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Q&A

Common questions or concerns patients may have at their AREXVY appointment

  • What are the side effects?

    The most commonly reported adverse reactions (≥10%) were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). For more information, please see the full Prescribing Information for AREXVY.1

  • What reactions should I be aware of?

    Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of AREXVY.1

    Syncope may occur in association with the vaccination process itself. It is important that precautions are in place to avoid injury from fainting.

  • When should AREXVY be administered?

    Administer 1 dose of AREXVY as an intramuscular injection. AREXVY may be administered concomitantly with seasonal influenza vaccine (quadrivalent, standard dose, unadjuvanted, inactivated). The need for revaccination has not been established.1

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 listed in sections “Powder (RSVPreF3 antigen and Suspension (AS01E Adjuvant System)”

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. 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 and breast-feeding: 
Arexvy is not recommended during pregnancy. 

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. Prescribing Information for AREXVY.

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