Arexvy (Respiratory Syncytial Virus Vaccine, recombinant, adjuvanted)

Indication

AREXVY is indicated for active immunisation for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults >60 years of age and in adults 50-59 years of age who are at increased risk of RSV disease.¹

Efficacy and safety

AREXVY has efficacy and safety data over 30 months in adults aged >60 years.²⁻⁴
(Median follow-up of 30.6 months, or over three RSV seasons).⁴

In the solicited safety population† within 4 days of vaccination, pain was the most common solicited injection-site reaction (AREXVY 60.9% vs. placebo 9.3%) and fatigue was the most common solicited systemic reaction (AREXVY 33.6% vs. placebo 16.1%).¹ ²

The frequency of serious adverse events and potential immune-mediated diseases remained low and balanced across groups through the study.⁴ ⁵

Dosing and administration

AREXVY is administered as a single, reconstituted dose of 0.5 mL by intramuscular injection. The need for revaccination has not been established.¹

Storage: AREXVY should be refrigerated. DO NOT FREEZE (discard if frozen).¹

• Store in the original package to protect vials from light.
• Store between 2°C and 8°C before reconstitution.
• After reconstitution, store between 2°C and 8°C or at room temperature up to 25°C for up to 4 hours prior to use.
• Discard reconstituted vaccine if not used within 4 hours.

Co-administration

AREXVY and any influenza vaccine can be administered in the same visit.¹ (Standard dose unadjuvanted, standard dose adjuvanted or high dose unadjuvanted).¹

Data are currently not available for concomitant administration with other vaccines. If AREXVY is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.¹

*Solicited reactions were those for which reports were solicited through 4 days after injection in the solicited safety population (participants in the reactogenicity-immunogenicity cohort who had solicited safety data available, AREXVY n=879; placebo n=878).²

References:

1. AREXVY Product Information
2. Papi A et al. N Engl J Med 2023;388(7):595–608.
3. Ison MG et al. Clin Infect Dis 2024;78(6):1732–44.
4. Ison MG et al. Lancet Respir Med 2025;doi.org/10.1016/S2213-2600(25)00048-7.
5. Ison MG et al. The efficacy of a single dose of the respiratory syncytial virus prefusion F protein vaccine in adults ≥60 years of age over 3 RSV seasons. Poster 3391 presented at: CHEST 2024; 2024 Oct 6-9; Boston, USA.

Please review Product Information before prescribing. Product Information can be accessed at www.gsk.com.au/arexvy

▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

PBS Information: AREXVY is not listed on the PBS or the National Immunisation Program (NIP).

For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. Trade marks are owned by or licensed to the GSK group of companies. ©2025 GSK group of companies or its licensor.

GlaxoSmithKline Australia Pty Ltd ABN 47 100 162 481, Melbourne, VIC

PM-AU-RSA-WCNT-250029 Date of approval: May 2025