Frequently asked questions
(FAQs)

Have a question about MAYZENT® or active
secondary progressive multiple sclerosis
(SPMS)? The answer may be here.

Have a question about MAYZENT? The answer may be here.
Have a question about MAYZENT? The answer may be here.

Frequently asked questions (FAQs)

Have a question about MAYZENT® or active secondary progressive multiple sclerosis (SPMS)? The answer may be here.

If you think your MS might be progressing

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What does it mean to have active SPMS?

Active SPMS is the early stage of SPMS that follows relapsing-remitting MS (RRMS) where:

  • You may have fewer relapses but your disability is still increasing
  • The number of active lesions appearing on your MRI may have decreased
  • Your MS symptoms are getting worse, you're experiencing new ones, or they're lingering between relapses

Learn more here.

I've noticed my relapses becoming less frequent. Does this mean my MS medication is working?

It might mean your medication is working, or it might mean something else. Keep in mind, everyone's MS is different so symptoms vary from person to person.

A confusing thing about active SPMS is that relapses or MRI lesions can become less frequent as disability progresses.

It's best to speak with your doctor as soon as you notice any changes in your relapses.

What are some signs that my relapsing-remitting MS (RRMS) could be progressing to active SPMS?

The transition from RRMS to active SPMS can happen gradually over time, which can make it difficult to detect. Because of this, active SPMS often goes unnoticed. But it's important to be familiar with the signs of active SPMS so you can get on an appropriate medication.

Some signs to look out for:

  • You're having fewer relapses
  • Your MS symptoms are getting worse, you're experiencing new ones, or they're lingering between relapses
  • There may be a decrease in active lesions that appear on your MRI
  • Physical and mental activities are becoming more challenging

What are common symptoms of active SPMS?

Signs of active SPMS may vary from person to person, but symptoms that commonly get worse or linger in between relapses include:

  • Difficulty balancing or walking
  • Bowel/bladder dysfunction
  • Poor memory and/or problems concentrating
  • Numbness
  • Fatigue
  • Pain
  • Vision problems
  • Muscle spasms
  • Difficulty speaking or swallowing

Everyone experiences MS differently, and other symptoms may appear.

If you want to know more about MAYZENT

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How can I know if MAYZENT is right for me and my active SPMS?

Your doctor is the one to determine if MAYZENT is a good fit for you. The MAYZENT clinical trial was the largest of its kind and included a wide range of people with SPMS. Because people with SPMS are not all alike, participants varied in age, levels of disability, and in other ways.

Learn more.

Could MAYZENT slow down disability progression?

The overall study result for 3-month confirmed disability progression was that nearly 3 out of 4 people taking MAYZENT showed no confirmed disability progression.* Learn more about the results from the MAYZENT clinical trial.

*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.

How does MAYZENT work?

MAYZENT readily enters your central nervous system (CNS) to possibly have an effect where MS is active and nerve damage is occurring. It also attaches to certain receptors on immune cells and then traps those cells in your lymph nodes. This minimizes damage to your nerves.

Because of the way your body processes MAYZENT, your immune cell count will return to normal within 10 days after stopping treatment. Learn more about how MAYZENT works.

This effect was only observed in animal studies.

What should I know about MAYZENT safety?

There are side effects associated with taking MAYZENT, including some that are serious. MAYZENT may slow your heart rate when you start taking it. Your doctor should give you an electrocardiogram (ECG) before you take your first dose. MAYZENT may also increase your risk of infections that may be life-threatening and cause death. MAYZENT may also cause a problem with your vision called macular edema. Learn more about safety and side effects here, or in the MAYZENT Medication Guide.

Is there any support for me while I'm taking MAYZENT?

The moment your doctor submits a Start Form for MAYZENT, you'll be automatically enrolled in our support program called Alongside MS™ and paired with a dedicated coordinator.

Your coordinator will help you get started on MAYZENT and provide you with support along the way while you're on treatment. Find out more about Alongside MS.

If you're starting MAYZENT

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My doctor prescribed MAYZENT for me. What happens next?

Once your Start Form is submitted, you're automatically enrolled in the Alongside MS support program and paired with an Alongside MS Coordinator who will help you get started. They'll call you to walk through the steps to get started and answer any questions you may have along the way.

Your coordinator will look into your insurance coverage and help schedule deliveries with your specialty pharmacy. You'll also need a few tests before taking your first dose of MAYZENT, which your coordinator can also help schedule.

What kind of tests will I have to take before starting MAYZENT?

Once your Start Form is submitted, your Alongside MS coordinator will contact you about scheduling the following tests.

  • Blood tests that will:
    • Identify your CYP2C9 genetic type to determine if MAYZENT is right for you and, if so, the most appropriate maintenance dose of MAYZENT
    • Check your liver function
    • Obtain a complete blood count
  • An electrocardiogram (ECG) to see if you have any preexisting heart conditions
  • An eye exam to check your vision for a condition called macular edema

If you have certain heart conditions, you might have to be monitored for a period of 6 hours after taking your first dose. Learn more about steps to get started.

Novartis offers options to help patients access and/or receive the pretests needed for onboarding on MAYZENT therapy. These options are designed to help cover or reduce the costs of the various tests and are subject to various eligibility requirements. Learn more about financial support.

For certain cardiac risk factors, for example a history of heart attacks or heart failure, you may have to be monitored for a period of 6 hours after taking your first dose of MAYZENT. An ECG should be conducted at the end of the observation period.

What happens if my doctor wants me to be monitored during my first dose?

Depending on the results of your electrocardiogram (ECG), or if you have a history of certain heart issues, you may have to be monitored for a period of 6 hours after taking your first dose of MAYZENT.§

If so, you'll have an ECG before taking your first dose and your pulse and blood pressure will be checked hourly. You'll then take a second ECG 6 hours after your first dose.

Results from this monitoring will determine if additional monitoring is needed or if you're ready to continue taking MAYZENT on a daily basis as your doctor prescribed.

§For certain cardiac risk factors, for example a history of heart attacks or heart failure, you may have to be monitored for a period of 6 hours after taking your first dose of MAYZENT. An ECG should be conducted at the end of the observation period.

How do I start taking MAYZENT?

Before you can start your maintenance dose, you'll have a 4- or 5-day titration period to help your body adjust to a new medication. On Day 1 you'll start with a low dose and gradually increase each day after the first 2 days until you reach your maintenance (full-strength) dose (either 1 or 2 mg). Learn more in the Starting MAYZENT Brochure.

If you miss 1 or more doses of MAYZENT during the initial titration period, you'll need to restart the medication.

What else should I know about taking MAYZENT?

Here are some things you should know:

  • Take MAYZENT once a day, with or without food
  • If you miss 1 or more doses of MAYZENT during the initial titration period, you'll need to restart the medication and retake the blood tests
  • If you miss a dose of MAYZENT after the initial titration period, take it as soon as you remember
  • If you stop taking MAYZENT for 4 or more days in a row, you'll have to restart treatment with the titration period and retake the blood tests
  • Always follow your doctor's instructions, and do not change your dose or stop taking MAYZENT unless they tell you to

To learn more about taking MAYZENT, check out the Starting MAYZENT Brochure.

Is there any financial support available to help me pay for MAYZENT?

Alongside MS will look into your insurance coverage and any savings offers you may qualify for. Depending on your insurance, some people will be eligible for a $0 co-pay offer.|| Find out more about MAYZENT financial support.

||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.

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.

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.

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.