Sponsored: A Different Pill for Ulcerative Colitis (UC): What You Need to Know
By ZEPOSIA®(ozanimod) and Bristol-Myers Squibb Company
Get to know ZEPOSIA®(ozanimod): A once-daily pill for adults with moderate to severe ulcerative colitis (UC)
Reasons to take a look at ZEPOSIA
For people with UC, finding a treatment that’s right for them can sometimes be a challenge. There’s ZEPOSIA, a once-daily pill that can help people achieve and maintain remission of ulcerative colitis.
ZEPOSIA is the first and only treatment of its kind for UC.* ZEPOSIA is different. It's not a biologic, 5-ASA, or steroid. Learn about 5 things you should know when it comes to ZEPOSIA.
ZEPOSIA selectively targets a specific part of immune cells called an S1P receptor. The S1P receptor plays an important role in the UC inflammation process.
1. ZEPOSIA is a once-daily pill, not an injection or infusion
ZEPOSIA can be taken:
- With or without food
- When and where you want
The Prescribing Information for ZEPOSIA has no requirement for refrigeration
“This once a day pill for patients with moderate to severe
ulcerative colitis is an exciting treatment option that offers
a different approach to addressing this inflammatory condition,
welcomed by patients and their healthcare providers.”
Russell D. Cohen, MD FACG AGAF
Professor of Medicine
The University of Chicago Medicine†
†Paid medical consultant of BMS.
2. ZEPOSIA was proven to help people achieve and maintain remission‡ of UC
ZEPOSIA was evaluated in a 1-year clinical trial where all study participants (ZEPOSIA: 429, placebo: 216) were first evaluated at 10 weeks. Patients were to be receiving treatment with an oral 5-ASA and/or steroids to enter the trial. Those who had achieved symptom relief§ at 10 weeks were then able to continue in the study and were evaluated at the 1-year mark (ZEPOSIA: 230, placebo: 227). Here are the results:
Early remission at 10 weeks
People taking ZEPOSIA were 3X more likely to achieve remission at 10 weeks of treatment than those on placebo.
Lasting remission at 1 year‖
Almost 40% of people taking ZEPOSIA were in remission at 1 year.
At 1 year, 37% of ZEPOSIA patients achieved remission compared to 19% on placebo. Only patients who achieved symptom relief at 10 weeks continued and were evaluated at the 1-year mark.
Relief in as early as 2 weeks
ZEPOSIA can reduce rectal bleeding and stool frequency in as early as
Reduces Inflammation From The Inside
ZEPOSIA treats ulcerative colitis by reducing inflammation below the surface and improving the appearance of the colon at 1 year.¶
¶30% of people taking ZEPOSIA achieved this result compared to 14% taking the placebo.
“Early symptom relief and lasting remission are possible for my
UC patients with this once-daily pill.”
Douglas C. Wolf, MD
Director of IBD Research
Medical Director, Southeastern Center for Crohn’s & Colitis
Atlanta Gastroenterology Associates
#Paid medical consultant of BMS.
3. ZEPOSIA was also studied for safety
The safety of ZEPOSIA was evaluated among people in a clinical trial. Of those evaluated at 10 weeks (N=429), 94% remained on treatment and 3.3% stopped due to a side effect they experienced. Of those evaluated at
1 year (N=230), 80% remained on treatment and 1.3% stopped due to a side effect they experienced.
Possible serious side effects
These are the serious side effects reported by people taking ZEPOSIA during the clinical trial:
- Progressive multifocal leukoencephalopathy (PML)
- Slow heart rate when you start taking ZEPOSIA
- Liver problems
- Increased blood pressure
- Breathing problems, such as shortness of breath
- Macular edema (a vision problem)
- Swelling and narrowing of blood vessels in your brain
Most common side effects
During the clinical trial, people who took ZEPOSIA were asked to report any side effects that they experienced. These were the most common:
- 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
4. ZEPOSIA is the first and only treatment of its kind for UC
ZEPOSIA is the first and only S1P receptor modulator approved for UC. S1P receptors are a specific part of immune cells that play an important role in inflammatory conditions like UC.
5. The ZEPOSIA 360 Support™ program can help you every step of the way
Have questions about ZEPOSIA or starting treatment? With ZEPOSIA 360 Support, a UC Nurse Navigator is there to make sure you have all the answers you need when it comes to ZEPOSIA. A dedicated UC Nurse Navigator can also help with insurance benefits, financial support, and so much more, including determining if you’re eligible for the ZEPOSIA $0 co-pay offer.**
Depending on insurance coverage, patients may be eligible to receive a prescription benefit offer for out-of-pocket drug costs and pay as little as $0 per prescription. Maximum savings limit applies; patient out-of-pocket expenses may vary. This program is not health insurance. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Please click here for Program Terms, Conditions, and Eligibility Criteria.
Wondering if ZEPOSIA is right for you? Here are 3 things you can do to get started:
- Connect with your healthcare provider. Here are some questions to get the conversation started
- Visit ZEPOSIA.com to learn more about ZEPOSIA and the ZEPOSIA 360 Support program
- Connect with a UC Nurse Navigator by calling 1-833-ZEPOSIA
(833-937-6742), Monday to Friday, 8 AM - 8 PM ET
ZEPOSIA® (ozanimod) 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.
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:
- feeling very tired
- flu-like symptoms
- painful and frequent urination (signs of a urinary tract infection)
- 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:
- feeling like your heart is beating slowly or skipping beats
- shortness of breath
- chest pain
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
- 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
- stomach area (abdominal) pain
- 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
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
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.
ZEPOSIA, ZEPOSIA 360 Support and ZEPOSIA logo are trademarks of Celgene Corporation, a Bristol Myers Squibb company.
© 2022 Bristol-Myers Squibb Company. 2084-US-2200112 03/22