Ozanimod belongs to the class of medications called sphingosine 1-phosphate (S1P) receptor modulators. It is used to treat the relapsing-remitting form of multiple sclerosis (RRMS).

Ozanimod does not cure MS, but it helps to reduce the number of attacks (relapses) that occur, reduce inflammation in the brain (brain lesions seen on MRI scans), and slow the buildup of physical problems due to MS (disability progression). It is generally used for people who have not responded well to, or cannot tolerate, one or more of the other treatments for MS.

Ozanimod is also used to treat adults with moderate-to-severely active ulcerative colitis who have not responded to or are unable to tolerate other treatments.

The exact way that ozanimod works is not known. It is believed to work by lowering the number of white blood cells (lymphocytes) circulating in your blood by preventing them from moving freely within the body. In MS, when lymphocytes reach the brain and spinal cord, they are thought to cause the inflammation that contributes to loss of the protective sheath (called myelin) that normally covers the nerve fibres and ensures that they work properly. Ozanimod may keep these cells from reaching the brain and spinal cord. For ulcerative colitis, ozanimod is believed to reduce inflammation by stopping certain white blood cells from reaching the lining of the intestine.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The starting dose of ozanimod is 0.23 mg taken by mouth once daily for the first 4 days. For the next 3 days (days 5 to 7) the daily dose is 0.46 mg. This gradual increase in dose helps to keep the heart rate from dropping too much and to prevent other side effects that can occur when starting ozanimod. After the first 7 days, the daily dose is 0.92 mg daily.

The starter pack of this medication contains 7 capsules only. This is enough to complete the first 7 days of treatment before continuing with the maintenance dose. Capsules should be swallowed whole, with a glass of water. Do not break, crush, or chew the capsules. Ozanimod may be taken with or without food.

Depending on other medical conditions, you may be asked to take the first dose of ozanimod in your doctor's office or clinic and stay at the office for at least 6 hours after the first dose. This will allow the doctor to monitor for side effects such as slowed heartbeat and treat the effects before they become an emergency.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you have been taking this medication for less than 14 days and you forget to take a dose for one day or more, or if you stop taking ozanimod for more than 7 days between weeks 2 to 4 of treatment, contact your doctor as soon as possible. Your doctor may choose to monitor you for heart and blood pressure effects before you restart the medication.

If this medication is stopped for more than 2 weeks, contact your doctor. You will be monitored for heart and blood pressure effects again when you restart the medication. You will need to restart with the lowest available dose and gradually increase your daily dose as before.

After the first 2 weeks of treatment, if you miss a dose take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice .

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

0.23 mg
Each size 4, opaque hard gelatin capsule, with light grey body and light grey cap, imprinted in black ink with "OZA" on cap and "0.23 mg" on the body, contains 0.23 mg of ozanimod. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose; capsule shell: black iron oxide (E172), gelatin, pharmaceutical ink, red iron oxide (E172), titanium dioxide (E171), and yellow iron oxide (E172).

0.46 mg
Each size 4, opaque hard gelatin capsule, with light grey body and orange cap, imprinted in black ink with "OZA" on cap and "0.46 mg" on the body, contains 0.46 mg of ozanimod. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose; capsule shell: black iron oxide (E172), gelatin, pharmaceutical ink, red iron oxide (E172), titanium dioxide (E171), and yellow iron oxide (E172).

0.92 mg
Each size 4, opaque hard gelatin capsule, with orange body and orange cap, imprinted in black ink with "OZA" on cap and "0.92 mg" on the body, contains 0.92 mg of ozanimod. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose; capsule shell: black iron oxide (E172), gelatin, pharmaceutical ink, red iron oxide (E172), titanium dioxide (E171), and yellow iron oxide (E172).

Initiation Pack
The "initiation pack" is a folding wallet containing 4 x 0.23 mg capsules and 3 x 0.46 mg capsules.

