What is the most important information I should know about TASCENSO ODT?
TASCENSO ODT may cause serious side effects, including:
1. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking TASCENSO ODT. TASCENSO ODT can cause your heart rate to slow down, especially after you take your first dose. You will have a test, called an electrocardiogram (ECG), to check the electrical activity of your heart before you take your first dose of TASCENSO ODT.

All adults and children will be observed by a healthcare professional for at least 6 hours after taking their first dose of TASCENSO ODT. Children should also be observed by a healthcare professional for at least 6 hours after taking their first dose of 0.5 mg of TASCENSO ODT when switching from the 0.25 mg dose.

After you take your first dose of TASCENSO ODT, and after a child takes their first dose of 0.5 mg of TASCENSO ODT when switching from the 0.25 mg dose:

• Your pulse and blood pressure should be checked every hour.
• You should be observed by a healthcare professional to see if you have any serious side effects. If your heart rate slows down too much, you may have symptoms, such as:
  • dizziness
  • tiredness
  • feeling like your heart is beating slowly or skipping beats
  • chest pain
• If you have any symptoms of slow heart rate, they will usually happen during the first 6 hours after your first dose of TASCENSO ODT. Symptoms can happen up to 24 hours after you take your first dose of TASCENSO ODT.
• 6 hours after you take your first dose of TASCENSO ODT you will have another ECG. If your ECG shows any heart problems or if your heart rate is still too low or continues to decrease, you will continue to be observed.
• If you have any serious side effects after your first dose of TASCENSO ODT, especially those that require treatment with other medicines, you will stay in the medical facility to be observed overnight. You will also be observed for any serious side effects for at least 6 hours after you take your second dose of TASCENSO ODT the next day.
• If you have certain types of heart problems, or if you are taking certain types of medicines that can affect your heart, you will be observed overnight after you take your first dose of TASCENSO ODT.

Your slow heart rate will usually return to normal within 1 month after you start taking TASCENSO ODT. Call your doctor or go to the nearest hospital emergency room right away if you have any symptoms of a slow heart rate.

If you miss 1 or more doses of TASCENSO ODT, you may need to be observed by a healthcare professional when you take your next dose. Call your doctor if you miss a dose of TASCENSO ODT. See "How should I take TASCENSO ODT?"

2. Pregnancy. Please consult your doctor before getting pregnant. You should avoid becoming pregnant while taking TASCENSO ODT or in the two months after you stop taking it because of the risk of harm to the baby.

3. Infections. TASCENSO ODT can increase your risk of serious infections that can be life-threatening and cause death. You should not receive live vaccines during treatment with TASCENSO ODT and for 2 months after you stop taking TASCENSO ODT. Talk to your doctor before you receive a vaccine during treatment and for 2 months after treatment with TASCENSO ODT. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with TASCENSO ODT.

Human Papilloma Virus (HPV). Due to risk of HPV infection please consult your doctor for routine pap smear.

TASCENSO ODT lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 2 months of stopping treatment. Your doctor may do a blood test to check your white blood cells before you start taking TASCENSO ODT. Call your doctor right away if you have any of these symptoms of an infection during treatment with TASCENSO ODT, and for 2 months after your last dose of TASCENSO ODT:

• fever
• tiredness
• body aches
• chills
• nausea
• vomiting
• headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)

4. Progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks.

Call your doctor right away if you have any new or worsening symptoms of PML, that have lasted several days, including:

• weakness on 1 side of your body
• loss of coordination in your arms and legs
• decreased strength
• problems with balance
• changes in your vision
• changes in your thinking or memory
• confusion
• changes in your personality

• blurriness or shadows in the center of your vision
• a blind spot in the center of your vision
• sensitivity to light
• unusually colored (tinted) vision

What is TASCENSO ODT?
TASCENSO ODT is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

It is not known if TASCENSO ODT is safe and effective in children under 10 years of age.

• have had a heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA) or certain types of heart failure in the last 6 months.
• have certain types of irregular or abnormal heartbeat (arrhythmia), including patients in whom a heart finding called prolonged QT is seen on ECG before starting TASCENSO ODT.
• have a heart rhythm problem that needs treatment with certain medicines.
• are allergic to fingolimod or any of the ingredients in TASCENSO ODT. See the end of this leaflet for a complete list of ingredients in TASCENSO ODT. Symptoms of an allergic reaction may include rash, itchy hives, or swelling of the lips, tongue or face.
• taking other products containing fingolimod, the active ingredient in TASCENSO ODT.

