Prescribing information

 

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).

Adverse reactions that occurred in ≥5% of patients taking MAYZENT, and at a rate ≥1% higher than in patients receiving placebo1

List of adverse reations occuring in the EXPAND study

*During treatment initiation.1

Safety considerations for MAYZENT2

List of contraindictions and patients in whom Mayzent (siponimod) is not recommended

Full list of common and very common adverse events per MAYZENT SmPC2

List of adverse reactions associated with Mayzent (siponimod)

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.

References

  1. Kappos L et al. Lancet. 2018;391:1263–1273, plus supplementary appendix. 
  2. MAYZENT (siponimod) Summary of Product Characteristics.
SIP20-C001b May 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]