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Choose AREXVY for your patients aged 60+

AREXVY is a vaccine indicated for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.1 

Demonstrated efficacy against RSV-LRTD for patients aged 60 years and older1*†

82.6% efficacy demonstrated in first occurrence of RSV-associated LRTD in patients ≥60 years of age (primary endpoint; incidence rate per 1,000 person-years: 1.0 vs. 5.8 for placebo; 95% CI: 57.9–94.1)1†‡
In patients with ≥1 comorbidity of interest (secondary endpoint), 94.6% (incidence rate per 1,000 person-years: 0.4 vs. 6.6 for placebo; 95% CI: 65.9–99.9) In patients with ≥1 comorbidity of interest (secondary endpoint), 94.6% (incidence rate per 1,000 person-years: 0.4 vs. 6.6 for placebo; 95% CI: 65.9–99.9)

Relative risk reduction versus placebo (96.95% CI for overall; 95% for all subgroups) for vaccine efficacy is derived based on Poisson model adjusted by age categories and regions.

* Data from an ongoing, Phase 3, placebo-controlled, randomized, observer-blind clinical study conducted in adults ≥60 years of age in 17 countries from Northern and Southern Hemispheres. Adults with pre-existing, chronic, stable disease, with or without specified treatment, such as diabetes, hypertension, or cardiac disease, were allowed to participate in the study if considered by the investigator as medically stable at the time of vaccination. The primary population for efficacy analysis included patients receiving 1 dose of AREXVY (n=12,466) or placebo (n=12,494) and who did not report an RSV-confirmed acute respiratory infection (ARI) prior to Day 15 after vaccination.

† LRTD was defined based on the following criteria: the participant must have experienced ≥2 lower respiratory symptoms/signs including ≥1 lower respiratory sign for ≥24 hours, or experienced ≥3 lower respiratory symptoms for ≥24 hours. Lower respiratory symptoms included: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, crackles/rhonchi, respiratory rate ≥20 respirations/min, low or decreased oxygen saturation (O2 saturation <95% or ≤90% if baseline is <95%) or need for oxygen supplementation.

‡ The primary endpoint for vaccine efficacy was defined as the first occurrence of RT-PCR-confirmed RSV-A and/or B-associated LRTD with an onset from 15 days after vaccination.

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Meet patients who may be at risk of RSV disease

Older adults aged ≥60 years, including those with certain comorbidities, are at risk of severe RSV infection.2,3

MEET THE PATIENTS

Meet patients who may be at risk of RSV disease

Older adults aged ≥60 years, including those with certain comorbidities, are at risk of severe RSV infection.2,3

MEET THE PATIENTS

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AREXVY is designed to enhance antigen-specific cellular immune response and humoral immune responses, including neutralizing antibodies against RSV-A and RSV-B subtypes.1*

* Clinical significance unknown.

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See AREXVY efficacy data

Efficacy of AREXVY against RSV-associated LRTD in adults 60 years and older was evaluated in Study AReSVi-006.1 

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Discover AREXVY safety profile

The safety profile of AREXVY in adults aged 60 years and older was evaluated in Study AReSVi-006.1 

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Recommendations

Review recommendations on RSV vaccination for adults aged ≥60 years.4-7

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Resources for you and your patients

GET STARTED WITH AREXVY

Learn about proper reconstitution, administration, and storage information for AREXVY.

RESOURCES FOR YOUR PRACTICE

Find more AREXVY resources to help you in your practice!

Important Safety Information

Indication and clinical use:

AREXVY is a vaccine indicated for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

Pediatrics: Safety and efficacy not assessed.

Geriatrics: Clinical studies include participants ≥65 years of age, and their data contributes to the overall assessment of safety and efficacy of AREXVY.

Relevant warnings and precautions:

  • There is no data for the use of AREXVY in pregnant individuals. Not recommended during pregnancy or in breast-feeding/lactating individuals
  • Postpone vaccination in individuals suffering from an acute severe febrile illness
  • Syncope
  • Caution driving and operating machinery
  • Caution in individuals with thrombocytopenia or any coagulation disorder
  • Protective immune response may not be elicited in all vaccinees
  • Systemic immunosuppressive medications and immunodeficiency

For more information:

Please consult the Product Monograph at gsk.ca/AREXVY/PM for important information relating to warnings, precautions, adverse reactions, drug interactions, and dosing. To request a Product Monograph or to report an adverse event, please call 1-800-387-7374.

References:

  1. AREXVY Product Monograph. GlaxoSmithKline Inc.
  2. Centers for Disease Control and Prevention. Respiratory syncytial virus infection (RSV): older adults. Available at: https://www.cdc.gov/rsv/high-risk/older-adults.html. Accessed February 22, 2023.
  3. Centers for Disease Control and Prevention. Respiratory syncytial virus infection (RSV): for healthcare providers. Available at: https://www.cdc.gov/rsv/clinical/index.html. Accessed September 28, 2023.
  4. Melgar M, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices—United States, 2023. Morb Mortal Wkly Rep 2023;72:793–801.
  5. Government of Canada. Respiratory syncytial virus (RSV): Canadian Immunization Guide. Available at: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html. Accessed January 26, 2024.
  6. American Diabetes Association Professional Practice Committee. 4. Comprehensive medical evaluation and assessment of comorbidities: Standards of Care in Diabetes – 2024. Diabetes Care 2024:47(Suppl.1):S52–76.
  7. Global Initiative for Chronic Obstructive Lung Disease 2024 Report. Available at: https://goldcopd.org/wp-content/uploads/2024/01/GOLD-2024_v1.2-11Jan24_WMV-1.pdf. Accessed February 8, 2024.

Trademarks are owned by or licensed to the GSK group of companies.

©2024 GSK Group of companies or its licensor.

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