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ADMINISTRATION

AREXVY is supplied in 2 vials for reconstitution1

Administer 1 dose (0.5 mL) of AREXVY as an intramuscular injection

Two circles with a vaccine being administered into arm in each

AREXVY and inactivated seasonal influenza vaccine can be administered in the same visit1*

  • There was no evidence for interference in the immune response to any of the antigens contained in both coadministered vaccines1
  • Concomitant influenza vaccine must be inactivated, unadjuvanted, quadrivalent, and standard dose1

SEE SAFETY PROFILE

Coming Soon: Learn how to reconstitute AREXVY appropriately

How AREXVY Is Prepared

AREXVY is supplied in 2 vials that must be reconstituted prior to administration.1

two vials labelled “1” and “2”

Vial 1: Adjuvant Suspension
Vial 2: Antigen Powder

Hands withdrawing substance from vial into a syringe

Step A:

Withdraw the entire contents of the vial containing the suspension into a syringe.

Hands withdrawing substance from syringe into vial with powder

Step B:

Add the entire contents of the syringe into the vial containing powder.

Hand swirling vial with syringe inserted

Step C:

Gently swirl until the powder is completely dissolved.

Hands withdrawing substance from vial into syringe

Step D:

Withdraw 0.5 mL from the vial containing the reconstituted vaccine into the syringe.

Hand holding syringe

Step E:

Change the needle so that you are using a new needle.

Hand administering vaccine into a person’s arm

Step F:

Administer the vaccine intramuscularly.

The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not reconstitute the vaccine.1

Lungs

EFFICACY

Review efficacy data against RSV-LRTD for your patients aged 60 years and older.1

LEARN MORE
shield

SAFETY

AREXVY was generally well tolerated with an acceptable safety profile. Review the safety findings now.1

LEARN MORE
lungs with particles on right side

MECHANISM OF ACTION

AREXVY includes both an antigen component and an adjuvant system.1

LEARN MORE

Abbreviations

LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus; 

Arexvy safety information1

Contraindications:
Hypersensitivity to the active substances or to any of the excipients

Special Warnings and Precautions: 
Prior to immunisation appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. Vaccination should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with the vaccination process itself. It is important that precautions are in place to avoid injury from fainting.
Precautions for use Do not administer the vaccine intravascularly or intradermally. No data are available on subcutaneous administration of Arexvy. As with other intramuscular injections, Arexvy should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these individuals. 

Pregnancy : 
There are no data from the use of Arexvy in pregnant women. After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3 557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo. Currently no conclusion on a causal relationship between administration of unadjuvanted RSVPreF3 and preterm birth can be drawn. Results from animal studies with an investigational unadjuvanted RSVPreF3 vaccine and results with Arexvy do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Arexvy is not recommended during pregnancy. 

Breast-feeding:
There are no data on the excretion of Arexvy in human or animal milk. Arexvy is not recommended in breast-feeding/lactating women. 

Undesirable effects 

Very common: Headache, myalgia, arthralgia, injection site pain, fatigue

Common: Injection site erythema, injection site swelling, fever, chills

References

  1. Arexvy prescribing information.

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

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PM-RCH-RSA-WCNT-240001 | August 2024