Overall study results for 3-month confirmed disability progression:

Nearly 3 out of 4 people taking MAYZENT showed no confirmed disability progression Nearly 3 out of 4 people taking MAYZENT showed no confirmed disability progression

Nearly 3 out of 4 people taking MAYZENT showed no confirmed disability progression*

*Nearly 3 out of 4 is 74%, compared to 68% taking placebo.

People taking MAYZENT had a 21% lower chance of disability progression compared to those taking placebo People taking MAYZENT had a 21% lower chance of disability progression compared to those taking placebo

People taking MAYZENT had a 21% lower chance of disability progression compared to those taking placebo

The effect of MAYZENT was significant in patients with active SPMS and not considered significant in patients with nonactive SPMS.

*Nearly 3 out of 4 is 74%, compared to 68% taking placebo.

The effect of MAYZENT was significant in patients with active SPMS and not considered significant in patients with nonactive SPMS.

Talk to your doctor to see if Mayzent could be right for you Talk to your doctor to see if Mayzent could be right for you

Important things you should know about MAYZENT

testing testing

Testing

  • Before beginning MAYZENT, your doctor will perform blood tests that will:
    • Determine if MAYZENT is right for you. This test will also determine your appropriate maintenance dose of MAYZENT
    • Check your liver function
    • Obtain a complete blood count
  • You will have an electrocardiogram (ECG) to see if you have any preexisting heart conditions
  • You will also have an eye exam to check your vision for a condition called macular edema
dosing dosing

Dosing

  • Starting treatment

    When you begin taking MAYZENT, you'll start with a low dose, and gradually increase each day until you reach your maintenance (full-strength) dose.

    If you miss 1 or more doses during the initial dosing period, you will need to restart your medication at the lowest dose and increase daily until you have reached your maintenance dose.

  • Maintenance dose

    Your maintenance dose will either be 1 mg or 2 mg taken once a day.

    If you miss your maintenance dose 4 days in a row, call your doctor, as you will have to restart your treatment with the lowest dose of MAYZENT and gradually increase the dose to your maintenance dose again.

first dose observation first dose observation

First-dose observation

  • If you have any preexisting heart conditions, you may need to be monitored by a doctor for 6 hours after taking your first dose of MAYZENT

For more information,
please see the Medication Guide.

Active SPMS Active SPMS

Want the facts about MAYZENT?


Learn more about MAYZENT and active SPMS in the
Discover MAYZENT Brochure.

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Find out more about taking MAYZENT


Learn about patient support and how to take MAYZENT in the Getting Started Brochure.

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If MAYZENT is right for you:

Prescription Prescription

Find out if you qualify for $0 co-pay


To see if you qualify for financial assistance, talk to your doctor about enrolling in the Alongside MS patient support program, or call 1-877-MAYZENT 1-877-MAYZENT (1-877-629-9368). (1-877-629-9368).

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by bringing a Start Form Start Form to your next doctor's appointment.

Limitations apply. Valid only for those with private insurance. The Program includes the Co-Pay Card, Payment Card (if applicable), and Rebate, with a combined annual limit of $18,000. Patient is responsible for any costs once limit is reached in a calendar year. Program not valid (i) under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, or (iii) where the patient's insurance plan reimburses for the entire cost of the drug. The value of this Program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. Program is not valid where prohibited by law. Patient may not seek reimbursement for the value received from this Program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States and Puerto Rico. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.

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INDICATION AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

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 health care provider. Ask your health care provider if you are not sure.

  • have had a heart attack, chest pain called unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months

What is MAYZENT® (siponimod) tablets?

MAYZENT is a prescription medicine that is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if MAYZENT is safe and effective in children.

  • have certain types of heart block or irregular or abnormal heartbeat (arrhythmia), unless you have a pacemaker

MAYZENT may cause serious side effects, including:

  1. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking MAYZENT. MAYZENT can cause your heart rate to slow down, especially after you take your first dose. You should have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of MAYZENT.

    During the initial updosing period (4 days for the 1-mg daily dose or 5 days for the 2-mg daily dose), if you miss 1 or more doses of MAYZENT, you need to restart the updosing. Call your health care provider if you miss a dose of MAYZENT.

