Drugs List

Therapeutic Indications

Uses

Active immunisation against hepatitis B virus infection caused by all known subtypes in non-immune 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, their sexual partners and household contacts.
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, blood stained body fluids 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.
Staff and inmates of custodial institutions.
Travellers to areas where there is a high or intermediate 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 or intermediate prevalence of hepatitis B.
Foster carers.

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

For intramuscular administration.

The deltoid muscle is the preferred site for injection in adults, adolescents and older children, the buttock should not be used as a lower immune response may occur.

The anterolateral thigh is the preferred site for injection in neonates, infants and younger children.

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.

Visually check for any foreign particulate matter and discolouration 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.

Contraindications

Severe febrile infections.

Precautions and Warnings

Hepatitis B has a long incubation period and it is therefore possible for unrecognised infection to be present at the time of immunisation. The vaccine may not prevent hepatitis B infection in these cases.

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

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.

The immune response to hepatitis B vaccine has been seen to be reduced by a number of factors including: increasing age, male gender, obesity, smoking, administration route and some chronic underlying diseases. These patients may require serological testing as there is a risk that they will not achieve seroprotection following a complete vaccination course. Consideration should be given to the need for additional doses in these subjects.

Patients with HIV infection, chronic hepatic disease or hepatitis C carriers should not be precluded from hepatitis B vaccination. Vaccination may be advisable as hepatitis B infection can be severe in these patients. In HIV infected patients, patients with renal insufficiency including patients undergoing haemodialysis, and persons with an impaired immune response, adequate anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.

The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants born at 28 weeks gestation or below, and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

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.

Pregnancy - see Pregnancy section.

Breastfeeding - see Lactation 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 and Schaefer and co-workers, 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.

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

Thrombocytopenia
Anaphylaxis
Anaphylactoid reaction
Serum sickness
Lymphadenopathy
Dizziness
Headache
Paraesthesia
Paralysis
Neuropathy
Neuritis
Guillain-Barre syndrome
Optic neuritis
Multiple sclerosis
Encephalitis
Encephalopathy
Meningitis
Convulsions
Hypotension
Vasculitis
Nausea
Vomiting
Diarrhoea
Abdominal pain
Rash
Pruritus
Urticaria
Angioedema
Erythema multiforme
Arthralgia
Myalgia
Arthritis
Local pain (injection site)
Erythema at injection site
Induration (injection site)
Fatigue
Fever
Malaise
Influenza-like symptoms
Lichen planus
Drowsiness
Decreased appetite
Swelling (injection site)
Irritability
Hypoaesthesia
Apnoea
Muscle weakness

Presentation

Suspension for injection containing 10micrograms/0.5ml hepatitis B virus surface antigen adsorbed on aluminium hydroxide and produced using the yeast Saccharomyces cerevisiae and recombinant DNA technology.

Suspension for injection containing 20micrograms/ml hepatitis B virus surface antigen adsorbed on aluminium hydroxide and produced using the yeast Saccharomyces cerevisiae and recombinant DNA technology.

Drugs List

Therapeutic Indications

Uses

Active immunisation against hepatitis B virus infection caused by all known subtypes in non-immune 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, their sexual partners and household contacts.
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, blood stained body fluids 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.
Staff and inmates of custodial institutions.
Travellers to areas where there is a high or intermediate 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 or intermediate prevalence of hepatitis B.
Foster carers.

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

National / local immunisation guidelines should be followed.

Adults

Children

Adolescents

Neonates

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For intramuscular administration.

The deltoid muscle is the preferred site for injection in adults, adolescents and older children, the buttock should not be used as a lower immune response may occur.

The anterolateral thigh is the preferred site for injection in neonates, infants and younger children.

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.

Visually check for any foreign particulate matter and discolouration 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.

Contraindications

Severe febrile infections.

Precautions and Warnings

Hepatitis B has a long incubation period and it is therefore possible for unrecognised infection to be present at the time of immunisation. The vaccine may not prevent hepatitis B infection in these cases.

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

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.

The immune response to hepatitis B vaccine has been seen to be reduced by a number of factors including: increasing age, male gender, obesity, smoking, administration route and some chronic underlying diseases. These patients may require serological testing as there is a risk that they will not achieve seroprotection following a complete vaccination course. Consideration should be given to the need for additional doses in these subjects.

Patients with HIV infection, chronic hepatic disease or hepatitis C carriers should not be precluded from hepatitis B vaccination. Vaccination may be advisable as hepatitis B infection can be severe in these patients. In HIV infected patients, patients with renal insufficiency including patients undergoing haemodialysis, and persons with an impaired immune response, adequate anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.

The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants born at 28 weeks gestation or below, and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

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.

Pregnancy - see Pregnancy section.

Breastfeeding - see Lactation 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 and Schaefer and co-workers, 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.

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

Thrombocytopenia
Anaphylaxis
Anaphylactoid reaction
Serum sickness
Lymphadenopathy
Dizziness
Headache
Paraesthesia
Paralysis
Neuropathy
Neuritis
Guillain-Barre syndrome
Optic neuritis
Multiple sclerosis
Encephalitis
Encephalopathy
Meningitis
Convulsions
Hypotension
Vasculitis
Nausea
Vomiting
Diarrhoea
Abdominal pain
Rash
Pruritus
Urticaria
Angioedema
Erythema multiforme
Arthralgia
Myalgia
Arthritis
Local pain (injection site)
Erythema at injection site
Induration (injection site)
Fatigue
Fever
Malaise
Influenza-like symptoms
Lichen planus
Drowsiness
Decreased appetite
Swelling (injection site)
Irritability
Hypoaesthesia
Apnoea
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 (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: www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation?Greenbook/index

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Engerix B 20 microgram/1ml. GlaxoSmithKline UK. Revised January 2012.

Summary of Product Characteristics: Engerix B 20 micrograms/1ml suspension for injection in pre-filled syringe. GlaxoSmithKline UK. Revised January 2012.

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 B vaccine. Last revised: April 3, 2012.
Last accessed: September 7, 2012.