SIDE EFFECTS

What are the possible side effects of BEXSERO?

Like any medication, BEXSERO can have side effects. BEXSERO has benefits and risks – ask your doctor if BEXSERO is right for you.

The most common side effects of BEXSERO are:

In babies and toddlers, the most common side effects are:³

Tenderness at the injection site
Loss of appetite
Painful joints
Headache
Irritability
Fever*

*Fever can be expected after any vaccination, but is more common with BEXSERO, particularly when BEXSERO is administered at the same time as other vaccines. The Immunisation Advisory Centre (IMAC) recommend the use of paracetamol with every dose of BEXSERO administered to children <2 years of age, regardless of the presence of fever.^5,13

In adolescents and adults, the most common side effects are:³

Pain at the injection site
Painful muscles and joints
Nausea
Headache

Your questions answered

Have more questions about BEXSERO? Find out the answers in our FAQs.

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What is BEXSERO?

Important safety information

What is BEXSERO & Safety Info

BEXSERO is a vaccine to prevent invasive disease caused by Neisseria meningitidis serogroup B.

BEXSERO is a vaccine to prevent invasive disease caused by Neisseria meningitidis serogroup B.

BEXSERO is a vaccine to prevent invasive disease caused by Neisseria meningitidis serogroup B.
BEXSERO is approved for vaccination of individuals from 2 months of age and older.³

Do not have BEXSERO if you are allergic (hypersensitive) to the active substances or any of the other ingredients in BEXSERO.
Please note that BEXSERO can only protect from meningococcal disease caused by Neisseria meningitidis group B.
BEXSERO is not expected to provide protection against all circulating meningococcal group B types.
There is an increased risk of fever in infants that receive BEXSERO. Paracetamol reduces the incidence and severity of fever and is recommended with every dose of BEXSERO in children under 2.3^3,5
The safety and efficacy of BEXSERO in adults above 50 years of age have not been established.³

Do not have BEXSERO if you are allergic (hypersensitive) to the active substances or any of the other ingredients in BEXSERO.
Please note that BEXSERO can only protect from meningococcal disease caused by Neisseria meningitidis group B.
BEXSERO is not expected to provide protection against all circulating meningococcal group B types.
There is an increased risk of fever in infants that receive BEXSERO. Paracetamol reduces the incidence and severity of fever and is recommended with every dose of BEXSERO in children under 2.^3,5
The safety and efficacy of BEXSERO in adults above 50 years of age have not been established.³

Important safety information

Do not have BEXSERO if you are allergic (hypersensitive) to the active substances or any of the other ingredients in BEXSERO.
Please note that BEXSERO can only protect from meningococcal disease caused by Neisseria meningitidis group B.
BEXSERO is not expected to provide protection against all circulating meningococcal group B types.
There is an increased risk of fever in infants that receive BEXSERO. Paracetamol reduces the incidence and severity of fever and is recommended with every dose of BEXSERO in children under 2.^3,5
The safety and efficacy of BEXSERO in adults above 50 years of age have not been established.³

