respiratory syncytial virus (RSV) vaccine, adjuvanted (Rx)

Brand and Other Names:Arexvy
Sections

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

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

Indicated for active immunization for prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection in adults aged ≥60 years

0.5 mL IM as a single dose

Dosing Considerations

Ongoing clinical trial

  • Clinical trial participants will remain in the study through 3 RSV seasons to assess duration of effectiveness, and safety and effectiveness of repeat vaccination
  • Data for a single dose from the first RSV season of the study were available for the FDA’s analysis for approval

Safety and efficacy not established

Evidence from an animal model strongly suggests that this vaccine would be unsafe in children aged <2 years because of an increased risk of enhanced respiratory disease

Next:

Adverse Effects

VAERS Reporting

Instruct vaccine recipients to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System (VAERS) or call 1-800-822-7967

>10%

Pain, any grade (60.9%)

Fatigue, any grade (33.6%)

Myalgia, any grade (28.9%)

Headache, any grade (27.2%)

Arthralgia, any grade (18.1%)

1-10%

Erythema, >20 mm (7.5%)

Swelling, >20 mm (5.5%)

Fever ≥38ºC/100.4ºF (2%)

Fatigue, Grade 3 (1.7%)

Myalgia, Grade 3 (1.4%)

Headache, Grade 3 (1.3%)

Arthralgia, Grade 3 (1.3%)

Pain, Grade 3 (1%)

<1%

Erythema, >100 mm (0.2%)

Swelling, >100 mm (0.2%)

Fever >39ºC/102.2ºF (0.1%)

Previous
Next:

Warnings

Contraindications

History of severe allergic reaction (eg, anaphylaxis)

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

Previous
Next:

Pregnancy & Lactation

Pregnancy

Not approved for use in persons aged <60 years

An increase in preterm births was observed compared to pregnant individuals who received placebo in 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 persons aged <60 years

Unknown if excreted in human milk; no human or animal data are available to assess effects on breastfed infants or on milk production/excretion

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Previous
Next:

Pharmacology

Mechanism of Action

Vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with AS01E adjuvant

Induces an immune response against RSVpreF3 that protects against lower respiratory tract disease caused by RSV

Previous
Next:

Administration

IM Preparation

Supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial of AS01E adjuvant as the adjuvant suspension component

Prepare by reconstituting lyophilized antigen component (sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid)

Use only supplied adjuvant suspension component for reconstitution

Do NOT shake vigorously; gently swirl vial until powder completely dissolved

Reconstituted vaccine should be an opalescent, colorless to pale brownish liquid

Visually inspect for particulate matter and discoloration before administration; discard if particles or discoloration observed

Vial stoppers are not made with natural rubber latex

Contains no preservatives

IM Administration

For IM injection only

Storage

Lyophilized antigen and adjuvant suspension vials

  • Refrigerated at 2-8ºC (36-46ºF)
  • Store in original package to protect from light
  • Do not freeze; discard if frozen

Reconstituted suspension

  • If not administered immediately, store protected from light in refrigerator at 2-8ºC (36-46ºF) or at room temperature up to 25ºC (77ºF)
  • Administer within 4 hr of reconstitution
  • Discard if not used within 4 hr
  • Do not freeze; discard if frozen
Previous
Next:

Images

No images available for this drug.
Previous
Next:

Patient Handout

A Patient Handout is not currently available for this monograph.
Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.