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FREQUENTLY ASKED QUESTIONS (FAQs)

FREQUENTLY ASKED QUESTIONS (FAQs)

Have a question about MAYZENT® or changes in relapsing multiple sclerosis (RMS)? See what others
are asking and get the answers here.

IF YOU THINK YOUR RMS MIGHT BE CHANGING

How can I tell if my RMS is changing?

It’s typical for RMS to change or progress over time. RMS progression can ultimately lead to increased physical disability and problems with thinking. Common signs to look for include:

  • You’re having fewer relapses but disability is increasing

  • Your multiple sclerosis (MS) symptoms are getting worse, you’re experiencing new ones, or they’re lingering in between relapses

  • It’s harder to do physical activities

  • The number of active lesions on your magnetic resonance imaging (MRI) has decreased

Learn more here.

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

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

A confusing thing about RMS progression is that relapses or MRI lesions can become less frequent as disability increases.

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

What are common symptoms of disability progression in RMS?

RMS progression can ultimately lead to increased physical disability and problems with thinking. Signs of RMS progression may vary from person to person, but symptoms that commonly get worse or linger in between relapses include:

  • Assistance required to walk
  • Weakness or problems moving limbs (MS fatigue)
  • Problems with coordination
  • Bowel and bladder issues
  • Trouble with memory or concentration (brain fog)
  • Vision problems
  • Difficulty with speech or swallowing
  • Numbness or loss of sensation

Everyone experiences RMS differently, and other symptoms may appear.

Where are definitions of the MS terms used on this site?

Click here to visit a glossary of terms. You can also click highlighted words to view their definition while reading this site.

IF YOU WANT TO KNOW MORE ABOUT MAYZENT

How can I know if once-daily MAYZENT is right for me and my RMS?

Your doctor is the one to determine if MAYZENT is right for you. They may look at the MAYZENT clinical trial, as well as your medical history to decide. The MAYZENT clinical trial was the largest clinical trial of people with relapsing MS progression. In this study, MAYZENT was found to be the first and only pill studied and proven to delay disability progression in people with more progressed RMS. Learn more here.

Could MAYZENT slow down disability progression?

MAYZENT is a once-daily pill proven to help 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 3-year MAYZENT clinical trial.

The effect of MAYZENT was significant in people who had a relapse in the 2 years before the study, but not considered significant in people who did not.

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

How does MAYZENT work?

MAYZENT is a once-daily pill that binds with two key receptors on immune cells (lymphocytes). By doing so, those immune cells are kept in the lymph nodes, preventing them from spreading to the CNS where they can cause nerve damage. MAYZENT also readily enters the CNS (brain and spinal cord) to possibly have an effect where RMS is active and where nerve damage (neurodegeneration) is known to occur.

The exact way in which MAYZENT works is unknown, but it’s believed to involve a reduction of lymphocytes in the brain and spinal cord. Learn more about how MAYZENT works.

This effect was only observed in animal studies.

What happens if I stop taking MAYZENT?

Because of the way the body processes MAYZENT, your immune cell count will return to normal within 10 days after stopping treatment. MAYZENT may continue to lower immune cell count for up to 3-4 weeks after the last dose.

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.

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.

Who should not take MAYZENT?

Some people cannot take MAYZENT, including those with a specific genotype called CYP2C9*3/*3 and certain heart conditions. Before starting treatment, your doctor will determine your genotype. Don’t take MAYZENT if you’ve had a heart attack, a type of 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. If you’ve had certain types of heart block or irregular or abnormal heartbeat (arrhythmia) you also cannot take MAYZENT, unless you have a pacemaker.

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™ MAYZENT 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 MAYZENT.

IF YOU’RE STARTING MAYZENT

My doctor prescribed MAYZENT for me. What happens next?

Once your Start Form is submitted, you’ll be enrolled in the Alongside MAYZENT support program and paired with a Coordinator who will help you get started. They’ll call you to walk through the steps to start taking MAYZENT 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 help schedule.

Taking MAYZENT but not yet an AlongsideTM MAYZENT member?

You can always enroll in Alongside MAYZENT by calling 1-877-MAYZENT (1-877-629-9368), or by completing the online form at start.mayzent.com.

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

There are 2 steps to complete before starting MAYZENT to ensure a safe and smooth start. The first step is pretests. Your Coordinator will help you schedule them at a time and place that works for you.

  • Routine blood test

  • Eye exam

  • Electrocardiogram (ECG). See below for additional information based on ECG results

  • Varicella zoster virus (VZV) test. Before you start taking MAYZENT, a VZV test will check for antibodies to VZV

These tests can take place in the comfort of your own home, your doctor’s office, or a nearby medical facility. Learn more about pretests to get started.

