Hepatitis b vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Suspension for injection containing 5micrograms/0.5ml hepatitis B virus surface antigen, recombinant (HBsAg), adsorbed on amorphous aluminium hydroxyphosphate sulfate.
Suspension for injection containing 10micrograms/ml hepatitis B virus surface antigen, recombinant (HBsAg), adsorbed on amorphous aluminium hydroxyphosphate sulfate.
HBsAg is produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3).
Drugs List
Therapeutic Indications
Uses
Active immunisation against hepatitis B virus infection caused by all known subtypes in individuals considered at risk of exposure to the hepatitis B virus.
It can be anticipated that hepatitis D infection will be prevented by immunisation with this vaccine as hepatitis D infection only occurs in the presence of hepatitis B infection.
At risk individuals who require immunisation are determined on the basis of official recommendations.
The following populations are considered to be at risk:
Parenteral drug abusers
Individuals who frequently change sexual partners
Close family contacts of a case or carrier
Infants born to mothers who had hepatitis B during pregnancy
Infants born to mothers who are positive for the hepatitis B surface antigen, with/without hepatitis B e-antigen
Individuals with haemophilia, those receiving regular blood transfusions or blood products, and carers responsible for administering these products
Individuals with chronic renal failure, including those on haemodialysis, and carers for these patients who are negative for the hepatitis B surface antigen
Individuals with chronic liver disease
Healthcare personnel, including trainees, who have direct contact with blood and tissues
Individuals with an occupational risk, such as morticians and embalmers
Staff and patients of day care or residential accommodation for patients with severe learning difficulties
Inmates of custodial institutions
Travellers to areas where there is a high prevalence of hepatitis B, who have an increased risk of developing the disease, or who plan to remain in the area for lengthy periods
Families adopting children from countries where there is a high prevalence of hepatitis B.
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
https://www.dh.gov.uk/en/Policyandguidance/Healthandsocialcaretopics/Greenbook/index.htm
Dosage
A course of vaccination should include at least three doses to ensure maximum protection.
Local immunisation guidelines should be followed.
Not all brands are licensed for all age groups.
The basic immunisation schedule
Immunisation at 0, 1 and 6 months.
This regimen produces a higher antibody level against hepatitis B virus surface antigen (anti-HBs) antibody titres but may take longer than other schedules to confer protection.
The accelerated immunisation schedule
Immunisation at 0, 1 and 2 months. A fourth dose should be administered at 12 months.
This regimen may confer protection more quickly and is expected to provide better patient compliance.
In infants this allows for simultaneous administration with other childhood vaccines.
Adults
Children
16 years and over
10micrograms (1ml) constitutes one dose
15 years and under, including neonates
5micrograms (0.5ml) constitutes one dose
Infants receiving the compressed regimen (0, 1, 2 months) dosing schedules must receive the 12 month booster to induce higher antibody titres.
Additional Dosage Information
In unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedules. The accelerated schedules including the 12 month booster dose can be proposed.
This vaccine may be used to complete a primary immunisation course or as a booster dose in individuals who have previously received a different hepatitis vaccine.
This vaccine can be administered with hepatitis B immunoglobulin or concomitantly with other vaccines, using separate injection sites and syringes. However, concomitant administration of pneumococcal conjugate vaccine (Prevenar) with hepatitis B vaccine has not been sufficiently studied.
Booster Doses
The need for booster doses in healthy individuals who have received a primary vaccination course is not yet defined. However, some local vaccination schedules currently include recommendations for periodic booster doses and these guidelines should be followed.
Immunocompromised individuals (e.g. patients receiving haemodialysis or transplant patients)
In individuals with an impaired immune system, additional doses of the vaccine may be considered if the antibody level against hepatitis B virus surface antigen is less than 10 iu/litre.
Revaccination of non-responders
When persons who do not respond to the primary vaccine series are revaccinated, 15 to 25% produce an adequate antibody response after one additional dose and 30 to 50% after three additional doses. However, because data are insufficient concerning the safety of hepatitis B vaccine when additional doses in excess of the recommended series are administered, revaccination following completion of the primary series is not routinely recommended. Revaccination should only be considered for high-risk individuals, after weighing the benefits of vaccination against the potential risk of experiencing increased local or systemic adverse reactions.
Recommendations for known or presumed exposure to hepatitis B virus (e.g. needle-stick with contaminated needle)
Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
The first dose of the vaccine should be initiated within 7 days of exposure and can be given simultaneously with hepatitis B immunoglobulin, although different injection sites should be used.
Subsequent doses should be given (if indicated by the serological status of the patient) according to the recommended immunisation schedule. The accelerated schedule may be proposed.
