Respiratory Syncytial Virus RSV Vaccine Adjuvanted

Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted, is used for active immunization for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

• RSV vaccine is available under the following brand names: Arexvy

Common side effects of respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted include:

• headache
• tiredness
• muscle pain
• joint pain
• injection site pain

Serious side effects of RSV vaccine, adjuvanted include:

• not available

Rare side effects of RSV vaccine, adjuvanted include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection kit, lyophilized antigen component, and adjuvant suspension

• After reconstitution, each 0.5-mL dose contains 120 mcg of recombinant RSVPreF3 antigen and 50 mcg of AS01E adjuvant

Prevention of Respiratory Syncytial Infection

Adult dosage

• 0.5 mL IM as a single dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• RSV Vaccine, adjuvanted, has no noted severe interactions with any other drugs.
• RSV vaccine, adjuvanted, has no noted serious interactions with any other drugs.
• RSV vaccine, adjuvanted, has no noted moderate interactions with any other drugs.
• RSV vaccine, adjuvanted, has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of a severe allergic reaction (eg, anaphylaxis)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted?”

Cautions

• Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration
• Syncope (fainting) may occur in association with administration; ensure procedures are established to avoid injury from fainting
• Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response

Pregnancy and Lactation

• Not approved for use in people younger than 60 years
• An increase in preterm births was observed compared to pregnant individuals who received a placebo in a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen
• Lactation
  • Not approved for use in people younger than 60 years
  • Unknown if excreted in human milk; no human or animal data are available to assess effects on breastfed infants or milk production/excretion