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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.

Frequently asked questions about ZEPOSIA

Find answers to some of the most frequently asked questions about ZEPOSIA below.

It’s important to tell your UC healthcare provider about any other medicines or supplements that you’re taking or have recently taken, including:

  • Prescription medicines
  • Over-the-counter medicines
  • Vitamins
  • Herbal supplements

Using ZEPOSIA with other medicines can cause serious side effects.

Especially tell your UC healthcare provider if you take or have taken other medicines, such as:

  • Medicines that affect your immune system, such as alemtuzumab
  • Medicines to control your heart rhythm (also called 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
  • Medicines to treat Parkinson's disease
  • Medicines to control your heart rate and blood pressure (beta blocker medicines and calcium channel blocker medicines)

Before you start taking ZEPOSIA, two routine tests are required. If you have a history of certain eye conditions (macular edema or uveitis) or diabetes, you may also need an eye exam.

Let your healthcare provider know if you’ve had some of these tests within the last six months, as they may not need to be repeated:

Blood work—including complete blood count and liver function tests.

An electrocardiogram (ECG)—a common test that uses small sensors to monitor your heart and makes sure it’s working normally before you start treatment.

The ZEPOSIA Prescribing Information does not require ongoing lab monitoring unless indicated by your healthcare provider.

How long will the medical tests take?

If you plan to complete all of the tests in one visit at a healthcare provider’s office, it may take as little as 1 hour to complete. If your appointment is at home*, please be available for up to 2 hours.

Are there any potential out-of-pocket costs?

Depending on your insurance coverage and financial needs, there may be several different ways to save on the cost of ZEPOSIA and the tests needed before treatment. To learn more, speak with our Support Coordinators or explore ZEPOSIA cost information.†

  • Additional eligibility requirements and terms and conditions apply. Please see ZEPOSIA In-Home Medical Services Program Terms and Conditions.
  • While Support Coordinators can answer questions about ZEPOSIA 360 Support™, they cannot provide medical advice.

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.

Talk to your UC healthcare provider before receiving any vaccines while on ZEPOSIA.

See the question below for information about the varicella zoster virus (VZV) vaccine and taking ZEPOSIA.

Your doctor may require you to receive the varicella zoster virus (VZV) vaccine, also known as the chicken pox vaccine, before you take ZEPOSIA. The VZV vaccine includes two doses. If you haven't received the VZV vaccine in the past, you may need to postpone the start of treatment with ZEPOSIA.

If you're unsure of your vaccination status, there is a test that can determine whether or not you've already received the VZV vaccine, 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 for chickenpox and then wait 1 month before you start taking ZEPOSIA.

You should take ZEPOSIA exactly as prescribed by your UC healthcare provider.

If you miss 1 or more doses during the first 14 days of treatment, contact your UC healthcare provider. You'll need a new 7-day Starter Pack to restart treatment. This will allow you to increase your dosage gradually to help avoid a decrease in heart rate, which is a possible serious side effect of ZEPOSIA.

If you miss a dose after the first 14 days of treatment, take your scheduled dose (1 pill) the next day at your usual time.

A missed dose is when you don’t take ZEPOSIA on the scheduled day your doctor has prescribed.

Tyramine (TIE-ruh-meen) is a type of compound (monoamine compound) found naturally in the body. It can also be found in high amounts in certain foods and beverages. Consuming a large amount of tyramine while taking ZEPOSIA could lead to severe high blood pressure (hypertension).

It’s recommended that people taking ZEPOSIA avoid foods and beverages that have more than 150 mg of tyramine. The following foods may be high in tyramine and should be avoided:

  • Aged foods
  • Fermented foods
  • Cured foods
  • Smoked foods
  • Pickled foods

Click here for a list of common high-tyramine foods and beverages

The list includes the amount of tyramine per serving as well as the amount of each food and beverage that could contain 150 mg of tyramine.

Keep in mind, consuming multiple foods and beverages with any level of tyramine in them could result in a high amount of tyramine in the body.

Please note that different people react to tyramine differently. Speak with your healthcare provider before making any changes to your diet.

You and your healthcare professional should work together to make sure ZEPOSIA is right for you before starting treatment. Be sure to let your healthcare professional know if you have any of these conditions or do not know if you have any of these conditions before taking ZEPOSIA:

  • Have had a heart attack, chest pain (also known as unstable angina), a stroke or mini-stroke (also known as 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 irregular or abnormal heartbeat (also known as arrhythmia) that is not corrected by a pacemaker
  • Have untreated, severe breathing problems during your sleep (also known as sleep apnea)
  • Take certain medicines called monoamine oxidase (MAO) inhibitors (eg, selegiline, phenelzine, linezolid)

Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a female who can become pregnant, you should use effective birth control during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA.

Tell your healthcare provider right away if you become pregnant while taking ZEPOSIA or if you become pregnant within 3 months after you stop taking ZEPOSIA.

If you are a female who can become pregnant, you should use effective birth control during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Talk with your healthcare provider about what birth control method is right for you during this time.

If you have private or commercial insurance, you may be eligible to pay as little as $0 a month for your ZEPOSIA prescription. Additional eligibility requirements and terms & conditions apply. Please click here for more information.

How do I sign up?

You can sign up and determine if you’re eligible in two ways:

  • While Support Coordinators can answer questions about ZEPOSIA 360 Support, they cannot provide medical advice.

Before you begin treatment, your Support Coordinator will help you understand your medical and pharmacy benefits.

If you have private or commercial insurance and are experiencing delays or issues with coverage, the ZEPOSIA Bridge Program† may be able to provide ZEPOSIA to you, as needed (for up to 24 months).

  • Additional eligibility requirements and terms and conditions apply. Please see ZEPOSIA Bridge Program Terms and Conditions.

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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

Want more information on ZEPOSIA?

Sign up for more information about ZEPOSIA, UC tips, stories from real people taking ZEPOSIA, and more from ZEPOSIA 360 Support™.

Sign up now

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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