Respiratory syncytial virus vaccine (Intramuscular)

Respiratory syncytial virus vaccine is an active immunizing agent used to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years and older. It is also given at 32 to 36 weeks of pregnancy to prevent LRTD and severe LRTD caused by RSV in infants from birth to 6 months of age. It works by helping your body produce its own protection (antibodies) against the disease.

Respiratory syncytial virus can cause serious breathing problems that may require hospitalization.

This vaccine is to be given only by or under the supervision of your doctor.

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

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

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

This vaccine will not protect everyone who gets it.

In deciding to use a vaccine, you need to consider the risks of the vaccine against the benefits it provides. This decision should be made with your doctor. For this vaccine, keep the following in mind:

Allergies

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

Pediatric

Research has not been done on how age affects the use of Abrysvo™ in non-pregnant women under 18 years old. Safety and effectiveness have not been established.

Research has not been done on how age affects the use of Abrysvo™ in infants born to women vaccinated when they were younger than 10 years old. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of Abrysvo™ for them.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all; however, in other cases, two different medicines may be used together even if an interaction could happen. In such cases, 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]) medicines.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical problems may affect the use of this vaccine. 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 needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, 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

• Blurred vision
• dizziness
• fever
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• fainting
• 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. Also, your health care professional may 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 or 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
• diarrhea
• joint pain
• muscle pain

Less common

• Nausea

Rare

• Vomiting

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.

• Abrysvo
• Arexvy

Available Dosage Forms:

• Powder for Solution
• Powder for Suspension

Therapeutic Class: Vaccine

Find detailed information on biosimilars for this medication.

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.

• What is the difference between Arexvy and Abrysvo?
• What are the symptoms of RSV(respiratory syncytial virus)