Drugs List

Therapeutic Indications

Uses

Meningococcal meningitis group B - prophylaxis

Administration

To be given by deep intramuscular injection only, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older subjects.

Contraindications

Children under 2 months
Severe febrile conditions

Precautions and Warnings

Children under 2 years
Immunosuppression
Patients over 50 years
Premature infants
Breastfeeding
Coagulopathy
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia

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
May contain trace amounts of kanamycin
Presentation (e.g. syringe, needle cap) may contain a derivative of latex
Do not mix with other vaccines in the same syringe
Do not use if solution is discoloured or particulates are apparent
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Remain alert to possible coincidental meningitis
Risk of apnoea in premature infants - monitor respiration for 72 hours
Follow national immunisation guidelines
Advise parent of vaccination schedule and antipyretic measures

The vaccine will only confer protection against group B of Neisseria meningitidis. It will not protect against other groups of Neisseria meningitidis or other organisms that cause meningitis. Complete protection against meningococcal serogroup B infection cannot be guaranteed.

Pregnancy and Lactation

Pregnancy

Use meningococcal group B vaccine with caution during pregnancy.

The potential risk for pregnant women is unknown. Nevertheless, vaccination should not be delayed when there is a clear risk of exposure to meningococcal infection.

Animal studies in rabbits showed no evidence of maternal or foetal toxicity using 10 times the human dose equivalent based on body weight.

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 meningococcal group B vaccine with caution in breastfeeding.

Information on the safety of the vaccine to women and their children during breastfeeding is not available. The benefit to risk ratio must be examined before making the decision to immunise during breastfeeding.

No adverse reactions were seen in vaccinated maternal rabbits or in their offspring through day 29 of lactation.

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
Anaphylactic reaction
Arthralgia
Blistering
Crying
Diarrhoea
Disturbances of appetite
Eczema
Erythema at injection site
Headache
Hyperventilation
Hypotonic hyporesponsive episode
Induration (injection site)
Irritability
Kawasaki disease
Limb swelling
Local pain (injection site)
Malaise
Myalgia
Nausea
Nodules (injection site)
Pallor
Pyrexia
Rash
Seizures
Sleepiness
Swelling (injection site)
Syncope
Tenderness (injection site)
Urticaria
Vomiting

Presentation

Vaccine containing protein from Neisseria meningitidis group B

These products have been produced by recombinant technology using E.coli.

Drugs List

Therapeutic Indications

Uses

Meningococcal meningitis group B - prophylaxis

Dosage

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

Adults

Children

Administration

To be given by deep intramuscular injection only, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older subjects.

Contraindications

Children under 2 months
Severe febrile conditions

Precautions and Warnings

Children under 2 years
Immunosuppression
Patients over 50 years
Premature infants
Breastfeeding
Coagulopathy
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia

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
May contain trace amounts of kanamycin
Presentation (e.g. syringe, needle cap) may contain a derivative of latex
Do not mix with other vaccines in the same syringe
Do not use if solution is discoloured or particulates are apparent
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Remain alert to possible coincidental meningitis
Risk of apnoea in premature infants - monitor respiration for 72 hours
Follow national immunisation guidelines
Advise parent of vaccination schedule and antipyretic measures

The vaccine will only confer protection against group B of Neisseria meningitidis. It will not protect against other groups of Neisseria meningitidis or other organisms that cause meningitis. Complete protection against meningococcal serogroup B infection cannot be guaranteed.

Pregnancy and Lactation

Pregnancy

Use meningococcal group B vaccine with caution during pregnancy.

The potential risk for pregnant women is unknown. Nevertheless, vaccination should not be delayed when there is a clear risk of exposure to meningococcal infection.

Animal studies in rabbits showed no evidence of maternal or foetal toxicity using 10 times the human dose equivalent based on body weight.

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 meningococcal group B vaccine with caution in breastfeeding.

Information on the safety of the vaccine to women and their children during breastfeeding is not available. The benefit to risk ratio must be examined before making the decision to immunise during breastfeeding.

No adverse reactions were seen in vaccinated maternal rabbits or in their offspring through day 29 of lactation.

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
Anaphylactic reaction
Arthralgia
Blistering
Crying
Diarrhoea
Disturbances of appetite
Eczema
Erythema at injection site
Headache
Hyperventilation
Hypotonic hyporesponsive episode
Induration (injection site)
Irritability
Kawasaki disease
Limb swelling
Local pain (injection site)
Malaise
Myalgia
Nausea
Nodules (injection site)
Pallor
Pyrexia
Rash
Seizures
Sleepiness
Swelling (injection site)
Syncope
Tenderness (injection site)
Urticaria
Vomiting

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: July 2018

Reference Sources

Immunisation against infectious diseases: 'The Green Book', Department of Health.
Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last accessed: 06 June 2019

Summary of Product Characteristics: Bexsero. GlaxoSmithKline UK. Revised July 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 August 2020