- Data available for inactivated, unadjuvanted, quadrivalent standard dose influenza vaccine.
ADMINISTRATION
AREXVY is supplied in 2 vials for reconstitution1
Administer 1 dose (0.5 mL) of AREXVY as an intramuscular injection
Learn how to reconstitute AREXVY appropriately
How AREXVY Is Prepared1
Administer 1 dose (0.5 mL) of AREXVY as an intramuscular injection. The need for revaccination has not been established.
AREXVY is supplied in 2 vials that must be combined prior to administration
![two vials labelled “1” and “2”](/content/dam/global/hcpportal/en_IE/Images/arexvy/two-bottel.png)
Vial 1 AS01E Adjuvant suspension component (liquid)
Vial 2: Lyophilized RSVPreF3 antigen component (powder)
![Hands withdrawing substance from vial into a syringe](/content/dam/global/hcpportal/en_IE/Images/arexvy/image-2.png)
Step A:
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.
![Hands withdrawing substance from syringe into vial with powder](/content/dam/global/hcpportal/en_IE/Images/arexvy/image-3.png)
Step B:
Slowly transfer entire contents of syringe into the lyophilized RSVPreF3 antigen component vial (powder). Vial 2 of 2.
![Hand swirling vial with syringe inserted](/content/dam/global/hcpportal/en_IE/Images/arexvy/image-4.png)
Step C:
Gently swirl until the powder is completely dissolved.
DO NOT SHAKE VIGORUSLY
![Hands withdrawing substance from vial into syringe](/content/dam/global/hcpportal/en_IE/Images/arexvy/image-5.png)
Step D:
After reconstitution, withdraw the entire contents of the reconstituted vaccine.
![Hand holding syringe](/content/dam/global/hcpportal/en_IE/Images/arexvy/image-6.png)
Step E:
Change the needle so that you are using a new needle and administer 0.5 mL intramuscularly.
![Hand administering vaccine into a person’s arm](/content/dam/global/hcpportal/en_IE/Images/arexvy/image-7.png)
Step F:
Administer the vaccine intramuscularly.
Use only the supplied adjuvant suspension component (liquid) for reconstitution. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. Parenteral drug products should be inspected for particulate matter and not discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccination should not be administered
AREXVY and seasonal influenza vaccine can be administered in the same visit1*
*In an open-label phase 3 study, participants ≥60 years of age received 1 dose of AREXVY and inactivated seasonal influenza vaccine (FLU QUADRIVALENT containing a combined total of 60 micrograms hemagglutinin [HA] per dose) at Month 0 (n=442) or 1 dose of FLU QUADRIVALENT at Month 0 followed by a dose of AREXVY at Month 1 (n=443). The observed safety events were balanced between coadministration and control groups.1
Abbreviations
LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus; RSVPreF3=recombinant RSV glycoprotein F stabilised in the pre-fusion conformation.
References
- Arexvy SPC, https://www.medicines.ie/medicines/arexvy-powder-and-suspension-for-suspension-for-injection-35441/spc. Accessed April 2024
Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
©2024 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.
PM-IE-RSA-WCNT-230002 | May 2024