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Prescribing Information

STORAGE

AREXVY should be refrigerated. DO NOT FREEZE (discard if frozen)¹

Store in the original package to protect vials from light
Store between 2 °C and 8 °C (36 °F and 46 °F) before reconstitution

After reconstitution, store between 2 °C and 8 °C (36 °F and 46 °F) or at room temperature up to 25 °C (77 °F) for up to 4 hours prior to use
Discard reconstituted vaccine if not used within 4 hours

Nature and Contents of Container

- Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber) and a mustard green flip-off cap (antigen).

- Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber) and a brown flip-off cap (adjuvant).

Use and Handling

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

EFFICACY

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

LEARN MORE

SAFETY

AREXVY was generally well tolerated with an acceptable safety profile. Review the safety findings now.²

LEARN MORE

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

Global Data Sheet 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