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INFANTS
Updated label introduces a 2-dose primary series starting at 2 months with a booster dose at 12-15 months, and with at least a 6-month interval between the primary series and booster dose1,2a
Dosing schedule
Bexsero offers flexible dosing options
aFirst dose should be given no earlier than 2 months of age. The safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established. No data are available.
bIn case of delay, the booster should not be given later than 24 months of age.
cThe need for, and timing of, further booster doses has not yet been determined.
dNo data are available for adults above 50 years of age.
Administration1,2
- Bexsero is given by deep intramuscular injection preferably in:
- The anterolateral aspect of the thigh in infants
- The deltoid muscle region of the upper arm in older patients
- Separate injection sites must be used if more than one vaccine is administered at the same time
- The vaccine must not be injected intravenously, subcutaneously, or intradermally and must not be mixed with other vaccines in the same syringe
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 of or closely after vaccination can reduce the incidence and intensity of postvaccination febrile reactions. Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age).
Co-administration with Bexsero
Bexsero can be co-administered with any of the following vaccine antigens, either as a monovalent or as combination vaccines1,2:
- Diphtheria
- Tetanus
- Acellular pertussis
- Haeomophilus influenzae type b
- Inactivated poliomyelitis
- Hepatitis B
- Heptavalent pneumococcal conjugate
- Measles
- Mumps
- Rubella
- Varicella
- Meningococcal groups A, C, W, Y conjugate
Clinical studies suggest there is no clinically relevant immunological interference when Bexsero is given concomitantly with routine infant vaccines1,2
Formulation1,2
Bexsero is available as a white opalescent liquid suspension for injection in a prefilled syringe and comes as a 0.5-ml dose.
Storage and stability1,2
- Shelf life: 4 years
- Store in a refrigerator (2°C-8°C)
- Do not freeze
- Store in the original package in order to protect from light
- Upon storage, a fine off-white deposit may be observed in the prefilled syringe containing the suspension
- Before use, the pre-filled syringe should be well shaken in order to form a homogeneous suspension
Prescribing information (Great Britain and Northern Ireland)
Summary of product characteristics and patient information leaflet (GB)
Summary of product characteristics and patient information leaflet (NI)
References:
- GSK. Bexsero (Great Britain) Summary of Product Characteristics (SPC)
- GSK. Bexsero (Northern Ireland) Summary of Product Characteristics (SPC)
- Gossger N, Snape MD, Yu LM, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573-582.
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
April 2022 I PM-GB-BEX-WCNT-200003 (V3.0)
