Prescribing information

 

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

Table detailing 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

Graph detailing incidence rates per 100 patient-years3

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

  1. MAYZENT Summary of Product Characteristics. January 2021.
  2. Kappos L et al. Lancet. 2018;391(10127):1263‒1273 and supplementary material.
  3. 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.
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UK | May 2021 | 124660
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at 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]