AREXVY is an injectable suspension vaccine intended for intramuscular use. Its active ingredient is a lyophilized recombinant respiratory syncytial virus glycoprotein F (RSVPreF3), which is stabilized in a pre-fusion conformation and reconstituted with an AS01 adjuvant to enhance its effect. The active component and adjuvant are prepared from genetically engineered Chinese Hamster Ovary cells and a liposomal formulation, respectively. Key inactive ingredients include trehalose, sodium chloride, and polysorbate 80.

How should I use this medication?

This vaccine is injected into a muscle. It is given by your care team. A copy of Vaccine Information Statements will be given before each vaccination. Be sure to read this information carefully each time. This sheet may change often. A copy of Vaccine Information Statements will be given before each vaccination. Be sure to read this information carefully each time. This sheet may change often. Talk to your care team about the use of this vaccine in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

Where should I keep my medication?

This vaccine is only given by your care team. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Feeling faint or lightheaded -Weakness and tingling in the feet and legs that spreads to upper body Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -General discomfort and fatigue -Headache -Muscle pain -Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Immune system problems -An unusual or allergic reaction to respiratory syncytial virus vaccine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Medications that lower your chance of fighting infection

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular health checks. Before you receive this vaccine, talk to your care team if you have an acute illness. Vaccines can be given to people with mild acute illness, such as the common cold or diarrhea. Discuss with your care team the risks and benefits of receiving this vaccine during a moderate to severe illness. Your care team may choose to wait to give you the vaccine when you feel better. Report any side effects to your care team or to the Vaccine Adverse Event Reporting System (VAERS) website at https://vaers.hhs.gov. This is only for reporting side effects; VAERs staff do not give medical advice.