5 things to know about this relapsing multiple sclerosis (MS) treatment that comes in a pill
Reasons to take a look at ZEPOSIA® (ozanimod)
If you have relapsing MS, finding treatment that works best for you means knowing what treatment options are out there. Discover a once-daily pill for people living with relapsing 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. It is not known if ZEPOSIA is safe and effective in children.
Here are 5 things to know about ZEPOSIA.
1. ZEPOSIA is a once-daily pill
Unlike many treatments for MS, ZEPOSIA is a pill that you take once a day.
2. ZEPOSIA was more effective than a leading injectable medicine (Avonex)*
More than 1,700 people participated in two clinical studies, combined. That’s the largest number of people in two studies that compared one MS medication to another.
*Avonex (interferon beta-1a).
In a one-year study, people who took ZEPOSIA had 48% fewer relapses than people who took a leading injectable medicine. And in a two-year study, people who took ZEPOSIA had 38% fewer relapses than with a leading injectable.†
†In the one-year study, people taking ZEPOSIA had an Annualized Relapse Rate (ARR) of 0.181 vs 0.350 with a leading injectable. In the two-year study, people taking ZEPOSIA had an ARR of 0.172 vs 0.276 with a leading injectable. To measure relapses, the Annualized Relapse Rate was used, which is the average number of relapses a group of people have in one year. A total of 895 people were in the one-year study (ZEPOSIA 447, a leading injectable 448). A total of 874 people were in the two-year study (ZEPOSIA 433, a leading injectable 441).
MORE PEOPLE WERE RELAPSE FREE
In the one-year study, 78% of people who took ZEPOSIA were relapse free at one year (versus 66% of people who took a leading injectable). And in the two-year study, 76% of people who took ZEPOSIA were relapse free at two years (versus 64% of people who took a leading injectable).‡
‡A relapse was defined as new or worsening symptoms directly associated with MS that lasted more than twenty-four hours (after having a mostly stable neurological state for at least thirty days).
FEWER NEW OR ENLARGING LESIONS (T2), TOO
The one-year study also showed that people taking ZEPOSIA had 48% fewer new or enlarging lesions (T2) than people who took a leading injectable medicine. And in the two-year study, people taking ZEPOSIA had 42% fewer new or enlarging lesions (T2) than with a leading injectable.§
§In the one-year study, people taking ZEPOSIA had an average of 1.47 lesions (T2) vs 2.84 with a leading injectable. In the two-year study, people taking ZEPOSIA had an average of 1.84 lesions (T2) vs 3.18 with a leading injectable.
Disability progression was also measured
When taking ZEPOSIA or Avonex, 9 out of 10 people experienced no progression of physical disability.THERE WAS NO SIGNIFICANT DIFFERENCE in disability progression: 7.6% of people experienced disability progression with ZEPOSIA vs 7.8% with a leading injectable medicine. Physical disability progression was measured every 3 months and combined from both studies.
3. ZEPOSIA was also studied for safety
It's important to know as much about your medicine as you can, including information about its safety.
There were two studies—one lasting one year and another lasting two years. The studies looked at 882 people taking ZEPOSIA, and 90% of them stayed with the treatment for the entire clinical study. Of those who stopped taking ZEPOSIA, 3% did so because of a side effect they experienced. The rest left the studies for a variety of other reasons.
Possible serious side effects
These are the serious side effects reported by people who took ZEPOSIA during the clinical studies.
Infections that can be life-threatening and cause death
Slow heart rate when you start taking ZEPOSIA
Increased blood pressure
Macular edema (a vision problem)
Swelling and narrowing of blood vessels in your brain
Severe worsening of MS after stopping ZEPOSIA compared to before or during treatment
To learn more about these side effects and the possible symptoms, please see the Important Safety Information below.
Most common side effects
During both of the clinical studies, 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 upon standing
Painful and frequent urination
High blood pressure
These are not all of the side effects of ZEPOSIA. Please see the Prescribing Information (link below) for information on all of the side effects reported by those taking ZEPOSIA. If you experience any side effects while taking ZEPOSIA, be sure to talk to your doctor right away.
“Once-daily oral dosing has held great appeal to my patients, and I am pleased with the clinical results seen with ZEPOSIA.”
—Edward J. Fox, MD, PhD Director, Multiple Sclerosis Clinic of Central Texas||
5. The ZEPOSIA 360 Support™ program will help you every step of the way
ZEPOSIA has a program to help guide you called ZEPOSIA 360 Support. You can talk to an MS Nurse Navigator about treatment with ZEPOSIA, navigating insurance benefits, assistance with financial support, and much more. You can call 1-833-ZEPOSIA (833-937-6742), Monday to Friday, 8 ᴀᴍ - 8 ᴘᴍ ET.
Wondering if ZEPOSIA is right for you?
Your MS healthcare team can tell you even more about ZEPOSIA. Schedule an appointment to ask about ZEPOSIA and whether it’s right for you. Here are some questions you can ask your MS healthcare team.
And to learn even more about ZEPOSIA and the ZEPOSIA 360 Support program, visit ZEPOSIA.com.
||Paid medical consultant of BMS.
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
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:
feeling very tired
painful and frequent urination (signs of a urinary tract infection)
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:
feeling like your heart is beating slowly or skipping beats
shortness of breath
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
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
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
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.
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:
stomach area (abdominal) pain
loss of appetite
yellowing of the whites of your eyes or skin
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 loss of vision or other changes in your vision
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
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)
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.