Mayzent: Uses, Side Effects and Dosage

What MAYZENT is used for:

MAYZENT is used to treat adults with a form of multiple sclerosis (MS) known as secondary progressive MS (SPMS), specifically SPMS with active disease. This means that patients still have relapses or signs of inflammation that can be seen in scans (MRI – magnetic resonance imaging).

MAYZENT is used to slow down the progression of physical disability.

How MAYZENT works:

Siponimod, the ingredient in MAYZENT, binds to selective receptors on your white blood cells and keeps them in your body’s lymph nodes. This lowers the number of your white blood cells circulating in your body. How MAYZENT works is not known, but it may be due to less white blood cells entering your central nervous system.

The ingredients in MAYZENT are:

Medicinal ingredient: siponimod.

Non-medicinal ingredients: Colloidal silicon dioxide, crospovidone, glyceryl dibehenate, lactose monohydrate, microcrystalline cellulose. The tablet coating consists of iron oxide (red and black iron oxides for the 0.25 mg and 1 mg strengths, and red and yellow iron oxides for the 2 mg strength), lecithin (soya), polyvinyl alcohol, talc, titanium dioxide, xanthan gum.

MAYZENT comes in the following dosage forms:

Film-coated tablets: 0.25 mg, 1 mg and 2 mg of siponimod.

Do not use MAYZENT if:

• you are allergic to:

  • siponimod
  • peanut
  • soya or
  • to any of the other ingredients in MAYZENT (see The ingredients in MAYZENT are above)
• you have a CYP2C9*3*3 genotype

• you are at an increased risk of opportunistic infection, i.e. if you have a weakened immune system due to:

  • treatments that suppress the immune system (cancer treatments, immunosuppressive or immune modulating therapies, total lymphoid irradiation or bone marrow transplantation)
  • disease (immunodeficiency syndrome)
• you currently have a bacterial, fungal or viral infection (such as hepatitis, tuberculosis). You should not take MAYZENT until your infection is treated and resolved.
• you currently have cancer (except for a type of skin cancer called basal cell carcinoma)

• you have had in the last 6 months a:

  • heart attack
  • unstable angina
  • stroke or warning signs of a stroke
  • a sudden worsening of the signs and symptoms of heart failure that required treatment or have been diagnosed with Class III or IV heart failure
• you have certain types of second or third degree atrioventricular (AV) heart block or certain heart rhythm problems and do not have a pacemaker
• you are pregnant, think you may be pregnant or plan to get pregnant
• you are of childbearing age and not using an effective method of birth control
• you are of childbearing age and your healthcare professional has not performed a pregnancy test to confirm that you are not pregnant before you start treatment, as MAYZENT may harm your baby.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MAYZENT. Talk about any health conditions or problems you may have, including if you:

• have or had problems with your heart:

  • an irregular or abnormal heartbeat
  • a heart attack
  • severe heart disease
  • uncontrolled high blood pressure
  • a history of stroke or other diseases related to blood vessels in the brain
  • a risk for, or if you have heart rhythm disturbances
  • where an electrocardiogram (ECG) shows a prolonged QT interval
• have severe sleep apnea (a disorder where your breathing repeatedly starts and stops while you sleep) that is not being treated
• have or had a history of fainting

• have difficulty breathing

  Your healthcare professional may decide not to prescribe MAYZENT if you have or have had one of these conditions, or may refer you to a cardiologist before you start treatment.

• are taking medications:

  • to lower your blood pressure
  • to treat an irregular heartbeat (medicines that cause QT prolongation)
  • that slow your heart rate

Depending on the medications you are taking, your healthcare professional may decide not to prescribe MAYZENT or refer you to a cardiologist to change your medication (see The following may interact with MAYZENT below for more information).

• suffer from a slow heart rate or you have a history of fainting. MAYZENT can cause your heart rate to slow down especially at beginning of treatment (in the first 6 days). MAYZENT can also cause an irregular heartbeat. If your heart rate slows down at the beginning of treatment, you may feel dizzy or tired.

  • the heart rate usually returns to normal within 10 days after start of treatment
  • an irregular heartbeat usually returns to normal in less than one day after you start treatment
• have high blood pressure. Your blood pressure will need to be checked regularly.
• have an infection. MAYZENT lowers your white blood cell count. This may increase your risk of infections including serious and life-threatening infections. This can occur while you are being treated with MAYZENT and up to 1 month after you stop treatment. Your healthcare professional should do a complete blood test to check your white blood cell count before you start treatment if you have not had one done within the last 6 months, during treatment and after you stop treatment.
• have never had chickenpox or have not been vaccinated against chickenpox (varicella zoster virus). While taking MAYZENT, you may develop an infection with the varicella zoster virus, such as herpes zoster (shingles). This may also cause other serious complications including meningitis (an infection of the membranes covering the brain) and/or encephalitis (inflammation of the brain). Your healthcare professional will check your antibody levels and may decide to vaccinate you if you do not have enough antibodies against the virus. If you get the vaccine, you will start treatment 1 month after the full course of the vaccination is completed.

