Indication and Important Safety Information: TASCENSO ODT® (fingolimod) 0.25 mg and 0.5 mg
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.
IMPORTANT SAFETY INFORMATION:
You should not take TASCENSO ODT if in the last 6 months you experienced heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure. Do not take TASCENSO ODT if you have an irregular or abnormal heartbeat (arrhythmia), including a heart finding called prolonged QT as seen on an ECG, or if you take medicines that change your heart rhythm. Do not take TASCENSO ODT if you are allergic to fingolimod or any of the other ingredients.
TASCENSO ODT MAY CAUSE SERIOUS SIDE EFFECTS:
- Slower heart rate. All patients will be monitored by a healthcare professional for at least 6 hours after their first dose or after a child takes their first dose of 0.5 mg of TASCENSO ODT when switching from 0.25 mg daily dose. You will have an electrocardiogram (ECG) before and then 6 hours after your first dose and your pulse and blood pressure will be checked hourly. You will continue to be monitored if any other heart issues arise or if your heart rate remains slow. If you have any serious side effects, especially those that require treatment with other medicines, or if you have certain types of heart problems, or if you’re taking medicines that can affect your heart, or your heart rate remains slow, you’ll be watched overnight. If you experience a slow heart rate it should return to normal within 1 month. Immediately call your doctor or seek medical attention if you have any symptoms of slow heart rate, such as dizziness, tiredness, feeling like your heart is beating slowly or skipping beats, or chest pain. Symptoms can happen up to 24 hours after the first dose. Call your doctor if you miss 1 or more doses of TASCENSO ODT as you may need to repeat the 6 hour monitoring.
- Increased risk of serious infections: You should not receive any live vaccines during treatment with TASCENSO ODT or for 2 months after you stop taking it. Vaccines may not work as well during treatment with TASCENSO ODT. Women should consult their doctor about a routine pap-smear, as TASCENSO ODT can increase the risk of human papilloma virus (HPV). Any HPV vaccination should be given before starting TASCENSO ODT. TASCENSO ODT will lower the number of white blood cells (lymphocytes) in your blood, this will normally return to normal within 2 months of stopping TASCENSO ODT. Your doctor may do a blood test to check your white blood cells before starting TASCENSO ODT. You should immediately call your doctor if while taking TASCENSO ODT, or for 2 months after your last dose, you have a fever, tiredness, body aches, chills, nausea, vomiting, or a headache accompanied by fever, neck stiffness, sensitivity to light, nausea and/or confusion, as these could be symptoms of meningitis.
- Progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that can occur mainly in people who have a weakened immune system but can also happen in people who have a healthy immune system, it can lead to severe disability or death. You should call your doctor immediately if you have any new or worsening symptoms of PML that have lasted several days, these include changes in your thinking or memory, changes in your vision, decreased strength, problem with balance, weakness on one side of your body, loss of coordination in your arms and legs, confusion or changes to your personality.
- Immune reconstitution inflammatory syndrome (IRIS). If PML is confirmed, treatment should be stopped. Your doctor will monitor you for development of Immune Reconstitution Inflammatory Syndrome (PML-IRIS), which has been reported in patients who stopped treatment after developing PML. IRIS presents as a decline in your condition that may be rapid which can lead to serious neurological complications or death. Your doctor will monitor you for PML-IRIS if or when you stop TASCENSO ODT, in the setting of PML.
- Macular Edema. Is a vision problem, if it occurs, it will usually happen 2-4 months after starting TASCENSO ODT. Your doctor will likely test your eyes before and 3-4 months after starting with TASCENSO ODT, they will also be tested any time you have vision changes. Vision problems may continue after macular edema has gone away. You have a higher risk of macular edema if you have diabetes or have an inflammation of you eye (uvetis). Immediately call your doctor if you have blurriness, shadows, or a blind spot in the centre of your vision, sensitivity to light or unusually colored vision.
- Liver damage. Your doctor should do blood tests before and periodically during treatment with TASCENSO ODT. Immediately call your doctor if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark colored urine, or if your skin or whites of your eyes turn yellow.
- Posterior reversible encephalopathy syndrome (PRES). PRES is swelling and narrowing of the blood vessels in your brain, it has rarely happened in adults taking fingolimod. Symptoms of PRES usually get better when finishing TASCENSO ODT, however, if left untreated it can lead to stroke. Immediately call your doctor if you experience any symptoms such as severe headache, sudden confusion, seizures or sudden vision loss.
- Breathing problems. Some patients can experience shortness of breath, immediately call your doctor if you have trouble breathing.
- Pregnancy. You should avoid becoming pregnant whilst taking TASCENSO ODT and for two months after stopping taking it because of the risk of harm it could have to the baby. You should consult your doctor before getting pregnant.
- Severe worsening of MS after stopping treatment. Many people who experience worsening of MS symptoms after stopping TASCENSO ODT do not return to the level of function they had before or during treatment. This can occur in women stopping due to pregnancy or planning pregnancy. Worsening of symptoms most often occurs within 12 weeks after stopping TASCENSO ODT but can happen later. Always consult a doctor before stopping treatment with TASCENSO ODT. Let your doctor know if you have worsening symptoms of MS after stopping treatment.
- Blood pressure increase. You may experience a higher blood pressure, so your blood pressure will be continuously monitored throughout treatment.
- Cancer. Cancers including basal, squamous, Merkel cell carcinomas and melanoma. Tell your doctor if you have any changes in the appearance of your skin, including changes to moles, new darkened areas to you skin, a sore that does not heal, growths such as bumps that may be shiny, pearly white, skin colored or pink. During treatment with TASCENSO ODT limit the amount of time you spend in the sunlight and ultraviolet light (UV). When in sunlight make sure to use sunscreen with a high sun protection factor and wear protective clothing. Lymphoma has also occurred in patients receiving treatment with TASCENSO ODT.
THE MOST COMMON SIDE EFFECTS:
Headache, abnormal liver tests, diarrhea, cough, flu, inflammation of the sinuses, back pain, stomach pain, and pain in arms or legs.
TASCENSO ODT can harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Women should stop taking TASCENSO ODT 2 months before trying to become pregnant. Women who can become pregnant should use effective birth control during treatment with TASCENSO ODT, and for at least 2 months after stopping. If you do become pregnant during treatment with TASCENSO ODT or within 2 months after stopping, immediately let your doctor know. It is unknown whether TASCENSO ODT can pass into breast milk so you should speak with your doctor about the best way to feed your baby during treatment with TASCENSO ODT.
You should tell your doctor about all your medical conditions, including if you have had or now have an irregular or abnormal heartbeat, stroke or mini-stroke, heart problems, a history of fainting, a fever, if you are unable to fight infections due to a disease or are taking medicines that lower your immune system, including corticosteroids, or have taken them in the past, eye problems, diabetes, breathing or liver problems, or uncontrolled blood pressure.
Let your doctor know if you have had chicken pox or have received the chicken pox vaccine, they may test for the chicken pox virus and you may need to get the full vaccine course and wait 1 month before starting TASCENSO ODT. Children 10 years and older should complete their full vaccination schedule before starting treatment with TASCENSO ODT.
You should tell your doctor about all medicines you take or have taken recently, including prescription, over the counter medicines, vitamins and herbal supplements.
If you take too much TASCENSO ODT immediately call your doctor or go to the nearest hospital emergency room.
You are encouraged to report negative side effects of prescription drugs. To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at +1 888-533-1625, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.
For more detailed information, please refer to the full Prescribing Information at www.tascenso.com/pi