in patients with certain pre-existing cardiac conditions that they will need to be observed in the doctor's officeor other facility for at least 6 hours after the first dose and after reinitiation if treatment is interrupted or discontinued forcertain periods [see Dosage and Administration (2.4)].
Respiratory Effects
Advise patients that they should contact their physician if they experience new onset or worsening of dyspnea [seeWarnings and Precautions (5.4)].
Liver Injury
Inform patients that MAYZENT may increase liver enzymes. Advise patient that they should contact their physician ifthey experience any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urineduring treatment [see Warnings and Precautions (5.5)].
Pregnancy and Fetal Risk
Inform patients that, based on animal studies MAYZENT may cause fetal harm [see Warnings and Precautions (5.7)].
Discuss with women of childbearing age whether they are pregnant, might be pregnant, or are trying to become pregnant.
Advise women of childbearing potential of the need for effective contraception during treatment with MAYZENT and for10 days after stopping MAYZENT. Advise a female patient to immediately inform that prescriber if she is pregnant orplanning to become pregnant [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1, 8.3)].
Posterior Reversible Encephalopathy Syndrome
Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severeheadache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead topermanent neurological sequelae [see Warnings and Precautions (5.8)].
Severe Increase in Disability After Stopping MAYZENT
Inform patients that severe increase in disability has been reported after discontinuation of another sphingosine 1-phosphate (S1P) receptor modulator like MAYZENT. Advise patients to contact their physician if they develop worseningsymptoms of MS following discontinuation of MAYZENT [see Warnings and Precautions (5.10)].
Immune System Effects After Stopping MAYZENT
Advise patients that MAYZENT continues to have effects, such as lowering effects on peripheral lymphocyte count, forup to 3-4 weeks after the last dose [see Warnings and Precautions (5.11)].
Storage and Handling
Instruct patients to store any unopened containers of MAYZENT in a refrigerator. Inform patients that opened starterpacks may be stored at room temperature for 1 week and opened bottles may be stored at room temperature for 1 month[see How Supplied/Storage and Handling (16.2)].
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
MAYZENT is a registered trademark of Novartis AG
https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/mayzent.pdf
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