CHANGES IN RMS > UNDERSTANDING RMS PROGRESSION

AS RMS PROGRESSES,
CONSIDER MORE THAN RELAPSES

AS RMS PROGRESSES,
CONSIDER MORE THAN RELAPSES

WHAT CAUSES RMS TO CHANGE?

When something is different with your

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relapsing multiple sclerosis

A general term used for all forms of MS that have distinct episodes of relapses, including CIS, RRMS, and active SPMS.

, it may not be easy to notice. Sometimes the changes are subtle, affecting not just your body, but your mind too. These subtle changes may mean that your RMS is progressing, and it’s important to get ahead of it. Let’s take a moment to understand the science behind why your RMS may be changing over time.

HOW PROGRESSION WORKS

In the brain and spinal cord, nerve impulses carry messages through your nerve cells. These nerve cells are covered in an insulating sheath called

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myelin

A protective, insulating sheath that coats nerve cells.

. When you have RMS, immune cells called

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lymphocytes

A type of white blood cell that plays several roles in the immune system, including protection against bacteria, viruses, fungi, and parasites.

mistakenly attack your myelin and damage your nerve cells. This causes

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inflammation

Part of your body's immune response to help protect from infection. In certain conditions such as MS, your immune system attacks your body's own tissue by mistake, and resulting inflammation causes nerve damage.

and can lead to

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relapses

Also called a "flare-up" or "exacerbation," an episode in which MS symptoms get worse, or new ones arise, for a period of 1 day to several months, followed by at least 30 days of stability.

, which are flare-ups of disease symptoms.

Nerve cell illustration featuring lymphocytes, myelin, and damaged myelin.

RMS is often described as having two distinct yet overlapping stages. In early stages of RMS, inflammation and relapses are more prominent. In later stages, there is less inflammation and fewer relapses, as nerve damage in the brain and spinal cord

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neurodegeneration

Nerve damage in the central nervous system (brain and spinal cord).

increases. This shift is what causes

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progression

The shift from less inflammation and relapses to increased nerve damage, this can lead to worsening cognitive and physical symptoms that accumulate over time.

, and can bring new or worsening symptoms that lead to disability. When RMS changes, you may feel different.

Chart showing disability progression over time during the course of RMS progression.

In the early stages of RMS, inflammation and relapses are more prominent.

Over time, inflammation and relapses lessen as nerve damage in the brain and spinal cord (neurodegeneration) worsens, which can lead to increased

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disability progression

Lingering or worsening of symptoms between relapses and over time, that leads to increased cognitive and physical disability.

.

Click highlighted terms to view definitions while reading
through the site. Click here to view the glossary.

HOW IS DISABILITY PROGRESSION MEASURED?

The

is commonly used in clinical trials to measure the combined effects of physical and cognitive disability, as well as track progression over time.

Your EDSS score is determined by how you function in 8 key functional areas, and can range from 0 to 10. The higher your EDSS score, the greater your level of disability.

KEY AREAS OF FOCUS FOR DETERMINING DISABILITY

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

Take a deeper look at MAYZENT efficacy with an MS expert in this video.

HOW CAN I TELL IF MY RELAPSING MS IS PROGRESSING?

relapses_in_ms

You may have fewer relapses and may not be fully bouncing back or recovering in between them

brain-graphic

The number of active lesions on magnetic resonance imaging (MRI) may decrease, but your symptoms persist or are increasing

subtle changes

You may experience subtle changes in different areas of the EDSS

Everyone experiences RMS differently, and other symptoms may appear.
Pay attention and talk to your doctor about any changes you notice, no matter how small.

DISABILITY PROGRESSION OVER TIME

Disability progression icon timeline

To measure the changes in disability during clinical trials, doctors commonly use

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confirmed disability progression (CDP)

Any change in disability that remains consistent over a certain period of time.

. Any change in disability that remains consistent over a certain period of time, such as 3 months, is considered CDP.*

*CDP is not the only measure for disease progression.

Book a virtual visit

BOOK A VIRTUAL
VISIT HERE

If your RMS is starting to feel different, consider scheduling a virtual visit with a neurologist to help answer your immediate questions.

Book a virtual visit

BOOK A VIRTUAL
VISIT HERE

If your RMS is starting to feel different, consider scheduling a virtual visit with a neurologist to help answer your immediate questions.

WHAT DOES THIS MEAN FOR ME?

Even a small increase in your disability can have an impact and interrupt the balance between your mind and body. Answer a few questions about your changing RMS and its daily impact to create your own personalized conversation guide, and see if your doctor thinks once-daily MAYZENT® may be right for you.

WHAT DOES THIS MEAN FOR ME?

Even a small increase in your disability can have an impact and interrupt the balance between your mind and body. Answer a few questions about your changing RMS and its daily impact to create your own personalized conversation guide, and see if your doctor thinks once-daily MAYZENT® may be right for you.

MS=multiple sclerosis.

PROVEN TO SLOW PROGRESSION

Learn how MAYZENT can help people with RMS delay disability progression.

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.

THANKS!

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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.