Special dosage recommendations for neonates born of mothers who are hepatitis B virus carriers
Hepatitis B immunoglobulin should be given within 24 hours of birth.
The first dose of the vaccine should be given within 7 days of birth and can be given simultaneously with hepatitis B immunoglobulin, although different injection sites should be used. Three additional doses are then required, these should be given at 1, 2 and 12 months.
Administration
For intramuscular administration.
The deltoid muscle is the preferred site for injection in adults, adolescents and children.
The anterolateral thigh is the preferred site for injection in neonates and infants.
In patients with thrombocytopenia or bleeding disorders the vaccine may be given subcutaneously.
Handling
Before use, the vaccine should be well shaken to obtain a white, slightly opaque suspension.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Precautions and Warnings
Not all brands are licensed for all age groups.
Use with caution in the following situations:
Premature infants born before the 28th week: Risk of apnoea. Monitor respiration for up to 72 hours after each injection of the primary immunisation series. Monitoring is particularly important for infants with respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Pregnancy - see Pregnancy section.
Breastfeeding - see Lactation section.
Hepatitis B has a long incubation period. It is therefore possible for unrecognised hepatitis B infection to be present at the time of immunisation. This vaccine may not prevent hepatitis B infection in such cases.
Infection caused by hepatitis A, hepatitis C, hepatitis E and other pathogens affecting the liver, will not be prevented by this vaccine. It can be anticipated that hepatitis D infection will be prevented by immunisation with this vaccine as hepatitis D infection only occurs in the presence of hepatitis B infection.
Appropriate medical facilities should be readily available in the case of an anaphylactic reaction to the vaccine.
Sensitisation reactions may occur due to the potential traces of formaldehyde and potassium thiocyanate in the vaccine. These substances are used during the manufacturing process.
Use caution when vaccinating latex-sensitive individuals since the syringe plunger stopper and tip cap contains dry natural latex rubber that may cause allergic reactions.
Note that response to the vaccine may be reduced in the following populations: males, elderly, obese, smokers and those suffering with chronic, underlying diseases. The serological status of these patients should therefore be monitored. This patient population may require additional doses of vaccine, but see the caveats under Revaccination of non-responders in the Dosage section.
Pregnancy and Lactation
Pregnancy
The Green Book recommends that hepatitis B vaccine should be given in pregnancy where there is a definite risk of infection, particularly if the pregnant woman is in a high-risk category.
UK licensed product information stresses that the effects of the hepatitis B vaccine on foetal development have not been assessed. However, together with the Green Book (2006), Schaefer (2007) and Briggs (2011) , it agrees that the risks to the foetus are likely to be negligible because the vaccine is inactivated.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
The Green Book recommends that hepatitis B vaccine should be given to breastfeeding mothers when there is a definite risk of infection. Hale (2010) also states no data are available on the use of hepatitis B vaccine in breastfeeding women, but it is unlikely to produce untoward effects on a breastfeeding infant.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Effects on Ability to Drive and Operate Machinery
None known.
Side Effects
Thrombocytopenia
Lymphadenopathy
Serum sickness
Anaphylaxis
Paraesthesia
Paralysis
Bell's palsy
Neuropathy
Neuritis
Guillain-Barre syndrome
Optic neuritis
Transverse myelitis
Encephalitis
Multiple sclerosis
Convulsions
Headache
Dizziness
Syncope
Hypotension
Vasculitis
Bronchospasm
Vomiting
Nausea
Diarrhoea
Abdominal pain
Rash
Pruritus
Urticaria
Erythema multiforme
Angioedema
Arthralgia
Arthritis
Myalgia
Local pain (injection site)
Erythema at injection site
Induration (injection site)
Fatigue
Fever
Malaise
Influenza-like symptoms
Uveitis
Polyarteritis nodosa
CNS demyelinating event
Alopecia
Eczema
Elevation of liver enzymes
Apnoea
Myelitis
Painful extremities
Encephalopathy
Meningitis
Lichen planus
Drowsiness
Decreased appetite
Irritability
Hypoaesthesia
Muscle weakness
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Reference Sources
British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.
BNF for Children (2011-2012) Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Immunisation against infectious disease (The Green Book) November 2006.
Available at: https://immunisation.dh.gov.uk/gb-individual-current-chapters/
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: HBVAXPRO 5mcg. Sanofi Pasteur MSD. Revised August 2011.
Summary of Product Characteristics: HBVAXPRO 10mcg. Sanofi Pasteur MSD. Revised August 2011.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Hepatitis A vaccine. Last revised: April 3, 2012
Last accessed: June 20, 2012.
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