Fingolimod

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Fingolimod comes as a capsule and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. Take with or without food once a day. Take fingolimod at around the same time every day.

Take fingolimod exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Fingolimod may cause your heartbeat to slow, especially within 6 hours and up to 24 hours after you take your first dose. In children, the heartbeat may also slow after the first dose when the dose is increased. You will receive an electrocardiogram (ECG; test that records the electrical activity of the heart) before you take your first dose and 6 hours after. Y Your heart and blood pressure will be monitored for at least 6 hours after you take your first dose. If you experience any of the following symptoms, especially during the first 24 hours after you take your first dose, call your doctor immediately: dizziness, tiredness, chest pain, or slow or irregular heartbeat.

To take the orally disintegrating tablet, use dry hands and peel back the foil packaging. Immediately take out the tablet and place it on your tongue. The tablet will quickly dissolve and can be swallowed with saliva. No water is needed.

Fingolimod may help control multiple sclerosis but will not cure it. Do not stop taking fingolimod without talking to your doctor.

You will be given the Medication Guide when you begin treatment with fingolimod and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visithttps://www.fda.gov/Drugs/DrugSafety/ucm085729.htmto obtain the Medication Guide.

What special precautions should I follow?

Before taking fingolimod,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• some medications should not be taken with fingolimod. Other medications may cause dosing changes or extra monitoring when taken with fingolimod. Make sure you have discussed any medications you are currently taking or plan to take before starting fingolimod with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking fingolimod, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with fingolimod: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking fingolimod. Do not start any of this medication while taking fingolimod without discussing with your healthcare provider.

• tell your doctor if you have or have had any of these conditions in the last six months: heart attack, angina (chest pain), stroke or mini-stroke, or heart failure. Also tell your doctor if you have long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death) or irregular heart rhythm. Your doctor may tell you not to take fingolimod.

• tell your doctor if you have ever fainted, had a stroke or mini stroke, or if you currently have a fever or other signs of infection., Also tell your doctor if you have or have ever had an infection that comes and goes or does not go away; diabetes; sleep apnea (condition in which you briefly stop breathing many times during the night) or other breathing problems; high blood pressure; uveitis (inflammation of the eye) or other eye problems; a heart attack, a slow heartbeat, or other heart problems; low levels of potassium or magnesium in your blood; skin cancer; or liver disease. Also tell your doctor if you have recently received a vaccine.

• tell your doctor if you are pregnant or plan to become pregnant, or are breastfeeding. You should use birth control to prevent pregnancy during your treatment and for 2 months after your final dose. If you become pregnant while taking fingolimod or within 2 months after your final dose, call your doctor.

• plan to avoid unnecessary or prolonged exposure to sunlight and UV light (such as tanning booths) and to wear protective clothing, sunglasses, and sunscreen. Fingolimod may make your skin more sensitive to the dangerous side effects of sunlight, and may increase your risk of developing skin cancer.

• do not have any vaccinations during your treatment with fingolimod or for 2 months after your final dose without talking to your doctor. Talk to your child's doctor about vaccinations that your child may need to receive before beginning his or her treatment with fingolimod.

• tell your doctor if you have never had chicken pox and have not received the chicken pox vaccine. Your doctor may order a blood test to see if you have been exposed to chicken pox. You may need to receive the chicken pox vaccine and then wait one month before beginning your treatment with fingolimod.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If you miss a dose of fingolimod, call your doctor as soon as possible. You may need to be monitored by your doctor for at least 6 hours when you take your next dose.

What side effects can this medicine cause?

Fingolimod may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness
• back pain
• pain in the arms or leg
• diarrhea
• stomach pain
• nausea
• headache or migraine
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• slow heartbeat
• rash, hives, itching; swelling of the face, eye, mouth, throat, tongue or lips; or difficulty swallowing or breathing
• sore throat, body aches, fever, chills, cough, and other signs of infection during treatment and for 2 months after your treatment
• headache, neck stiffness, fever, sensitivity to light, nausea, or confusion during treatment and for 2 months after your treatment
• sudden severe headache, confusion, changes in vision, or seizures
• blurriness, shadows, or a blind spot in the center of your vision; sensitivity to light; unusual color to your vision or other vision problems
• weakness on one side of the body or clumsiness of the arms or legs that worsens over time; changes in your thinking, memory, or balance; confusion or personality changes; or loss of strength
• new or worsening shortness of breath
• nausea, vomiting, loss of appetite, abdominal pain, yellowing of skin or eyes, or dark urine

Fingolimod may increase the risk of developing skin cancer and lymphoma (cancer that begins in the cells that fight infection). Your doctor will check your skin before and during treatment for signs of skin cancer. If you experience any of the following symptoms, call your doctor immediately: new sores or discoloration on the skin; changes in mole shape, size, or color or bleeding; small lesion with an irregular border; or skin growths or bumps that appear shiny, pearly white, skin-colored, or pink. Talk to your doctor about the risks of taking this medication.

Fingolimod may increase the risk of human papillomavirus (HPV) infections (infections that can cause certain types of cancers, including cervical cancer in women, penile cancer in men, and cancers of the mouth and throat in men and women). You may need to receive the HPV vaccine before beginning your treatment with fingolimod. If you are a woman, your doctor may tell you to have routine Pap smear (a test to detect cancer of the cervix) testing during your treatment with fingolimod.

A sudden increase episodes of MS symptoms and worsening of disability may occur within 3 to 6 months after you stop taking fingolimod. Tell your doctor if your MS symptoms worsen after stopping fingolimod.

Fingolimod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• slow or irregular heartbeat

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests, eye exams, and will monitor your blood pressure before and during your treatment to be sure that it is safe for you to begin taking or continue to take fingolimod.

Before having any laboratory test, including a Pap smear, tell your doctor and the laboratory personnel that you are taking fingolimod.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Gilenya^®
• Tascenso^® ODT