Prescribing Information: English Spanish

Important Safety Information

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Get the facts about BEXSERO
INDICATION
INDICATION AND IMPORTANT SAFETY INFORMATION

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years.

IMPORTANT SAFETY INFORMATION
  • Do not administer BEXSERO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of BEXSERO or after a previous dose of BEXSERO
  • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following the administration of BEXSERO
  • The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • BEXSERO may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains
  • Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO
  • Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO
  • Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B even if they develop antibodies following vaccination with BEXSERO
  • The most commonly reported (≥10%) solicited adverse reactions in a Phase 3 clinical trial were pain at the injection site (87%-92%), fatigue (45%-49%), headache (37%-41%), nausea (11%-13%), erythema (10%-15%), myalgia (10%-14%), and swelling (10%-14%)

Please see full Prescribing Information for BEXSERO: English or Spanish.