• an irregular or abnormal heartbeat (arrhythmia).
• a history of stroke or mini-stroke.
• heart problems, including heart attack or angina.
• a history of repeated fainting (syncope).
• a fever or infection, or you are unable to fight infections due to a disease or take or have taken medicines that lower your immune system.
• recently received a vaccine or are scheduled to receive a vaccine.
• chickenpox or have received the vaccine for chickenpox. Your doctor may do a blood test for chickenpox virus. You may need to get the full course of the vaccine for chickenpox and then wait 1 month before you start taking TASCENSO ODT.
• your child has completed their vaccination schedule. Your child needs to have completed their vaccination schedule before starting treatment with TASCENSO ODT.
• eye problems, especially an inflammation of the eye called uveitis.
• diabetes.
• breathing problems, including during your sleep.
• liver problems.
• high blood pressure.
• types of skin cancer called basal cell carcinoma (BCC) or melanoma.
• are pregnant or plan to become pregnant. TASCENSO ODT may harm your unborn baby. Talk to your doctor if you are pregnant or are planning to become pregnant. Tell your doctor right away if you become pregnant while taking TASCENSO ODT or if you become pregnant within 2 months after you stop taking TASCENSO ODT.
  • You should stop taking TASCENSO ODT 2 months before trying to become pregnant.
  • If you are a female who can become pregnant, you should use effective birth control during your treatment with TASCENSO ODT and for at least 2 months after you stop taking TASCENSO ODT.
• are breastfeeding or plan to breastfeed. It is not known if TASCENSO ODT passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take TASCENSO ODT.

Tell your doctor about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take medicines that affect your immune system, including corticosteroids, or have taken them in the past.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

Using TASCENSO ODT and other medicines together may affect each other causing serious side effects.

Do not take TASCENSO ODT with Gilenya or other medicines containing fingolimod.

How should I take TASCENSO ODT?

• Adults and children will be observed by a healthcare professional for at least 6 hours after taking their first dose of TASCENSO ODT. Children should also be observed by a healthcare professional for at least 6 hours after taking their first dose of 0.5 mg of TASCENSO ODT when switching from the 0.25 mg dose. See "What is the most important information I should know about TASCENSO ODT?"
• Take TASCENSO ODT exactly as your doctor tells you to take it.
• Take TASCENSO ODT 1 time each day.
• The ODT may be taken with or without water.
• Take TASCENSO ODT with or without food.
• Take the TASCENSO ODT immediately after opening the blister pack. Do not store the TASCENSO ODT outside the blister pack for future use.
• Use dry hands when opening the blister pack.
• Peel back the foil covering of 1 blister pack and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
• As soon as the blister pack is opened, remove the ODT and place on the tongue and allow it to dissolve.
• If you take too much TASCENSO ODT, call your doctor or go to the nearest hospital emergency room right away.
• Do not stop taking TASCENSO ODT without talking with your doctor first.
• Call your doctor right away if you miss a dose of TASCENSO ODT. You may need to be observed by a healthcare professional for at least 6 hours when you take your next dose. If you need to be observed by a healthcare professional when you take your next dose of TASCENSO ODT you will have:
  • an ECG before you take your dose
  • hourly pulse and blood pressure measurements after you take the dose
  • an ECG 6 hours after your dose

• See "What is the most important information I should know about TASCENSO ODT?"
• swelling and narrowing of the blood vessels in your brain. A condition called PRES (Posterior Reversible Encephalopathy Syndrome) has happened rarely in adults taking fingolimod, the active ingredient in TASCENSO ODT. Symptoms of PRES usually get better when you stop taking TASCENSO ODT.
  However, if left untreated, it may lead to a stroke. Call your doctor right away if you have any of the following symptoms:
  • sudden severe headache
  • sudden confusion
  • sudden loss of vision or other changes in your vision
  • seizure
• liver damage.TASCENSO ODT may cause liver damage. Your doctor should do blood tests to check your liver before you start taking TASCENSO ODT and periodically during treatment. Call your doctor right away if you have any of the following symptoms of liver damage:
  • nausea
  • vomiting
  • stomach pain
  • tiredness
  • loss of appetite
  • your skin or the whites of your eyes turn yellow
  • dark urine
• breathing problems. Some people who take TASCENSO ODT have shortness of breath. Call your doctor right away if you have new or worsening breathing problems.
• severe worsening of multiple sclerosis after stopping TASCENSO ODT. When TASCENSO ODT is stopped, symptoms of MS can return and become worse compared to before or during treatment. Many people who have worsening of MS symptoms after stopping TASCENSO ODT do not return to the level of function that they had before stopping TASCENSO ODT. This worsening happens most often within 12 weeks after stopping TASCENSO ODT but can happen later. Always talk to your doctor before you stop taking TASCENSO ODT for any reason. Tell your doctor if you have worsening symptoms of MS after stopping TASCENSO ODT.
• increased blood pressure. Your doctor should check your blood pressure during treatment with TASCENSO ODT.
• types of skin cancer called basal cell carcinoma (BCC) and melanoma. Tell your doctor if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes during treatment with TASCENSO ODT. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.
• allergic reactions. Call your doctor if you have symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue or face.

• headache
• abnormal liver tests
• diarrhea
• cough
• flu
• inflammation of the sinuses (sinusitis)
• back pain
• stomach-area (abdominal) pain
• pain in arms or legs

• Store TASCENSO ODT in the blister pack in a dry place.
• Store TASCENSO ODT at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not open the blister pack until ready to take TASCENSO ODT.
• Keep TASCENSO ODT and all medicines out of the reach of children.