AREXVY Dosing, Administration, & Storage

Video transcript

On Screen Text

DOSING, ADMINISTRATION, AND STORAGE

PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.

On Screen Text

AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE, ADJUVANTED)

Audio

I would like to review the instructions for preparing, administering, and storing AREXVY.

So now, let's talk about dosing, and we're going to talk about dosing, administration, and storage; and we're going to talk about what we do before reconstitution.

On Screen Text

Dosing and Administration Instructions1

  • AREXVY is supplied in 2 vials that must be reconstituted prior to administration.
  • Administer as a single dose (0.5 mL) of AREXVY as an intramuscular injection.

1. Prescribing Information for AREXVY.

PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.

Audio

AREXVY is supplied in 2 vials that must be reconstituted prior to administration, and it's then administered as a single dose as an intramuscular injection.

On Screen Text

Storage Instructions1

STORAGE BEFORE RECONSTITUTION

  • Store in the original package to protect vials from light
  • Store both adjuvant suspension and lyophilized antigen component vials in a refrigerator between 2 °C and 8 °C (36 °F and 46 °F)
  • Discard if frozen

STORAGE AFTER RECONSTITUTION

  • Administer immediately or store in the refrigerator between 2 °C and 8 °C (36 °F to 46 °F) or at room temperature up to 25 °C (77 °F) for up to 4 hours prior to use, and protect vials from light
  • Discard reconstituted vaccine if not used within 4 hours
  • Do not freeze. Discard if the vaccine has been frozen

1. Prescribing Information for AREXVY.

PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.

Audio

You want to store it in the original package to protect vials from the light. You don't want it being exposed to light. You want to store both the adjuvant suspension component and the lyophilized antigen component vials in the refrigerator between 2 degrees Centigrade and 8 degrees Centigrade — which is 36 and 46 degrees Fahrenheit. After the reconstitution, you want to administer AREXVY immediately, or store in the refrigerator 2 degrees - 8 degrees Centigrade, or at room temperature up to 25 degrees Centigrade ... or, up to 77 degrees Fahrenheit. And we want to use that within 4 hours. You want to discard reconstituted vaccine if it isn't used within 4 hours. You don't want to freeze before or after reconstitution. You want to discard the vaccine if it has been frozen.

On Screen Text

How AREXVY Is Prepared1

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

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 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.

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.

1. Prescribing Information for AREXVY.

PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.

Audio

So again, it's supplied in 2 vials that must be reconstituted. Now, I know most people don't have purple hands, but just imagine these hands aren't purple, and you're reconstituting this vaccine. You want to prepare the AREXVY vaccine by reconstituting the lyophilized antigen component with the accompanying adjuvant suspension component. Use only the supplied adjuvant suspension component for reconstitution. You want to cleanse both the stoppers. Using a sterile needle and syringe, withdraw the entire contents of the vial containing the adjuvant suspension component by slightly tilting the vial. You want to get everything in that component.

Second step — or, "Step B," if you want — you want to slowly transfer the entire contents of the syringe into the lyophilized antigen vial.

The powder — that 3rd step — you want to gently swirl the vial until the powder is completely dissolved. You don't want to shake it vigorously; you want to gently swirl this component after reconstitution.

The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution container permits. You want to be able to look at these things -- right? If either of these conditions exist, don't use it; don't administer that vaccine.

The last step – you want to withdraw 0.5 cc from the vial containing the reconstituted vaccine and administrate that intramuscularly.

On Screen Text

Intended for US healthcare professionals only.

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

©2023 GSK or licensor.

RSAVID230042 July 2023

Produced in USA.

Please see Important Safety Information and full Prescribing Information available on this website.

close