Sandoz Fingolimod: Uses, Side Effects and Dosage

What SANDOZ FINGOLIMOD is used for:

SANDOZ FINGOLIMOD is used to treat:

• Adults with relapsing and remitting multiple sclerosis (MS): With this type of MS, new symptoms can appear, or existing symptoms can get worse during flare-ups (relapses). Between relapses, recovery is complete or almost complete. SANDOZ FINGOLIMOD is recommended for people who have not responded well to or who cannot tolerate other treatments.

How SANDOZ FINGOLIMOD works:

SANDOZ FINGOLIMOD does not cure MS, but it helps by:

• reducing the number of flare-ups (relapses).
• lessening inflammation in the brain and spinal cord (seen on MRI scans) that can damage nerves.
• slowing down the worsening of physical problems caused by MS.

SANDOZ FINGOLIMOD changes how your immune system works by making it harder for certain white blood cells (lymphocytes) to move around your body. This lowers the number of these cells in your blood and keeps them from reaching your brain and spinal cord. As a result, this may help lessen the inflammation and nerve damage that happens with MS.

The ingredients in SANDOZ FINGOLIMOD are:

Medicinal ingredient(s): fingolimod hydrochloride.

Non-medicinal ingredients: gelatin, magnesium stearate, mannitol, titanium dioxide and yellow iron oxide.

SANDOZ FINGOLIMOD comes in the following dosage form(s):

Hard capsules: 0.5 mg of fingolimod (as fingolimod hydrochloride).

Do not use SANDOZ FINGOLIMOD if:

• you are allergic to fingolimod or to any of the other ingredients in SANDOZ FINGOLIMOD (see The ingredients in SANDOZ FINGOLIMOD are:).

• your immune system is weakened because of:

  • disease like immunodeficiency syndrome.
  • treatments like cancer medicines or bone marrow transplantation.
• you currently have a severe infection or long-term infection such as hepatitis or tuberculosis (TB).
• you currently have cancer, but it is not the type of skin cancer called basal cell carcinoma.
• you have serious liver disease.

• you have heart problems, like:

  • a heart attack, chest pain (angina), stroke or signs of a stroke, or certain types of heart failure in the last 6 months.
  • certain types of irregular or abnormal heartbeat (arrhythmia), or prolonged QT interval on your heart test (ECG).
• you are taking or have recently taken medicine for irregular heartbeat such as quinidine, disopyramide, amiodarone or sotalol, which may affect your heartbeat.
• you are pregnant, think you might be pregnant or plan to get pregnant.
• you are of childbearing age and are not using effective birth control.
• you are of childbearing age until a pregnancy test confirms that you are not pregnant. This test is done just before you start SANDOZ FINGOLIMOD.

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

• have or have had heart issues like:

  • high or low blood pressure.
  • a slow heart rate.
  • already taking other medicines that slow your heart rate.
  • or having fainted before.
• have severe untreated sleep apnea. This is a condition where your breathing repeatedly starts and stop while you sleep.
• have a weakened immune system because of a disease or other medicines or treatments you are receiving.
• got a vaccine within 1 month before starting SANDOZ FINGOLIMOD or plan to get one. Avoid certain types of vaccines (called “live attenuated vaccines”) during and for up to 2 months after treatment with SANDOZ FINGOLIMOD.
• have never had chickenpox or have not been vaccinated for it.
• have had infections like hepatitis or tuberculosis (TB).

• have or have had eye problems like:

  • eyesight issues or swelling in a part of your eye called the macula.
  • inflammation or infection of the eye (uveitis).
• have diabetes.
• have issues with your liver or kidneys.
• have high level of cholesterol or fat in your blood.
• have breathing problems.
• are breastfeeding.
• are 65 years of age or older. You may have a higher risk of side effects.

Other warnings you should know about:

• Chickenpox: If you have not had chickenpox or the chickenpox vaccine, you could get a serious and life-threatening chickenpox infection during treatment with SANDOZ FINGOLIMOD. Very rarely, chickenpox infections have been deadly in people taking fingolimod capsules along with relatively long course of corticosteroid treatments. Your healthcare professional may recommend getting the chickenpox vaccine 1 month before starting SANDOZ FINGOLIMOD.

