Drugs List

Therapeutic Indications

Uses

Immunisation against hepatitis A and hepatitis B infections.

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/Publichealth/Healthprotection/Immunisation/Greenbook/index.htm

Administration

Handling

Before use, the vaccine should be well shaken to obtain a white, slightly opaque suspension.

Visually check for any foreign particulate matter and/or abnormal physical appearance prior to administration.

Any unused product or waste material should be disposed of in accordance with local requirements.

Incompatibilities

The vaccine should not be mixed in the same syringe with other vaccines or parenterally administered medicinal products.

Separate vaccines should be administered at different injection sites when given concurrently.

Precautions and Warnings

It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination. It is not known whether the vaccine will prevent hepatitis A and hepatitis B in such cases.

The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.

It is not recommended for post exposure prophylaxis (e.g. needle stick injury).

Postpone immunisation if there is active or suspected infection.

The vaccine has not been tested in patients with impaired immunity. In haemodialysis patients and persons with an impaired immune system, adequate anti-hepatitis A virus and anti-hepatitis B antibody titres may not be obtained after the primary immunisation course and such patients may therefore require additional doses of vaccine.

A number of factors have been observed to reduce the immune response to hepatitis B vaccines, which include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases. Serological testing should be considered for those subjects who may be at risk of not achieving seroprotection. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.

Appropriate medical treatment and supervision should always be available in case of a rare anaphylactic event following administration of the vaccine.

Intradermal injection and intramuscular administration into the gluteal muscle should be avoided as this may lead to a suboptimal response. In exceptional circumstances, the vaccine may be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders.

A protective immune response may not be elicited in all vaccinees.

Pregnancy - see Pregnancy section

Breastfeeding - see Lactation section

Obesity, defined as a BMI greater than 30kg per square meter, has been observed to reduce the immune response to hepatitis A vaccines.

Syncope can occur before or following vaccination, especially in adolescents as a psychogenic response to the needle injection. Ensure procedures are in place to avoid injury from faints.

Not all brands are licensed for all age groups.

Pregnancy and Lactation

Pregnancy

The Green Book recommends that hepatitis A and 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.

The effect of this vaccine on embryo-fetal, perinatal and post natal survival and development has been assessed in rats. This did not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal development, parturition or post natal development.

Harm to the human foetus is not anticipated with inactivated vaccines, and while it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the foetus, the effect of this vaccine has not been assessed and should be delayed until after delivery unless there is an urgent need to protect the mother.

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 A and hepatitis B vaccine should be given to breastfeeding mothers when there is a definite risk of infection.

UK product information notes the lack of controlled clinical studies on infants exposed to the vaccine via breast milk. However, together with the Green Book and Schaefer and co-workers, it agrees that the risks to the foetus are likely to be negligible because the vaccine is inactivated.

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

Side Effects

Local reaction at injection site
Fever
Headache
Malaise
Fatigue
Nausea
Vomiting
Influenza-like symptoms
Paraesthesia
Decreased appetite
Diarrhoea
Abdominal pain
Altered liver function tests
Rash
Urticaria
Syncope
Serum sickness-like reactions
Anaphylaxis
Allergic reaction
Dizziness
Pruritus
Vasculitis
Hypotension
Lymphadenopathy
Multiple sclerosis
Optic neuritis
Myelitis
Facial palsy
Guillain-Barre syndrome
Polyneuritis
Meningitis
Encephalitis
Encephalopathy
Convulsions
Thrombocytopenia
Thrombocytopenic purpura
Erythema multiforme
Drowsiness
Irritability
Myalgia
Arthralgia
Hypoaesthesia
Swelling (injection site)
Chills
Neuritis
Neuropathy
Paralysis
Angioneurotic oedema
Lichen planus
Arthritis
Muscle weakness
Local pain (injection site)
Upper respiratory tract infection
Gastro-intestinal symptoms
Anaphylactic reaction
Anaphylactoid reaction
Vasovagal syncope
Stinging (injection site)
Burning (injection site)
Haematoma (injection site)

Presentation

1ml dose contains 720 ELISA units of purified inactivated hepatitis A virus and 20 micrograms of recombinant purified hepatitis B surface antigen.

Drugs List

Therapeutic Indications

Uses

Immunisation against hepatitis A and hepatitis B infections.

