The safety profile of MAYZENT was characterised in the pivotal EXPAND study.
- Discontinuation rates due to adverse events: 8% with MAYZENT vs 5% with placebo.1
- Macular oedema was more frequently reported in patients receiving MAYZENT (1.8%) than in those given placebo (0.2%).1
- Overall rate of infections was comparable between the patients on MAYZENT and those on placebo (49.0% vs 49.1%, respectively).1
Adverse reactions that occurred in ≥5% of patients taking MAYZENT, and at a rate ≥1% higher than in patients receiving placebo1
*During treatment initiation.1
Safety considerations for MAYZENT2
Full list of common and very common adverse events per MAYZENT SmPC2
Other safety considerations
Patients with hepatic dysfunction symptoms should have liver enzymes checked. Discontinue MAYZENT if significant liver injury is confirmed.2
Initiation of treatment should be delayed in patients with severe active infection until resolution. Suspension of treatment with MAYZENT should be considered if a patient develops a serious infection.2
Patients with certain pre-existing cardiac conditions should be observed for period of 6 hours after the first dose of MAYZENT for signs and symptoms of bradycardia (see dosing & administration for further details).2
Indication: MAYZENT is indicated for the treatment of adult patients with SPMS with active disease evidenced by relapses or imaging features of inflammatory activity.2
SmPC, summary of product characteristics; SPMS, secondary progressive multiple sclerosis.
- Kappos L et al. Lancet. 2018;391:1263–1273, plus supplementary appendix.
- MAYZENT (siponimod) Summary of Product Characteristics.