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Uses

What is Zeposia used for?

Zeposia is commonly used to treat multiple sclerosis (MS) or moderate-to-severe ulcerative colitis (UC). For MS, Zeposia can treat the following relapsing forms.

  • Clinically isolated syndrome (CIS)
  • Relapsing-remitting MS (RRMS)
  • Active secondary progressive MS (SPMS)

Learn more about Zeposia for MS and UC.

Zeposia may also be used for other conditions as determined by your healthcare provider.

How does Zeposia work (mechanism of action)?

Zeposia works by targeting immune cells, called lymphocytes. These cells play a key role in the inflammatory process in both the intestine and central nervous system. Zeposia helps reduce the frequency of multiple sclerosis relapses. 

How is Zeposia supplied (dosage forms)?

Brands and other names

  • Zeposia

Dosage forms and strengths

  • 0.23 mg, 0.46 mg, 0,92 mg oral capsules

How should I store Zeposia?

Zeposia should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Zeposia?

The most common side effects of Zeposia are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms 
  • Increased liver function tests
  • Low blood pressure upon standing (orthostatic hypotension)
  • Painful or frequent peeing because of an infection
  • Headache
  • Increased blood pressure (see below)
  • Back pain

There may be other side effects of Zeposia that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Zeposia?

While less common, the most serious side effects of Zeposia are described below, along with what to do if they happen.

Severe Allergic Reactions. Zeposia may cause allergic reactions, which can be serious. Stop taking Zeposia and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Zeposia can increase the risk of infection, including serious infections that can be life-threatening. This risk can last up to three months after you stop taking Zeposia. Call your healthcare provider if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Headache and a stiff neck, with fever, light sensitivity, nausea, or confusion (may be symptoms of an infection of the lining around your brain and spine)

Progressive Multifocal Leukoencephalopathy (PML). People taking Zeposia may develop a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop taking Zeposia and call your healthcare provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Weakness on one side of your body that gets worse
  • Seizures

Vision Problems. Zeposia may increase your risk of macular edema. Macular edema happens when fluid builds up in the back of your eye. People with eye inflammation (uveitis) or diabetes may have a higher risk of macular edema while taking Zeposia. Your healthcare provider will likely check your vision before you start taking Zeposia. Keep any scheduled eye exams. Call your healthcare provider right away if you have any of the following symptoms suggestive of macular edema.

  • Blurriness or shadows in the middle of your vision
  • Light sensitivity
  • A blind spot in the middle of your vision
  • Unusually colored or tinted vision

Posterior Reversible Encephalopathy Syndrome (PRES). Zeposia may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your healthcare provider right away if you have the following symptoms of PRES.

  • Changes in thinking or behavior
  • Confusion or hallucinations
  • Sudden decrease or change in vision
  • Sudden severe headache
  • Seizures

Heart Rate Changes. Zeposia can make your heart beat slower than normal (bradycardia). You will have an electrocardiogram (ECG) before starting therapy. This is a common test to monitor the rate and rhythm of your heart. Call your healthcare provider right away if you have any of the following symptoms of bradycardia. 

  • Feeling lightheaded, dizziness, or fainting
  • Confusion
  • Feeling weak or easily tired 
  • Chest pain
  • Shortness of breath
  • Feeling your heart beat slower or skipping a beat

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Zeposia. Keep all appointments to have your blood checked. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Increased Blood Pressure. Zeposia may increase your blood pressure or make your high blood pressure (hypertension) worse. In particular, Zeposia may make your blood pressure go up quickly (hypertensive crisis) when you eat certain foods that contain high amounts of tyramine (see Interactions section). Your healthcare provider will likely monitor your blood pressure while you are taking Zeposia. Tell your healthcare provider if you check your blood pressure and it is high or higher than usual.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea/vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Breathing Problems. Zeposia may cause shortness of breath (dyspnea), which can be serious. Contact your healthcare provider right away if you have new or worsening breathing problems.

Warnings & Precautions

Who should not use Zeposia?

Allergies to Ingredients. People who are allergic to any of the following should not use Zeposia.

  • Ozanimod
  • Zeposia
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Zeposia.

Heart Rhythm Problems. You should not take Zeposia if you have any of the following heart rhythm problems unless you have a working pacemaker.

  • Complete heart block (third-degree) or Mobitz type II second-degree atrioventricular (AV) block
  • Sick sinus syndrome
  • Sino-atrial block

Heart Problems. You should not take Zeposia if you have had any of the following heart problems in the last six months.

Sleep Apnea. You should not take Zeposia if you have sleep apnea that is not treated.

