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.
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.
You should not use ozanimod if you are allergic to it, or if you have certain serious heart conditions, especially:
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:
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.
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.
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:
Common side effects may include:
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.
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:
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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