Respiratory syncytial virus vaccine, adjuvanted (Intramuscular)

Respiratory syncytial virus vaccine is a medicine that helps your body fight off lower respiratory tract infections caused by respiratory syncytial virus (RSV). It does this by making your body create its own protection (antibodies) against the virus.

Respiratory syncytial virus can lead to serious breathing issues that might need hospital care.

This vaccine should only be given by your doctor or someone working under their supervision.

Be sure to tell your doctor about any side effects (for example, feeling faint) that happen after you receive this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical help. Let your doctor know right away if you experience a rash, itching, a fast heartbeat, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth after getting the vaccine.

Fainting may happen after you receive this vaccine. You may need to stay for observation after the injection to prevent or manage fainting.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine against the benefits it provides. For this vaccine, you should think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how Arexvy™ affects children. Safety and effectiveness have not been established for this age group.

Geriatric

Studies done so far have not shown any specific problems in elderly patients that would limit the usefulness of Arexvy™.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how well this vaccine works. Be sure to tell your doctor if you have any other medical issues, especially:

• Immune system problems—This vaccine may not be as effective in patients with a weak immune system.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Fever

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• difficulty in moving
• headache
• joint pain
• muscle aches, cramps, pains, or stiffness
• swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Arexvy

Available Dosage Forms:

• Powder for Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you this vaccine. It is given as a shot into one of your muscles.

This vaccine is given as a single dose.

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