Zeposia (ozanimod) is a sphingosine 1-phosphate (S1P) receptor modulator that's used to treat adults with ulcerative colitis (UC) or relapsing forms of multiple sclerosis (MS). It's a capsule that's taken by mouth, usually once per day (or as directed by your provider if you have certain liver problems). There are starter packs of the medication that help you slowly raise the dosage to a maintenance dosage over a week. Side effects typically depend on your medical condition, but generally include infections and changes in liver tests.
Relapsing forms of multiple sclerosis (MS) in adults
Moderate-to-severe ulcerative colitis (UC) in adults
Zeposia (ozanimod) is a sphingosine 1-phosphate (S1P) receptor modulator. It attaches to the S1P receptor protein that's found on your white blood cells. It's thought that this blocks white blood cells from leaving your lymph nodes and releasing into the body. This helps to lower inflammation in the body, which might help improve symptoms of UC and MS.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Only need to take up to once daily
7-capsule starter pack available to help make it easier to know what dose to take at the beginning of treatment
Can start to work within a couple weeks to improve UC symptoms
Many people with MS are relapse-free after taking this medication for 1 year
Must raise your dose slowly over the first week of treatment, which can be confusing
Might raise your risk of infections
Unknown if it works well or is safe to use for children under 18 years of age
Not recommended for use in people with severe liver problems
When you first start Zeposia (ozanimod), you'll get a 7-day starter pack with different-colored capsules: light grey, half-light grey and half-orange, and orange. This starter pack helps you slowly raise your dose to reach the maintenance dose. The pack shows you which dose to take each day for the first week. After the first week, you'll take the same dose each time you need to take the medication.
Take Zeposia (ozanimod) at the same time every day. Swallow the capsules whole, with or without food. But if it's upsetting your stomach, taking the medication with food might help.
Avoid foods and drinks that have a high amount of tyramine (e.g., aged cheeses, alcohol, pickled or fermented foods). Consuming these products while you're taking Zeposia (ozanimod) can cause dangerously high blood pressure.
Before you get any vaccines, it's important to tell your provider or pharmacist that you're taking Zeposia (ozanimod). It's generally safe to get most types of vaccines, including the flu shot. But you should avoid live vaccines because they might not be safe or work well with Zeposia (ozanimod). It's best to get any live vaccines at least 1 month before you start or 3 months after you stop the medication.
Tell your providers about all your medications so they can check for dangerous drug interactions with Zeposia (ozanimod). For example, taking Zeposia (ozanimod) with medications that affect your immune system could raise your risk for serious infections. And taking Zeposia (ozanimod) with beta-blockers can cause severely low heart rate.
If you can get pregnant, use reliable birth control during treatment with Zeposia (ozanimod) and for at least 3 months after your last dose. Based on animal studies, it's possible that the medication can harm an unborn baby. Tell your providers if you become pregnant so they can discuss with you about enrolling in the Zeposia pregnancy registry. This registry keeps track of your health and your baby's health if you've taken the medication during pregnancy.
It's generally recommended to avoid breastfeeding while you're taking Zeposia (ozanimod) because it can be toxic to your baby. Talk to your provider about safe ways to feed your baby or about your options if it isn't possible to avoid breastfeeding.
Ask your provider or pharmacist what to do if you miss a dose. If you miss a dose during your first 2 weeks of treatment, your provider might have you restart the starter pack and go back to the starting dose.
Don't stop taking Zeposia (ozanimod) without talking to your provider first. Stopping the medication can cause your MS symptoms to come back. Sometimes, the symptoms can be worse than they were before you started the medication. Tell your provider if you have worsening symptoms of MS if you stop Zeposia (ozanimod) so they can help you manage your symptoms.
Zeposia (ozanimod) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Active, chronic (long-term), or recurrent infection | Age 65 years and older | Having other conditions that raise your risk of infection | Taking medications that weaken your immune system
Zeposia (ozanimod) can lower your body's ability to fight off infections, which can put you at risk for serious bacterial, viral, or fungal infections. Make sure you're up-to-date on all of your vaccinations before you start this medication. Let your provider know if you develop symptoms of an infection, such as fever, chills, cough, trouble breathing, or diarrhea. Your provider might ask you to stop taking Zeposia (ozanimod) if you develop an infection during treatment, so your body can fight the infection first.
