Vaccine, hepatitis B


Concise Prescribing Info
Indications/Uses
Active immunisation against hepatitis B.
Dosage/Direction for Use
Adult : IM Primary immunisation as recombinant hepatitis B surface antigen: 20 mcg for 3 doses given at 0, 1, and 6 months. Alternatively, or for patients known or presumed exposed to HBV: 20 mcg for 3 doses given at 0, 1, and 2 months followed by a booster at 12 months as accelerated dose schedule. Patient traveling to endemic areas: 20 mcg, given within 1 month prior to departure for 3 doses given at 0, 7, 21 days, followed by a booster at 12 months. As recombinant, adjuvanted hepatitis B surface antigen: 20 mcg for 4 doses given at 0, 1, 2, and 6 months. May be given via SC administration in patients with bleeding disorders.
Dosage Details
Intramuscular
Active immunisation against hepatitis B
Adult: Primary immunisation as recombinant hepatitis B surface antigen: 20 mcg for 3 doses given at 0, 1, and 6 months. Alternatively, or for patients known or presumed exposed to HBV: 20 mcg for 3 doses given at 0, 1, and 2 months followed by a booster at 12 months as accelerated dose schedule. Patient traveling to endemic areas: 20 mcg, given within 1 month prior to departure for 3 doses given at 0, 7, 21 days, followed by a booster at 12 months. As recombinant, adjuvanted hepatitis B surface antigen: 20 mcg for 4 doses given at 0, 1, 2, and 6 months. May be given via SC administration in patients with bleeding disorders.
Child: Primary immunisation as recombinant hepatitis B surface antigen: ≥16 years Same as adult dose. Patient born to HBV-carrier mother: In combination with hepatitis B immunoglobulin: 10 mcg given at 0, 1, 2 and 12 months with 1st dose at birth or within 24 hours of birth. Alternatively, 10 mcg given at 0, 1, 6 months. ≤15 years 10 mcg for 3 doses given at 0, 1, 6 months. Alternatively, 10 mcg for 3 doses given at 0, 1, 2 months followed by a booster at 12 months as accelerated schedule. As recombinant, adjuvanted hepatitis B surface antigen: ≥15 years: Same as adult dose. May be given via SC administration in patients with bleeding disorders.
Special Patient Group
Immunocompromised patients: Primary immunisation: Same as adult dose. Booster dose: 10 mcg every 6-12 months.
Renal Impairment
≥16 years 40 mcg for 3 doses given at 1, 2, and 4-6 months.
Contraindications
Hypersensitivity. Acute severe febrile illness.
Special Precautions
Patient with bleeding disorders including thrombocytopaenia, altered immunocompetence (e.g. patient receiving chemotherapy or immunosuppressants). Concomitant use with anticoagulant (e.g. warfarin). Renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Anaphylactoid reactions, syncope, bleeding/haematoma.
Cardiac disorders: Tachycardia.
Ear and labyrinth disorders: Vertigo, otalgia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, diarrhoea, dyspepsia.
General disorders and administration site conditions: Fatigue/malaise, inj site reaction (e.g. pain/swelling/redness/induration), fever.
Metabolism and nutrition disorders: Appetite loss.
Musculoskeletal and connective tissue disorders: Myalgia, tendinitis, neck stiffness, weakness, neck pain.
Nervous system disorders: Headache, drowsiness, dizziness.
Psychiatric disorders: Irritability.
Respiratory, thoracic and mediastinal disorder: Cough, pharyngitis, rhinitis, upper respiratory tract infection.
Skin and subcutaneous tissue disorders: Diaphoresis, pruritus, skin rash, urticaria.
Vascular disorders: Hypotension.
Patient Counseling Information
This drug may cause drowsiness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for anaphylaxis and syncope, 15 minutes after administration.
Drug Interactions
Diminished therapeutic effect with immunosuppressants. Risk of bleeding with anticoagulants.
Lab Interference
May interfere with Hepatitis B surface antigen detection test.
Action
Description: Hepatitis B vaccine is derived from recombinant or recombinant, adjuvanted hepatitis B surface antigen (HBsAg). It induces specific humoral antibodies against HBV.
Duration: Immunity: ≥30 years.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.
Disclaimer: This information is independently developed by MIMS based on Vaccine, hepatitis B 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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