References

Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367:397–403
World Health Organization. Meningococcal meningitis. September 28, 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/meningitis. Accessed January 2022.
GlaxoSmithKline NZ, BEXSERO Data Sheet 2021. Available at: https://medsafe.govt.nz/profs/Datasheet/b/bexseroinj.pdf. Accessed: January 2023
PHARMAC. Decision to widen access to the meningococcal B vaccine and secure supply of the shingles vaccine. 2022. Available at: https://pharmac.govt.nz/news-and-resources/consultations-and-decisions/2022-12-08-meningococcal-b-vaccine-notification/. Accessed: January 2023
Immunisation Advisory Centre (IMAC). Bexsero: A vaccine to protect against Meningococcal group B disease Fact Sheet. Available at: https://assets-global.website-files.com/637315ab5c5af16c7e809c42/637315ab5c5af12a1680a03f_NonprogrammeVaccineBexseroImac20210701%20V04.pdf. Accessed: January 2023
The Institute of Environmental Science and Research. Invasive Meningococcal Disease Monthly Report. November 2022. Available at: https://surv.esr.cri.nz/PDF_surveillance/MeningococcalDisease/2022/Meningococcal_disease_monthy_report_November2022.pdf. Accessed January 2023
Ministry of Health website. Meningococcal disease (including meningitis). Summary tab. Available at: https://www.health.govt.nz/your-health/conditions-and-treatments/diseasesand-illnesses/meningococcal-disease-including-meningitis. Accessed January 2023
Rosenstein NE, et al. Meningococcal disease. N Engl J Med 2001; 344(18):1378-88.
Vetter V, Baxter R, Denizer G, et al. Routinely vaccinating adolescents against meningococcus: targeting transmission and disease. Expert Rev Vaccines. 15;5:641-658. doi:10.1586/14760584.2016.1130628
Mayo Clinic. Symptoms and causes: meningitis. Available at: https://www.mayoclinic.org/diseases-conditions/meningitis/symptoms-causes/syc-20350508. Accessed: January 2023
Pelton SI. Meningococcal disease awareness: clinical and epidemiological factors affecting prevention and management in adolescents. J Adol Health. 2010;46:S9-S15. doi:10.1016/j.jadohealth.2009.11.220
Ministry of Health. Meningococcal Disease - Don’t Wait, Take Action. Available at: https://healthed.govt.nz/products/meningococcal-disease-dont-wait-take-action. Accessed: January 2023
Ministry of Health. Immunisation Handbook 2020. Meningococcal disease. Available at: https://www.health.govt.nz/our-work/immunisation-handbook-2020/13-meningococcaldisease. Accessed: January 2023
GlaxoSmithKline NZ. BEXSERO Consumer Medicine Information 2021. Available at: https://medsafe.govt.nz/Consumers/CMI/b/bexsero.pdf. Accessed: January 2023

BEXSERO (Multicomponent meningococcal group B vaccine) is for immunisation against invasive disease caused by N. meningitidis group B from 2 months of age or as per official recommendations. BEXSERO is a prescription medicine. It is funded as part of the National Immunisation Schedule for infants and children under 5, people aged 13-25 years in close-living situations, and for people who are close contacts of a meningococcal case, or who are at high risk due to reduced immune function. See Pharmaceutical Schedule for full funding criteria. BEXSERO is also available for private purchase – you will need to pay the full cost of this medicine. Normal doctor’s charges apply. A 0.5 mL dose contains 50 mcg of Neisseria meningitidis Group B Neisseria Heparin Binding Antigen fusion protein, 50 mcg of Neisseria meningitidis Group B Neisseria Adhesin A protein, 50 mcg of Neisseria meningitidis Group B Factor H Binding Protein fusion protein, 25 mcg of Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4. BEXSERO has risks and benefits. Ask your doctor if BEXSERO is right for you. Use strictly as directed. BEXSERO should not be administered if you or your child are hypersensitive to any component of this vaccine. Very common side effects: Infants, toddlers & children: eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, fever (≥38°C), injection site reactions, irritability, arthralgia. Use paracetamol to prevent and reduce the risk of fever in children under the age of 2. Adolescents & Adults: headache, nausea, injection site reactions, malaise, myalgia, arthralgia. If you or your child have side effects, see your doctor. Additional product information and Consumer Medicine Information (CMI) is available at www.medsafe.govt.nz. Trademarks are owned by or licensed to the GSK group of companies. ©2023 GSK group of companies or its licensor. Marketed by GlaxoSmithKline NZ Ltd, Auckland. Adverse events involving GlaxoSmithKline products should be reported to GSK Medical Information on 0800 808 500.

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©2023 GSK Group of companies or its licensor. All Rights Reserved. Registered office: Level 2, Generator @GridAKL, 12 Madden Street, Auckland 1010, New Zealand. For information regarding GSK products or to report an adverse event, please call Medical Information on 0800 808 500. This site is intended for NZ audience only.

TAPS NP18971-PM-NZ-BEX-WCNT-230006 Date of Approval: 02 2023 Date of Expiry 02 2025