Arexvy

/ GSK

This medicinal product is administered as a single dose of 0.5 mL.
The safety and efficacy in children and in adults 80 years of age and older have not been established.
Method of administration
For intramuscular injection only, preferably in the deltoid muscle.
See prescribing information for more details.

Active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older.

Hypersensitivity to the active substances or to any of the excipients.

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.
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.
As with other intramuscular injections, this medicinal product 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 are not available for immunocompromised individuals. Patients receiving immunosuppressive treatment or patients with immunodeficiency may have a reduced immune response to this vaccine.
See prescribing information for more details.

Very common: Headache, myalgia, arthralgia, injection site pain, injection site erythema , fatigue.
Common: Injection site swelling, fever, chills.
See prescribing information for more details.

Use with other vaccines
May be administered concomitantly with inactivated seasonal influenza vaccines (standard dose unadjuvanted, high dose unadjuvanted, or standard dose adjuvanted).
Upon concomitant administration with seasonal influenza vaccines, numerically lower RSV A and B neutralising titres and numerically lower influenza A and B haemagglutination inhibition titres were observed as compared to the separate administration. This was not observed consistently across studies. The clinical relevance of these findings is unknown.
If this vaccine is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
Concomitant administration with other vaccines than those listed above has not been studied.

Pregnancy: There are no data from the use 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 do not indicate direct or indirect harmful effects with respect to developmental and reproductive toxicity.
Breastfeeding: There are no data on the excretion of this vassine in human or animal milk.         

No case of overdose has been reported in the clinical studies.