View transcript +

Doctor: When it comes to treating ulcerative colitis, or “UC,” it’s important to understand what’s going on inside.

Visuals: Doctor points to a whiteboard that reads, “Ulcerative colitis (UC): a type of inflammatory bowel disease that causes inflammation in the lining of the colon.”

Patient: That would be helpful!

Doctor: Great! Let’s take a closer look at why UC happens and how ZEPOSIA, a once-daily pill, is thought to help. We’ll start with one of the key players in UC—the immune system.

Visuals: Doctor rotates the whiteboard which now displays: “Immune system = your body’s defense”
[images of] Molecules, Cells, Tissues, Organs “It protects your body.”

Doctor: The immune system is your body’s natural defense system. It’s made up of molecules, cells, tissues, and organs that all work together to protect your body. And your immune cells are especially important. They circulate throughout the body, traveling to where they’re needed most.

In fact, think of your body as a vast network of roads and pathways that connect all of the important systems, functions, and locations within.

Visuals: Doctor points outside the window, revealing a vast network of roads representing the immune system. A car labeled “immune cell” drives down one of the roads, passing a “lymph node ahead” sign.

If the body is functioning normally, it recruits some of these immune cells from the lymph nodes to fight off problems, like infections.

Visuals: White cars are traveling around the “lymph node” roundabout. One car takes an exit, as another enters the roundabout.

But for someone with UC, the immune system has an irregular response—specifically, in the colon.

Visuals: Three of the cars take an exit labeled “colon” into a tunnel road. The digital sign above the tunnel entrance reads “Colon traffic.”

This means immune cells travel to the large intestine and rectum when they aren’t needed, which can lead to inflammation and tissue damage. That’s what causes the unpleasant symptoms we associate with UC—like rectal bleeding and increased stool frequency.

Visuals: Several cars are in the tunnel, causing a traffic jam. A red light emanates from the tunnel and the digital sign changes to “Caution: Inflammation Ahead,” then flashes “Caution: Rectal Bleeding,” “Caution: Increased Stool Frequency.”

However, there are ways to treat the inflammation caused by UC. And one option is ZEPOSIA.

ZEPOSIA is a once-daily pill for adults with moderate to severe UC—and the first and only treatment of its kind.

Visuals: A car passes a billboard that reads:
Once-daily
ZEPOSIA® (ozanimod) | 0.92 mg capsules
A once-daily pill for adults with moderate to severe UC
ZEPOSIA is the first and only S1P receptor modulator approved for UC.

Patient: So, how does it work?

Doctor: It’s thought to act as a gatekeeper, helping to prevent certain immune cells from leaving the lymph nodes altogether.

Visuals: A toll booth at the colon exit stops ZEPOSIA cars from entering the colon. When a regular immune cell approaches, the gate goes up, but when a ZEPOSIA immune cell enters, the gate goes down.

ZEPOSIA is what’s known as an S1P receptor modulator. This means it works differently than other treatment options like biologics, 5-ASAs, or steroids.

Visuals: A ZEPOSIA-labeled car drives down the road and text appears above it: “ZEPOSIA is an S1P receptor modulator. Not a biologic, 5-ASA, or steroid.”

How? Well, it modulates.

ZEPOSIA attaches to something called S1P receptors, which are located on the surface of certain immune cells. This attachment sends a signal that prevents these immune cells from leaving the lymph nodes and, ultimately, entering the colon.

The exact way ZEPOSIA works isn't fully understood, but fewer immune cells in your colon may mean a lower risk of damaging inflammation—and the symptoms that come with it.

Visuals: Regular immune cells are able to enter the colon tunnel, while ZEPOSIA immune cells remain in the lymph node. With fewer immune cells in the tunnel, traffic clears and the green arrow appears on the digital traffic board.

Patient: Makes sense!

Doctor: It’s important to understand how a treatment works in order to determine your best path forward. And if you’re experiencing UC symptoms, it may be time to consider something different.

Narrator: Don’t let UC stop you from doing you. Ask your UC healthcare provider about once-daily ZEPOSIA today.

View transcript +

Doctor: When it comes to treating ulcerative colitis, or “UC,” it’s important to understand what’s going on inside.

Visuals: Doctor points to a whiteboard that reads, “Ulcerative colitis (UC): a type of inflammatory bowel disease that causes inflammation in the lining of the colon.”

Patient: That would be helpful!

Doctor: Great! Let’s take a closer look at why UC happens and how ZEPOSIA, a once-daily pill, is thought to help. We’ll start with one of the key players in UC—the immune system.

Visuals: Doctor rotates the whiteboard which now displays:
“Immune system = your body’s defense”
[images of] Molecules, Cells, Tissues, Organs
“It protects your body.”

