Drugs List

Therapeutic Indications

Uses

Active immunisation against hepatitis B in dialysis/predialysis patients

Active immunisation against hepatitis B virus infection caused by all known subtypes in dialysis and predialysis patients.

It can be anticipated that hepatitis D infection will be prevented by immunisation with this vaccine as hepatitis D infection does not occur in the absence of hepatitis B infection.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Administration

To be given by intramuscular injection in the deltoid region.

Contraindications

Children under 15 years
Severe febrile conditions

Precautions and Warnings

Elderly
Immunosuppression
Obesity
Tobacco smoking
Breastfeeding
Immunodeficiency syndromes
Pregnancy

Consider administering other vaccines at least 2-3 weeks before/after dose
Postpone immunisation if there is active or suspected infection
Advise ability to drive/operate machinery may be affected by side effects
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
Different brands of this product are not interchangeable
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
May not be effective in patients incubating hepatitis
Follow national immunisation guidelines

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

The immune response to hepatitis B vaccine is related to 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.

Pregnancy and Lactation

Pregnancy

Use hepatitis B vaccine with caution in pregnancy.

There is limited clinical data on use of this product during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post natal development.
The Department of Health 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.

Schaefer (2007) concludes vaccination of pregnant mothers in hepatitis B high risk populations may provide adequate protection to the infant before the child is vaccinated. No negative effects are expected due to the non-infective nature of the vaccine. If possible, Schaefer (2007) suggests that the vaccine should be given after the twelve week of pregnancy.

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 to 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

Use hepatitis B vaccine with caution in breastfeeding.

Adequate human data on use during breastfeeding are not available. In a reproductive study in animals which included post-natal follow up until weaning, no effect on the development of the pups was observed. Vaccination should only be performed if the risk benefit ratio at individual level outweighs possible risks for the infant.

As the vaccine is inactivated, it is unlikely to produce any adverse effects on the nursing infant (Hale, 2014).

Schaefer (2007) concludes that hepatitis B vaccines are considered safe during breastfeeding.

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

Allergic reaction
Anaphylactoid reaction
Anaphylaxis
Asthenia
Back pain
Convulsions
Encephalitis
Encephalopathy
Fatigue
Fever
Gastro-intestinal disturbances
Guillain-Barre syndrome
Headache
Hot flushes
Injection site reactions
Local pain (injection site)
Maculopapular rash
Meningitis
Multiple sclerosis
Nervousness
Neuritis
Neuropathy
Optic neuritis
Paraesthesia
Paralysis
Rigors
Serum sickness-like reactions
Stinging, redness and swelling at injection site
Syncope
Tendinitis
Thirst
Tonic-clonic spasms
Vertigo
Viral infection
Visual disturbances

Presentation

Vaccine containing inactivated hepatitis B virus surface antigen (HBsAg).
These products have been produced by recombinant technology using Saccharomyces cerevisiae.

Drugs List

Therapeutic Indications

Uses

Active immunisation against hepatitis B in dialysis/predialysis patients

Active immunisation against hepatitis B virus infection caused by all known subtypes in dialysis and predialysis patients.

It can be anticipated that hepatitis D infection will be prevented by immunisation with this vaccine as hepatitis D infection does not occur in the absence of hepatitis B infection.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Dosage

Adults

Elderly

Adolescents

Administration

To be given by intramuscular injection in the deltoid region.

Contraindications

Children under 15 years
Severe febrile conditions

Precautions and Warnings

Elderly
Immunosuppression
Obesity
Tobacco smoking
Breastfeeding
Immunodeficiency syndromes
Pregnancy

Consider administering other vaccines at least 2-3 weeks before/after dose
Postpone immunisation if there is active or suspected infection
Advise ability to drive/operate machinery may be affected by side effects
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
Different brands of this product are not interchangeable
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
May not be effective in patients incubating hepatitis
Follow national immunisation guidelines

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

The immune response to hepatitis B vaccine is related to 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.

Pregnancy and Lactation

Pregnancy

Use hepatitis B vaccine with caution in pregnancy.

There is limited clinical data on use of this product during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post natal development.
The Department of Health 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.

Schaefer (2007) concludes vaccination of pregnant mothers in hepatitis B high risk populations may provide adequate protection to the infant before the child is vaccinated. No negative effects are expected due to the non-infective nature of the vaccine. If possible, Schaefer (2007) suggests that the vaccine should be given after the twelve week of pregnancy.

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 to 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

Use hepatitis B vaccine with caution in breastfeeding.

Adequate human data on use during breastfeeding are not available. In a reproductive study in animals which included post-natal follow up until weaning, no effect on the development of the pups was observed. Vaccination should only be performed if the risk benefit ratio at individual level outweighs possible risks for the infant.

As the vaccine is inactivated, it is unlikely to produce any adverse effects on the nursing infant (Hale, 2014).

Schaefer (2007) concludes that hepatitis B vaccines are considered safe during breastfeeding.

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

Allergic reaction
Anaphylactoid reaction
Anaphylaxis
Asthenia
Back pain
Convulsions
Encephalitis
Encephalopathy
Fatigue
Fever
Gastro-intestinal disturbances
Guillain-Barre syndrome
Headache
Hot flushes
Injection site reactions
Local pain (injection site)
Maculopapular rash
Meningitis
Multiple sclerosis
Nervousness
Neuritis
Neuropathy
Optic neuritis
Paraesthesia
Paralysis
Rigors
Serum sickness-like reactions
Stinging, redness and swelling at injection site
Syncope
Tendinitis
Thirst
Tonic-clonic spasms
Vertigo
Viral infection
Visual disturbances

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 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 24 August 2016.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Fendrix. GlaxoSmithKline UK. Revised November 2014.

Immunisation against infectious disease 'The Green Book' Department of Health.
Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last accessed: 07 September 2016