Arexvy

AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)

Suspension for Intramuscular Injection

Indications and Usage

AREXVY serves as a vaccine specifically formulated for the active immunization against the lower respiratory tract disease (LRTD) instigated by the respiratory syncytial virus. It is indicated for use in individuals aged 60 and above.

Dosage and Administration

• Route: Only for intramuscular administration.
• Dosage: Administer a singular dose of 0.5 mL through an intramuscular injection.

Dosage Forms and Strengths

• The product is available as a suspension for injection. This is provided in the form of a single-dose vial comprising a lyophilized antigen component.
• For the actual vaccination, it is essential to reconstitute this component with the accompanying vial filled with the adjuvant suspension component. After this reconstitution process, the resultant single dose amounts to 0.5 mL.

Contraindications

AREXVY is not recommended for individuals who have previously manifested severe allergic reactions, such as anaphylaxis, to any constituent of the vaccine.

Adverse Reactions

Reported adverse reactions with the administration of AREXVY include:

• Local Adverse Reactions:
• Injection site pain observed in 60.9% of recipients.
• Systemic Adverse Reactions:
• Fatigue in 33.6% of recipients.
• Myalgia (muscle pain) in 28.9%.
• Headaches in 27.2%.
• Arthralgia (joint pain) in 18.1%.

Product approval

Initial U.S. FDA Approval: 2023

Product manufacturer

Manufacturer: GlaxoSmithKline

Report side effects

For the reporting of suspected adverse reactions or any unexpected effects:

• Contact GlaxoSmithKline directly at 1-888-825-5249.
• Alternatively, reports can be made to VAERS at 1-800-822-7967 or on their official website at WWW.VAERS.HHS.GOV.

Also see

• RSV vaccine

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