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ZEPOSIA is a once-daily pill for adults with relapsing multiple sclerosis (MS).

Take as directed by your doctor if certain liver problems exist.

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ZEPOSIA is a once-daily pill for adults with relapsing multiple sclerosis (MS).

Take as directed by your doctor if certain liver problems exist.

About MS

Relapsing-remitting multiple sclerosis, or RRMS, is one type of MS and is the most common course of the condition. Understanding how MS occurs, the progression of RRMS, common symptoms, and ways to manage the condition may bring you closer to finding the help you need.

The types of relapsing MS

Although there is no way to predict relapsing MS from one person to another, there are three different common types of relapsing MS.

CIS is the first “episode” of MS symptoms. To be considered CIS, these symptoms must last at least 24 hours. Many people who experience a CIS episode do not always go on to develop MS.

This is the most common form of MS, as 85% of people with MS are diagnosed with RRMS. This type of MS is defined by attacks of new or worsening neurological symptoms called “relapses.” Relapses can often be followed by periods of partial or complete recovery, called “remissions.”

RRMS can be categorized as “active” with relapses and or new MRI activity over a specific period of time, or “not active,” and as “worsening” with an increase in disability progression after experiencing a relapse or “not worsening.”

SPMS initially follows the course of RRMS, which can progress to "active SPMS." This type of MS is categorized by frequent relapses and a progressive worsening of neurological function and disability over time.

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A closer look at MS

In all types of MS, the body’s immune system to attack the central nervous system (CNS), which consists of the brain, the optic nerves, and the spinal cord.

When MS attacks happen, CNS tissue is damaged and lesions can occur

Lesions disrupt the CNS and keep the brain from sending signals to the rest of the body. These “signal breakdowns” can lead to MS symptoms

Nerve cell

The nerves within the CNS are covered by a protective coating called myelin.

MS attacking nerve cell illustration

MS attack

MS attacks the myelin, causing damage that can prevent the CNS from functioning like it should.

MS attacking nerve cell illustration
MS symptoms icon

MS symptoms

MS can lead to both physical and cognitive symptoms. And they can be different for everyone: Here are a few of the most common MS symptoms.

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Physical symptoms can include

  • Numbness and tingling (in the face, feet, legs, and arms)
  • Trouble walking and balance issues
  • MS fatigue (in about 80% of people with MS)
  • Impaired vision (blurry or even trouble seeing colors)
  • Bowel and bladder problems
Human head silhouette with brain icon

Cognitive symptoms can include

  • Trouble processing information
  • Worsening of memory
  • Problems with attention or concentration
  • Challenges with planning and prioritization
  • Difficulty thinking of the right word
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Ways to manage MS

One of the ways to help treat MS is with a type of medication called a disease-modifying therapy (DMT). Making healthy lifestyle choices is another way to help manage MS.

How DMTs may help:

  • Reducing the number of MS relapses and lesions
  • Preventing the development of new lesions
  • Impacting the progression of the disease

How should DMTs be used?

According to The Use of Disease-Modifying Therapies in Multiple Sclerosis, it is important to:

  • Begin treatment as soon as possible after being diagnosed, since MS is a progressive disease that can get worse over time
  • Maintain ongoing treatment unless otherwise directed by your MS healthcare team. Gaps in treatment can be associated with increased relapses and disability progression over time

To manage symptoms, look beyond DMTs

DMTs are not meant for managing MS symptoms day to day. However, there are other types of medications that can help. Talk to your MS healthcare team to learn more.

Lifestyle choices can help, too

Making healthy lifestyle choices such as staying active, getting enough sleep, and eating right can help with MS. To learn more, visit CanDo-MS.org

Get an overview of ZEPOSIA with key facts

These five key facts can help you get a better understanding of ZEPOSIA, a once-daily pill for MS.

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The information on this page comes from sources that include:

Brain health: time matters in multiple sclerosis

Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al. Mult Scler Relat Disord. 2016;9(Suppl 1):S5-S48.

Cognitive changes

National Multiple Sclerosis Society.
Accessed March 28, 2023. https://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms/Cognitive-Changes

Disease-modifying therapies for MS

National Multiple Sclerosis Society.
Accessed March 28, 2023. https://nms2cdn.azureedge.net/cmssite/nationalmssociety/media/msnationalfiles/brochures/brochure-the-ms-disease-modifying-medications.pdf

Managing relapses

National Multiple Sclerosis Society.
Accessed March 28, 2023. https://www.nationalmssociety.org/Treating-MS/Managing-Relapses

MS signs & symptoms

National Multiple Sclerosis Society.
Accessed March 28, 2023. https://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms

Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis

Rae-Grant A, Day GS, Marrie RA, et al. Neurology. 2018;90(17):777-788.

The use of disease-modifying therapies in multiple sclerosis: principles and current evidence. A consensus paper by the Multiple Sclerosis Coalition

Costello K, Kalb R.
Updated June 2019. Accessed March 28, 2023. http://www.nationalmssociety.org/getmedia/5ca284d3-fc7c-4ba5-b005-ab537d495c3c/DMT_Consensus_MS_Coalition_color

IMPORTANT SAFETY INFORMATION

Do not take ZEPOSIA if you:

  • have had a heart attack, chest pain (unstable angina), stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months
  • have or have had a history of certain types of an irregular or abnormal heartbeat (arrhythmia) that is not corrected by a pacemaker
  • have untreated, severe breathing problems during your sleep (sleep apnea)
  • take certain medicines called monoamine oxidase (MAO) inhibitors (such as selegiline, phenelzine, linezolid)

Talk to your healthcare provider before taking ZEPOSIA if you have any of these conditions or do not know if you have any of these conditions.

