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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.

More is possible—with proven results from once-daily ZEPOSIA

ZEPOSIA was proven effective in clinical studies. For more information about how the study was designed, click here

Lasting remission and symptom relief

ZEPOSIA® a proven UC treatment icon

Achieve lasting remission with ZEPOSIA (fewer symptoms and reduced inflammation seen during a colonoscopy at 1 year).*

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Reduced rectal bleeding and fewer trips to the bathroom are possible in as early as 2 weeks.

Steroids-free icon

You can experience steroid-free remission with ZEPOSIA.†

  • 37% achieved remission vs 19% on placebo. Reduces symptoms of rectal bleeding and stool frequency. Reduced inflammation representing mild or inactive disease in the colon.
  • 32% of patients achieved steroid-free remission at 1 year vs 17% on placebo.

ZEPOSIA was studied in a 1-year clinical study where all participants (ZEPOSIA: 429, placebo: 216) were evaluated at 10 weeks. Those who had achieved symptom improvement at 10 weeks were then able to continue (ZEPOSIA: 230, placebo: 227) and be evaluated at 1 year. Learn more about the study

When you may expect results
Day 1
ZEPOSIA® pill icon

Start ZEPOSIA, a once-daily pill

How to take ZEPOSIA
Week 2
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Reduced rectal bleeding and fewer trips to the bathroom

Week 10
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48% experienced symptom improvement Symptom improvement or “clinical response” was defined as an improvement in symptoms (stool frequency and rectal bleeding) and/or the clinical results of an endoscopy. “Clinical response” can be different for everyone because it is based on the severity of your UC when you start taking a certain treatment.
(vs 26% on placebo)

ZEPOSIA® remission icon 1

18% were in remission Remission was defined as: No rectal bleeding Reduction of stool frequency to normal, or one or two stools more than normal Improvement in how the intestinal lining looked during an endoscopy, representing mild or inactive disease in the colon
(vs 6% on placebo)

Only patients who achieved symptom improvement at 10 weeks continued and were evaluated at the 1-year mark.

1 year
365 days icon

60% experienced symptom improvement Symptom improvement or “clinical response” was defined as an improvement in symptoms (stool frequency and rectal bleeding) and/or the clinical results of an endoscopy. “Clinical response” can be different for everyone because it is based on the severity of your UC when you start taking a certain treatment.
(vs 41% on placebo)

ZEPOSIA® remission icon 2

37% were in remission Remission was defined as: No rectal bleeding Reduction of stool frequency to normal, or one or two stools more than normal Improvement in how the intestinal lining looked during an endoscopy, representing mild or inactive disease in the colon
(vs 19% on placebo)

ZEPOSIA was studied against placebo.
Individual results may vary.

More than half the people (n=41/79) in remission at 10 weeks with ZEPOSIA continued to experience lasting remission at the 1-year mark.

Additional results at 1 year

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Reduced intestinal inflammation

ZEPOSIA can help with intestinal healing by reducing inflammation on and below the surface of the colon lining.‡

  • 30% of patients achieved this result compared to 14% on placebo. Impact of intestinal healing on UC progression and long-term outcomes were not studied.
Steroids-free icon

Steroid-free remission

People taking ZEPOSIA were nearly 2 times more likely to achieve lasting steroid-free remission compared to those on placebo at 1 year.†

  • 32% of patients taking ZEPOSIA vs 17% on placebo.
Amy, real ZEPOSIA® patient Amy, real ZEPOSIA® patient
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Within weeks of starting ZEPOSIA, I felt very much like I had before my diagnosis. My symptoms have gone into remission and have stayed that way.

—Amy
A real ZEPOSIA patient compensated for her time.
(Individual results may vary.)

Watch Amy’s story
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Learn about ZEPOSIA safety and side effects

ZEPOSIA has a well-established safety profile across 4 clinical trials and 2 conditions.§ See the side effects that were reported in the UC clinical trials.

Explore safety
  • ZEPOSIA was studied in ulcerative colitis and multiple sclerosis in over 1,300 patients.

How the clinical study was designed

ZEPOSIA was studied in a 1-year clinical study where all participants (ZEPOSIA: 429, placebo: 216) were first evaluated at 10 weeks. Those who had achieved symptom improvement at 10 weeks were then able to continue in the study (ZEPOSIA: 230, placebo: 227) and be evaluated at the 1-year mark.

Patients were to be receiving treatment with an oral 5-ASA and/or steroids to enter the study.

The study was randomized and placebo controlled. This means participants were randomly placed into 1 of 2 groups: those taking ZEPOSIA and those taking a placebo pill (not ZEPOSIA).

The demographics of the study participants were:

ZEPOSIA® clinical study participant average age graphic ZEPOSIA® clinical study participant average age graphic

Learn about the safety and side effects of ZEPOSIA

Learn about the side effects that were reported in the UC clinical trial.

Explore safety

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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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