ABOUT MAYZENT > SAFETY & SIDE EFFECTS

UNDERSTANDING SAFETY
AND SIDE EFFECTS

UNDERSTANDING SAFETY
AND SIDE EFFECTS

HERE'S WHAT YOU NEED TO KNOW ABOUT THE SAFETY
OF MAYZENT

Before starting any new medication, it’s important to consider possible side effects. Keep in mind that everyone reacts to medications differently. The only way to determine if MAYZENT® is right for you is by talking with your doctor. Here are some serious side effects and the most common side effects that occurred in the core MAYZENT clinical study. Additionally, the safety of MAYZENT was studied and shown to be consistent for up to 5 years in an ongoing, open-label* extension study.

*A type of study where participants are aware of the type of treatment they're being given. Interpreting results from open-label studies can be uncertain. They are not considered representative results, since participants chose whether to stay in the trial.

Take a deeper look at MAYZENT safety and possible side effects with an MS expert in this video.

SELECT SERIOUS SIDE EFFECTS OF MAYZENT

SLOW HEART RATE
(bradycardia or
bradyarrhythmia)

MAYZENT may 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.

INFECTIONS

MAYZENT lowers the number of white blood cells (lymphocytes) in your blood, which may increase
your risk of serious infections that can be life-threatening or cause death. 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 treatment.

MACULAR EDEMA

MAYZENT may cause macular edema, a buildup of fluid in the eyes that can occur with or without
visual symptoms. If macular edema happens, it usually starts within the first 1 to 4 months after
you begin treatment. Your health care provider should test your vision before you start MAYZENT
and any time you notice vision changes during treatment. Your risk of macular edema is higher if
you have diabetes or have had an inflammation of your eye called uveitis.

THE MOST COMMON SIDE EFFECTS OF MAYZENT

MAYZENT

Placebo

Headache

15%

14%

High blood
pressure

13%

9%

Abnormal
liver test

11%

3%

Other common side effects including falls, limb swelling, nausea, dizziness, diarrhea, slowed heart rate, and limb pain.

These are not all of the possible side effects of MAYZENT. To see more information about safety, including all possible side effects of MAYZENT, please see the full Prescribing Information, including Medication Guide.

SAFETY ASSESSED IN AN ONGOING EXTENSION STUDY

After the initial 3-year clinical study, people taking MAYZENT had the opportunity to continue
on MAYZENT, while people taking a placebo could choose to switch to MAYZENT. Everyone
who continued taking MAYZENT beyond 3 years were counted in an ongoing, open-label*
extension study for up to five years. The safety profile for these people remained
consistent with the original study, as defined by the incidence of side effects.

*A type of study where participants are aware of the type of treatment they’re being given. Interpreting results from open-label
studies can be uncertain. They are not considered representative results, since participants chose whether to stay in the trial.

MS=multiple sclerosis; RMS=relapsing MS.

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.

IMPORTANT SAFETY INFORMATION AND INDICATION

COLLAPSE
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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.

    • Pregnancy Registry: There is a registry for women who become pregnant during treatment with MAYZENT. If you become pregnant while taking MAYZENT, talk to your health care provider. For more information or to register, contact MotherToBaby by calling 1-877-311-8972, by sending an email to MotherToBaby@health.ucsd.edu, or go to www.mothertobaby.org/join-study.

  • 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 at the start of and 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.