Administration and Storage¹

AREXVY is supplied in 2 vials that must be reconstituted prior to administration.

Administer a single dose (0.5 mL) of AREXVY as an intramuscular injection
Please refer to the full Prescribing Information for AREXVY for full details

AREXVY should be refrigerated. DO NOT FREEZE (discard if frozen).

Store in the original package to protect vials from light. Store adjuvant suspension component vials and lyophilized antigen component vials between 2 °C and 8 °C (36 °F and 46 °F) before reconstitution
After reconstitution, administer immediately or store between 2 °C and 8 °C (36 °F and 46 °F) or at room temperature up to 25 °C (77 °F) for up to 4 hours prior to use and protect from light
Discard reconstituted vaccine if not used within 4 hours
Discard if reconstituted vaccine, adjuvant suspension, or lyophilized antigen components have been frozen.

AREXVY coadministration with other adult vaccines

According to the US Prescribing Information, AREXVY can be coadministered with flu vaccination. Data are not available for concomitant administration with other vaccines¹
According to the CDC, coadministration of RSV vaccines with other adult vaccines during the same visit is acceptable²
Available data on immunogenicity of coadministration of RSV vaccines and other vaccines are currently limited²

Demonstrated Safety Profile

SEE SAFETY PROFILE

Watch Now

Watch the Reconstitution and Administration Video

View the instructions to reconstitute and administer AREXVY appropriately. Please refer to the full Prescribing Information for AREXVY for full details.

Prescribing Information

How AREXVY Is Prepared¹

AREXVY is supplied in 2 vials that must be reconstituted prior to administration

Prepare AREXVY by reconstituting the lyophilized antigen component (a sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid). Use only the supplied adjuvant suspension component for reconstitution. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Vial 1

Adjuvant suspension component (liquid)

Vial 2

Lyophilized antigen component (powder)

STEP A: Withdraw

Cleanse both vial stoppers. Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the adjuvant suspension component (liquid) by slightly tilting the vial. Vial 1 of 2.

STEP B: Transfer

Slowly transfer entire contents of syringe into the lyophilized antigen component vial (powder). Vial 2 of 2.

STEP C: Swirl

Gently swirl the vial until the powder is completely dissolved. DO NOT SHAKE VIGOROUSLY.

STEP D: After Reconstitution

After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine and administer intramuscularly.

Indication & Important Safety Info

Indication

Important Safety Information

Indication

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:

individuals 60 years of age and older;
individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

Important Safety Information

AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY
The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY
Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting
Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY
In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%)
In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%)
There are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use in persons <50 years of age
Vaccination with AREXVY may not result in protection of all vaccine recipients

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or
1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

CDC=Centers for Disease Control and Prevention; RSV=respiratory syncytial virus.