AREXVY Powder for suspension for injection Ref.[50990] Active ingredients: Respiratory syncytial virus vaccine

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 immunosuppressive 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 inactivated seasonal influenza vaccines (standard dose unadjuvanted, high dose unadjuvanted, or standard dose adjuvanted).

Upon concomitant administration of Arexvy 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 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 than those listed above 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 Arexvy or with an investigational unadjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to developmental and 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 Arexvy or with an investigational unadjuvanted RSVPreF3 vaccine 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 in Table 1 is based on a pooled analysis of data generated in two placebo-controlled Phase III clinical studies (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥60, and 50 through 59 years of age.

In study participants 60 years of age and older (more than 12 000 adults received one dose of Arexvy and more than 12 000 received placebo, with a follow-up period of approximately 12 months), 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.

In study participants 50 through 59 years of age (769 participants, including 386 participants with pre- defined, stable, chronic medical conditions leading to an increased risk for RSV disease), a higher incidence of injection site pain (76%), fatigue (40%), myalgia (36%), headache (32%), and arthralgia (23%) was observed, compared with those 60 years of age and older (381 participants) in the same study. However, the duration and severity of these events were comparable across age groups in the study.

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.