THE SAFETY PROFILE OF MAYZENT® REMAINED CONSISTENT WITH CORE STUDY UP TO 5 YEARS1,2
EXPAND CORE SAFETY1
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Adverse events (AEs) that occurred in ≥5% of patients taking MAYZENT, and;
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Occurred at a rate ≥1% higher than in patients receiving placebo
PROPORTION OF PATIENTS WITH ADVERSE EVENTS


The most common adverse events (incidence ≥10%) were headache (15%), hypertension (13%), and transaminase increases (11%).
Treatment discontinuation rates due to adverse events were similar across treatment arms.
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8.5% of patients taking MAYZENT discontinued treatment due to adverse events vs 5.1% with placebo
The most common adverse events (incidence ≥10%) were headache (15%), hypertension (13%), and transaminase increases (11%).
Treatment discontinuation rates due to adverse events were similar across treatment arms.
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8.5% of patients taking MAYZENT discontinued treatment due to adverse events vs 5.1% with placebo
EXPAND EXTENSION SAFETY UP TO 5 YEARS2
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AEs that occurred in ≥3% of patients taking MAYZENT in the core and extension studies
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Analysis results were consistent with core study per listed criteria
PROPORTION OF PATIENTS WITH ADVERSE EVENTS
Information at bottom of page.


Information at bottom of page.
SAFETY CONSIDERATIONS FOR INITIATION1
Genotype testing: Patients undergo a genotype test to identify their specific variant of
CYP2C9, the principal enzyme that metabolizes MAYZENT.* This genotype test identifies
the appropriate MAYZENT maintenance dose.
FDO: An FDO is required only for patients with certain preexisting cardiac conditions.
Most patients will not need an FDO during initiation.
Titration schedule: Initiation of MAYZENT treatment results in a transient decrease in
heart rate and atrioventricular conduction delays. For all patients, a dose titration is
recommended for initiation of MAYZENT treatment to help patients safely reach their
maintenance dose.
SAFETY CONSIDERATIONS FOR INITIATION1
Genotype testing: Patients undergo a genotype test to identify their specific variant of CYP2C9, the principal enzyme that metabolizes MAYZENT.* This genotype test identifies the appropriate MAYZENT maintenance dose.
FDO: An FDO is required only for patients with certain preexisting cardiac conditions. Most patients will not need an FDO during initiation.
Titration schedule: Initiation of MAYZENT treatment results in a transient decrease in heart rate and atrioventricular conduction delays. For all patients, a dose titration is recommended for initiation of MAYZENT treatment to help patients safely reach their maintenance dose.
GET PATIENTS STARTED ON MAYZENT®
FDO=first-dose observation; MOA=mechanism of action; MOD=mechanism of disease; MS=multiple sclerosis; RMS=relapsing MS.
*Patients with a CYP2C9*3/*3 genotype should not be treated with MAYZENT.1
*Patients with a CYP2C9*3/*3 genotype should not be treated with MAYZENT.1
References: 1. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; January 2021. 2. Data on file. Long-term Efficacy and Safety of Siponimod in Patients with SPMS: EXPAND Extension Analysis up to 5 Years. Novartis Pharmaceuticals Corp; May 2020.