Interactions : אינטראקציות

4.5   Interaction with other medicinal products and other forms of interaction

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.

Nirsevimab does not interfere with reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen detection RSV diagnostic assays that employ commercially available antibodies targeting antigenic site I, II, or IV on the RSV fusion (F) protein.

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.