• have not been vaccinated against:

  • Human Papilloma Virus (HPV). Your healthcare professional will decide whether you need to be vaccinated against HPV before starting treatment. For female patients, your healthcare professional may also recommend HPV screening. HPV infection, including papilloma, dysplasia, warts and HPV-related cancer, has been reported in patients treated with medicines similar to MAYZENT.

• plan to receive a vaccine:

  • you should not receive certain types of vaccines (called “live attenuated vaccines”) while you are being treated with MAYZENT and for 4 weeks after stopping treatment
  • other vaccines can be less effective if received at the same time as MAYZENT. Your healthcare professional may want you to temporarily stop MAYZENT.
• have a weakened immune system due to a disease or from medicines that suppress the immune system. You may get infections more easily or an infection you already have may get worse. MAYZENT lowers your white blood cell count during treatment and for up 1 month after you stop taking it.
• have not had a test to check your liver function within the last 6 months
• have a history of seizures. MAYZENT may cause you to have seizures more often.
• have breathing problems. MAYZENT can have a slight effect on your lung function.

• have an allergy to:

  • lactose or
  • have a rare hereditary problem of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

You should not take MAYZENT if you have any of these conditions.

• have or have had:

  • changes in your vision or other signs of swelling in the central vision area at the back of the eye - a condition known as macular edema
  • disease of the retina
  • inflammation or infection of the eye (uveitis) or
  • have diabetes

The macula is a small area of the retina at the back of the eye. It allows you to see shapes, colors, and details clearly and sharply. MAYZENT may cause swelling in the macula and it usually happens during the first 3 to 4 months treatment.

Your chance of developing macular edema is higher if you have diabetes, have had an inflammation or infection of the eye or are on long-term treatment with MAYZENT.

Your healthcare professional may want you to undergo an eye examination:

• before you start MAYZENT
• 3 to 4 months after starting treatment
• during treatment and
• at anytime throughout your treatment if you notice changes in your vision. Tell your healthcare professional about any changes in your vision.
• have liver problems. MAYZENT may affect your liver function. If you notice any of the following symptoms, tell your healthcare professional right away:
• yellowing of your skin or the whites of your eyes
• abnormally dark urine
• unexplained nausea or vomiting
• tiredness

Your healthcare professional may carry out blood tests to check your liver function and may consider stopping MAYZENT treatment if your liver problem is serious.

Other warnings you should know about:

Cancer risk: You could be at an increased risk for developing cancer, particularly skin cancer. Basal cell carcinoma (BCC), malignant melanoma and squamous cell carcinoma (SCC) were reported with patients on MAYZENT therapy. Your healthcare professional should check for any abnormal skin growths before you start treatment and regularly during your treatment with MAYZENT especially if you are at a higher risk for skin cancer. During treatment you should:

• check your skin regularly for unusual changes. If you notice symptoms such as skin nodules (e.g. shiny pearly nodules or firm red nodules), sore with a crust, a new sore on an existing scar, patches or open sores that do not heal within weeks, or symptoms of other skin growths, including abnormal growth or changes of skin tissue (e.g. unusual moles) which may present as a change in colour, shape, elevation or size over time, and may itch, bleed, or ulcerate, tell your healthcare professional right away. These may be symptoms of skin cancer.
• limit how much time you are exposed to the sun and UV rays. Wear protective clothes and regularly apply sunscreen with a high degree of UV protection.

Depression, thoughts of suicide and suicidal behaviour: are known to occur in patients with MS. Thoughts of suicide and suicidal behaviour have been reported with patients taking MAYZENT. Tell your family you are taking this medicine. If you, your caregiver or family members notice changes in your mood, or you start to have thoughts about hurting yourself, contact your healthcare professional right away.

Pregnancy: You should avoid becoming pregnant while taking MAYZENT and for at least 10 days after you stop taking it before planning a pregnancy. MAYZENT may harm your unborn baby. Female patients who might become pregnant should use effective birth control methods during treatment and for at least 10 days after stopping MAYZENT. Ask your healthcare professional about options of effective birth control. See also After you stop treatment above.

