The US Food and Drug Administration (FDA) approved Zeposia® (ozanimod) in 2020. Initially, Zeposia was used to treat certain types of multiple sclerosis (MS).1
As of May 27, 2021, Zeposia was also approved to treat adults with moderately to severely active ulcerative colitis (UC).1
Zeposia is classified as a sphingosine 1-phosphate (S1P) receptor modulator. It is the first and only S1P receptor modulator approved for UC.1
What is the ingredient in Zeposia?
The active ingredient in Zeposia is ozanimod.1,2
How does Zeposia work?
The way Zeposia works for UC is not fully understood. Zeposia targets receptors called sphingosine 1-phosphate receptors. It is thought to reduce the movement of lymphocytes (a type of white blood cell) into the intestines and lower the number of lymphocytes in circulating blood.1,2
What are the possible side effects of Zeposia?
The most common side effects of Zeposia in adults with UC are:2
- Abnormal liver function tests
- Upper respiratory infection
Other, less common, side effects may include:2
- Joint pain
Serious side effects may occur. These include:2
- A temporary decrease in heart rate
- Allergic reaction
- Liver problems
- Increased blood pressure
- Breathing problems
- Fluid in the center of the retina
- Swelling of the arms and legs
These are not all the possible side effects of Zeposia. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Zeposia.
Things to know about Zeposia
When you fill or refill your Zeposia prescription, you will receive a Medication Guide. The Medication Guide has important information on side effects and warnings.
Zeposia can increase the risk of serious infections. These infections can be fatal. Call your doctor right away if you have any of the following symptoms when taking Zeposia and for 3 months after you stop taking Zeposia:2
- Extreme tiredness
- Flulike symptoms
- Painful and frequent urination
- Headache with fever, stiff neck, nausea, or confusion
Zeposia may cause a slowed heart rate. This is more likely to happen during the first 8 days of treatment. Your doctor will give you a test called an electrocardiogram (ECG) before you start Zeposia. Call your doctor if you have symptoms of a slow heart rate, such as:2
- Dizziness or lightheadedness
- Shortness of breath
- Chest pain
- Feeling like your heart is beating slowly or skipping beats
Zeposia may cause liver problems. Your doctor will order lab tests before you take Zeposia. Call your doctor right away if you have nausea, vomiting, appetite loss, yellow skin or eyes, stomach pain, dark urine, or tiredness.2
Zeposia may cause increased blood pressure. Your doctor will monitor your blood pressure when you take Zeposia. Avoid foods that are high in tyramine. Tyramine-rich foods include aged, fermented, pickled, cured, or smoked foods.2
Zeposia may cause shortness of breath. Call your doctor right away or seek emergency medical care if you have breathing problems.2
Zeposia may cause a vision problem called macular edema. The risk is higher if you have diabetes or have had eye inflammation. Your doctor will check your vision before you take Zeposia if you are at higher risk, or during treatment if you have vision changes. Tell your doctor right away if you have vision changes, blind spots, or sensitivity to light.2
Zeposia can cause a rare condition called posterior reversible encephalopathy syndrome (PRES). With PRES, blood vessels in the brain swell and narrow. If untreated, PRES can cause a stroke. PRES usually goes away when you stop taking the drug. Seek emergency medical help if you have a sudden severe headache, sudden loss of vision or vision changes, confusion, or seizure.2
If you have signs of an allergic reaction, such as hives, shortness of breath, or swelling of the face, tongue, or lips, get emergency medical help right away.
Zeposia can harm an unborn baby. Women who can become pregnant and men with partners who can become pregnant should use birth control during treatment and for 3 months after the last dose of Zeposia. There is no data about breastfeeding in humans.2 Talk to your doctor about your options for birth control and breastfeeding while taking Zeposia.
Zeposia is not safe for everyone. People with certain heart problems, untreated sleep apnea, or who take a type of medication classified as a monoamine oxidase inhibitor (MAOI) cannot take Zeposia.2
Before beginning treatment with Zeposia, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs. You should not get a live vaccine for at least 1 month before taking Zeposia, while taking Zeposia, and for 3 months after you stop Zeposia.
For more information, read the full Prescribing Information for Zeposia.