitivity reactions; apnoea (particularly in premature infants).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain.
General disorders and administration site conditions: Inj site pain, redness, swelling and induration; fever, malaise.
Metabolism and nutrition disorders: Appetite loss.
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Headache, drowsiness, dizziness.
Psychiatric disorders: Irritability, insomnia, nervousness.
Skin and subcutaneous tissue disorders: Rash.
Monitoring Parameters
Assess for signs of anaphylaxis and syncope for 15 minutes after administration. May consider monitoring of respiratory function for 48-72 hours after administration in preterm infants. Perform serologic testing for those patients who may be at risk of not achieving seroprotection after a complete course of the vaccine (refer to specific product or local country guidelines).
Drug Interactions
Diminished therapeutic effect with immunosuppressants. Increased risk of bleeding with anticoagulants.
Action
Description:
Mechanism of Action: Hepatitis B vaccine is a noninfectious viral vaccine which induces formation of anti-hepatitis B antibodies, leading to active immunity against hepatitis B virus (HBV) infection.
Storage
Store between 2-8°C. Do not freeze. Storage recommendations may vary according to individual products and between countries (refer to specific product or official country guidelines).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.
References
Anon. Hepatitis B Vaccine (Recombinant [Adjuvanted]). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/06/2023.

Anon. Hepatitis B Vaccine (Recombinant) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/06/2023.

Anon. Hepatitis B Vaccine (Recombinant). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/06/2023.

Anon. Hepatitis B Vaccine Recombinant. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/06/2023.

Buckingham R (ed). Hepatitis B Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2023.

Engerix B 20 mcg/1 mL Suspension for Injection (SmithKline Beecham Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2023.

Engerix-B Injection, Suspension (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/06/2023.

Euvax B Injection (Pharmaniaga Marketing Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/06/2023.

GlaxoSmithKline NZ Limited. Engerix-B 20 mcg/mL, Suspension for Injection; Engerix-B Paediatric 10 mcg/0.5 mL, Suspension for Injection data sheet 11 August 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 02/06/2023.

Hepatitis B Vaccine, Recombinant. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 04/08/2023.

Heplisav B 20 mcg Solution for Injection in Pre-filled Syringe (Dynavax GmbH). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2023.

Heplisav-B Injection, Solution (Dynavax Technologies Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/06/2023.

Joint Formulary Committee. Hepatitis B Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2023.

Disclaimer: This information is independently developed by MIMS based on Hepatitis B vaccine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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