onimod exposure;concomitant use of MAYZENT with moderate CYP2C9 and strongCYP3A4 inducers is not recommended (7.6)
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 siponimod exposure;concomitant use of MAYZENT with moderate CYP2C9 and strongCYP3A4 inducers is not recommended (7.6)
See 17 for PATIENT COUNSELING INFORMATION and MedicationGuide.
Revised: 3/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Assessments Prior to First Dose of MAYZENT
2.2 Recommended Dosage in Patients With CYP2C9 Genotypes
*1/*1, *1/*2, or *2/*2
2.3 Recommended Dosage in Patients With CYP2C9 Genotypes
*1/*3 or *2/*3
2.4 First Dose Monitoring in Patients With Certain PreexistingCardiac Conditions
2.5 Reinitiation of MAYZENT After Treatment Interruption
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Infections
5.2 Macular Edema
5.3 Bradyarrhythmia and Atrioventricular Conduction Delays
5.4 Respiratory Effects
5.5 Liver Injury
5.6 Increased Blood Pressure
5.7 Fetal Risk
5.8 Posterior Reversible Encephalopathy Syndrome
5.9 Unintended Additive Immunosuppressive Effects From PriorTreatment With Immunosuppressive or Immune-ModulatingTherapies
5.10 Severe Increase in Disability After Stopping MAYZENT
5.11 Immune System Effects After Stopping MAYZENT
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Anti-Neoplastic, Immune-Modulating, or ImmunosuppressiveTherapies
7.2 Anti-Arrhythmic Drugs, QT Prolonging Drugs, Drugs ThatMay Decrease Heart Rate
7.3 Beta-Blockers
7.4 Vaccination
7.5 CYP2C9 and CYP3A4 I
