ozanimod (Zeposia)

Brand Names: Zeposia

Generic Name: ozanimod

• What is ozanimod (Zeposia)?
• What are the possible side effects of ozanimod (Zeposia)?
• What is the most important information I should know about ozanimod (Zeposia)?
• What should I discuss with my healthcare provider before taking ozanimod (Zeposia)?
• How should I take ozanimod (Zeposia)?
• What happens if I miss a dose (Zeposia)?
• What happens if I overdose (Zeposia)?
• What should I avoid while taking ozanimod (Zeposia)?
• What other drugs will affect ozanimod (Zeposia)?
• Where can I get more information (Zeposia)?

Ozanimod is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Ozanimod is used only if you have a specific genotype. Your doctor will test you for this genotype.

Ozanimod may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives, rash; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats;
• a light-headed feeling, like you might pass out;
• cough, new or worsening shortness of breath;
• sudden confusion, severe headache, or vision loss;
• a seizure;
• pounding in your neck or ears;
• liver problems--nausea, vomiting, upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• changes in vision--blurred vision, increased sensitivity to light, seeing an unusual color in your vision, or having a blind spot or shadows in the center of your vision; or
• symptoms of infection--fever, tiredness, cough, rash, increased urination, pain or burning when you urinate, neck stiffness, increased sensitivity to light.

Common side effects may include:

• back pain;
• urination problems;
• high or low blood pressure;
• abnormal liver function tests; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You should not use ozanimod if you have a serious heart condition such as "AV block" or sick sinus syndrome and no pacemaker, or if you've recently had heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke. You also should not use ozanimod if you have severe untreated sleep apnea.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take ozanimod.

Ozanimod can slow your heart rate when you start taking it. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, rash, painful and frequent urination, confusion, neck stiffness, or increased sensitivity to light. Your risk of infection could last for 3 months after you stop taking this medicine.

You should not use ozanimod if you are allergic to it, or if you have certain 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); or
• severe untreated sleep apnea (breathing stops during sleep).

Do not use ozanimod if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. Wait at least 14 days after stopping an MAO inhibitor before you take ozanimod.

Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, or sotalol.

Before you take ozanimod, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking ozanimod.

Tell your doctor if you have received any vaccine within the past 30 days, or if you are scheduled to receive a vaccine.

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

• a weak immune system (caused by disease or by using certain medicine);
• 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; or
• an eye condition called uveitis.

Tell your doctor if you are pregnant or you plan to become pregnant. Ozanimod may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 3 months after your last dose. Tell your doctor if you become pregnant during this time.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ozanimod can slow your heart rate when you start taking it. Before your first dose, your heart function will be checked using an electrocardiograph or ECG (sometimes called an EKG).

Ozanimod comes in a 7-day Starter pack containing capsules of different strengths. Taking these capsules as directed will increase your dose gradually during the first week.

You may take ozanimod with or without food. Avoid foods high in tyramine (aged, fermented, cured, smoked and pickled foods). Eating these foods while taking ozanimod can raise your blood pressure.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have symptoms such as fever, tiredness, cough, painful and frequent urination, neck stiffness, or increased sensitivity to light. Your risk of infection could last for 3 months after you stop taking this medicine.

If you have get an infection, further doses may be delayed until your infection clears up.

If you stop taking ozanimod or miss a dose during the first 2 weeks, ask your doctor before you start taking the medicine again. You may need to use a 7-day Starter pack again, to gradually increase your dose.

Store at room temperature away from moisture and heat.

Always ask your doctor before you stop taking ozanimod for any reason. When you stop taking ozanimod, your MS symptoms may return. In rare cases, some people who stopped taking ozanimod had MS symptoms that were worse than before or during treatment with this medicine. Watch for signs of worsening MS, and tell your doctor if you have any new or worsening symptoms.

SLIDESHOW

What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See Slideshow

Call your doctor for instructions. If you miss 1 or more doses in the first 2 weeks of treatment, you may need to start a new 7-day Starter pack.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting a vaccine without first asking your doctor. While you are taking ozanimod, some vaccines may not work as well and may not fully protect you from disease.

Receiving a "live" vaccine while using ozanimod may cause you to develop an infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You should not receive a live vaccine within 1 month before taking ozanimod, while taking it, and for at least 3 months after you stop taking it.

Ozanimod can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• alemtuzumab, clopidogrel, eltrombopag, gemfibrozil, rifampin;
• an antidepressant;
• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection;
• heart rhythm medicine;
• medicine to treat Parkinson's disease; or
• opioid pain medicine.

This list is not complete and many other drugs may affect ozanimod. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ozanimod can have long lasting effects on your body, especially on your immune system. For 3 or 4 weeks after your last dose, tell any doctor who treats you that you have used ozanimod.

Your doctor or pharmacist can provide more information about ozanimod.