The first and only vaccine against Neisseria meningitidis serogroup B strains (MenB) indicated as early as 2 months of age.*
BEXSERO is indicated for active immunization of individuals from 2 months through 17 years old against invasive disease caused by Neisseria meningitidis serogroup B strains.1
As with any vaccine, BEXSERO may not protect all vaccine recipients. BEXSERO is not expected to provide protection against all circulating meningococcal serogroup B strains.
Consumers should consult and discuss the advantages and disadvantages of the product with their healthcare professional, to make sure that it is suitable for them.
* Comparative clinical significance is unknown.
Indications and clinical use:
BEXSERO is indicated for active immunization of individuals from 2 months through 17 years old against invasive disease caused by N. meningitidis serogroup B strains.
As the expression of antigens included in the vaccine is epidemiologically variable in circulating B strains, meningococci that express them at sufficient levels are predicted to be susceptible to killing by vaccine-elicited antibodies.
- BEXSERO should not be administered to individuals with hypersensitivity to this vaccine or to any ingredient in the formulation or components of the container closure.
Relevant warnings and precautions:
- The vaccine is not expected to provide protection against all circulating strains of meningococcal serogroup B strains
- Protection against invasive meningococcal disease caused by serogroups other than serogroup B should not be assumed
- As with any vaccine, BEXSERO may not fully protect all vaccine recipients
- As with any vaccine, anxiety-related reactions may occur
- Administration of BEXSERO should be postponed in subjects suffering from an acute severe febrile illness
- Temperature elevation may occur following vaccination of infants and children (less than 2 years of age). Antipyretic treatment can be initiated according to local treatment guidelines
- Availability of appropriate medical treatment and supervision in case of an anaphylactic event following administration of the vaccine
- Risk of apnea in premature infants; consider respiratory monitoring for 48-72 hours
- Caution in subjects with known hypersensitivity to latex
- Vaccine use in kanamycin-sensitive recipients has not been established
- Individuals with thrombocytopenia, hemophilia or any coagulation disorder that would contraindicate intramuscular injection
- Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic disorder, or other causes, have reduced antibody response to active immunisation. However, immunogenicity data are available in individuals with complement deficiencies, and in individuals with splenic dysfunction or asplenia
The most frequent local and systemic adverse reactions after vaccination with BEXSERO observed in clinical trials were:
Infants and children (less than 2 years of age):
- systemic reactions – change in eating habits, fever ≥38°C, irritability, unusual crying, sleepiness, vomiting, diarrhea, rash
Children (aged 2 years through 10 years):
- local reactions – pain, tenderness, erythema, induration, swelling
- systemic reactions – change in eating habits, sleepiness, diarrhea, irritability, unusual crying, arthralgia, vomiting, headache, rash, fever ≥38°C
Adolescents and adults (11 years or older):
- local reactions – pain, erythema, induration
- systemic reactions – malaise, headache, muscle and joint pain, nausea, myalgia
Recommended dose and dosage adjustment:
Infants aged 2 months through 5 months:
The recommended immunization series consists of four doses. The primary infant series consists of three doses, given at 2, 4 and 6 months of age, followed by a fourth dose (booster).
The primary series can also be given at 2, 3 and 4 months of age, but the immune response to the NHBA antigen is lower.
With both schedules, a fourth dose (booster) is required in the second year of life between 12 and 23 months of age. It is preferred this dose be given early in the second year of life, whenever possible.
Unvaccinated infants aged 6 months through 11 months:
The vaccination schedule consists of three doses, with an interval of at least 2 months between the first and second dose. A third dose is required in the second year of life with an interval of at least 2 months between the second and third dose. The need for further booster doses has not been established.
Unvaccinated children aged 12 months through 10 years:
The vaccination schedule consists of two doses, with an interval of at least 2 months between doses. The need for a booster dose after this vaccination schedule has not been established.
Individuals aged 11 years through 17 years:
The vaccination schedule consists of two doses, with an interval of at least 1 month between doses. The need for a subsequent dose after this vaccination schedule has not been established.
BEXSERO should be given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the non-dominant deltoid muscle region of the upper arm in older subjects.
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.
BEXSERO must not be mixed with other medicinal products.
For more information:
Please consult the Product Monograph at gsk.ca/bexsero/pm for important information relating to adverse reactions, post-market adverse drug reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling Medical Information at 1-800-387-7374.
To report an adverse event, please call 1-800-387-7374.