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 failures—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 of MAYZENT, you’ll have a 4- or 5-day titration period to help your body adjust to the new medication. On Day 1, you’ll start with a low dose and gradually increase that dose each day after the first 2 days until you reach your maintenance (full-strength) dose of either 1 or 2 mg. Learn more in the Ready to Start 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
  • 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
  • Always follow your doctor’s instructions, and do not change your dose or stop taking MAYZENT unless your doctor tells you to

To learn more about taking MAYZENT, check out the Ready to Start MAYZENT Brochure.

How can I share my experience on MAYZENT with others?

Become a MAYZENT Mentor as part of the Inspired Moments Network, and empower yourself to share your experience with RMS and treatment journey with MAYZENT. You’ll also have the opportunity to be featured in communication materials on behalf of MAYZENT.

Click to find out how.

IF YOU NEED HELP PAYING FOR MAYZENT

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

Alongside MAYZENT 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 or free medication while their coverage is sorted out.§ 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.

What if I don’t have insurance coverage?

For people who are eligible, the Novartis Patient Assistance Foundation (NPAF) can provide free medication to those who are experiencing financial hardship and have limited or no prescription coverage.

Will my insurance cover MAYZENT?

While everyone’s case is different, 4 out of 5 people who have a commercial or government insurance plan will be eligible for prescription coverage, with potential plan-specific requirements.

Currently, more than 85% of patient reimbursement claims are being approved|| across all insurance providers.

||As of June 2021.

IF YOU WANT TO KNOW MORE ABOUT COVID-19 AND MAYZENT

Can I get the COVID-19 vaccine before starting MAYZENT?

It’s understandable to have questions about getting a COVID-19 vaccine. Vaccines like the COVID-19 vaccines are an important part of public health. So, you should talk to your doctor to better understand the types of vaccines available to you and how to manage getting a vaccine before starting MAYZENT.

The MAYZENT Medication Guide does not advise against taking non-live vaccines; however, they may not work as well when given during treatment with MAYZENT.

The National Multiple Sclerosis Society (NMSS) offers more information and guidance on COVID-19 and relapsing multiple sclerosis. Visit their website at nationalmssociety.org.

For more information about COVID-19, visit the Centers for Disease Control and Prevention (CDC) website at CDC.gov and search: COVID-19 vaccines.

Can I get the COVID-19 vaccine while taking MAYZENT?

It’s understandable to have questions about getting a COVID-19 vaccine. Vaccines like the COVID-19 vaccines are an important part of public health. So, you should talk to your doctor to better understand the types of vaccines available to you and how to manage getting a vaccine before starting MAYZENT.

The MAYZENT Medication Guide does not advise against taking non-live vaccines; however, they may not work as well when given during treatment with MAYZENT. You should never stop taking MAYZENT before talking to your doctor. If you stop taking MAYZENT, your MS symptoms may return or become worst (compared to before or during treatment).

The National Multiple Sclerosis Society (NMSS) offers more information and guidance on COVID-19 and relapsing multiple sclerosis. Visit their website at nationalmssociety.org.

For more information about COVID-19, visit the Centers for Disease Control and Prevention (CDC) website at CDC.gov and search: COVID-19 vaccines.

Are the available COVID-19 vaccines live or non-live?

Just like some other vaccines you may have received in the past, the COVID-19 vaccines available in the US as of March 2021 are non-live vaccines. That means the vaccines do not contain live virus and will not cause COVID-19 disease.

Are there any known risks of getting the COVID-19 vaccine while being
treated with MAYZENT?

The MAYZENT Medication Guide does not advise against taking non-live vaccines; however, they may not work as well when given during treatment with MAYZENT. COVID-19 vaccines haven’t been specifically studied in people taking MAYZENT. When we have more clinical information, we’ll reach out to both you and the healthcare community.

As always, your doctor will be the best person to talk to about your overall health concerns and to help make decisions about your treatment.

Where can I get more information about the COVID-19 vaccines and RMS?

The National Multiple Sclerosis Society (NMSS) offers more information and guidance on COVID-19 and relapsing multiple sclerosis (RMS).

For more information about COVID-19, visit the Centers for Disease Control and Prevention (CDC) website and search: COVID-19 vaccines.

SPOTLIGHT ON MAYZENT VIDEOS

The Spotlight on MAYZENT video series features discussions with real MS experts, along with real people taking MAYZENT.

STAY INFORMED, STAY AHEAD

Interested in starting MAYZENT? To help decide if it’s right for you, sign up to get information on RMS, tracking progression, MAYZENT effectiveness, and more.

IMPORTANT SAFETY INFORMATION AND INDICATION

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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

  • had or now have a type of skin cancer called basal cell carcinoma (BCC), melanoma, or squamous cell carcinoma

  • 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.

  • a type of skin cancer called basal cell carcinoma (BCC), melanoma, and squamous cell carcinoma. Tell your doctor if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes during treatment with MAYZENT. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.

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.