Special warnings and precautions for use¹

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 cold, 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 professional 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 or 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
• The tip cap of the syringe may contain natural rubber latex. Although the risk for developing allergic reactions is very small, healthcare professionals should consider the benefit-risk prior to administering this vaccine to subjects with known history of hypersensitivity to latex
• 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

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