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ZEPOSIA is a once-daily pill for adults with moderate to severe ulcerative colitis (UC).

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

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ZEPOSIA is a once-daily pill for adults with moderate to severe ulcerative colitis (UC).

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

Helpful resources for UC

When it comes to managing UC, there are many resources and materials that can help. Here you can find materials to download about ZEPOSIA and UC and discover advocacy organizations.

A Guide to ZEPOSIA® thumbnail

A Guide to ZEPOSIA

An overview of ZEPOSIA with clinical study results, safety information, support information, and more.

English En español
Download PDF
ZEPOSIA® Discussion Guide thumbnail

ZEPOSIA Discussion Guide

A guide for talking with your healthcare provider to help you get the answers you need about ZEPOSIA.

English En español
Download PDF
Ulcerative colitis (UC) treatment options In-office Discussion Guide thumbnail

Ulcerative Colitis Treatment Options Overview

A guide for talking with your healthcare provider about each of the treatment options available for people with UC.

English En español
Download PDF
Hand holding mobile phone with apps icon

An app to help you get started and stay on track

The Redi.Health for ZEPOSIA app is a tool that can help support you on your UC journey. It includes medication tracking, UC-friendly recipes, information on ZEPOSIA, and more.

There are two ways to get started:

Download the Redi.Health app from your mobile device and enter code ZEPOSIA.

Download on Apple Store button Download on Google Play button

Rather use the online version? Click here to sign up and get started.

ZEPOSIA® Start Form thumbnail

ZEPOSIA Start Form

A detailed ZEPOSIA prescription that’s filled out by you and your healthcare provider.

English En español
Sign and submit authorization electronically Sign and submit authorization electronically
Download PDF
A Guide to Starting ZEPOSIA® for UC thumbnail

A Guide to Starting Treatment

A helpful guide and checklist that explains the steps for getting started on ZEPOSIA once you and your healthcare provider have decided it’s right for you.

English En español
Download PDF
A Guide to Staying on ZEPOSIA® Treatment thumbnail

A Guide to Staying on Treatment

A resource dedicated to helping you remember to take ZEPOSIA each day, with useful tips.

English En español
Download PDF
Ulcerative Colitis Restroom Access Card thumbnail

Restroom Access Card

A card that can be downloaded, printed, and carried around, explaining your legal rights to gain access to a bathroom, according to some states’ restroom access legislation. Click here to learn more about this law.

English En español
Download PDF
Understanding Tyramine PDF thumbnail

Understanding Tyramine

A helpful list of foods and beverages that are high in tyramine (150 mg or more)—a substance that should be avoided if you’re taking ZEPOSIA.

English En español
Download PDF
Color of Crohn’s & Chronic Illness logo

Works to improve the quality of life for BIPOC who are affected by inflammatory bowel disease (IBD), digestive disorders, and associated chronic illnesses.

cocci.org

Connecting to Cure Crohn’s & Colitis logo

Unites the IBD community to promote public awareness about Crohn’s and colitis.

connectingtocure.org
Crohn’s & Colitis Foundation logo

A non-profit organization dedicated to finding cures and improving the quality of life for those with Crohn’s and colitis.

crohnscolitisfoundation.org
Girls with Guts logo

Supports and empowers women with inflammatory bowel disease (Crohn’s disease and ulcerative colitis).

girlswithguts.org
Gut It Out logo

Provides educational resources and support group opportunities, posts for Crohn’s and colitis.

gutitoutfoundation.org
IBD Support Foundation logo

An organization providing comprehensive, patient-centered psychosocial support and educational programs.

ibdsf.org
The Great Bowel Movement logo

Empowers patients with IBD to realize the power of their own story.

thegreatbowelmovement.org

See if you could save on treatment costs

Those who are eligible and commercially insured may pay as little as $0 a month for ZEPOSIA with a co-pay savings offer. Additional eligibility requirements and terms & conditions apply. Please click here for more information.

Enroll now

Hear from real people taking ZEPOSIA

Hear stories from real people with UC and see how ZEPOSIA fits into their everyday lives.

See their stories

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