• Human Papilloma Virus (HPV): Your healthcare professional will let you know if you need an HPV vaccine before starting SANDOZ FINGOLIMOD. If you are a woman they will recommend an HPV test. People using fingolimod capsules have reported HPV infection, which can cause:

  • finger-like growths on the skin and mucous membranes (papilloma).
  • abnormal cells in the lower part of the uterus (dysplasia), found by a screening test (PAP smear) in women.
  • warts (small bumps on the skin) and cancer.

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• Blood Tests and Monitoring: Before you start taking SANDOZ FINGOLIMOD and during treatment, your healthcare professional will do tests to check for side-effects. Tests you may need include:

  • blood tests to check:

    • your white blood cell counts.
    • your liver health (see Liver Problems below).
  • eye exams to look for eye problems (see Eye Problems below).
  • possibly lung function tests.

  • heart rhythm and blood pressure checks.

    Because fingolimod can affect your heart (see Heart Problems below), you will need a heart test (ECG) before starting fingolimod. After taking the first dose, you will need to stay in the clinic for at least 6 hours so your heart rate and blood pressure can be checked every hour. A second ECG will be done after 6 hours. Depending on the results, you may need to stay longer, possibly overnight, for checking. This process may also apply if you restart treatment after a break.

• Heart Problems: SANDOZ FINGOLIMOD can slow down your heart rate, especially in the first month. It can also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal in less than one day. Slow heart rate usually returns to normal within one month. People with heart disease or those taking certain medicines are at higher risk. People aged 65 and older are also at higher risk.

  • If you have an irregular heartbeat or a history of fainting, your condition may temporarily worsen with SANDOZ FINGOLIMOD. This might also happen if you have a slow heart rate or are taking medicines which slow the heartbeat.
  • If you experience symptoms like dizziness, palpitations (rapid or irregular heartbeat), fainting, or seizures while taking SANDOZ FINGOLIMOD, seek immediate medical help.

• Liver Problems: SANDOZ FINGOLIMOD may cause liver damage. Tell your healthcare professional right away if you have any of the following symptoms of liver problems:

  • nausea,
  • vomiting,
  • stomach pain,
  • tiredness,
  • loss of appetite,
  • your skin or the whites of your eyes turn yellow,
  • dark urine.

• Infections: SANDOZ FINGOLIMOD can make it harder for your body to fight infections. This means you may get infections more easily while taking it, and for up to 2 months after stopping. If you have an infection before starting SANDOZ FINGOLIMOD, tell your healthcare professional, as it could get worse. Infections can be serious and sometimes

  • life-threatening.

    • Before starting SANDOZ FINGOLIMOD, your healthcare professional will check your white blood cell count.
    • While taking SANDOZ FINGOLIMOD, if you think you have an infection, have a fever, feel like you have the flu, or have a headache with a stiff neck, sensitivity to light, nausea, confusion, or seizures, tell your healthcare professional right away. These could be signs of brain inflammation (encephalitis) or meningitis caused by a serious fungal or viral infection.
    • If you think your MS is getting worse (e.g., weakness or vision changes) or notice any new or unusual symptoms, talk to your healthcare professional as soon as possible. These could be signs of a rare serious brain disorder called progressive multifocal leukoencephalopathy (PML) that is caused by an infection. Your healthcare professional might do an MRI scan to check for this condition and decide if you need to stop SANDOZ FINGOLIMOD. After stopping SANDOZ FINGOLIMOD because of PML, your healthcare professional will watch for signs of immune reconstitution inflammatory syndrome (IRIS). IRIS is a condition that can occur with PML. It can worsen your condition rapidly and might be life-threatening. Tell your healthcare professional right away if your MS symptoms become worse after stopping SANDOZ FINGOLIMOD.
    • Avoid using other medications that affect the immune system while taking SANDOZ FINGOLIMOD, as they can increase the risk of infections.
• Eye Problems: When you start SANDOZ FINGOLIMOD, you may get a problem with your eyesight called macular edema. It can cause eyesight issues similar to those during an MS attack, like optic neuritis. Sometimes, you may not notice any symptoms. Macular edema usually starts within the first 3 to 4 months of taking SANDOZ FINGOLIMOD. Your healthcare professional will check your eyesight around this time, or any time you notice any vision changes. Your risk of macular edema is higher if you have diabetes or have had an inflammation of the eye called uveitis. If you have had eyesight problems, diabetes, uveitis, or other signs of swelling in the central vision area at the back of the eye called macula, your healthcare professional should check your eyesight before you start SANDOZ FINGOLIMOD.
• Seizures: Some people have had seizures (fits) while taking fingolimod capsules. It is not clear if the seizures were caused by their MS, fingolimod capsules, or both. If you have a seizure while taking SANDOZ FINGOLIMOD, get medical help right away.
• Depression and Suicidal Thoughts: People with MS can have depression and suicidal thoughts. If you are taking SANDOZ FINGOLIMOD, you, your family, and caregivers should watch for these symptoms. Tell your healthcare professional right away if any of these symptoms occur.

