Zeposia was at first approved for multiple sclerosis (MS) in adults. In 2021, the FDA added its use for moderate to severe ulcerative colitis (UC) in adults. UC is an inflammatory bowel disease (IBD). The main symptom is diarrhea, which can have blood in it. Other symptoms of UC include stomach pain or cramps, sudden bowel movement urges, and weight loss.
How Does Zeposia Work for UC?
UC causes irritation, inflammation, and ulcers in the lining of your large intestine (colon). UC is classified as mild, moderate, or severe, depending on your symptoms. Zeposia is approved for moderate or severe types of UC.
The active ingredient in Zeposia is ozanimod. It is a sphingosine 1-phosphate receptor modulator. Ozanimod works by restricting lymphocytes (an immune system cell) from leaving the lymph nodes. The way Zeposia works in the body for UC is not fully known, but it is thought to be related to the lower number of lymphocytes in the intestine. This prevents inflammation and helps with UC.
What Should I Do Before Starting Treatment?
Your health care provider will do tests including:
- Blood tests
- Complete blood count (CBC)
- Liver function tests (LFTs)
- Electrocardiogram (EKG)
- Eye exam if you have a history of uveitis or macular edema
Your health care provider will also review your vaccination record and recommend any vaccines you may need. If you need a live vaccine, you will not be able to start Zeposia until 1 month after you have received that vaccine. Live vaccines include measles, mumps, rubella (MMR) and chickenpox.
How Do I Take Zeposia?
Zeposia comes as a 0.23-milligram, 0.46-milligram, and 0.92-milligram capsule that you take by mouth, with or without food. The dose is increased slowly over your first few days of treatment.
- On days 1-4, you will take 0.23 milligram daily.
- On days 5-7, you will take 0.46 milligram daily.
- On day 8 and after, you will take 0.92 milligram daily.
If you have mild or moderate liver problems, your dosage will be a little different. You will follow the same directions as above for the first 7 days, then on day 8 and after, you will take 0.92 milligram every other day.
If you have severe liver problems, you will need to avoid Zeposia.
Studies and Benefits
For UC, two studies were done to see if Zeposia was effective, compared to a placebo containing no medicine. Most of the people in the studies did not know if they were getting Zeposia or the placebo.
Both studies included people ages 18 to 75 who had moderate to severe UC. People were required to have taken stable doses of oral aminosalicylates (mesalamine or sulfasalazine) or steroids (budesonide or prednisone) for at least 2 weeks before the study and then continued those medications during the first 10 weeks of treatment. The steroid medication was slowly stopped after the first 10 weeks of the trial.
In the 10-week study, people took a placebo or Zeposia at a dose that increased slowly over the first 7 days then reached a 1-milligram daily dose. At the end of the 10 weeks, people who had the response to Zeposia were entered into a longer study where people took a placebo or Zeposia for up to 52 weeks. This was measuring how well Zeposia worked for maintenance therapy for UC. It was measured by the percentage of people that reached clinical remission of symptoms at the end of the 10-week and 52-week study periods.
At the start of the studies, most people being studied had moderate UC (86%). Most people in the studies were male (57%-66%). The average age of people in the studies was 41 to 42 years.
People in the studies who took Zeposia during the first 10-week period had significantly higher rates of remission than those who took the placebo. About 18% of people who took Zeposia, compared to about 6% for those that took the placebo, reached remission.
Similarly, during the maintenance period, people who took Zeposia had a significantly higher rate of remission than those that took the placebo. About 37% of people who took Zeposia had clinical remission at week 52, compared to 19% of people who took the placebo.
More studies have been done. These show that there was a continued response to Zeposia for many people for up to 4 years.
Your results may differ from what was seen in clinical studies.
How Long Does It Take for Zeposia to Start Working?
Zeposia should start working within 10 weeks. Tell your health care provider if your UC symptoms do not improve. Consider keeping a symptoms diary to keep track of when you have bowel movements and their consistency. This can help you and your health care provider find out how well your medicines are working for you.