ZEPOSIA may cause serious side effects, including:

  • Infections. ZEPOSIA can increase your risk of serious infections that can be life-threatening and cause death. ZEPOSIA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 months of stopping treatment. Your healthcare provider may do a blood test of your white blood cells before you start taking ZEPOSIA.

    Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with ZEPOSIA and for 3 months after your last dose of ZEPOSIA:

    • fever
    • feeling very tired
    • flu-like symptoms
    • cough
    • painful and frequent urination (signs of a urinary tract infection)
    • rash
    • headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)

    Your healthcare provider may delay starting or may stop your ZEPOSIA treatment if you have an infection.

  • Progressive multifocal leukoencephalopathy (PML). ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including: weakness on one (1) side of your body, changes in your vision, changes in your thinking or memory, confusion, changes in your personality, loss of coordination in your arms or legs, decreased strength, and/or problems with balance.
  • Slow heart rate (also known as bradyarrhythmia) when you start taking ZEPOSIA. ZEPOSIA may cause your heart rate to temporarily slow down, especially during the first 8 days. You will have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of ZEPOSIA.

    Call your healthcare provider if you experience the following symptoms of slow heart rate:

    • dizziness
    • lightheadedness
    • feeling like your heart is beating slowly or skipping beats
    • shortness of breath
    • confusion
    • chest pain
    • tiredness

Follow directions from your healthcare provider when starting ZEPOSIA and when you miss a dose.

Continue reading for additional possible serious side effects of ZEPOSIA.

Before taking ZEPOSIA, tell your healthcare provider about all of your medical conditions, including if you:

  • have a fever or infection, or are unable to fight infections due to a disease, or take or have taken medicines that lower your immune system
  • received a vaccine in the past 30 days or are scheduled to receive a vaccine. ZEPOSIA may cause vaccines to be less effective
  • before you start ZEPOSIA, your healthcare provider may give you a chickenpox (Varicella Zoster Virus) vaccine if you have not had one before
  • have had chickenpox or have received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the vaccine and wait 1 month before taking ZEPOSIA
  • have a slow heart rate
  • have an irregular or abnormal heartbeat (arrhythmia)
  • have a history of stroke
  • have or have had heart problems, including a heart attack or chest pain
  • have high blood pressure
  • have liver problems
  • have breathing problems, including during your sleep
  • have eye problems, especially an inflammation of the eye called uveitis
  • have diabetes
  • are or plan to become pregnant or if you become pregnant within 3 months after you stop taking ZEPOSIA. ZEPOSIA may harm your unborn baby. If you are a female who can become pregnant, talk to your healthcare provider about what birth control method is right for you during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA. If you become pregnant while taking ZEPOSIA for MS, tell your healthcare provider right away and enroll in the ZEPOSIA Pregnancy Registry by calling 1-877-301-9314 or visiting www.zeposiapregnancyregistry.com
  • are breastfeeding or plan to breastfeed. It is not known if ZEPOSIA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ZEPOSIA

Tell your healthcare provider about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using ZEPOSIA with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:

  • medicines that affect your immune system, such as alemtuzumab
  • medicines to control your heart rhythm (antiarrhythmics), or heartbeat
  • CYP2C8 inducers such as rifampin
  • CYP2C8 inhibitors such as gemfibrozil (medicine to treat high fat in your blood)
  • opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinson’s disease
  • medicines to control your heart rate and blood pressure (beta blocker medicines and calcium channel blocker medicines)

You should not receive live vaccines during treatment with ZEPOSIA, for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Vaccines may not work as well when given during treatment with ZEPOSIA.

ZEPOSIA can cause serious side effects, including:

  • liver problems. Your healthcare provider will do blood tests to check your liver before you start taking ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:
    • unexplained nausea
    • vomiting
    • stomach area (abdominal) pain
    • tiredness
    • loss of appetite
    • yellowing of the whites of your eyes or skin
    • dark colored urine
  • increased blood pressure. Your healthcare provider should check your blood pressure during treatment with ZEPOSIA. A sudden, severe increase in blood pressure (hypertensive crisis) can happen when you eat certain foods that contain high levels of tyramine.
  • breathing problems. Some people who take ZEPOSIA have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.
  • a problem with your vision called macular edema. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Your healthcare provider should test your vision before you start taking ZEPOSIA if you are at higher risk for macular edema or any time you notice vision changes during treatment with ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:
    • blurriness or shadows in the center of your vision
    • sensitivity to light
    • a blind spot in the center of your vision
    • unusually colored vision
  • swelling and narrowing of the blood vessels in your brain. Posterior Reversible Encephalopathy Syndrome (PRES) is a rare condition that has happened with ZEPOSIA and with drugs in the same class. Symptoms of PRES usually get better when you stop taking ZEPOSIA. If left untreated, it may lead to stroke. Your healthcare provider will do a test if you have any symptoms of PRES. Call your healthcare provider right away if you have any of the following symptoms:
    • sudden severe headache
    • sudden confusion
    • sudden loss of vision or other changes in your vision
    • seizure
  • severe worsening of multiple sclerosis (MS) after stopping ZEPOSIA. When ZEPOSIA is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking ZEPOSIA for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping ZEPOSIA.

The most common side effects of ZEPOSIA can include:

  • upper respiratory tract infections
  • elevated liver enzymes
  • low blood pressure when you stand up (orthostatic hypotension)
  • painful and frequent urination (signs of urinary tract infection)
  • back pain
  • high blood pressure
  • headache

These are not all of the possible side effects of ZEPOSIA. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATIONS

Multiple Sclerosis (MS): ZEPOSIA® (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Ulcerative Colitis (UC): ZEPOSIA is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults.

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

Please see full Prescribing Information, including Medication Guide.

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2084-US-2301034 10/23