• Supporting You with UC Provides Patients with Resources to Help Manage Their UC and Tips on Ways to Communicate with Their Doctor

PRINCETON, N.J. / Jul 12, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) has launched Supporting You with UC, an ulcerative colitis (UC) educational campaign with patient ambassador* Rosie White. The Supporting You with UC website includes White’s personal UC diagnosis and treatment journey, along with a collection of practical resources for people living with the disease to help manage symptoms on the go and in their everyday lives.

There are approximately 600,000 to 900,000 people in the United States living with UC — a chronic, immune-mediated inflammatory bowel disease (IBD).^1,2,3 UC presents as a range of symptoms that can be unique to each patient, hard to predict and can change over time.⁴ People with UC can find the symptoms of this condition — which can include urgent and frequent bowel movements and bloody stool, among others — stressful, embarrassing and having a negative impact on their daily lives.⁵

White is using her platform as a TV sports commentator, former professional soccer player, coach, public speaker and person living with moderate to severe UC to empower others to speak up about their experiences.

“When I first experienced symptoms of ulcerative colitis, I found it uncomfortable to talk to my loved ones and my doctor, making me feel isolated and stressed and causing my symptoms to worsen to the point of ending up in the hospital,” said White. “By getting involved in Supporting You with UC, I hope to motivate others to find the courage to have a voice and have those difficult conversations sooner than I did.”

White suffered with symptoms for years prior to being diagnosed with moderate to severe UC. To manage her UC symptoms, White’s physician prescribed Zeposia^® (ozanimod), a once-daily, oral treatment regimen for moderate to severe ulcerative colitis.⁶ White allowed Zeposia to become part of her routine, and it provided the flexibility she needed for travel and work. White’s doctor helped her understand the serious side effects that are possible with Zeposia, including an increased risk of serious infections, PML — a rare brain infection, slow heart rate, liver problems, increased blood pressure, breathing problems, a vision problem called macular edema and swelling and narrowing of the blood vessels in the brain.⁶ See additional Important Safety Information below.

“Our aim is for people with ulcerative colitis to have support that helps them navigate their illness,” explained Michael Braun, senior vice president, U.S. Immunology, Bristol Myers Squibb. “We hope patients find inspiration in Rosie’s story and feel empowered to share their experiences and advocate for themselves to better manage their disease.”

To learn more, visit www.SupportingYouwithUC.com. Additional patient resources are available such as: a downloadable resource with lifestyle tips for living with moderate to severe UC, a UC symptoms quiz and a bathroom access card with information on bathroom access laws by U.S. state.

To learn more, visit Zeposia.com.

*Rosie White is an actual Zeposia^® patient who was compensated by Bristol Myers Squibb for her time.

About Ulcerative Colitis

Ulcerative colitis (UC), a type of chronic IBD, is an immune-mediated disease that causes inflammation and ulcers (sores) in the large intestine, affecting the colon and rectum.^1,2 Approximately 600,000 to 900,000 people are living with UC in the United States.¹ Symptoms can include urgent and frequent bowel movements, bloody stool, abdominal cramps and pain and diarrhea.^1,4 Ulcerative colitis can have an impact on patients' health-related quality of life, including physical functioning, social and emotional well-being and ability to go to work/school.⁷ UC can be diagnosed at any age, but many people are diagnosed between the ages of 15 and 30.¹

About Zeposia^® (ozanimod)

Zeposia^® (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5.^1,8 Zeposia reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood.⁸ The mechanism by which Zeposia exerts therapeutic effects in ulcerative colitis is unknown, but may involve the reduction of lymphocyte migration into the intestines.

Zeposia was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. Zeposia was approved by the FDA for the treatment of moderate to severe ulcerative colitis (UC) in May 2021.

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.

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 https://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.

Zeposia is available as 0.92mg capsules.

Please see full Prescribing Information, including Medication Guide.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

References

1. “Definition & Facts of Ulcerative Colitis.” National Institute of Diabetes and Digestive Kidney Diseases, Sept. 2020, https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis/definition-facts.
2. “Ulcerative Colitis.” Mayo Clinic, 16, Sept. 2022, https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326.
3. Singh, S., et. al. “Systematic review with network meta-analysis: first- and second-line pharmacotherapy for moderate-severe ulcerative colitis.” Alimentary Pharmacology & Therapeutics, vol. 47, no. 2, 2017, pp. 162-175.
4. “Overview.” American College of Gastroenterology, May 2010, https://gi.org/topics/ulcerative-colitis/.
5. “Ulcerative Colitis.” Cleveland Clinic, 23 Apr. 2020, https://my.clevelandclinic.org/health/diseases/10351-ulcerative-colitis.
6. “HIGHLIGHTS OF PRESCRIBING INFORMATION.” Bristol Myers Squibb, Nov. 2022, https://packageinserts.bms.com/pi/pi_zeposia.pdf.
7. Rubin D, Ananthakrishnan A, Siegel C, Sauer B, Long M. ACG Clinical Guideline: Ulcerative Colitis in Adults. American Journal of Gastroenterology. 2019;114:384–413. doi:10.14309
8. Scott FL, Clemons B, Brooks J, et al. Ozanimod (RPC1063) is a potent sphingosine-1- phosphate receptor-1 (S1P1) and receptor-5 (S1P5) agonist with autoimmune disease-modifying activity. Br J Pharmacol. 2016;173(11):1778-1792. doi:10.1111/bph.13476