If you have trouble remembering to take it, consider following a routine. For example, take it every day at the same time, such as after brushing your teeth. You can also use calendar or smartphone reminders to help.
After your last dose, Zeposia can have an effect on the body for up to 3 months.
How to Prevent and Manage Side Effects
The most common side effects seen in clinical trials with Zeposia are changes in liver function, upper respiratory tract infections, and headaches.
Risk of infection:
Zeposia increases your risk of infection because of how it works on your immune system. The most common infections reported in clinical studies included upper respiratory tract infections, urinary tract infections, and herpes infections. To reduce the risk of infection when taking Zeposia and for 3 months after stopping it, your health care provider will review your vaccination record and recommend vaccines for you. It is also important to use good hygiene practices such as disinfecting surfaces, washing your hands, and avoiding touching your face. You should also avoid being in close contact with someone you know is sick and avoid large crowds. Call your health care provider right away if you have any signs of infection such as a fever, cough, rash, or painful urination.
Liver function changes:
Zeposia can cause changes to your liver. Your health care provider will monitor your liver with a blood test before starting treatment. If you have any symptoms of liver issues, you should tell your health care provider right away. These symptoms include:
- Nausea or vomiting
- Stomach pain
- Fatigue
- Skin turning yellow
- Dark urine
If liver issues are diagnosed, Zeposia will likely be stopped.
Slow heart rate:
When you start to take Zeposia, it can change your heart rate. This side effect is most likely to happen during the first 8 days. Your health care provider will check your heart with a test called an electrocardiogram (EKG) before your first dose. Call your health care provider if you have any of the following symptoms of a low heart rate.
- Dizziness
- Lightheadedness
- Shortness of breath
- Confusion
- Fatigue
These are not all of the possible side effects of Zeposia. Talk with your health care provider if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
What Interactions With Foods and Other Medicines Can Happen?
Several medicines can interact with Zeposia. This may increase the risk of side effects from Zeposia or can cause it to not work as well.
Inhibitors of cytochrome P450 2C8 (CYP2C8). Cytochrome P450 2C8 is an enzyme that processes and removes some medicines from the body. Taking CYP2C8 inhibitors (medicines that block the activity of CYP2C8) could increase the amount of Zeposia in your body, which may lead to excessive or dangerous side effects.
Inducers of cytochrome P450 2C8 (CYP2C8). Taking CYP2C8 inducers (medicines that increase the activity of CYP2C8) could decrease the amount of Zeposia in your body, causing it to work less well or not work at all.
Ask your pharmacist or other health care provider if any of your medicines are a CYP2C8 inhibitor or inducer.
Monoamine oxidase inhibitors (MAOIs). MAOIs include medications such as linezolid, phenelzine, and selegiline. Taking an MAOI with Zeposia is not recommended because it can increase your blood pressure significantly. Tyramine-containing foods also have this drug interaction. Tyramine-containing foods include foods that are aged, fermented, cured, smoked, or pickled. (For example, aged cheese or pickled herring)
Live vaccinations. Live vaccinations should be avoided while taking Zeposia and for 3 months after you stop taking it. This is because the vaccination may not work as well and can risk infection. Your health care provider will review your vaccination record before starting Zeposia and recommend any vaccinations at that time.
This is not a complete list of medicines that may interact with Zeposia. Tell your health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them find out if there are any interactions with Zeposia. Do not start or stop other medicines while taking Zeposia without talking to your health care provider.
How Can I Get Zeposia?
Zeposia requires a prescription from a health care provider. Your primary care provider or gastroenterologist may prescribe Zeposia. Zeposia is considered a specialty drug. Check with your insurance company to see if there is a specific pharmacy you need to use to fill the prescription. You can also check with your local pharmacy to see if they can get the medication for you or if they have a local specialty pharmacy location they can refer you to.
Zeposia offers support services to help you with medication costs. There is a copay card available from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out about all the financial services at https://www.zeposiahcp.com/ulcerative-colitis/support/zeposia-360.
