Fingolimod Capsules 0.5 mg | Therapeutically equivalent to Gilenya^® 0.5 mg.^†

IMPORTANT SAFETY INFORMATION

Who should not use FINGOLIMOD CAPSULES?

Do not take FINGOLIMOD CAPSULES if you:

• have had a heart attack, unstable angina, stroke or mini stroke (transient ischemic attack or TIA), or certain types of heart failure.
• have certain types of irregular or abnormal heartbeat (arrythmia), including if a heart finding called QT has been seen on ECG before starting FINGOLIMOD CAPSULES.
• have a heart rhythm problem that needs treatment with certain medicines.
• are allergic to fingolimod or any of the ingredients in FINGOLIMOD CAPSULES.

Before you take FINGOLIMOD CAPSULES, tell your healthcare provider if you:

• have an irregular or abnormal heartbeat (arrythmia).
• have a history of stroke or mini stroke.
• have a history of heart problems, including heart attack or angina.
• have a history of repeated fainting (syncope).
• have 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.
• have recently received a vaccine or are scheduled to receive a vaccine.
• have chickenpox or have received the vaccine for chickenpox. Your doctor may do a blood test for chickenpox virus. You may need to get the vaccine for chicken pox and then wait 1 month before you start taking FINGOLIMOD CAPSULES.
• have a child who has not completed their vaccination schedule. Your child needs to have completed their vaccination schedule before taking FINGOLIMOD CAPSULES.
• have eye problems, especially an inflammation of the eye called uveitis.
• have diabetes.
• have breathing problems, including during your sleep.
• have liver problems.
• have high blood pressure.
• have types of skin cancer called basal cell carcinoma (BCC) or melanoma.
• are pregnant or plan to become pregnant. FINGOLIMOD CAPSULES may harm your unborn baby. Tell your doctor right away if you become pregnant while taking FINGOLIMOD CAPSULES or if you become pregnant within 2 months after you stop taking FINGOLIMOD CAPSULES.
  • You should stop taking FINGOLIMOD CAPSULES 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 FINGOLIMOD CAPSULES and for at least 2 months after you stop taking FINGOLIMOD CAPSULES.

How do I take FINGOLIMOD CAPSULES?

• Adults and children will be observed by a healthcare professional for at least 6 hours after taking their first dose of FINGOLIMOD CAPSULES. Children should also be observed by a healthcare professional for at least 6 hours after taking their first dose of 0.5 mg FINGOLIMOD CAPSULES after switching from the 0.25 mg 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 FINGOLIMOD CAPSULES.
  • Your pulse and blood pressure should be checked every hour while you are being observed. After 6 hours, you will have another ECG.
• Take FINGOLIMOD CAPSULES exactly as your doctor tells you to take it.
• Take FINGOLIMOD CAPSULES 1 time each day. If you take too many FINGOLIMOD CAPSULES, call your doctor or go to the nearest hospital emergency room right away.
• Take FINGOLIMOD CAPSULES with or without food.
• Do not stop taking FINGOLIMOD CAPSULES without talking to your doctor first.
• Call your doctor right away if you miss a dose of FINGOLIMOD CAPSULES. You may need to be observed by a healthcare professional for at least 6 hours when you take your next dose.

What are possible side effects of FINGOLIMOD CAPSULES?

FINGOLIMOD CAPSULES may cause serious side effects, including:

• Slow heart rate (bradycardia or bradyarrhythmia), especially after the first dose. All adults and children will be observed by a healthcare professional for at least 6 hours after taking their first dose of FINGOLIMOD CAPSULES. See "How do I take FINGOLIMOD CAPSULES?"
  • 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, or chest pain.
  • If you have any of the symptoms of slow heart rate, they will usually happen during the first 6 hours after your first dose of FINGOLIMOD CAPSULES. Symptoms can happen up to 24 hours after you take your first FINGOLIMOD CAPSULES dose.
  • 6 hours after you take your first dose of FINGOLIMOD CAPSULES 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 FINGOLIMOD CAPSULES, especially those that require treatment with other medicines, you will stay for overnight observation. You will also be observed for any serious side effects for at least 6 hours after you take your second dose of FINGOLIMOD CAPSULES 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 FINGOLIMOD CAPSULES.
  • Your slow heart rate will usually return to normal within 1 month after you start taking FINGOLIMOD CAPSULES. Call your doctor or go to the nearest hospital emergency room right away if you have symptoms of a slow heart rate.
• Increased risk of serious infections that can be life-threatening and cause death. You should not receive live vaccines during treatment with FINGOLIMOD CAPSULES and for 2 months after you stop taking FINGOLIMOD CAPSULES. Talk to your doctor before you receive a vaccine during treatment and for 2 months after treatment with FINGOLIMOD CAPSULES. 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 FINGOLIMOD CAPSULES. Call your doctor right away if you have symptoms of an infection during treatment with FINGOLIMOD CAPSULES, and for 2 months after your last dose of FINGOLIMOD CAPSULES, including fever, tiredness, body aches, chills, nausea, vomiting, or 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).
  • Human Papilloma Virus (HPV). Due to risk of HPV infection please consult your doctor for routine pap smear.
• Progressive multifocal leukoencephalopathy (PML), 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 symptoms of PML that have l asted several days, including weakness on 1 side of your body, loss of coordination of your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
• Macular edema, a problem with your vision that can cause some of the same vision symptoms as an MS attack (optic neuritis). If macular edema happens, it usually starts in the first 3 to 4 months after starting FINGOLIMOD CAPSULES. Your doctor should test your vision before you start FINGOLIMOD CAPSULES, 3 to 4 months after you start FINGOLIMOD CAPSULES, and any time you notice vision changes. Vision problems may continue after macular edema has gone away. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye (uveitis). Call your doctor right away if you have blurriness, shadows, or a blind spot in the center of your vision; sensitivity to light; or unusually colored vision.
• Swelling and narrowing of the blood vessels in your brain that cause a condition called PRES (posterior reversible encephalopathy syndrome). PRES has happened rarely in adults taking FINGOLIMOD CAPSULES. Symptoms of PRES usually get better when you stop taking FINGOLIMOD CAPSULES. However, if left untreated, it may lead to a stroke. Call your doctor right away if you experience any symptoms such as sudden severe headache, sudden confusion, seizures, or sudden loss of vision.
• Liver damage. Your doctor should do blood tests to check your liver before you start FINGOLIMOD CAPSULES and periodically during treatment. Call your doctor right away if you have symptoms of liver damage which include nausea, vomiting, stomach pain, tiredness, loss of appetite, yellowish skin or whites of the eyes, or dark urine.
• Breathing problems. Some patients who take FINGOLIMOD CAPSULES have shortness of breath. Call your doctor right away if you have new or worsening breathing problems.
• Severe worsening of MS after stopping FINGOLIMOD CAPSULES. When FINGOLIMOD CAPSULES are 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 FINGOLIMOD CAPSULES do not return to the level of function they had before stopping FINGOLIMOD CAPSULES. This worsening happens most often within 12 weeks after stopping FINGOLIMOD CAPSULES, but can happen later. Do not stop taking FINGOLIMOD CAPSULES without talking with your doctor. Always talk to your doctor before you stop taking FINGOLIMOD CAPSULES for any reason. Tell your doctor if you have worsening symptoms of MS after stopping FINGOLIMOD CAPSULES.
• Increases in blood pressure (BP). Your doctor should check your blood pressure during treatment with FINGOLIMOD CAPSULES.
• 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, new darkened area in 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 FINGOLIMOD CAPSULES. 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.

The most common side effects of FINGOLIMOD CAPSULES include:

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

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

The risk information here is not complete. Please read the full Prescribing Information (0.5 mg), Patient Information, and Medication Guide for FINGOLIMOD CAPSULES. For more information, ask your healthcare provider or pharmacist.