Do not take this medication if you:

• are allergic to ozanimod or any ingredients of the medication
• have a severe active infection or an active chronic infection such as hepatitis or tuberculosis
• have a weakened immune system due to disease (e.g., immunodeficiency syndrome) or use medicines or treatments that suppress the immune system (e.g., to treat cancer or bone marrow transplantation)
• have an active cancer (except for a type of skin cancer called basal cell carcinoma)
• have had a heart attack, unstable angina, stroke, a transient ischemic attack (mini-stroke), or heart failure in the past 6 months
• have severe irregular heartbeat and taking certain medications to treat the condition
• have heart block or sick-sinus syndrome and do not have a pacemaker
• are taking a monoamine oxidase inhibitor (MAOI), such as tranylcypromine, moclobemide, or selegiline
• are or may become pregnant and are not using effective birth control

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• flu-like symptoms (e.g., tiredness, chills, sore throat, joint or muscle aches, fever)
• headache
• infection of the nose, mouth, or throat

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• increased blood pressure (e.g., headache, fatigue, shortness of breath, chest pain or pressure)
• low blood pressure (e.g., dizziness or lightheadedness when rising from a sitting or lying position)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of infection from herpes simplex (cold sores) (e.g., small red or tiny fluid fluid-filled blisters or sores around the mouth)
• symptoms of infection from herpes zoster (chickenpox) (e.g., rash of fluid-filled blisters on reddened skin)
• symptoms of macular edema (swelling in the central vision area of the retina at the back of the eye) such as shadows or blind spots in the centre of your vision, blurred vision, or problems seeing colours or details
• symptoms of slow heartbeat (e.g., dizziness, fatigue, decreased blood pressure)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• unusual growths on the skin (e.g., shiny, raised growths or purple, red, or brown blotches)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• irregular heartbeat
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of meningitis (e.g., headache with stiff neck, sensitivity to light, nausea, confusion)
• symptoms of posterior reversible encephalopathy syndrome (PRES; e.g., include confusion, drowsiness, personality change, headache, paralysis, nausea, vomiting, vision changes)
• symptoms of progressive multifocal leukoencephalopathy (PML) (e.g., weakness on one side, problems thinking, vision changes)
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
• symptoms of stroke (e.g., weakness and/or loss of sensation of limbs or face, difficulty speaking, headache, dizziness, clumsiness, or vision problems)
• thoughts of suicide or self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood pressure: Ozanimod may increase blood pressure and is not recommended for people who have uncontrolled high blood pressure. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Additionally, foods with a high tyramine content are known to interact with ozanimod, which can cause severe increases in blood pressure. People taking ozanimod should avoid aged, fermented, cured, smoked, and pickled foods. Examples included aged cheeses, smoked or pickled fish, processed meats and sausages, and yeast extracts. In particular, avoid meat, fish, or daily products that may have undergone protein breakdown by aging, pickling, fermentation, or smoking to improve flavour.

Cancer: Medications such as ozanimod may increase your risk for certain cancers, particularly skin cancer. Your doctor will monitor you for skin cancer while you are taking this medication. Report any changes to your skin, such as change in size, colour, or shape of moles, to your doctor as soon as possible.

Depression: People with MS often experience depression more often than the general public. Ozanimod may contribute to the symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Eye problems: People who have diabetes or a history of inflammation of the middle of the eye are at an increased risk of developing swelling in the macula of the eye. It is recommended that you have an eye examination after taking this medication for 3 or 4 months to check for changes in your eyes that have not caused symptoms. Report any changes in vision to your doctor as soon as possible.

Heart problems: Ozanimod causes a decrease in heart rate a few hours after taking the first dose. Your doctor will want to check your heart before you start this medication. You may be asked to stay at your doctor's office or clinic for 6 hours after your first dose to allow the doctor to monitor your heart rate and treat any problems before they become an emergency. It may be necessary to be monitored for a longer period of time if you develop very low heart rate or an irregular heartbeat.

