Ozanimod - Oral

Ozanimod is used to treat relapsing remitting multiple sclerosis (a certain type of disease affecting the brain and spinal cord).

This medicine is also used to treat moderately to severely ulcerative colitis (a disease that causes inflammation and sores in the linings of the large intestine and rectum) in individuals who have inadequate response or have failed previous therapy.

Take Ozanimod exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

You may take this medicine with or without food. Try to take it at the same time each day.

Swallow the tablet whole with a glass of water.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the treatment timeframe depending on your response to the medication.

Ozanimod must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.

If you missed a dose and it is within the first 2 weeks of treatment, more than 7 consecutive days between weeks 3 and 4 of treatment, or more than 14 consecutive days after 4 weeks of treatment, inform your doctor immediately. Your doctor may require you to restart the treatment.

If a dose is missed after the first 2 weeks of treatment, take the missed dose as soon as possible within the same day. However, if it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.

Alert your doctor if you also have the following conditions:

• 2nd- or 3rd-degree heart block
• have experienced heart attack, chest pain, stroke, and heart failure in the past 6 months
• sick sinus syndrome (abnormal heart rhythms due to problems with your heart's natural pacemaker)
• severe untreated sleep apnoea (sleep disorder that causes interrupted breathing during sleep)
• weak immune system
• cancer
• severe infections e.g. tuberculosis, hepatitis

as Ozanimod may not be suitable for you.

Do not take this medicine if you are pregnant. If you become pregnant while on Ozanimod therapy, alert your doctor immediately. This medicine may cause harm to your unborn child.

It is important that you do not get pregnant while taking this medicine. You must use proven birth control methods during Ozanimod therapy and for 3 months after stopping the treatment. You may wish to discuss other reliable methods of birth control with your doctor.

Do not take Ozanimod if you are currently taking or have taken a medicine that is used to treat depression known as a monoamine oxidase inhibitor (MAOI) such as phenelzine and selegiline in the last 14 days.

Inform your doctor if you have the following conditions:

• ischaemic heart disease (narrowing of the blood vessels of the heart)
• recurring temporary loss of consciousness; fainting or passing out
• uncontrolled high blood pressure
• irregular or abnormal heartbeat
• slow heart rate
• heart rhythm disorder
• severe lung disease
• chronic obstructive pulmonary disease (a long-term lung disease that causes airflow obstruction making it hard to breathe)
• pulmonary fibrosis (scarring and thickening of the lung tissue causing low oxygen levels into your blood)
• history of uveitis (eye inflammation)
• history of problems with the retina (the thin layer of tissue at the back of the eye)
• diabetes
• mild to moderate liver disease

Let your doctor know if you are breastfeeding.

Be sure to check with your doctor or pharmacist before giving Ozanimod to the elderly. Elderly people may be more sensitive to the side effects.

Inform your doctor if you never had, or not sure if you have had chickenpox, or if you have not been vaccinated against varicella zoster virus (VZV), your doctor may need to perform a blood test to check if you need the vaccination. Do not receive any vaccinations without first asking your doctor.

If you are going to have phototherapy (light therapy that uses an artificial light source such as ultraviolet [UV] lights), inform your doctor that you are taking this medicine.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy tests must be done before treatment to know if this medicine is suited for you to take.
• Routine tests (e.g. complete blood count, liver function, ECG [test used to record the electrical activity of the heart], VZV antibodies test, lung function, eye examination) may be done before and while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Your blood pressure may fall or rise to unsafe levels, or your heart rate may fall to unsafe levels without you noticing it. Monitor your blood pressure and heart rate regularly during treatment.
• Regular monitoring for signs and symptoms of liver problems and changes in vision may also be needed.

Ozanimod may cause any of the following side effects: nausea, upper abdominal pain, joint pain, back pain, rash, and itching.

This medicine may also make your skin more sensitive to sunlight. Apply sunscreen when going outdoors and avoid prolonged exposure to sunlight and UV lamps.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• slow heart rate
• shortness of breath
• increase in blood pressure
• eye swelling, changes in vision such as shadows, blind spots, or blurred vision
• loss of vision, severe headache, confusion, fits or seizures
• weakness or numbness on one side of the body, vision problems, altered mental status, changes in behaviour
• headache with fever, upset stomach, sensitivity to light
• genital sores, eye redness, eye pain
• yellowing of the skin or eyes, abdominal pain, dark coloured urine, tiredness, swelling in the legs and ankles

This medicine may cause the level of your lymphocytes (a type of immune cell or white blood cell) to drop.

Lymphocytes help your body to fight infections. A fall in the level of your lymphocytes may put you at higher risk for infections, such as coughs, colds and flu, which may lead to more serious infections. Avoid crowded places and people who are sick. Inform your doctor if you have a fever, cough, or flu that does not go away.

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Do not take Ozanimod if you are currently taking or have taken medicine known as a monoamine oxidase inhibitor (MAOI) such as phenelzine (medicine to treat depression), selegiline, (medicine for Parkinson's disease [a disorder that affects the movement of a person, causing symptoms such as tremors, muscle stiffness, slowed movement and impaired balance or walking]), and linezolid (antibiotic) in the last 14 days.

Inform your doctor and pharmacist if you are taking any of these medicines:

• other medicines for multiple sclerosis e.g. alemtuzumab, natalizumab
• medicines for high blood pressure and control of heart rate e.g. diltiazem, verapamil, propranolol
• medicines used in organ transplants or certain immune disorders e.g. ciclosporin
• medicines for irregular heartbeat e.g. amiodarone, quinidine, procainamide, sotalol
• rifampicin (medicine to treat TB [an infection known as tuberculosis])
• gemfibrozil (cholesterol-lowering medicine)
• clopidogrel (blood-thinning medicine)

This list does not include all medicines that may interact with Ozanimod.

Avoid vaccinations with live vaccines during treatment and for 3 months after treatment with this medicine. Inform your doctor if you have been recently vaccinated or if you are planning to get vaccinated.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol and other drinks that contain tyramine such as red wine and beer.

Avoid foods that are rich in tyramine, such as cheese, sausages, soya beans, fava beans, broad beans, and pickled foods like sauerkraut. Ask your doctor or dietitian about the types of food you should avoid.

Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.