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/Publichealth/Healthprotection/Immunisation/Greenbook/index.htm

Dosage

Adults

Elderly

Children

Additional Dosage Information

Administration

Handling

Before use, the vaccine should be well shaken to obtain a white, slightly opaque suspension.

Visually check for any foreign particulate matter and/or abnormal physical appearance prior to administration.

Any unused product or waste material should be disposed of in accordance with local requirements.

Incompatibilities

The vaccine should not be mixed in the same syringe with other vaccines or parenterally administered medicinal products.

Separate vaccines should be administered at different injection sites when given concurrently.

Precautions and Warnings

It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination. It is not known whether the vaccine will prevent hepatitis A and hepatitis B in such cases.

The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.

It is not recommended for post exposure prophylaxis (e.g. needle stick injury).

Postpone immunisation if there is active or suspected infection.

The vaccine has not been tested in patients with impaired immunity. In haemodialysis patients and persons with an impaired immune system, adequate anti-hepatitis A virus and anti-hepatitis B antibody titres may not be obtained after the primary immunisation course and such patients may therefore require additional doses of vaccine.

A number of factors have been observed to reduce the immune response to hepatitis B vaccines, which include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases. Serological testing should be considered for those subjects who may be at risk of not achieving seroprotection. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.

Appropriate medical treatment and supervision should always be available in case of a rare anaphylactic event following administration of the vaccine.

Intradermal injection and intramuscular administration into the gluteal muscle should be avoided as this may lead to a suboptimal response. In exceptional circumstances, the vaccine may be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders.

A protective immune response may not be elicited in all vaccinees.

Pregnancy - see Pregnancy section

Breastfeeding - see Lactation section

Obesity, defined as a BMI greater than 30kg per square meter, has been observed to reduce the immune response to hepatitis A vaccines.

Syncope can occur before or following vaccination, especially in adolescents as a psychogenic response to the needle injection. Ensure procedures are in place to avoid injury from faints.

Not all brands are licensed for all age groups.

Pregnancy and Lactation

Pregnancy

The Green Book recommends that hepatitis A and 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.

The effect of this vaccine on embryo-fetal, perinatal and post natal survival and development has been assessed in rats. This did not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal development, parturition or post natal development.

Harm to the human foetus is not anticipated with inactivated vaccines, and while it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the foetus, the effect of this vaccine has not been assessed and should be delayed until after delivery unless there is an urgent need to protect the mother.

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 A and hepatitis B vaccine should be given to breastfeeding mothers when there is a definite risk of infection.

UK product information notes the lack of controlled clinical studies on infants exposed to the vaccine via breast milk. However, together with the Green Book and Schaefer and co-workers, it agrees that the risks to the foetus are likely to be negligible because the vaccine is inactivated.

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

Local reaction at injection site
Fever
Headache
Malaise
Fatigue
Nausea
Vomiting
Influenza-like symptoms
Paraesthesia
Decreased appetite
Diarrhoea
Abdominal pain
Altered liver function tests
Rash
Urticaria
Syncope
Serum sickness-like reactions
Anaphylaxis
Allergic reaction
Dizziness
Pruritus
Vasculitis
Hypotension
Lymphadenopathy
Multiple sclerosis
Optic neuritis
Myelitis
Facial palsy
Guillain-Barre syndrome
Polyneuritis
Meningitis
Encephalitis
Encephalopathy
Convulsions
Thrombocytopenia
Thrombocytopenic purpura
Erythema multiforme
Drowsiness
Irritability
Myalgia
Arthralgia
Hypoaesthesia
Swelling (injection site)
Chills
Neuritis
Neuropathy
Paralysis
Angioneurotic oedema
Lichen planus
Arthritis
Muscle weakness
Local pain (injection site)
Upper respiratory tract infection
Gastro-intestinal symptoms
Anaphylactic reaction
Anaphylactoid reaction
Vasovagal syncope
Stinging (injection site)
Burning (injection site)
Haematoma (injection site)

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 ).

Further Information

Last Full Review Date: September 2012

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

BNF for Children (2012-2013) 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/category/the-green-book/

Summary of Product Characteristics: Ambirix suspension for injection. GlaxoSmithKline UK. Revised July 2012.

Summary of Product Characteristics: Twinrix Adult Vaccine, suspension for injection in pre-filled syringe. GlaxoSmithKline UK. Revised January 2012.