Administration and Storage1

Two vials and needle icon

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
Thermometer icon

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

DO NOT FREEZE

Discard if reconstituted vaccine, adjuvant suspension, or lyophilized antigen components have been frozen.

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. 

Video transcript

On Screen Text 

Reconstitution and Administration

Audio

Welcome, this video will walk you through the reconstitution and administration process for AREXVY.

On Screen Text

How Supplied; Preparation

Reconstitution and Administration

Audio

Important information about how AREXVY is supplied will also be discussed.

On Screen Text

How Supplied

AREXVY 0.5 mL IM Injection

1. Adjuvant suspension component (liquid)

2. Lyophilized antigen component (powder)

Reconstitution and Administration

Audio

AREXVY is supplied in 2 vials, an adjuvant suspension component (liquid) and a lyophilized antigen component (powder), that must be combined prior to administration. Use only the supplied adjuvant suspension component for reconstitution.

On Screen Text

How Supplied

Refrigerated

Between 2-8°C (36-46°F)

Protect From Light

Do Not Freeze

Reconstitution and Administration

Audio

Prior to reconstitution, store both the adjuvant suspension component vials and the lyophilized antigen component vials refrigerated between 2 degrees Celsius and 8 degrees Celsius (36 to 46 degrees Fahrenheit). Store in the original package in order to protect vials from light. Do not freeze. Discard if the adjuvant suspension component or the antigen component have been frozen.

On Screen Text

Preparation

Reconstitution and Administration

Audio

When you are ready to reconstitute the vaccine, follow these steps.

On Screen Text

Preparation

Step A: Withdraw the entire contents of the vial containing the adjuvant suspension component (liquid).

Step B: Slowly transfer the entire contents of the syringe into the lyophilized antigen component vial (powder).

Step C: Gently swirl the vial until the powder is completely dissolved. Do not shake vigorously.

Wash your hands or wear gloves. Preparation will also require needles, syringes, disinfecting swabs, and a bandage.

DO NOT SHAKE VIGOROUSLY

Reconstitution and Administration

Audio

Check the expiration date of both vials. If expired, do not use. Cleanse both vial stoppers with a sterile alcohol swab. Using sterile needles and sterile syringes, withdraw the entire contents of the vial containing the adjuvant suspension component (liquid) by slightly tilting the vial.

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

Gently swirl the vial until the powder is completely dissolved. Do not shake vigorously. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid.

On Screen Text

Preparation

Refrigerated

Between 2-8°C (36-46°F) or at Room Temperature up to 25°C (77°F)

Protect From Light

Discard Reconstituted Vaccine if Not Used Within 4 Hours

Do Not Freeze

Reconstitution and Administration

Audio

After reconstitution, administer AREXVY immediately or store protected from light in the refrigerator between 2 degrees Celsius and 8 degrees Celsius (36 to 46 degrees Fahrenheit) or at room temperature up to 25 degrees Celsius (77 degrees Fahrenheit) and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours. Do not freeze. Discard if the vaccine has been frozen.

On Screen Text

Preparation

Prior to administration, inspect for particulate matter and discoloration

Questions about AREXVY?

Call 877-AREXVY1 (877-273-9891)

Reconstitution and Administration

Audio

Immediately prior to administering, parenteral drug products should be inspected visually for particulate matter and discoloration immediately prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

On Screen Text

Preparation

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

AREXVY is for intramuscular injection only

For illustrative purposes only.

Reconstitution and Administration

Audio

After reconstitution, if stored, cleanse the vial stopper with a sterile alcohol swab prior to administration. Withdraw 0.5 mL from the vial containing the reconstituted vaccine. Disinfect the injection site prior to administration, and administer intramuscularly. AREXVY is for intramuscular injection only.

On Screen Text

GSK Logo

Trademarks are owned by or licensed to the GSK group of companies.

©2023 GSK or licensor.

RSASTBD230013 June 2023

Produced USA.

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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 one icon

Vial 1

Adjuvant suspension component (liquid)

Vial two icon

Vial 2

Lyophilized antigen component (powder)

Step A icon

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 icon

STEP B: Transfer

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

Step C icon

STEP C: Swirl

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

Step D icon

STEP D: After Reconstitution

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