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Dosing and administration

BEXSERO offers flexible dosing options, allowing for integration into the routine vaccination schedule[1]

 

Dosing schedule

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 dose[1] a

 

CHILDREN AND ADOLESCENTS (2 YEARS AND OLDER)

Only BEXSERO offers a 2-dose vaccination series with 1-month interval between the first and second dose[1][2] b



BEXSERO offers flexible dosing options for the broadest population1

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

  • 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. Antipyreic 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 vaccines 1:

  • 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 3

Formulation1

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

  • Shelf life: 3 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

  • ADMINISTRATION

    Administration¹

    • 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

    Co-administration with BEXSERO

    BEXSERO can be co-administered with any of the following vaccine antigens, either as a monovalent or as combination vaccines¹:

    • 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 vaccines¹,³

  • FORMULATION

    Formulation¹

    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 STABILITY

    Storage and stability¹

    • Shelf life: 3 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

References

  1. Bexsero Prescribing Information GDS 10/ Date: 09 November 2018.
  2. Pfizer Ltd. Trumenba. Annex I; Summary of Product Characteristics. EMA; May 2018.
  3. 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.

 

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PM-SA-BEX-WCNT-200003 Date of preparation: September 2020