The safety profile of MAYZENT was characterised in the pivotal EXPAND study.1,2
- Discontinuation rates due to adverse events: 8% with MAYZENT vs 5% with placebo.2
- 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 events that occurred in ≥5% of study patients overall and more commonly with MAYZENT than with placebo2
Bradycardia is included as an adverse event of interest.2
The EXPAND trial was a randomised, double-blind, placebo-controlled, Phase III study of 1651 patients with SPMS over 24 months, followed by an optional open-label extension.2
*During treatment initiation.2
†MAYZENT should not be initiated in patients with macular oedema.1
‡Initiation of treatment should be delayed in patients with severe infection.1
The safety profile of MAYZENT remained consistent with the core study for up to 5 years3
Adverse events that occurred in ≥3% of patients taking MAYZENT in the core and extension studies3
The EXPAND trial was a randomised, double-blind, placebo-controlled, Phase III study of 1651 patients with SPMS over 24 months, followed by an optional open-label extension.2
SPMS, secondary progressive multiple sclerosis.
Safety considerations for MAYZENT1
Mayzent contraindications
- Hypersensitivity to the active substance, or to peanut, soya or any of the excipients listed in the summary of product characteristics.
- Immunodeficiency syndrome.
- History of progressive multifocal leukoencephalopathy or cryptococcal meningitis.
- Active malignancies.
- Severe live impairment (Child-Pugh class C).
- Patients who in the previous 6 months has a myocardial infarction (MI), unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure.
- Patients with a history of second-degree Mobitz type II atrioventricular (AV) block, third-degree AV block, sino-atrial heart block or sick-sinus syndrome, if they do not wear a pacemaker.
- Patients homozygous for CYP2C9*3 (CYP2C9*3*3) genotype (poor metaboliser)
- During pregnancy and in women of childbearing potential not using effective contraception.
Not recommended
- Patients with severe cardiac arrhythmias requiring Class Ia (quinidine, procainamide) or Class III (amiodarone, sotatol) antiarrhythmic drugs.
- Patients with a history of symptomatic bradycardia or recurrent syncope, cerebrovascular disease, uncontrolled hypertension, or severe untreated sleep apnoea.
- Patients with QTc prolongation >500 msec.
Full list of common and very common adverse events per MAYZENT SmPC1
| Infections and infestations | Vascular disorders |
| Common Herpes zoster |
Very common Hypertension |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | |
| Common Melanocytic naevu, Basel cell carcinoma |
Common Nausea, Diarrhoea |
| Blood and lymphatic system disorders | Musculoskeleteal and connective tissue disorders |
| Common Lymphopenia |
Common Pain in extremity |
| Nervous system disorders | General disorders and administration site conditions |
| Very common Headache Common Dizziness, Seizure, Tremor |
Common Oedema peripheral, Asthenia |
| Eye disorders | Investigations |
| Common Macular oedema |
Very common Liver function test increased Common Pulmonary function test decreased |
| Cardiac disorders | |
| Common Bradycardia, Atrioventricular block (first and second degree) |
Other safety considerations
Patients with hepatic dysfunction symptoms should have liver enzymes checked. Discontinue MAYZENT if significant liver injury is confirmed.1
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.1
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).1
Indication: MAYZENT is indicated for the treatment of adult patients with SPMS with active disease evidenced by relapses or imaging features of inflammatory activity.1
SmPC, summary of product characteristics; SPMS, secondary progressive multiple sclerosis.
References
- MAYZENT Summary of Product Characteristics. January 2021.
- Kappos L et al. Lancet. 2018;391(10127):1263‒1273 and supplementary material.
- Kappos L et al. Long-term efficacy and safety of Siponimod in patients with SPMS: EXPAND extension analysis up to 5 years. Poster presented at 72nd Congress of the American Academy of Neurology; April 25‒May 1, 2020; Virtual.