• Cancer Risk: Taking SANDOZ FINGOLIMOD can increase your risk of developing cancers like lymphoma and skin cancer.

  • Watch for changes: While you are taking SANDOZ FINGOLIMOD, you should check your skin regularly. If you already have moles or open sores before starting SANDOZ FINGOLIMOD, watch for changes, keep an eye on them. Looks for changes in the size, shape or color of moles or if the open sores do not heal within weeks after you start SANDOZ FINGOLIMOD. These may be signs of skin cancer and you should talk to your healthcare professional about them.

  • Types of Skin Cancer: The types of skin cancer reported in patients taking fingolimod capsules include:

    • Basal cell carcinoma (BCC): Look for shiny, pearly nodules or open sores that don’t heal within weeks.
    • Other skin cancer like malignant melanoma, squamous cell carcinoma, Kaposi’s sarcoma and Merkel cell carcinoma: Look for changes, such as unusual moles that may change in color, shape or size over time.
  • Regular Checks: Your healthcare professional will regularly check your skin during your treatment.
  • Sun Exposure: Long-term exposure to the sun and UV rays, and a weak immune system can affect the risk of a type of skin cancer called Merkel cell carcinoma. Protect yourself by wearing appropriate clothing and regularly applying sunscreen with a high UV protection.
• Return of MS Symptoms: After you stop SANDOZ FINGOLIMOD, your MS symptoms can come back and may be worse than before or during treatment. If your MS symptoms get worse after stopping SANDOZ FINGOLIMOD, tell your healthcare professional right away.
• Brain Lesions: Rarely, during an MS relapse or flare-up, people taking SANDOZ FINGOLIMOD may get unusually large brain lesions, known as tumefactive lesions. If you have a severe flare-up, your healthcare professional may request an MRI scan to check for this condition and decide if you should stop SANDOZ FINGOLIMOD.

• Blood Disorders: SANDOZ FINGOLIMOD may cause the following blood problems:

  • Breakdown of red blood cells (autoimmune hemolytic anemia): You may feel weak, look pale, or feel tired.
  • Low levels of platelets (thrombocytopenia): You may bruise easily, have bleeding from a cut that is hard to stop, have heavier periods, bleed from your gums or nose, or see small, red, pink, or purple spots on your skin.

If you notice any of these symptoms, tell your healthcare professional right away.

• Pregnancy:

  • Do not take SANDOZ FINGOLIMOD if you are pregnant. It can harm your unborn baby.

  • If you could become pregnant or are planning to become pregnant, before you start SANDOZ FINGOLIMOD your healthcare professional will:

    • explain the risk to your unborn baby.
    • ask you to do a pregnancy test.
    • discuss birth control options with you. You must use effective birth control while you are taking SANDOZ FINGOLIMOD and for two months after stopping it.
  • If you become pregnant while taking SANDOZ FINGOLIMOD tell your healthcare professional right away. Together, you will decide what is best for you and your baby. If you become pregnant while taking SANDOZ FINGOLIMOD, you can call the SANDOZ FINGOLIMOD Pregnancy Registry at 1-855-788-5333.
• Breastfeeding: Do not breastfeed while taking SANDOZ FINGOLIMOD. SANDOZ FINGOLIMOD can pass into breast milk and may cause serious side effects for your baby.

• Driving and using machines:

  • After the first dose of SANDOZ FINGOLIMOD, you will be monitored in a medical setting for at least 6 hours to check your heart rate and blood pressure.
  • Your ability to drive and use machines may be affected during and possibly after this period. Do not drive or operate machinery until you know how you respond to SANDOZ FINGOLIMOD.

