Interactions : אינטראקציות

4.5   Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.
The co-administration of agents known to inhibit T cell function has not been formally studied. The co-administration of agents known to stimulate T cell function has not been investigated and the effects are unknown.

Tocilizumab or siltuximab and corticosteroid use

Some patients required tocilizumab or siltuximab and/or corticosteroid for the management of CRS (see section 4.8). The use of tocilizumab or siltuximab and/or corticosteroids for CRS management was more common inpatients with higher cellular expansion.

In the KarMMa-3 study, patients with CRS treated with tocilizumab or siltuximab had higher Abecma cellular expansion levels, as measured by 3.1-fold and 2.9-fold higher median Cmax (N = 156) and AUC0- 28days (N = 155), respectively, compared to patients who did not receive tocilizumab or siltuximab (N = 64 for Cmax and N = 63 for AUC0-28days). Patients with CRS treated with corticosteroids had higher Abecma cellular expansion levels, as measured by 2.3-fold and 2.4-fold higher median Cmax (N = 60) and AUC0- 28days (N = 60), respectively, compared to patients who did not receive corticosteroids (N = 160 for C max and N = 158 for AUC0-28days).

Similarly, in the KarMMa study, patients with CRS treated with tocilizumab had higher Abecma cellular expansion levels, as measuredby 1.4-fold and 1.6-fold higher median Cmax (N = 66) and AUC0- 28days (N = 65), respectively, compared to patients who did not receive tocilizumab (N = 61 for C max and N = 60 for AUC0-28days). Patients with CRS treated with corticosteroids had higher Abecma cellular expansion levels, as measured by 1.7-fold and 2.2-fold higher median Cmax (N = 18) and AUC0-28days (N = 18), respectively, compared to patients who did not receive corticosteroids (N = 109 for Cmax and N = 107 for AUC0-28days).



Live vaccines

The safety of immunisation with live viral vaccines during or following treatment with Abecma has not been studied. As a precautionary measure, vaccination with live vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Abecma treatment and until immune recovery following treatment.