Drug Interactions. Zeposia should not be taken while you are using certain other medicines. Before taking Zeposia, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vaccines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Zeposia before using it?

Do not take Zeposia unless it has been prescribed to you by a healthcare provider. Take it as prescribed.  Zeposia starts with a seven-day Starter Pack. Swallow the capsule whole. 

Do not share Zeposia with other people, even if they have the same condition as you. It may harm them.

Keep Zeposia out of the reach of children.

Do not stop taking Zeposia without talking to your healthcare provider. When Zeposia is stopped, your multiple sclerosis symptoms may return and be worse than before starting treatment. If your symptoms become worse, talk with your healthcare provider.

Before you start taking Zeposia, your healthcare provider may check to see if you have antibodies against the varicella-zoster virus. If you need to get the varicella zoster vaccine, you will likely wait about four weeks after receiving the vaccine before you start taking Zeposia.

What should I tell my healthcare provider before using Zeposia?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Zeposia is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines right before, while using Zeposia, and for three months after stopping treatment. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Slow heartbeat 
  • Heart problems, such as heart attack or chest pain
  • Stroke
  • High blood pressure
  • Liver problems
  • Breathing problems, including during sleep (sleep apnea)
  • Diabetes
  • Eye problems, such as inflammation of the eye (uveitis)
  • Irregular heart rhythm (arrhythmia)
  • Fever, infection, or a weak immune system
  • Chickenpox infection
  • Skin cancer

Pregnancy. Zeposia may harm your unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Zeposia can take up to three months to leave your body. You should use effective birth control while taking Zeposia and for up to three months after stopping. If you get pregnant while taking Zeposia for multiple sclerosis, you can sign up for a special registry called the Zeposia Pregnancy Registry by calling 877-301-9314 or by visiting https://www.zeposiapregnancyregistry.com/. This registry collects safety information about taking Zeposia during pregnancy.  

Breastfeeding. It is not known if Zeposia passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Zeposia while breastfeeding.

How can I get more information about Zeposia?

For more information about Zeposia, you can visit the manufacturer’s website at https://www.zeposia.com/ or call them at 833-ZEPOSIA (833-937-6742).

Interactions

Does Zeposia interact with foods or drinks?

Eating foods that have high levels of tyramine while taking Zeposia may cause severe increases in blood pressure. Limit or do not eat the following foods and talk with your healthcare provider about maintaining a healthy diet while taking Zeposia.  

  • Aged cheeses, like cheddar, blue cheese, Parmesan, feta
  • Cured or processed meats, like salami, pepperoni, hot dogs, smoked fish
  • Pickled or fermented foods, like sauerkraut, kimchi, miso, pickled peppers
  • Soy or teriyaki sauces
  • Overripe fruits, like bananas, pineapple, or avocados

It is unknown if drinking alcohol will affect Zeposia, but both Zeposia and alcohol can cause liver damage. It is likely best to limit the amount of alcohol you drink while taking Zeposia.

Does Zeposia interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vaccines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any or have had any of the following before taking Zeposia.

  • Alemtuzumab (Lemtrada, Campath), which is a medicine used to treat multiple sclerosis or a certain type of cancer
  • Gemfibrozil (Lopid), which is a medicine for high cholesterol
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Any medicine that affects or weakens your immune system
  • A beta-blocker, such as metoprolol (Lopressor, Toprol XL, and others), atenolol (Tenormin), or propranolol (Inderal LA, Innopran XL), which is a medicine that may be used for certain heart conditions or to reduce blood pressure
  • Diltiazem (Cardizem CD and others), which is a medicine used for high blood pressure and other conditions
  • Verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or chest pain
  • Medicines that can cause QT prolongation, such as quinidine, procainamide, amiodarone, or sotalol, which is a potentially dangerous heart rhythm problem
  • A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease 
  • An opioid, such as oxycodone, morphine, codeine, or fentanyl, which is a medicine used for certain types of pain
  • A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
  • A selective serotonin reuptake inhibitor (SSRI), such as fluoxetine, paroxetine, or sertraline, which is a medicine commonly used for anxiety and depression
  • A serotonin and norepinephrine reuptake inhibitor (SNRI), such as duloxetine or venlafaxine, which is a medicine commonly used for anxiety and depression

Some other medicines may alter the blood levels of Zeposia. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Zeposia. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Zeposia?

If you or someone else has used too much Zeposia, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Zeposia?

If you miss a dose during the first two weeks, talk with your healthcare provider. You will need to complete another 7-day starter pack.  

If you miss a dose after the first two weeks, take the next scheduled dose the following day. Do not take double or extra doses.

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