BEXSERO

Indications and clinical use:

BEXSERO is indicated for active immunization of individuals from 2 months through 25 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.

Contraindications:

• 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
  
• Do not inject intravascularly, subcutaneously or intradermally
  
• As with any vaccine, anxiety-related reactions may occur
  
• Administration of BEXSERO should be postponed in subjects suffering from an acute severe febrile illness; however, the presence of a minor infection, such as a cold, should not be a reason to defer vaccination
  
• 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. Prophylactic administration of acetaminophen at the time of, and closely after vaccination, can reduce the incidence and intensity of post-vaccination febrile reactions in infants and children (less than 2 years of age)
  
• Availability of appropriate medical treatment and supervision in case of an anaphylactic event following administration of the vaccine
  
• Potential 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
  
• The vaccine should not be given to 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 immunization. However, immunogenicity data are available in individuals with complement deficiencies, and in individuals with splenic dysfunction or asplenia
• The potential risk for use in pregnant women is unknown. Vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection
  
• There is no data available for use in nursing women. The benefit-risk ratio must be examined prior to use
  
• Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis group B even following vaccination with BEXSERO
  
• The side effects of being administered BEXSERO may temporarily affect the ability to drive or use machines

Adverse events:

The most frequent local and systemic adverse reactions after vaccination with BEXSERO were:

Infants and children (less than 2 years of age):

• Tenderness
• Erythema
• Induration
• Fever
• Irritability
• Unusual crying
• Sleepiness

Adolescents and adults:

• Pain
  
• Erythema
• Induration
• Malaise
• Headache
• Myalgia

Recommended dose and dosage adjustment:

Infants aged 2 months through 5 months of age at the time of first dose:

The recommended immunization series consists of three or four doses, each of 0.5 mL. It consists of two or three primary doses. The interval between vaccinations should be at least 2 months if two primary doses are given or at least 1 month if three primary doses are given. A booster will be given in the second year of life with an interval of at least 6 months between the primary series and booster dose.*

Infants aged 6 months through 11 months of age at the time of first dose:

The vaccination schedule consists a total of three doses, each of 0.5 mL. It consists of two primary doses, given not less than 2 months between doses, followed by a booster in the second year of life with an interval of at least 2 months between the primary doses and the booster.*

Children aged 12 months through 23 months of age at the time of first dose:

The vaccination schedule consists of two primary doses, each of 0.5 mL, given not less than with 2 months between doses, followed by a booster given at an interval of 12 to 23 months between the primary series and booster.*

Children, adolescents and adults aged 2 years through 25 years of age at the time of first dose:

The vaccination schedule consists of two primary doses, each of 0.5 mL, given not less than 1 month between doses. A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease, based on guideline recommendations.

Administration:

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.

* The need for, and timing of further doses has not yet been determined.