If you have a heart problem, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infections: Ozanimod works by decreasing the number of white blood cells in the blood stream. White blood cells are responsible for fighting infection in the body. As a result, people taking ozanimod may have an increased risk of infections. If you notice signs of an infection, such as fever, redness, or swelling, contact your doctor as soon as possible. Ozanimod stays in your body for about 3 months after you stop taking it, so you will continue to be at risk of infection during this time.

Liver function: People taking ozanimod may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking this medication. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using ozanimod. PML is a rare viral infection that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, personality changes, or difficulty walking, contact your doctor immediately.

Posterior Reversible Encephalopathy Syndrome (PRES): This is a rare disease of the brain that may occur when using ozanimod. If you have had a previous episode of PRES, this may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of PRES, such as headache, nausea, vomiting, seizures, change in awareness or consciousness, or vision changes, contact your doctor immediately.

Serotonin syndrome: Severe reactions are possible when ozanimod is combined with other medications that act on serotonin, such as serotonin reuptake inhibitors, medications used to treat depression, and certain migraine medications. These combinations should be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, or changes in mental state including delirium and agitation. Coma and death are possible.

Stopping this medication: Ozanimod works while it is being taken properly. Because it stays in the body for a long period of time, you may experience the benefit of having taken ozanimod for several weeks after stopping. After that, symptoms of MS may return and be more severe than before starting to take this medication. Speak to your doctor before stopping this medication.

Vaccines: Talk to your doctor to determine whether you need any vaccines before starting treatment. Your doctor may recommend that you be vaccinated against human papilloma virus (HPV) prior to starting treatment with ozanimod. During and for up to 3 months after stopping treatment you should avoid any vaccines containing live viruses.

Pregnancy: This medication may cause harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. Women who could become pregnant who are taking ozanimod should use an effective method of birth control (e.g., birth control pill, condoms) during treatment, and for 3 months after stopping treatment with ozanimod.

Breast-feeding: It is not known if ozanimod passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between ozanimod and any of the following:

• abatacept
• alpha-agonists (e.g., clonidine, methyldopa)
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• anakinra
• antiarrhythmics (e.g., amiodarone, disopyramide, dronedarone, flecainide, propafenone)
• anticancer medications (e.g., capecitabine, chlorambucil, cladribine, doxorubicin, paclitaxel)
• atazanavir
• atomoxetine
• azathioprine
• baricitinib
• BCG
• beta-2 agonists (e.g., formoterol, indacaterol, olodaterol, salbutamol, salmeterol)
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• calcium channel blockers (e.g., diltiazem, verapamil)
• ceritinib
• clonidine
• clopidogrel
• cobicistat
• corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• denosumab
• dexmethylphenidate
• digoxin
• donepezil
• doxepin
• echinacea
• eltrombopag
• eluxadoline
• etanercept
• fentanyl
• fingolimod
• galantamine
• gemfibrozil
• guanfacine
• haloperidol
• hepatitis C antivirals (e.g., elbasvir, glecaprevir and pibrentasvir, grazoprevir, ledipasvir, velpatasvir, voxilaprevir)
• ivabradine
• lacosamide
• lanreotide
• leflunomide
• linezolid
• lumacaftor and ivacaftor
• methadone
• methylene blue
• methylphenidate
• mifepristone
• mirtazapine
• monoamine oxidase inhibitors ((MAOIs; e.g., moclobemide, phenelzine, tranylcypromine)
• monoclonal antibodies (e.g., alemtuzumab, natalizumab, rituximab, sarilumab)
• mycophenolate
• octreotide
• pasireotide
• pimecrolimus
• protein kinase inhibitors (e.g., bosutinib, dasatinib, idelalisib, imatinib, lapatinib, nilotinib, regorafenib)
• quinine
• rifampin
• rivastigmine
• roflumilast
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• siponimod
• tacrolimus
• teriflunomide
• theophylline
• tizanidine
• tobacco (smoked)
• tofacitinib
• tolvaptan
• tramadol
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine)
• tryptophan
• upadacitinib
• vaccines
• ziprasidone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.