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- MAYZENT is a sphingosine 1-phosphate (S1P) receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
- Most common adverse reactions (incidence greater than 10%) are headache, hypertension, and transaminase increases.
Vaccination: Avoid live-attenuated vaccines during and for up to 4 weeks after treatment with MAYZENT. (7.4)
• CYP2C9 and CYP3A4 Inhibitors: Increase in siponimod exposure; concomitant use of MAYZENT with moderate CYP2C9 and moderate or strong CYP3A4 inhibitors is not recommended. (7.5)
• CYP2C9 and CYP3A4 Inducers: Decrease in siponimod exposure; concomitant use of MAYZENT with moderate CYP2C9 and strong CYP3A4 inducers is not recommended.
Infections: MAYZENT may increase the risk. Obtain a complete blood count (CBC) before initiating treatment. Monitor for infection during treatment. Do not start in patients with active infection. (5.1)
• Macular Edema: An ophthalmic evaluation is recommended before starting treatment 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: MAYZENT may result in a transient decrease in heart rate; titration is required for treatment initiation. Consider resting heart rate with concomitant betablocker use; obtain cardiologist consultation before concomitant use with other drugs that decrease heart rate. (5.3, 7.2, 7.3)
• Respiratory Effects: May cause a decline in pulmonary function. Assess pulmonary function (e.g., spirometry) if clinically indicated. (5.4)
• Liver Injury: Obtain liver enzyme results before initiation. Closely monitor patients with severe hepatic impairment. Discontinue if significant liver injury occurs. (5.5)
• Cutaneous Malignancies: Periodic skin examination is recommended. (5.6)
• Increased Blood Pressure: Monitor blood pressure (BP) during treatment. (5.7)
• Fetal Risk: Women of childbearing potential should use effective contraception during and for 10 days after stopping MAYZENT. (5.8)
