Mayzent (siponimod)

Mayzent is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is not known if Mayzent is safe and effective in children.

Important Side Effects and Facts about Mayzent (siponimod)

1. Slow heart rate: Mayzent can cause your heart rate to slow down, especially after your first dose. Before taking your first dose of Mayzent, you should have an electrocardiogram (ECG) to check the electrical activity of your heart. During the initial updosing period, if you miss a dose, you need to restart the updosing and contact your healthcare provider.

2. Infections: Mayzent can increase your risk of serious and life-threatening infections by lowering the number of white blood cells in your blood. Your healthcare provider should review a recent blood test of your white blood cells before you start taking Mayzent. Contact your healthcare provider immediately if you experience symptoms of infection during treatment with Mayzent and for several weeks after your last dose.

• fever
• vomiting
• tiredness
• headache with fever, neck stiffness, sensitivity to light, nausea, confusion
• body aches
• chills
• nausea

3. Macular edema: Mayzent can cause macular edema, which may result in vision symptoms similar to an MS attack (optic neuritis). It is important to have your vision tested before starting Mayzent and to monitor any vision changes during treatment. If you experience blurriness or shadows in the center of your vision, sensitivity to light, a blind spot in the center of your vision, or unusually colored vision, contact your healthcare provider immediately.

Other Side Effects of Mayzent (siponimod)

Mayzent may also cause other serious side effects:

• increased blood pressure
• liver problems

The most common side effects of Mayzent include headache, high blood pressure, and abnormal liver tests. If you experience any side effects that bother you or do not go away, inform your healthcare provider.

This is not an exhaustive list of possible side effects. For more information, consult your healthcare provider or pharmacist. Seek medical advice about side effects by contacting the FDA at 1-800-FDA-1088.

QUESTION

Dosage for Mayzent (siponimod)

The daily maintenance dose of Mayzent is either 1 mg or 2 mg, depending on your CYP2C9 genotype. Consult your healthcare provider for the appropriate maintenance dose. Use the following titration schedule to start your treatment with Mayzent:

Table 2: Dose Titration Regimen to Reach MAYZENT 1 mg Maintenance Dosage

• Take Mayzent exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Mayzent without your healthcare provider’s approval.
• Take Mayzent once daily, with or without food.
• If you miss one or more doses during the initial dose titration, you need to restart the medication.
• If you miss a dose after the initial dose titration, take it as soon as you remember.
• If Mayzent treatment is stopped for four consecutive days, you need to restart with the titration.
• Do not stop taking Mayzent without consulting your healthcare provider first.

Are Your MS Drugs
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Mayzent (siponimod) Contraindications, Pregnancy Safety, and Drug Interactions

Do not take Mayzent if you:

• have a CYP2C9 *3*3 genotype. Before starting treatment with Mayzent, your CYP2C9 genotype should be determined by your healthcare provider.
• have had a heart attack, unstable angina, stroke, mini-stroke, or certain types of heart failure in the last six months.
• have certain types of heart block or irregular heartbeat, unless you have a pacemaker.

What to Tell Your Healthcare Provider before Taking Mayzent

Prior to taking Mayzent, inform your healthcare provider about all your medical conditions, including:

• an irregular or abnormal heartbeat
• a history of stroke or other blood vessel-related diseases in the brain
• breathing problems, including sleep-related issues
• a fever or infection, or inability to fight infections due to a disease or medications that suppress the immune system
• slow heart rate
• liver problems
• diabetes
• eye problems, especially uveitis
• high blood pressure
• pregnancy or plans to become pregnant. Mayzent may harm your unborn baby. Use effective birth control during treatment and for at least 10 days after stopping Mayzent. If you are a woman who can become pregnant, consult your healthcare provider for appropriate contraceptive measures.

Make sure to keep a list of all the medicines you take and share it with your healthcare provider and pharmacist when starting a new medication. Combining Mayzent with other medicines can cause serious side effects.

Summary

Mayzent is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults. It is not recommended for children. Mayzent may cause serious side effects, including slow heart rate, infections, macular edema, increased blood pressure, liver problems, and more. Stopping Mayzent may worsen symptoms of MS compared to before or during treatment. Consult your doctor before taking Mayzent if you are pregnant or breastfeeding.

Mayzent is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults. It is not recommended for children. Mayzent may cause serious side effects, including slow heart rate, infections, macular edema, increased blood pressure, liver problems, and more. Stopping Mayzent may worsen symptoms of MS compared to before or during treatment. Consult your doctor before taking Mayzent if you are pregnant or breastfeeding.