@oxkcom Please review Bexsero Product information before prescribing. Full Product Information is available at ‘wun. gsk.com.au/bexsero or scan the QR code: sk Level 3498 Jotrsten St Abbotsforé ViC 3087 PO Box 18005 Metboume VIG 8003, AUSTRALIA January 20 2023 T +81 39413 7200 Bexsero Product Information Dosage Update ww au.gsk.com Dear Healthcare Professional, This letter is to inform you of recent changes to the dosage schedule for Bexsero [Multicomponent Meningococcal group B vaccine (recombinant, adsorbed)) Baxsero is indicated for active immunisation agsinst invasive meningococcal disease caused by Neisseria ‘meningitidis group B in individuals from 2 months of age and older. Please see below a summary of the changes and updated dosage schedule: + For children aged 12 to 23 months, a booster dose is now recommended 12 to 23 months post primary series! ‘+ For children 2 years of age and older, adolescents and adults, a booster dose should be considered in individuals at continued risk of exposure to meningococcal disease’, based on offical recommendations? fo Age atfst doe eo) ee Booster i i i i 1 dose 240 5 months" 2 doses 22months inthe second yeer off rom 12 months ‘of age ( 6 months post paimary series) 11 dose 8 to 11 months 2 doses B2months in the second year off rom 12 months ‘of age (22 montts post primary series) 1 dose. 120 28 months 2dosee 22 monthe (12 to 28 months post primery series) Children 22 years, adolescents and adults* 2doses 21 month [Need not established’ -Atemate schertule avaliable ~ refer to Product information,” ‘The safety and efficacy ofthe vaccine in infarts less than 8 weeks have rot been established. No data avaiable." ‘The safely ard eficacy ofthe vaccine in indvduals above 80 years of age have nt baen estabisnec “Abooster dose should be corsidered in ncivduals at continued ek of exposure fe anengocaccal disease, based on ofl recommendations? Noe: Each dove is 0.8m in a pre-fled syringe. Administered by deep Invarnuscutarinosion. Sexsero must not be jected intravenously, ‘subcutaneously orinvadermaly Bexsero is generally well tolerated. The most common adverse reactions observed in clinical trials were: + InInfants, Toddlers & Children (up to 10 years of age): eating disorders, sleopiness, unusual crying, headache, diarrhoea, vomiting, rash, fever (238°C), injection site reactions, initebility and arthralgia * * In Adolescents (from 11 years of age) & Adults: headache, nausea, injection site reactions, malaise, myalgia and arthralgia."For any further questions please reach out to your locall representative or contact GSK Medical Information on 4800 033 109, Yours Sincerely, Lauren Katos ‘Senior Vaccines Brand Manager, GSK Australia PBS Information: This producti listed on the National Immunisation Program (NIP) for Aboriginal and Torres Strait islander children aged <2 years and for people ofall ages with some medical risk conditions. Refer to NIP schedule or your State or Territory Health department, References: 1. Bexsero Approved PRODUCT INFORMATION 2. Australian Technical Advisory Group on Immunisation (ATAG!). Australian Immunisation Handbook, ‘Australian Government Department of Heaith and Aged Care, Canberra, 2022, immunisationhandbook health. gov.au For information on GSK Products or to report an adverse event involving a GSK Product, please contact GSK ‘Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd, ABN 47 100 162 481. Melbourne VIC. Trademarks are owned by or licensed to GSK group of companies. ©2023. NP-AU-BEX-LTR-230001. Date of approval: January 2023 Papen