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>39,000 PATIENTS
evaluated with Bexsero in clinical and postmarketing studies (from 2 months of age)1-3
Most common adverse reactions with Bexsero1,2 |
|
|---|---|
| Infants and children (less than 2 years of age) |
Tenderness and erythema at the injection site, fever, and irritability
|
| Adolescents and adults |
Pain at injection site, malaise, and headache |
aPneumococcal 7-valent conjugate vaccine, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis, and Haemophilus influenzae type b vaccine.
bSeparate injection sites must be used if more than one vaccine is administered at the same time.
Frequency of adverse reactions1,2
Up to 10 years of age
Allergic reactionsc
Hypotonic-hyporesponsive episode
Meningeal irritationd
Injection-site reactionse
Lymphadenopathy
11 years of age and older
Allergic reactionsc
Syncope or vasovagal responses to injection
Meningeal irritationd
Fever
Lymphadenopathy
Rash
Injection-site reactionse
(≥1/10,000 to <1/1,000)
Up to 10 years of age
Pallor after booster
Kawasaki syndrome
Urticaria
(≥1/1,000 to <1/100)
Up to 10 years of age
Seizures (including febrile seizures)
Pallor
Eczema
Fever (≥40°C)
Vomiting after booster
Rash after booster (children aged 12 to 23 months)
(≥1/100 to <1/10)
Up to 10 years of age
Rash (infants and children 2 to 10 years of age)
(≥1/10)
Up to 10 years of age
Eating disorders
Sleepiness
Unusual crying
Headache
Diarrhoea
Vomiting
Rash (children aged 12 to 23 months)
Arthralgia
Fever (≥38C)
Injection-site tendernessf, injection-site erythema, injection-site swelling, injection-site induration
Irritability
11 years of age and older
Headache
Nausea
Myalgia
Arthralgia
Injection-site paing, injection-site swelling, injection-site induration, injection-site erythema
Malaise
cIncluding anaphylactic reactions.
dSigns of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination. These symptoms have been of mild and transient nature.
eIncluding extensive swelling of the vaccinated limb, blisters at or around the injection site and injection-site nodule, which may persist for more than one month.
fIncluding severe injection-site tenderness defined as crying when injected limb is moved.
gIncluding severe injection-site pain defined as unable to perform normal daily activity.
Contraindications1,2
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the Bexsero summary of product characteristics (Great Britain and Northern Ireland).
Special warnings and precautions for use1,2
As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness.
However, the presence of a minor infection, such as colds, should not result in the deferral of vaccination.
- Do not inject intravascularly
- As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from fainting
- This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration
- As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients
- Bexsero is not expected to provide protection against all circulating meningococcal group B strains
- As with many vaccines, healthcare professionals should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age). Prophylactic administration of antipyretics at the time and closely after vaccination can reduce the incidence and intensity of post-vaccination febrile reactions. Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age)
- Individuals with impaired immune responsiveness, whether due to the use of immune-suppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation
- Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunctions
- Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group B, even if they develop antibodies following vaccination with Bexsero
- There are no data on the use of Bexsero in subjects above 50 years of age and limited data in patients with chronic medical conditions.
- 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 ≤28 weeks of gestation) 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
- Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture. If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose. The safe use of Bexsero in kanamycin-sensitive individuals has not been established
- This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’
- In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Pregnancy
- Insufficient clinical data on exposed pregnancies are available
- The potential risk for pregnant women is unknown. Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection
- There was no evidence of maternal or foetal toxicity, and no effects on pregnancy, maternal behaviour, female fertility, or postnatal development in a study in which female rabbits received Bexsero at approximately 10 times the human dose equivalent based on body weights
Breast-feeding & Lactation
- Information on the safety of the vaccine to women and their children during breast-feeding is not available. The benefit-risk ratio must be examined before making the decision to immunise during breast-feeding
- No adverse reactions were seen in vaccinated maternal rabbits or in their offspring through day 29 of lactation. Bexsero was immunogenic in maternal animals vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined
Fertility
- There are no data on fertility in humans. There were no effects on female fertility in animal studies
Effects on ability to drive and use machines
- Bexsero has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 of the SmPC “Undesirable effects” may temporarily affect the ability to drive or use machines
Prescribing information (Great Britain and Northern Ireland)
Summary of product characteristics and patient information leaflet (Great Britain)
Summary of product characteristics and patient information leaflet (Northern Ireland)
References:
- GSK. Bexsero (Great Britain) Summary of Product Characteristics (SPC)
- GSK. Bexsero (Northern Ireland) Summary of Product Characteristics (SPC)
- Watson PS, Turner DPJ. Clinical experience with the meningococcal B vaccine, Bexsero: prospects for reducing the burden of meningococcal serogroup B disease. Vaccine. 2016;34(7):875-880.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline 0800 221 441
August 2023 | PM-GB-BEX-WCNT-200004 (V5.0)
