INDICATION & IMPORTANT SAFETY INFO
INDICATION
INDICATION
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 FOR BEXSERO
- 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
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.
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 FOR BEXSERO
- 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
- 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
- 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.
