Zeposia

What is Zeposia?

Zeposia (ozanimod) capsules are utilized to address adults with relapsing forms of multiple sclerosis (MS) and moderately to severely active ulcerative colitis (UC). Zeposia aims to reduce the relapse rate and the number and size of brain lesions in multiple sclerosis. In the case of ulcerative colitis, Zeposia is employed to alleviate symptoms and aid in achieving and maintaining remission.

Zeposia is FDA-approved for adults with moderately to severely active ulcerative colitis and also FDA-approved for treating relapsing forms of multiple sclerosis, covering clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Multiple sclerosis and ulcerative colitis are both autoimmune disorders wherein immune cells (lymphocytes) erroneously attack healthy tissue, believing it to be a foreign substance. In multiple sclerosis, the immune system targets and damages the myelin sheath covering nerves in the brain and spinal cord (CNS), leading to symptoms like numbness, tingling, balance issues, vision problems, and fatigue. For ulcerative colitis, the immune system causes inflammation in the colon lining, resulting in symptoms such as abdominal pain, rectal bleeding, diarrhea, and fatigue.

How does Zeposia work?

Zeposia is believed to prevent immune cells (lymphocytes) from entering the intestines and central nervous system (CNS). This is achieved by trapping immune cells in the lymph nodes, potentially preventing harmful inflammation in the CNS (for multiple sclerosis) and the colon (for ulcerative colitis). By mitigating inflammation caused by lymphocytes, Zeposia may improve the symptoms of these conditions.

Zepsosia belongs to a class of medications known as sphingosine 1-phosphate (S1P) receptor modulators. Zeposia exerts its effects by binding to S1P1 receptors on various cells, potentially impeding lymphocytes from leaving the lymph nodes.

Related/similar drugs
Entyvio, Stelara, Vumerity, Copaxone, dexamethasone, hydrocortisone, Humira

Warnings

Infections: You may be more susceptible to infections, including serious or fatal ones. Contact your doctor if you experience fever, flu symptoms, extreme fatigue, cough, rash, painful and frequent urination, neck stiffness, or increased sensitivity to light. Your infection risk could persist for 3 months after discontinuing this medicine.

Heart rate: Zeposia can initially slow your heart rate. Inform your doctor of any slow heartbeats, chest pain, shortness of breath, or sensations of your heart skipping beats.

Progressive multifocal leukoencephalopathy (PML): Zeposia may heighten the risk of PML, a rare brain infection often resulting in severe disability or death. While more common in individuals with weakened immune systems, PML has occurred in those without weakened immune systems. Symptoms of PML typically worsen over days to weeks, including weakness on one side of the body, loss of coordination, decreased strength, balance problems, changes in vision, alterations in thinking or memory, confusion, or personality changes.

Before taking this medicine
Do not use Zeposia if you are allergic to the active ingredient ozanimod or any inactive ingredients. A complete list of ingredients can be found here: Zeposia ingredients.

Avoid Zeposia if you have specific serious heart conditions, especially:

• Recent (within the past 6 months) heart failure, heart attack, stroke, “mini-stroke” or TIA, chest pain (unstable angina), or other serious heart problem.
• “AV block” or sick sinus syndrome (unless you have a pacemaker).
• Severe untreated sleep apnea (breathing stops during sleep).

Certain heart rhythm medications may have unwanted or dangerous effects when combined with this medicine. Your doctor might alter your treatment plan if you use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol.

Do not use this medicine if you’ve used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before taking Zeposia.

Refrain from receiving live vaccines during Zeposia treatment, for at least 1 month before commencing treatment, and for 3 months after treatment cessation. Vaccines may not be as effective during Zeposia treatment.

Notify your doctor if you have a fever, infection, or if you have ever had:

• A weakened immune system (due to disease or certain medications).
• A very slow heart rate.
• Heart rhythm problems, long QT syndrome.
• A heart attack, stroke, or chest pain.
• High blood pressure.
• Sleep apnea or other breathing problems.
• Diabetes.
• Liver disease.
• An eye condition called uveitis.

Before using this medicine, undergo a complete blood count, cardiac evaluation, liver function tests, and ophthalmic assessment. Your doctor will assess your current or past medications, vaccination history, and confirmation of chickenpox.

Pregnancy: Zeposia may harm an unborn baby. Inform your doctor if you are planning a pregnancy or are pregnant. Use effective birth control during Zeposia use and for at least 3 months after the last dose. If you become pregnant while taking Zeposia, discuss registering with the Pregnancy Registry, aiming to collect information about your and your baby’s health.

Breastfeeding: It’s unclear if Zeposia passes into breast milk. Consult your healthcare provider about the best way to feed your baby while using this medicine.

How should I take Zeposia?
Take Zeposia precisely as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally adjust your dose.

This medicine can slow your heart rate when you initiate treatment. Before your first dose, your heart function will be assessed using an electrocardiograph or ECG.

Zeposia is available in a 7-day starter pack with capsules of various colors and strengths. Adhere to the prescribed dosing schedule to lower the risk of side effects.

You may be more susceptible to infections, even serious or fatal ones. Frequent medical tests are necessary, and your infection risk may persist for 3 months after stopping this medicine. If an infection occurs, further doses might be delayed until the infection clears.

Always consult your doctor before discontinuing this medicine. Symptoms may worsen upon discontinuation. If you miss 1 or more days of your dose during the first 14 days of treatment, contact your healthcare provider. A new 7-day starter pack may be required. If you miss a dose after the first 14 days, take the next scheduled dose the following day.

Follow the dose schedule:

Days 1-4:

• Take 0.23 mg (capsule in light grey color) once a day.

Days 5-7:

• Take 0.46 mg (capsule in half-light grey and half-orange color) once a day.