Bexsero (meningococcal group B vaccine, 4-component)

MenB-4C (Bexsero(R)) and MenB-FHbp (Trumenba(R)) are given in a series of either 2 or 3 doses. Each dose consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe containing the vaccine.

The choice of dosing schedule (i.e., number and timing of doses) may depend on the individual's risk of exposure and susceptibility to Neisseria meningitidis serogroup B.

The manufacturers state that data available to date are insufficient regarding the interchangeability of MenB-4C and MenB-FHbp to complete the vaccination series. The US Public Health Service Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) state that MenB-4C and MenB-FHbp are not interchangeable and recommend that the meningococcal group B (MenB) vaccine used for the initial dose should be used to complete the vaccination series, as well as for any booster doses.

Consult the US Centers for Disease Control and Prevention (CDC)/ACIP vaccination schedules for additional information, including specific detailed recommendations for specific scenarios and conditions.

Two meningococcal group B (MenB) vaccine are commercially available: MenB-4C (Bexsero(R)) and MenB-FHbp (Trumenba(R)).

MenB-4C and MenB-FHbp are administered only by IM injection.

The MenB vaccine may be given simultaneously with other age-appropriate vaccines. When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given with a different syringe and at different injection sites. Injection sites should be separated by at least 1 inch if possible.

To ensure delivery of vaccine into muscle, IM injections should be made at a 90degrees angle to the skin using a needle length appropriate for the individual's age and body mass, thickness of adipose tissue and muscle at the injection site, and injection technique.

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune response in vaccinees. All vaccines should be inspected upon delivery and monitored during storage to ensure that the appropriate temperature is maintained. In general, vaccines that have been mishandled or not stored at the recommended temperature should not be administered. If there are concerns about mishandling, the manufacturer or state or local immunization or health departments should be contacted for guidance on whether the vaccine is usable.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*MenB-4C (Bexsero(R)): Hypersensitivity, including severe allergic reactions, to any component of the vaccine or a previous dose of the vaccine.

*MenB-FHbp (Trumenba(R)): Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

MenB-4C: The most common adverse reactions (>=10%) are pain at the injection site, fatigue, headache, nausea, erythema, myalgia, and swelling.

MenB-FHbp: The most common adverse reactions in adolescents and young adults are pain at the injection site, fatigue, headache, and muscle pain.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

MenB-4C (Bexsero(R)): Safety and efficacy have not been established in pediatric children younger than 10 years of age.

MenB-FHbp (Trumenba(R)): Safety and efficacy have not been established in children younger than 10 years of age. In a clinical study in infants younger than 12 months of age+ who received a reduced dosage of MenB-FHbp, fever occurred in 90% of vaccinees. Clinical data strongly suggest that a 2-dose series of MenB-FHbp would not be effective in children 1 to <10 years of age.

The manufacturers state that there are no adequate and well-controlled studies using the MenB vaccine (MenB-4C, MenB-FHbp) in pregnant women; available human data on MenB-4C or MenB-FHbp administered to pregnant women are insufficient to inform vaccine-associated risks during pregnancy.

In a developmental toxicity study in female rabbits administered MenB-4C (0.5 mL dose at each occasion) prior to mating and during gestation, no adverse effects on fetal or pre-weaning development were observed due to the vaccine. Similarly, in two developmental toxicity studies in female rabbits administered MenB-FHbp (0.5 mL dose at each occasion) prior to mating and during gestation, no adverse effects on fetal or pre-weaning development were observed.

ACIP states that administration of MenB vaccine should be deferred in pregnant individuals, unless the individual is at increased risk for meningococcal serogroup B disease and benefits of vaccination outweigh potential risks.

It is not known whether the vaccine components of MenB-4C are distributed into human milk. Available data are insufficient to assess the effects of MenB-4C or MenB-FHbp on breast-fed infants or on milk production/excretion.

Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the MenB vaccine and any potential adverse effects on the breast-fed child from the vaccine or from susceptibility to meningococcal disease.

The manufacturers make no specific dosage recommendations for geriatric individuals.

MenB-4C and MenB-FHbp: Safety and efficacy have not been established in adults >65 years of age.