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. 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. Systemic immunosuppressive medicinal products and immunodeficiency Safety and immunogenicity data on Arexvy are not available for immunocompromised individuals. Patients receiving immunosuppresive treatment or patients with immunodeficiency may have a reduced immune response to Arexvy.

Pregnancy and breast-feeding: 
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. 

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

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