Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 12 April 2018

Indication(s)

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 10 through 25 years of age. (1)

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed. (1)

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Advisory information

contraindications

Hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO. (4)

Special warnings and precautions

The tip caps of the pre-filled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. (5.3)

Adverse reactions

The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥ 28%), nausea (≥18%), and arthralgia (≥13%). (6.1)

Usage information

Dosing and administration

For intramuscular use only. (2)

Administer two doses (0.5 mL each) of BEXSERO at least 1 month apart. (2.1)

Use in special populations
• Pregnancy: BEXSERO should be used during pregnancy only if clearly needed. Pregnancy registry available for BEXSERO. Contact Novartis Vaccines and Diagnostics at 1-877-683-4732. (8.1)

More information

Category Value
Authorisation number BLA125546
Orphan designation No
Product NDC 46028-114
Date First Approved 23-01-2015
Marketing authorisation holder Novartis Vaccines and Diagnostics, Inc