BEYFORTUS Solution for injection Ref.[50357] Active ingredients: Nirsevimab

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.

Hypersensitivity including anaphylaxis

Serious hypersensitivity reactions, including anaphylaxis, have been observed with monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medicinal products and/or supportive therapy.

Clinically significant bleeding disorders

As with any other intramuscular injections, nirsevimab should be given with caution to infants with thrombocytopenia or any coagulation disorder.

No interaction studies have been performed. Monoclonal antibodies do not typically have significant interaction potential, as they do not directly affect cytochrome P450 enzymes and are not substrates of hepatic or renal transporters. Indirect effects on cytochrome P450 enzymes are unlikely as the target of nirsevimab is an exogenous virus.

Concomitant administration with vaccines

Since nirsevimab is a monoclonal antibody, a passive immunisation specific for RSV, it is not expected to interfere with the active immune response to co-administered vaccines.

There is limited experience of co-administration with vaccines. In clinical trials, when nirsevimab was given with routine childhood vaccines, the safety and reactogenicity profile of the co-administered regimen was similar to the childhood vaccines given alone. Nirsevimab can be given concomitantly with childhood vaccines.

Nirsevimab should not be mixed with any vaccine in the same syringe or vial (see section 6.2). When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.

Not applicable.

Not applicable.

Summary of the safety profile

The most frequent adverse reaction was rash (0.7%) occurring within 14 days post dose. The majority of cases were mild to moderate in intensity. Additionally, pyrexia and injection site reactions were reported at a rate of 0.6% and 0.4% within 7 days post dose, respectively. Injection site reactions were non-serious.

Tabulated list of adverse reactions

Table 1 presents the adverse reactions reported in 1 955 term and preterm infants (GA ≥29 weeks) who received nirsevimab in clinical trials.

Adverse reactions reported from controlled clinical trials are classified by MedDRA System Organ Class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: 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) and not known (cannot be estimated from available data).

Table 1. Adverse reactions:

^a Rash was defined by the following grouped preferred terms: rash, rash maculo-papular, rash macular.
^b Injection site reaction was defined by the following grouped preferred terms: injection site reaction, injection site pain, injection site induration, injection site oedema, injection site swelling.

Infants at higher risk for severe RSV disease

Safety was also evaluated in MEDLEY in 918 infants at higher risk for severe RSV disease, including 196 extremely preterm infants (GA <29 weeks) and 306 infants with chronic lung disease of prematurity, or haemodynamically significant congenital heart disease entering their first RSV season, who received nirsevimab (614) or palivizumab (304). The safety profile was comparable to the palivizumab comparator and consistent with the safety profile in term and preterm infants GA ≥29 weeks (D5290C00003 and MELODY).

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity.

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.