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Bexsero

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Dosing and administration

BEXSERO offers flexible dosing options, allowing for integration into the routine vaccination schedule1

 

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 dose1,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 dose1,2,b

dosing table dosing table

**2-5 Months: 1 dose between ages 12-15 months, ≥6 months post-primary series. In case of delay, the booster should not be given later than 24 months of age,†
6-11 Months: 1 dose in the second year of life, ≥2 months post-primary series†
12-23 Months: 1 dose between 12-23 months post-primary series†
2 Years Onwards: A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease, based on official recommendations
*First 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
†The need for, and timing of, further booster doses has not yet been determined
††No data are available in adults ≥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. Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age).

child_vaccination

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

mother_and_son

Formulation1

BEXSERO is available as a white opalescent liquid suspension for injection in a prefilled syringe and comes as a 0.5-ml dose.

Pack shot

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
packshot

  • ADMINISTRATION

    Administration¹

    doctors_hand_with_syringe_vaccinating_child
    • 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

    arabian_family_mother_and_son_sitting_on_the_couch_in_their_living_room

    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_pack_mockup

    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

    packshot
    • 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

Bexsero Safety Information1

Contraindications1 : 
Hypersensitivity to the active substances or to any of the excipients listed as below

Warning and precautions1: 
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

Adverse Events1 : 
Very Common : sleepiness, unusual crying, headache Uncommon: seizures (including febrile seizures)
Not known: hypotonic-hyporesponsive episode, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination. diarrhoea, vomiting

References

  1. Bexsero Prescribing Information.
  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.

 

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

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PM-RCH-BEX-WCNT-240001 Date of preparation: July 2024