  2. Infections. MAYZENT can increase your risk of serious infections that can be life-threatening and cause death. MAYZENT lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 to 4 weeks of stopping treatment. Your health care provider should review a recent blood test of your white blood cells before you start taking MAYZENT.

    Call your health care provider right away if you have any of these symptoms of an infection during treatment with MAYZENT and for 3 to 4 weeks after your last dose of MAYZENT:

    • fever

    • tiredness

    • body aches

    • chills

    • nausea

    • vomiting

    • headache with fever, neck stiffness, sensitivity to light, nausea, confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)

  3. A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). You may not notice any symptoms with macular edema. If macular edema happens, it usually starts in the first 1 to 4 months after you start taking MAYZENT. Your health care provider should test your vision before you start taking MAYZENT and any time you notice vision changes during treatment with MAYZENT. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis.

    Call your health care provider right away if you have any of the following: blurriness or shadows in the center of your vision, a blind spot in the center of your vision, sensitivity to light, or unusually colored (tinted) vision.

Before taking MAYZENT, tell your health care provider about all of your medical conditions, including if you:

  • have an irregular or abnormal heartbeat

  • have a history of stroke or other diseases related to blood vessels in the brain

  • have breathing problems, including during your sleep

  • have a fever or infection, or you are unable to fight infections due to a disease or are taking medicines that lower your immune system. Tell your health care provider if you have had chickenpox or have received the vaccine for chickenpox. Your health care provider may do a blood test for chickenpox virus. You may need to get the full course of vaccine for chickenpox and then wait 1 month before you start taking MAYZENT.

  • have slow heart rate

  • have liver problems

  • have diabetes

  • have eye problems, especially an inflammation of the eye called uveitis

  • have high blood pressure

  • are pregnant or plan to become pregnant. MAYZENT may harm your unborn baby. Talk to your health care provider right away if you become pregnant while taking MAYZENT or if you become pregnant within 10 days after you stop taking MAYZENT.

    • If you are a woman who can become pregnant, you should use effective birth control during your treatment with MAYZENT and for at least 10 days after you stop taking MAYZENT.

  • are breastfeeding or plan to breastfeed. It is not known if MAYZENT passes into your breast milk. Talk to your health care provider about the best way to feed your baby if you take MAYZENT.

Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take medicines to control your heart rhythm (anti-arrhythmics), or blood pressure (antihypertensives), or heart beat (such as calcium channel blockers or beta-blockers); take medicines that affect your immune system, such as beta-interferon or glatiramer acetate, or any of these medicines that you took in the past.

Tell your health care provider if you have recently received a live vaccine. You should avoid receiving live vaccines during treatment with MAYZENT. MAYZENT should be stopped 1 week before and for 4 weeks after receiving a live vaccine. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with MAYZENT.

MAYZENT may cause possible side effects, including:

  • increased blood pressure. Your health care provider should check your blood pressure during treatment with MAYZENT.

  • liver problems. MAYZENT may cause liver problems. Your health care provider should do blood tests to check your liver before you start taking MAYZENT. Call your health care provider right away if you have any of the following symptoms of liver problems:

    • nausea

    • vomiting

    • stomach pain

    • tiredness

    • loss of appetite

    • your skin or the whites of your eyes turn yellow

    • dark urine

  • breathing problems. Some people who take MAYZENT have shortness of breath. Call your health care provider right away if you have new or worsening breathing problems.

  • swelling and narrowing of the blood vessels in your brain. A condition called PRES (Posterior Reversible Encephalopathy Syndrome) has happened with drugs in the same class. Symptoms of PRES usually get better when you stop taking MAYZENT. However, if left untreated, it may lead to a stroke. Call your health care provider right away if you have any of the following symptoms: sudden severe headache, sudden confusion, sudden loss of vision or other changes in vision, or seizure.

  • severe worsening of multiple sclerosis after stopping MAYZENT. When MAYZENT is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your doctor before you stop taking MAYZENT for any reason. Tell your health care provider if you have worsening symptoms of MS after stopping MAYZENT.

The most common side effects of MAYZENT include: headache, high blood pressure (hypertension), and abnormal liver tests.

These are not all of the possible side effects of MAYZENT. Call your doctor for medical advice about side effects.

What is MAYZENTŪ (siponimod) tablets?

MAYZENT is a prescription medicine that is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if MAYZENT is safe and effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.