MAYZENT
Generic Name/API: siponimod
Manufacturer: Novartis
Dosage Forms & Strength & Pack Size:
Tablets: 0.25 mg, 1 mg, and 2 mg
Storage:
Unopened Containers
Store MAYZENT 0.25 mg, 1 mg, and 2 mg film-coated tablets in a refrigerator between 2°C to 8°C (36°F to 46°F). After dispensed by pharmacy to patient, MAYZENT 0.25 mg, 1 mg, and 2 mg film-coated tablets may be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] for up to 3 months.
Opened Containers
Bottles
MAYZENT 0.25 mg, 1 mg, and 2 mg film-coated tablets may be stored at 20°C to 25°C (68°F to 77°F) [see USP
Controlled Room Temperature] for up to 3 months. Do not refrigerate after opening.
Starter Pack/Blister Card
MAYZENT 0.25 mg film-coated tablets may be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room
Temperature] for up to 3 months. Do not refrigerate after opening. Store in original calendarized blister wallet container.
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.
WARNINGS AND PRECAUTIONS
• 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)
• Progressive Multifocal Leukoencephalopathy (PML): Withhold MAYZENT at the first sign or symptom of PML. (5.2)
• Macular Edema: Increases the risk of macular edema. Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with MAYZENT. Conduct an evaluation of the fundus, including the macula, periodically while on therapy and any time there is a change in vision. Consider discontinuing MAYZENT if macular edema develops.
Diabetes mellitus and uveitis increase the risk. (5.3)
• 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. (5.4, 7.2, 7.3)
• Respiratory Effects: May cause a decline in pulmonary function. Assess pulmonary function (e.g., spirometry) if clinically indicated. (5.5)
• Liver Injury: Obtain liver enzyme results before initiation. Closely monitor patients with severe hepatic impairment. Discontinue if significant liver
injury occurs. (5.6)
• Cutaneous Malignancies: Skin examination prior to or shortly after the start of treatment and periodically thereafter is recommended. Suspicious skin lesions should be evaluated. (5.7)
• Increased Blood Pressure: Monitor blood pressure (BP) during treatment.
(5.8)
• Fetal Risk: Women of childbearing potential should use effective contraception during and for 10 days after stopping MAYZENT.
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