AREXVY Powder for suspension for injection Ref.[50990] Active ingredients: RSV glycoprotein F antigen

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

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.

Excipients

This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Use with other vaccines

Arexvy may be administered concomitantly with seasonal influenza vaccine (quadrivalent, standard dose, unadjuvanted, inactivated). In a randomised study in adults 60 years of age and older, the criteria for non-inferiority of the immune responses in the co-administration versus the separate administration group were met. However, numerically lower RSV A and B neutralising titres and numerically lower influenza A and B haemagglutination inhibition titres were observed when Arexvy and inactivated seasonal influenza vaccine were co-administered than when they were administered separately. The clinical relevance of this finding is unknown. There are no data on co-administration with high dose or adjuvanted seasonal influenza vaccines.

If Arexvy is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.

Concomitant administration of Arexvy with other vaccines has not been studied.

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 (see section 5.3). 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.

Fertility

There are no data on the effects of Arexvy on human fertility. Animal studies with an investigational unadjuvanted RSVPreF3 vaccine or Arexvy do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

No studies on the effects of Arexvy on the ability to drive and use machines have been performed.

Arexvy has a minor influence on the ability to drive and use machines. Some of the effects mentioned under section 4.8 “Undesirable effects” (e.g. fatigue) may temporarily affect the ability to drive or use machines.

Summary of the safety profile

The safety profile presented below is based on a placebo-controlled Phase III clinical study (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥60 years of age in which more than 12 000 adults received one dose of Arexvy and more than 12 000 received placebo.

In study participants 60 years of age and older, the most commonly reported adverse reactions were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). These adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Most other adverse reactions were uncommon and similarly reported between the study groups.

Tabulated list of adverse reactions

Adverse reactions are listed below by MedDRA system organ class and frequency.

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to <1/1 000), Very rare (<1/10 000)

Table 1. Adverse reactions:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.