Risk factors: Medical conditions that cause a weak immune system | Taking medications that weaken your immune system
Medications like Zeposia (ozanimod) can put you at risk of developing progressive multifocal leukoencephalopathy (PML), which can lead to a serious inflammatory reaction. PML is a brain infection caused by the John Cummingham virus (JCV). Though it's a common virus, people who get infected with JCV usually don't have any symptoms. But in people who have a weakened immune system, JCV can cause PML, which can be fatal or lead to severe disability. Seek medical attention right away and get tested for PML if you have weakness on one side of the body, feel clumsy, or notice changes in personality, vision, or memory.
Risk factors: Taking other medications that affect heart rate | History of heart problems | Starting Zeposia (ozanimod) | Restarting Zeposia (ozanimod) after not taking it for awhile
Zeposia (ozanimod) can cause a temporary drop in heart rate when you take the medication. This brief drop in heart rate can start with the first dose of Zeposia (ozanimod). Sometimes, the drop in heart rate can be dangerous, though there haven't been any reports of serious heart block in clinical studies of the medication so far.
Let your provider know if you have any heart-related conditions or if you're taking medications that also affect heart rate. Seek medical help if you have symptoms of low heart rate while you're taking Zeposia (ozanimod), such as fatigue, weakness, confusion, feeling faint, trouble breathing, and chest pain.
Risk factors: History of heart problems | Uncontrolled high blood pressure
Zeposia (ozanimod) can raise your blood pressure, even at recommended doses. Ask your provider whether Zeposia (ozanimod) is safe for you before you start treatment if you have heart problems or high blood pressure.
It's recommended to avoid certain foods that contain very high amounts (more than 150 mg) of tyramine because they can cause high blood pressure while you're taking Zeposia (ozanimod). Get medical attention right away if you get severe headaches, nosebleeds, trouble breathing, vision changes, irregular heartbeat, or chest pain while you're taking Zeposia (ozanimod). These can be signs of severely high blood pressure.
Zeposia (ozanimod) can raise the level of liver enzymes in your blood, which can be a sign of liver damage. Your provider will regularly order blood tests (called liver function tests) while you're taking this medication to check your liver health. Tell your provider if you have symptoms of liver problems, such as nausea, stomach pain, or yellowing of your skin or whites of your eyes.
Based on animal studies, it's possible that Zeposia (ozanimod) can harm an unborn baby when it's taken during pregnancy. If you're able to have a child, you should use birth control to avoid pregnancy during treatment and for at least 3 months after your last dose of Zeposia (ozanimod). Let your provider know right away if you become pregnant or think you might be pregnant while you're taking this medication.
Zeposia (ozanimod) can cause breathing problems. This can sometimes happen as early as 3 months after you start the medication. Tell your provider if you have trouble breathing while you're taking this medication. You might need to do routine breathing tests to check how well your lungs are working.
Risk factors: Diabetes | History of eye inflammation (uveitis)
A few people developed an eye condition called macular edema while they were taking Zeposia (ozanimod). Your provider will examine your eyes before and during treatment. Make sure you let them know if you start to have blurry or worsening vision at any time while you're taking Zeposia (ozanimod).
Although rare, there have been reports of a brain problem called posterior reversible encephalopathy syndrome (PRES) in people who take medications like Zeposia (ozanimod). So far, there haven’t been many reports of PRES in people who take Zeposia (ozanimod). But it's important to be aware of this risk because it can lead to serious complications, such as stroke. Contact your provider right away if you notice a sudden headache, seizures, loss of consciousness, or changes in vision or behavior.
Days 1 to 4: The typical dose is 0.23 mg by mouth once daily.
Days 5 to 7: The typical dose is 0.46 mg by mouth once daily.
Day 8 and onward: The typical dose is 0.92 mg by mouth once daily.
Your provider will adjust the dose if you have liver problems.
Recent heart attack, unexpected chest pain, stroke, "mini-stroke", or severe heart failure within the last 6 months
Certain heart rate or rhythm problems (e.g., AV block, sick sinus syndrome), unless you have a functioning pacemaker
Severe untreated sleep apnea
Take a medication called a monoamine oxidase inhibitor (MAOI)
Relapsing forms of multiple sclerosis (MS) in adults
Moderate-to-severe ulcerative colitis (UC) in adults
Relapsing forms of multiple sclerosis (MS)
Relapsing forms of multiple sclerosis (MS)
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