AREXVY™

Product Information

• Name: AREXVY™
• Type: Respiratory Syncytial Virus (RSV) Vaccine (recombinant, AS01E adjuvanted)
• Form: Lyophilized Powder and Suspension for Reconstitution, administered intramuscularly
• Manufacturer: GlaxoSmithKline Inc.

Indications and Clinical Use

• Indication: Prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older.
• Pediatrics: Safety and efficacy not assessed in individuals under 18 years of age.
• Geriatrics: Clinical studies include participants 65 years and older, contributing to the safety and efficacy assessment.

Dosage and Administration

• Recommended Dose: Single dose of 0.5 mL containing both antigen and adjuvant components.
• Reconstitution:
  • Combine lyophilized RSVPreF3 antigen (powder) with AS01E adjuvant suspension (liquid).
  • Inspect for foreign particulate matter and variation in appearance before reconstitution.
  • Administer intramuscularly, preferably in the deltoid muscle.
• Storage After Reconstitution: Use promptly or store at 2°C to 8°C or up to 25°C for use within 4 hours.

Contraindications

• Hypersensitivity to the active ingredients, any component of the formulation, or the container.

Warnings and Precautions

• General:
  • Postpone vaccination in individuals with acute severe febrile illness.
  • Be prepared for anaphylactic reactions; epinephrine should be available.
• Hematologic: Caution in individuals with thrombocytopenia or coagulation disorders.
• Immune Response: Protective immune response may not be elicited in all vaccinees. Data not available for immunocompromised individuals.
• Special Populations:
  • Pregnant Women: Not recommended; limited data.
  • Breastfeeding: Not recommended; limited data.
  • Geriatrics: Safety and efficacy assessed in clinical studies.

Adverse Reactions

• Very Common: Injection site pain, fatigue, headache, myalgia, arthralgia.
• Common: Injection site erythema, swelling, fever, chills, rhinorrhea.
• Uncommon: Injection site pruritus, lymphadenopathy, hypersensitivity reactions, nausea, abdominal pain.
• Serious: Atrial fibrillation, Guillain-Barré syndrome, suspected acute disseminated encephalomyelitis.

Drug Interactions

• Concomitant Administration: Can be given with inactivated quadrivalent seasonal influenza vaccine. Administer at different injection sites.
• Storage and Stability: Store in original package to protect from light, at 2°C to 8°C. Do not freeze. Discard reconstituted vaccine if not used within 4 hours.

Clinical Trials and Efficacy

• Efficacy: Significant reduction in RSV-associated LRTD in adults 60 years and older.
• RSV OA=ADJ-006 (NCT04886596): Demonstrated 82.6% efficacy against RSV-associated LRTD.
• Immunogenicity: Demonstrated robust immune response with significant increases in neutralizing antibodies against RSV-A and RSV-B subtypes.
• RSV OA=ADJ-004 (NCT04732871): Significant geometric mean increases in neutralizing titers and RSVPreF3-specific CD4+ T-cells post-vaccination.
• RSV OA=ADJ-007 (NCT04841577): No significant interference with immune response when co-administered with influenza vaccine, though numerically lower titers observed.