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 adults with moderately to severely active ulcerative colitis.

It is not known if this medicine is safe and effective in children.

Take ozanimod exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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).

Your doctor will need to check your skin, vision, and liver function before you start taking ozanimod and periodically during treatment.

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 this medicine 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.

Store at room temperature away from moisture and heat.

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.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light. Your risk of infection could last for 3 months after you stop taking ozanimod.

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 ozanimod 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 this medicine.

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 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 this medicine.

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;
• an eye condition called uveitis; or
• any type of skin cancer.

Ozanimod may harm an unborn baby. Use effective birth control while using ozanimod and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction to ozanimod: 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, 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;
• symptoms of a rare brain infection - weakness on one side of your body, loss of coordination, changes in your thinking or memory, confusion, or changes in your personality;
• 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;
• symptoms of infection - fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light; or
• skin changes - a new darkened area, a sore that does not heal, or a new bump that may be shiny, pearly white, skin-colored, or pink.

Common ozanimod 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.

Usual Adult Dose for Multiple Sclerosis:

DOSE TITRATION REGIMEN:-Days 1 through 4: 0.23 mg orally once a day-Days 5 through 7: 0.46 mg orally once daily-Day 8 and thereafter: 0.92 mg orally once a dayMAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8Uses:-For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease-For the treatment of moderately to severely active ulcerative colitis

Usual Adult Dose for Ulcerative Colitis:

DOSE TITRATION REGIMEN:-Days 1 through 4: 0.23 mg orally once a day-Days 5 through 7: 0.46 mg orally once daily-Day 8 and thereafter: 0.92 mg orally once a dayMAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8Uses:-For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease-For the treatment of moderately to severely active ulcerative colitis

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.

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.

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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.

Avoid exposure to sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.

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 interact with 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 at least 4 weeks after your last dose, tell any doctor who treats you that you have used this medicine.