Doctor: The immune system is your body’s natural defense system. It’s made up of molecules, cells, tissues, and organs that all work together to protect your body. And your immune cells are especially important. They circulate throughout the body, traveling to where they’re needed most.

In fact, think of your body as a vast network of roads and pathways that connect all of the important systems, functions, and locations within.

Visuals: Doctor points outside the window, revealing a vast network of roads representing the immune system. A car labeled “immune cell” drives down one of the roads, passing a “lymph node ahead” sign.

If the body is functioning normally, it recruits some of these immune cells from the lymph nodes to fight off problems, like infections.

Visuals: White cars are traveling around the “lymph node” roundabout. One car takes an exit, as another enters the roundabout.

But for someone with UC, the immune system has an irregular response—specifically, in the colon.

Visuals: Three of the cars take an exit labeled “colon” into a tunnel road. The digital sign above the tunnel entrance reads “Colon traffic.”

This means immune cells travel to the large intestine and rectum when they aren’t needed, which can lead to inflammation and tissue damage. That’s what causes the unpleasant symptoms we associate with UC—like rectal bleeding and increased stool frequency.

Visuals: Several cars are in the tunnel, causing a traffic jam. A red light emanates from the tunnel and the digital sign changes to “Caution: Inflammation Ahead,” then flashes “Caution: Rectal Bleeding,” “Caution: Increased Stool Frequency.”

However, there are ways to treat the inflammation caused by UC. And one option is ZEPOSIA.

ZEPOSIA is a once-daily pill for adults with moderate to severe UC—and the first and only treatment of its kind.

Visuals: A car passes a billboard that reads:
Once-daily
ZEPOSIA® (ozanimod) | 0.92 mg capsules
A once-daily pill for adults with moderate to severe UC
ZEPOSIA is the first and only S1P receptor modulator approved
for UC.

Patient: So, how does it work?

Doctor: It’s thought to act as a gatekeeper, helping to prevent certain immune cells from leaving the lymph nodes altogether.

Visuals: A toll booth at the colon exit stops ZEPOSIA cars from entering the colon. When a regular immune cell approaches, the gate goes up, but when a ZEPOSIA immune cell enters, the gate goes down.

ZEPOSIA is what’s known as an S1P receptor modulator. This means it works differently than other treatment options like biologics, 5-ASAs, or steroids.

Visuals: A ZEPOSIA-labeled car drives down the road and text appears above it: “ZEPOSIA is an S1P receptor modulator. Not a biologic, 5-ASA, or steroid.”

How? Well, it modulates.

ZEPOSIA attaches to something called S1P receptors, which are located on the surface of certain immune cells. This attachment sends a signal that prevents these immune cells from leaving the lymph nodes and, ultimately, entering the colon.

The exact way ZEPOSIA works isn't fully understood, but fewer immune cells in your colon may mean a lower risk of damaging inflammation—and the symptoms that come with it.

Visuals: Regular immune cells are able to enter the colon tunnel, while ZEPOSIA immune cells remain in the lymph node. With fewer immune cells in the tunnel, traffic clears and the green arrow appears on the digital traffic board.

Patient: Makes sense!

Doctor: It’s important to understand how a treatment works in order to determine your best path forward. And if you’re experiencing UC symptoms, it may be time to consider something different.

Narrator: Don’t let UC stop you from doing you. Ask your UC healthcare provider about once-daily ZEPOSIA today.

Show all topics +

The immune system is the body's natural defense against infection.

Immune cells circulate in the bloodstream, some of them passing through small glands called lymph nodes, traveling throughout the body to wherever they are needed.

If a problem is detected, like an infection, immune cells circulating in the body recruit more cells from the lymph nodes to help fight it off.

Graphic showing colon and rectum Graphic showing colon and rectum

The exact cause of UC is unknown, but it is believed to be related to an irregular immune response. In UC, the immune system responds incorrectly and recruits immune cells to the colon (large intestine and rectum).

This results in ongoing (chronic) inflammation that damages the colon and causes the symptoms that people with UC may experience. Learn more about UC.

Graphic explains what happens in people with ulcerative colitis Graphic explains what happens in people with ulcerative colitis

*The exact way ZEPOSIA works is not known. However, by binding to S1P receptors on immune cells, ZEPOSIA is thought to act as a gatekeeper, helping to keep these cells from moving out of the lymph nodes and into the colon.

By keeping these cells out of the intestines, ZEPOSIA may help prevent them from causing the damaging inflammation seen in UC.

Graphic explains how ZEPOSIA (ozanimod) is meant to help in patients with ulcerative colitis Graphic explains how ZEPOSIA (ozanimod) is meant to help in patients with ulcerative colitis

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Important Safety Information

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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 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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Important Safety Information

Expand

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.

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