THE SAFETY PROFILE OF MAYZENT® REMAINED CONSISTENT WITH THE CORE STUDY UP TO 5 YEARS1
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EXPAND CORE SAFETY2
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Adverse events 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 EVENTS2
![Adverse reactions table The most common adverse reactions with MAYZENT were headache, hypertension, and increased transaminase levels](/images/body/mayzent-adverse-reactions-table.png)
![Adverse reactions table The most common adverse reactions with MAYZENT were headache, hypertension, and increased transaminase levels](/images/body/mobile/mayzent-adverse-reactions-table.png)
In the core study, the most common adverse events (incidence ≥10%) were headache (15%), hypertension (13%), and transaminase increases (11%).2
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 placebo2
In the core study, the most common adverse events (incidence ≥10%) were headache (15%), hypertension (13%), and transaminase increases (11%).2
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 placebo2
EXPAND EXTENSION STUDY SAFETY UP TO 5 YEARS1
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Adverse events 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 EVENTS1
Information at bottom of page.
![Adverse reactions table The most common adverse reactions with MAYZENT were headache, hypertension, and increased transaminase levels](/images/body/safety-chart.png)
![Adverse reactions table The most common adverse reactions with MAYZENT were headache, hypertension, and increased transaminase levels](/images/body/mobile/safety-chart-mobile.png)
Information at bottom of page.
CONSIDERATIONS FOR INITIATION2
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.
Most patients won’t require an FDO during initiation: An FDO is required only for patients with certain preexisting cardiac conditions.2,3
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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 required for initiation of MAYZENT treatment to help patients safely reach their maintenance dose.2
CONSIDERATIONS FOR INITIATION2
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.
Most patients won’t require an FDO during initiation: An FDO is required only for patients with certain preexisting cardiac conditions.2,3
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 required for initiation of MAYZENT treatment to help patients safely reach their maintenance dose.2
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.2
*Patients with a CYP2C9*3/*3 genotype should not be treated with MAYZENT.2
References: 1. 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. 2. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 3. Data on file. Mayzent FDO Analysis. Novartis Pharmaceuticals Corp; March 2022.