• If you become pregnant or think you are pregnant, tell your healthcare professional right away. You and your healthcare professional will decide what is best for you and your baby.

Breastfeeding: You should not breastfeed while you are taking MAYZENT. MAYZENT can pass into breast milk and there is a risk of serious side effects for a breastfed baby. Talk with your healthcare professional before breastfeeding while you take MAYZENT.

Laboratory Tests:

• Abnormal liver function test results: high levels of enzymes called alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT) and aspartate aminotransferase (AST) have been reported in MS patients taking MAYZENT.
• Lower lung function test results: decreases in lung function (breathing) tests have been reported in MS patients taking MAYZENT.

Tell your healthcare professional right away, if you get any of the following symptoms during your treatment with MAYZENT. It could be serious:

• if you believe your MS is getting worse or if you notice any new symptoms, such as changes in mood or behavior, new or worsening weakness on one side of the body, changes in vision, confusion, memory lapses or speech and communication difficulties. These may be symptoms of progressive multifocal leukoencephalopathy (PML), a rare brain disorder caused by an infection. PML can cause symptoms similar to SPMS. Your healthcare professional might do an MRI scan to check for this condition. If PML is confirmed, your healthcare professional will stop your treatment with MAYZENT. Some people with PML may have a reaction as MAYZENT is removed from the body. This reaction is known as immune reconstitution inflammatory syndrome (IRIS). IRIS may lead to your condition getting worse, including worsening of the symptoms described above (see After you stop treatment below).
• if you have fever, feel like you have a flu, or have a headache accompanied by stiff neck, sensitivity to light, nausea, and/or confusion. These may be symptoms of meningitis (inflammation of the membranes covering the brain) and/or encephalitis (inflammation of the brain) caused by a fungal (Cryptococcus) or viral (chickenpox) infection.

Get immediate medical help if you get any of the following symptoms during your treatment with MAYZENT. It could be serious:

• if you have symptoms such as the sudden start of a severe headache, confusion, seizures, changes in your behaviour and changes to your vision. These may be symptoms of a condition called posterior reversible encephalopathy syndrome (PRES).

Seizures: Some patients have had seizures (fits) while taking MAYZENT. It is not known whether the seizures were related to the effects of their MS, MAYZENT, or a combination of both. If you have a seizure while taking MAYZENT, get immediate medical help.

After you stop treatment:

• MAYZENT will stay in your body for at least 10 days after you stop taking it. Your white blood cell count may remain low during this time and for up to 3 to 4 weeks after. This means you could be more prone to infections. Tell your healthcare professional right away if you notice any signs of infection after you have stopped treatment with MAYZENT.

• your symptoms of MS can return and may become worse compared to before you started treatment

  • or during treatment. These could be signs of PML and/or immune reconstitution inflammatory syndrome (IRIS). IRIS often accompanies PML, and it can worsen your condition rapidly. Tell your healthcare professional right away if your MS symptoms become worse after you stop taking MAYZENT.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MAYZENT:

• Medicines that treat an irregular heartbeat (medicines that cause QT prolongation)

  • quinidine
  • procainamide
  • amiodarone
  • sotalol

Your healthcare professional may decide not to prescribe MAYZENT if you are taking these medicines to reduce the possible additive effect of an irregular heartbeat.

• Medicines that slow down your heartbeat such as:

  • beta-blockers (such as atenolol or propranolol)
  • calcium channel blockers (such as verapamil or diltiazem)
  • cholinomimetics
  • other substances that can decrease your heart rate (ivabradine or digoxin)

MAYZENT can slow your heartbeat when you first start treatment. Your healthcare professional may decide to refer you to a cardiologist to change your medicine before you start treatment.

If you are taking a beta-blocker, your healthcare professional will check your resting heart rate before deciding if you can start treatment. When MAYZENT is taken with a beta-blocker the effects of a slow heartbeat are more noticeable.

• Medicines that suppress or modulate the immune system such as chemotherapy or other medicines used to treat MS and medicines used to treat cancer:

  • beta-interferons
  • glatiramer acetate
  • natalizumab
  • mitoxantrone
  • dimethyl fumarate
  • teriflunomide
  • alemtuzumab
  • corticosteroids
  • ocrelizumab

MAYZENT should not be started while you are taking these medicines or if you are switching to or from other therapies used to treat MS with immunosuppressive or immune modulating effects. Your healthcare professional may want to wait for several weeks after you stop taking these medicines before starting you on MAYZENT to reduce the possible additive effect on your immune system. MAYZENT can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.

