HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useMAYZENT safely and effectively. See full prescribing information forMAYZENT.

MAYZENT(siponimod)tablets, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
MAYZENT is a sphingosine 1-phosphate receptor modulator indicated for thetreatment of relapsing forms of multiple sclerosis (MS), to include clinicallyisolated syndrome, relapsing-remitting disease, and active secondaryprogressive disease, in adults. (1)
DOSAGE AND ADMINISTRATION
Assessments are required prior to initiating MAYZENT (2.1)
Titration is required for treatment initiation (2.2, 2.3)
The recommended maintenance dosage is 2 mg (2.2)
The recommended maintenance dosage in patients with a CYP2C9*1/*3or *2/*3 genotype is 1 mg (2.3)
First-dose monitoring is recommended for patients with sinusbradycardia, first- or second-degree [Mobitz type I] atrioventricular(AV) block, or a history of myocardial infarction or heart failure (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg and 2 mg (3)
CONTRAINDICATIONS
Patients with a CYP2C9*3/*3 genotype (4)
In the last 6 months, experienced myocardial infarction, unstable angina,stroke, TIA, decompensated heart failure requiring hospitalization, orClass III/IV heart failure (4)
Presence of Mobitz type II second-degree, third-degree AV block, orsick sinus syndrome, unless patient has a functioning pacemaker (4)
WARNINGS AND PRECAUTIONS
Infections: MAYZENT may increase the risk. Obtain a complete bloodcount (CBC) before initiating treatment. Monitor for infection duringtreatment. Do not start in patients with active infection. (5.1)
Macular Edema: An ophthalmic eva luation is recommended before startingtreatment and if there is any change in vision while taking MAYZENT.
Diabetes mellitus and uveitis increase the risk. (5.2)
Bradyarrhythmia and Atrioventricular Conduction Delays: MAYZENTmay result in a transient decrease in heart rate; titration is required fortreatment initiation.Consider resting heart rate with concomitant betablockeruse; obtain cardiologist consultation before concomitant use withother drugs that decrease heart rate (5.3, 7.2, 7.3)
Respiratory Effects: May cause a decline in pulmonary function. Assesspulmonary function (e.g., spirometry) if clinically indicated. (5.4)
Liver Injury: Obtain liver enzyme results before initiation. Closely monitorpatients with severe hepatic impairment. Discontinue if significant liverinjury occurs. (5.5)
Increased Blood Pressure (BP): Monitor BP during treatment. (5.6)
Fetal Risk: Women of childbearing potential should use effectivecontraception during and for 10 days after stopping MAYZENT. (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than 10%) are headache,hypertension, and transaminase increases. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact NovartisPharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Vaccines: Avoid live attenuated vaccines during and for up to 4 weeks aftertreatment with MAYZENT (7.4)
CYP2C9 and CYP3A4 Inhibitors: Increase in siponimod exposure;concomitant use of MAYZENT with moderate CYP2C9 and moderate orstrong CYP3A4 inhibitors is not recommended (7.5)
CYP2C9 and CYP3A4 Inducers: Decrease in sip