Arexvy

Arexvy is a vaccine used to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD, lung infections) in adults 60 years and older, and adults aged 18 through 59 years at increased risk for LRTD caused by RSV. It is administered as a single intramuscular (IM) injection.

• Only one dose of Arexvy is needed.
• Arexvy may be given at any time of the year, but where possible, should be offered before the start of the RSV season. It is not given every RSV season.
• RSV season is usually late fall (November) through spring (April), with a peak in January and February.

Arexvy works by stimulating the immune system to produce antibodies against RSVpreF3, a key RSV protein. This immune response creates protection against LRTD caused by RSV.

Arexvy gained FDA approval on May 3, 2023, and was the first RSV vaccine to be approved for older adults. Approval was based on favorable results from the AReSVi-006 clinical trial (NCT04886596, n=24,966), which reported:

• 82.6% effectiveness against RSV lower respiratory tract disease
• 94.1% effectiveness against severe disease
• 71.7% effectiveness against acute respiratory infection.

Effectiveness was consistent across age groups and comorbidities, with mostly mild-to-moderate transient adverse events.

In Studies 4 (NCT05590403) and 7 (NCT06389487), Arexvy met immunobridging criteria in at-risk adults aged 18-59 with chronic conditions (cardiopulmonary, diabetes, renal, hepatic, and neurologic). Neutralizing antibody responses to RSV-A and RSV-B were noninferior and numerically higher than in adults ≥60 years, confirming adequate immune responses across both younger at-risk age groups following a single dose.

Do not receive an Arexvy vaccine if you have a history of severe allergic reactions (such as anaphylaxis) to RSV vaccines, Arexvy, or any of its inactive ingredients.

Before receiving Arexvy, tell your healthcare provider about all your medical conditions, including if you:

• have bleeding or bruising problems
• are prone to fainting after a vaccination
• are younger than 18 years old
• are pregnant or intending to become pregnant
• are breastfeeding.

Arexvy is given by intramuscular injection, usually into the deltoid muscle of the upper arm.

• A single dose is given.

The most common side effects of Arexvy in adults aged 60 and older are:

• injection site pain
• fatigue (tiredness)
• muscle aches
• headache
• joint pain.

The most common side effects of Arexvy in adults 50 through 59 years are:

• injection site pain
• fatigue (tiredness)
• muscle aches
• headache
• joint pain
• redness
• swelling.

The most common side effects of Arexvy in adults 18 through 49 years are:

• injection site pain
• muscle aches
• fatigue (tiredness)
• headache
• joint pain.

Serious side effects and warnings

Arexvy may cause the following serious side effects:

• Guillain‑Barré Syndrome. Postmarketing reports suggest an increased risk of Guillain‑Barré syndrome developing within 42 days of vaccination with Arexvy. This is a condition in which the body's immune system attacks the nerves. Seek urgent medical attention for symptoms such as weakness or tingling in your legs that may spread to your upper body and arms, muscle weakness, or difficulty breathing, swallowing, or speaking.
• Anaphylaxis. Possible anaphylactic reactions may occur. Do not administer Arexvy to anyone with a known history of a severe allergic reaction to it or any of its components. Always administer in a facility that can provide the appropriate medical treatment and supervision to manage possible anaphylactic reactions following administration.
• Syncope (fainting). Fainting may occur following the administration of vaccines. Procedures should be in place to avoid injury from fainting.
• Immunosuppression. People who are immunocompromised, including those receiving immunosuppressive therapy, may have a diminished immune response to Arexvy.

Arexvy is not for use in children or adolescents <18 years or pregnant or breastfeeding women.

These are not all the side effects of Arexvy. Report all side effects to your healthcare provider, GlaxoSmithKline at 1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Dose of Arexvy for Adults 18 Years and Older

• 0.5 mL

Review the Arexvy Prescribing Information for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Arexvy is supplied in two vials. One vial contains the antigen component and the other contains the AS01E adjuvant. Arexvy must be reconstituted before administration.

Active ingredient (antigen vial): lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (RSVPreF3)

Adjuvant vial: AS01E adjuvant is composed of saponin purified from the plant extract Quillaja saponaria saponin (QS-21, 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota.

Inactive ingredients (antigen vial): trehalose, sodium chloride, potassium dihydrogen phosphate, dipotassium phosphate, polysorbate 80, disodium phosphate anhydrous, DOPC, cholesterol.

Arexvy contains no preservatives.

The vial stoppers are not made with natural rubber latex.

Arexvy vaccine is made by GlaxoSmithKline Biologicals, Belgium, U.S. License 1617, and distributed by GlaxoSmithKline, Durham, NC 27701.