RSV
PROTECTION
STARTS HERE *
* AREXVY is indicated for active immunisation of individuals 60 years and older for the prevention of lower respiratory tract disease caused by respiratory syncytial virus ( RSV ). Vaccines may not protect all recipients . 1
EFFICACY
HIGH EFFICACY AGAINST RSV-LRTD FOR YOUR PATIENTS AGED 60 YEARS AND OLDER . † 1 , 2
OVERALL EFFICACY AGAINST RSV-LRTD . 1 , 2 PRIMARY ENDPOINT , VS . PLACEBO ‡
82.6 %
‡
( 96.95 % CI 57.9 , 94.1 ). PRIMARY OBJECTIVE MET : LOWER CI LIMIT > 20 %. § 2
RSV-LRTD events : AREXVY 7 / 12,466 ; placebo 40 / 12,494 . 2
INDICATED EFFICACY AGAINST RSV-LRTD IN PATIENTS WITH ≥1 COEXISTING CONDITION OF INTEREST . 1 , 2
SECONDARY DESCRIPTIVE ENDPOINT , VS . PLACEBO ‖
SAFETY
AREXVY has an acceptable safety profile . 2
Very common adverse events ( ≥10 %) are headache , myalgia , arthralgia , injection site pain and fatigue . Common adverse events ( ≥1 %) are injection site erythema , injection site swelling , fever , chills and rhinorrhoea ( not a complete list ; see full PI ). 1
94.6 %
‖
( 95 % CI , 65.9 , 99.9 ); NO ADJUSTMENT FOR MULTIPLICITY , P VALUE NOT REPORTED . ¶ 2
At baseline , 39 % of participants had coexisting conditions of interest : COPD , asthma , any chronic respiratory or pulmonary disease , chronic heart failure , diabetes mellitus type 1 or type 2 , advanced liver or renal disease . 2
RSV-LRTD events : AREXVY 1 / 4,937 ; placebo 18 / 4,861 . 2
SCAN QR CODE to see full AREXVY Product Information
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 ).
† Ongoing , international , randomised , observer-blind , placebo-controlled , phase III trial to evaluate the efficacy of one dose of AREVXY ( n = 12,466 ) versus placebo ( n = 12,494 ) to prevent RSV-LRTD in adults ≥60 years of age during one RSV season ( median follow-up 6.7 months , maximum follow up 10.1 months ). RSV-LRTD was confirmed by RT-PCR and defined as presence for ≥24 hours of ≥2 lower respiratory symptoms or signs ( including at least one sign ) or ≥3 lower respiratory symptoms . 2 § The criterion for meeting the primary endpoint was a lower limit of the two-sided CI for vaccine efficacy > 20 %. 2 ¶ No adjustment for multiplicity was applied , so no inferences can be made without a hypothesis test . 2
CI , confidence interval ; COPD , chronic obstructive pulmonary disease ; RSV , respiratory syncytial virus ; RSV-LRTD , RSV-related lower respiratory tract disease ; RT-PCR , reverse-transcriptase polymerase chain reaction .
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
References : 1 . AREXVY Product Information . 2 . Papi A et al . N Engl J Med 2023 ; 388 ( 7 ): 595 – 608 .
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 . © 2023 GSK group of companies or its licensor . GlaxoSmithKline Australia Pty Ltd , Melbourne , VIC .
PM-AU-RSA-JRNA-230005 | Date of approval : January 2024