How does this medication work? What will it do for me?

Respiratory syncytial virus (RSV) vaccine belongs to the class of medications called vaccines. It is used to prevent serious respiratory (lung) infection caused by a virus called respiratory syncytial virus (RSV) in adults who are at least 60 years old.

The vaccine works by stimulating your body’s defenses to produce antibodies designed to attack RSV if you are exposed to the virus in the future. These antibodies stay in the body, reducing the risk of developing infection.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

When reconstituted with the included vial of solution, each 0.5 mL dose of sterile, opalescent, colourless-to-pale-brownish liquid, contains 25mg each of Quillaja saponaria Molina, fraction 21 (QS-21) and  3-O-desacyl-4’-monophosphoryl lipid A (MPL) to improve how the body uses the vaccine, and 120 mg of Respiratory Syncytial Virus PreF3 (RSVPreF3) glycoprotein F antigen. Nonmedicinal ingredients: cholesterol, dioleoyl phosphatidylcholine, dipotassium phosphate, disodium phosphate anhydrous, polysorbate 80, potassium dihydrogen phosphate, sodium chloride, trehalose dihydrate, and water for injection.

How should I use this medication?

This medication is given as an intramuscular (into the muscle) injection by a qualified health care professional.

This medication should be stored in the refrigerator in its original package. Do not allow it to freeze. Remove it from the refrigerator immediately before taking it to your doctor or other health care provider for injection. The vaccine may be stored safely at room temperature (25oC) for up to 4 hours. Keep out of reach of children.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to respiratory syncytial virus or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • fever or chills
  • general feeling of being unwell
  • headache
  • muscle or joint pain
  • itching, pain, redness, or swelling at the injection site
  • runny nose
  • nausea
  • stomach pain
  • tiredness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • allergic reaction, such as rash
  • swollen lymph nodes

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bleeding: RSV vaccine is injected into a muscle. This can cause bleeding at the injection site if you have a bleeding disorder or are taking a medication that slows down blood clotting. If you have a bleeding disorder or if you take anticoagulants (blood thinners), talk to your doctor about how this vaccine may affect your medical condition and whether any special monitoring is needed.

Immune system: As with any vaccine, influenza vaccine may not be as effective for those who have a weakened immune system (e.g., people on chemotherapy, people who have had an organ transplant, or people with HIV).

Vaccine protection: As with any vaccine, this vaccine may not protect 100% of people who receive it. The vaccine only provides protection against respiratory syncytial virus.

Pregnancy: This medication is not intended for use by adults younger than 60 years of age. The safety and effectiveness of using this medication have not been established for people who may be pregnant.

Breast-feeding: This medication is not intended for use by adults younger than 60 years of age. The safety and effectiveness of using this medication have not been established for people who may be breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between RSV vaccine and any of the following:

  • medications that suppress the immune system:
    • corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
    • medications used to treat conditions such as cancer, inflammatory bowel disease, multiple sclerosis, psoriasis, rheumatoid arthritis, or medications used after a transplant

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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