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