• Vaccines. If you need to receive a vaccine, talk to your healthcare professional first. For more information about vaccines see To help avoid side effects and ensure proper use above.
• Treatment with medicines such as carbamazepine and rifampin (strong CYP3A4/moderate CYP2C9 dual inducers) is not recommended. These types of medicines can lower the level of MAYZENT in your blood.
• If you have the CYP2C9 *1*3 or *2*3 genotype: treatment with medicines such as modafinil and efavirenz (moderate CYP3A4 inducers) or with strong CYP3A4 inducers is not recommended. These types of medicines can lower the level of MAYZENT in your blood.
• Treatment with medicines such as fluconazole (moderate CYP2C9/CYP3A4 dual inhibitors) is not recommended. These types of medicines can increase the level of MAYZENT in your blood.

How to take MAYZENT:

You should only be prescribed MAYZENT by a neurologist who is experienced in the treatment of multiple sclerosis who can discuss the benefits, harms and the safe use MAYZENT with you.

Before you start treatment:

Your healthcare professional will:

• confirm your CYP2C9 genotype:

  • If you have the CYP2C9*3*3 genotype: Do not take MAYZENT
• conduct an electrocardiogram (ECG) to check for any pre-existing heart conditions

• perform:

  • liver tests if you have not had one within the last 6 months
  • a complete blood test if you have not had one in the last 6 months
  • a check your antibody levels for the chickenpox virus (varicella zoster virus)
  • a pregnancy test if you are a woman of childbearing potential
• check if you currently have a severe infection
• check your medication history
• check you for any abnormal skin growths

Your healthcare professional may also:

• have you go for an eye exam if you have or had uveitis (a swelling in the middle layer of tissue in the eye wall), a history of retinal disorders or diabetes
• have you vaccinated against HPV

Patients with certain heart conditions or risk factors:

If you have certain heart conditions or risk factors the first dose MAYZENT will have to be taken in your healthcare professional’s office or hospital where your heart rate and blood pressure can be monitored (hourly blood pressure and pulse measurements, ECG monitoring) for at least 6 hours.

Usual dose:

On Days 1 to 5 (Titration doses):

When you start treatment with MAYZENT you will be given a starter pack. The starter pack contains 12 tablets. Over a period of 5 days you will slowly increase (titrate) your dose. Follow the directions on the starter pack and the table below.

Take your titration doses once a day in the morning. Swallow the tablets whole with water.

Starter pack dosing schedule:

On Day 6 (Maintenance dose):

Switch to your maintenance dose. Depending on the results of your genotype test your healthcare professional will either prescribe a 1 mg dose or a 2 mg dose.

• If dose is 1 mg: Take 4 (four) 0.25 mg tablets or 1 (one) 1 mg tablet
• If your dose is 2 mg: Take 1 (one) 2 mg tablet

Take your maintenance dose once a day at about the same time each day. Swallow the tablets whole with water.

Continue taking MAYZENT every day for as long as your healthcare professional tells you. Do not stop taking this medicine without talking to your healthcare professional.

If you have questions about how long to take MAYZENT, talk to your healthcare professional or your pharmacist.

Overdose:

Missed dose:

If you miss a dose during the first 6 days of treatment:

• If you miss 1 of your doses during the first 6 days of treatment, contact your healthcare professional right away before you take the next dose. You will have to re-start treatment (from Day 1) using a new starter pack.

If you miss a dose after the first 6 days of treatment (Day 7 and onwards):

• if you miss taking your dose for 1, 2 or 3 days in a row, take the missed dose as soon as you remember. Then take your next dose as usual.
• if you miss taking your dose for 4 or more days in a row, you will have to re-start treatment using a new starter pack. Contact your healthcare professional right away if this happens.

Possible side effects from using MAYZENT:

These are not all the possible side effects you may have when taking MAYZENT. If you experience any side effects not listed here, tell your healthcare professional.

Side effects include:

• Headache.
• Dizziness.
• Involuntary shaking of the body (tremors).
• Diarrhea.
• Nausea.
• Pain in the hands and feet.
• Swollen hands, ankles, legs or feet.
• Weakness / lack of energy.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

• Do not take this medicine after the expiry date, which is stated on the box.
• Store in the refrigerator (between 2 to 8°C). May also be stored at room temperature (below 25°C) for up to 3 months.
• Keep in the original package.
• Keep out of reach and sight of children.

Ask your pharmacist how to dispose of medicines you no longer use.

If you want more information about MAYZENT:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.novartis.ca), or by calling 1-800-363-8883.

Date of Authorization: 2026-09-01

MAYZENT is a registered trademark.