Supporting the Multiple Sclerosis Patient Community

Bristol Myers Squibb’s oral treatment for relapsing forms of MS now commercially available, with support offerings

June 01, 2020

??This is intended for U.S. residents 18 years of age and older.
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nticipation surrounding the U.S. Food and Drug Administration’s (FDA) approval of Bristol Myers Squibb’s ZEPOSIA??(ozanimod) 0.92 mg, a new, once-daily oral medication for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease,1?was high. Patients had been in need of new options, and it marked the first approval since Bristol Myers Squibb and Celgene combined. Yet, hardly anything about this approval felt like “business as usual.” The company received the news on March 25, 2020, in the midst of an unprecedented pandemic.1

“Our focus at Bristol Myers Squibb is to always put patients at the center of what we do, so we made the difficult decision to delay the ZEPOSIA launch,” said Tina Deignan, vice president and U.S. head of Immunology, Bristol Myers Squibb. “It simply was not the right time to introduce a new therapy to multiple sclerosis patients, who may face a worsening of symptoms in response to infections like COVID-19,2?and were, in many cases, unable to leave their homes to see their doctors.”

In the subsequent weeks, the company closely monitored the environment in partnership with neurologists and the MS community, leading to an announcement on June 1 that ZEPOSIA is now commercially available in the U.S.

“We’re pleased to be able to offer this new treatment option1 to MS patients. There is no one-size-fits-all treatment for MS patients, and this community’s unmet need is still central to every action we take, and we are now turning our focus to making it accessible to all appropriate patients who need it,” Deignan added.

While the mechanism by which ZEPOSIA exerts therapeutic efforts in MS is unknown, the therapy may involve reducing lymphocyte (a type of white blood cell important to the immune system) movement from lymph nodes into the central nervous system, reducing the number of lymphocytes in peripheral blood. ZEPOSIA targets sphingosine-1-phospate (S1P) receptors with selectivity.1

ZEPOSIA is the only approved S1P receptor modulator that offers relapsing forms of MS patients an initiation with no genetic test and no label-based first-dose observation required for patients.1,3,4?An up-titration scheme should be used to reach the maintenance dosage of ZEPOSIA, as a transient decrease in heart rate and atrioventricular conduction delays may occur.1?Before initiation of treatment with ZEPOSIA, all patients require assessments including a recent complete blood count including lymphocyte count (within six months or after discontinuation of prior MS therapy), an ECG to determine whether preexisting conduction abnormalities are present, a recent liver function test (within six months), and consideration of current and prior medications, including vaccinations.1?For patients with a history of uveitis or macular edema, an ophthalmic assessment is required.1

ZEPOSIA is contraindicated in patients who in the last six months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure; patients who have a presence of Mobitz type II second or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial, unless the patient has a functioning pacemaker; patients with severe untreated sleep apnea; and patients taking a monoamine oxidase inhibitor.1 ZEPOSIA is associated with the following Warnings and Precautions: increased risk of infections, bradyarrhythmia and atrioventricular conduction delays, liver injury, fetal risk, increased blood pressure, respiratory effects, macular edema, posterior reversible encephalopathy syndrome, additive immunosuppressive effects from prior immune-modulating treatments, severe increase in disability after stopping ZEPOSIA, and immune system effects after stopping ZEPOSIA.1 Please see Important Safety Information for additional details. The most common adverse reactions (incidence ≥4%) were upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.1

The new therapy is launching with a support program – ZEPOSIA 360 Support?. The program offers support and many different financial options to participating appropriate adult patients with MS. This includes a co-pay of as little as $0 for eligible appropriate patients, assistance with financial support, reimbursement for some out-of-pocket medical costs – and a bridge program that may help appropriate patients with commercial insurance to receive free medication while they are waiting for insurance approvals. Dedicated MS Nurse Navigators will help ZEPOSIA MS patients schedule key appointments, understand insurance benefits, and assist with financial support. Terms, conditions, and eligibility criteria apply. More information is available at ZEPOSIA.com.

“Multiple sclerosis is a devastating neurological disease. We are committed to leveraging our Immunology expertise to do all we can to ensure this innovative compound ultimately benefits as many patients as possible,” said Deignan.

INDICATION?

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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.

It is not known if ZEPOSIA is safe and effective in children.

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

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 (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.

  • 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 below 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
  • 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 pregnant or plan to become pregnant. 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 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
  • strong CYP2C8 inhibitors such as gemfibrozil or?clopidogrel
  • medicines that inhibit breast cancer resistance protein transporters, such as cyclosporine and?eltrombopag
  • CYP2C8 inducers such as rifampin
  • opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinson's disease

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.

For additional safety information, please see the full?Prescribing Information?and?Medication Guide.

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 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.
  • allergic reactions.?Call your healthcare provider if you have symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue, or face

References:

  1. ZEPOSIA?(ozanimod) capsules for oral use.?Celgene Corporation. Full?presscribing?information. 3/2020.
  2. National MS Society. Multiple sclerosis & coronavirus.?Accessed at?https://www.nationalmssociety.org/What-you-need-to-know-about-Coronavirus-(COVID-19)?on April 17, 2020.
  3. GILENYA (fingolimod) capsules for oral use. Novartis Pharmaceuticals Corporation. Full prescribing information. 8/2019.
  4. MAYZENT (siponimod) tablets for oral use. Novartis Pharmaceuticals Corporation. Full prescribing information. 3/2019.

US-ZEP-20-0475?05-2020

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