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

Serious drug interactions:

Do not take SANDOZ FINGOLIMOD if you are taking, or have recently taken, medicines for an irregular heartbeat such as:

• quinidine
• disopyramide
• amiodarone
• sotalol

The following may also interact with SANDOZ FINGOLIMOD:

• Medicines for heart problems or high blood pressure.
• Medicines that slow down the heartbeat such as atenolol or metoprolol (called beta-blockers), verapamil, or diltiazem (called calcium channel blockers) or ivabradine or digoxin.
• Medicines to treat fungal infections, such as ketoconazole.
• Antibiotics, used to treat bacterial infections, such as erythromycin.
• Medicines used to treat HIV infection.
• Medicines used to treat asthma.

• Medicines that suppress or change the immune system including other medicines used to treat MS (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, dimethyl

  • fumarate, teriflunomide, alemtuzumab or corticosteroids) or medicines used to treat cancer.

    • Do not start SANDOZ FINGOLIMOD while you are on these medications.
    • If you are switching to SANDOZ FINGOLIMOD from another MS treatment, your healthcare professional may wait for several months to reduce the added effect on your immune system and the risk of serious infections.

• Vaccines.

  • If you need a vaccine, talk to your healthcare professional first.
  • While you are taking SANDOZ FINGOLIMOD and for up to 2 months after stopping it some vaccines with live virus (live attenuated vaccines) may cause the infection that they are meant to prevent.
  • Other vaccines may not work well enough to protect you.

How to take SANDOZ FINGOLIMOD:

• Always take SANDOZ FINGOLIMOD exactly as your healthcare professional has told you.
• Do not stop taking SANDOZ FINGOLIMOD or change your dose without talking to your healthcare professional.

• Take SANDOZ FINGOLIMOD once a day, at the same time each day with half a glass of water. You can take SANDOZ FINGOLIMOD with or without food.

• SANDOZ FINGOLIMOD will stay in your body for up to 2 months after you stop it. The side effects described in this leaflet may still occur during that time.

Usual dose:

Adults: One 0.5 mg capsule per day.

Overdose:

If you think you, or a person you are caring for, have taken too much SANDOZ FINGOLIMOD, contact a healthcare professional, hospital emergency department, regional poison control centre, or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Take the medication package with you when you go to the hospital.

Missed dose:

• If you forget a dose, skip it and take the next dose as planned. Do not take a double dose to make up for a missed one.
• If you miss one dose during the first 2 weeks or stop taking SANDOZ FINGOLIMOD for more than 7 days during weeks 3 and 4, tell your healthcare professional right away. They may decide to monitor you when you take the next dose.
• If you stop taking SANDOZ FINGOLIMOD for 2 weeks or more, you will need to restart it in a medical setting. Do not restart SANDOZ FINGOLIMOD after stopping it for more than two weeks without talking to your healthcare professional.

Possible side effects from using SANDOZ FINGOLIMOD:

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

Side effects may include:

• Flu virus infection;
• Headache;
• Diarrhea;
• Back pain;
• Cough;
• Sinusitis (sinus infection);
• Fungal infections affecting skin, nails or hair;
• Dizziness;
• Migraine;
• Weakness;
• Mild increase in blood pressure;
• Skin rash;
• Hair loss;
• Itchy skin;
• Weight loss;
• Blurred vision;
• Breathlessness;
• Tingling or numbness;
• Depression;
• Eye pain;
• Nausea;
• Muscle pain;
• Joint pain.

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.

Storage:

• Do not use SANDOZ FINGOLIMOD after the expiry date shown on the box.
• Store at 15-25°C.
• Store in the original package, protect from moisture.
• Keep out of reach and sight of children.

If you want more information about SANDOZ FINGOLIMOD:

• Talk to your healthcare professional.

• Find the full Product Monograph that is prepared for healthcare professionals and includes the 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 (https://www.sandoz.ca/en); or by calling the manufacturer, Sandoz Canada Inc., at 1-800-361-3062.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

If you become pregnant while taking SANDOZ FINGOLIMOD, talk to your healthcare professional about registering with the SANDOZ FINGOLIMOD Pregnancy Registry. You can enroll in this registry by calling:

1-800-343-8893 ext 4636.

Date of Authorization: 2025-10-29