ozanimod

What is the most important information I should know about 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, or feel like your heart is skipping beats.

What is ozanimod?

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 also used to treat ulcerative colitis in adults.

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

What should I discuss with my healthcare provider before taking ozanimod?

• 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 this medicine if you have 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 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, ibutilide, procainamide, quinidine, or sotalol.

Before you take ozanimod, tell your doctor if you have never had chickenpox or 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.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ozanimod on the baby.

How should I take ozanimod?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Ozanimod comes in a 7-day starter pack containing capsules of different colors and strengths. You should follow the dosing schedule as prescribed by your doctor. This may lower the risk of side effects.

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. You will need frequent medical tests, and your risk of infection could last for 3 months after you stop taking this medicine.

If you 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 starter pack again, to gradually increase your dose.

Always ask your doctor before you stop taking ozanimod for any reason. Your MS symptoms may return and become worse than before or during treatment with this medicine. Tell your doctor if you have any signs of worsening MS.

What happens if I miss a dose?

If you miss a dose after the first 2 weeks: Skip the missed dose and use your next dose at the regular time.

Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking ozanimod?

Avoid getting a vaccine without first asking your doctor. While you are taking ozanimod, a "live" vaccine may not fully protect you from disease and you could develop an infection.

Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

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.

What are the possible side effects of ozanimod?

• slow heartbeats, chest pain, shortness of breath, or feel 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, vision loss, or 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, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light.

Common side effects may include:

• headache, 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.

What other drugs will affect ozanimod?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about ozanimod.