Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64Especially tell your doctor if you take vaccines. Tell your doctor if you have been vaccinated within 1 month before you start taking GILENYA. You should not get certain vaccines, called live attenuated vaccines, while you take GILENYA and for at least 2 months after you stop taking GILENYA. If you take certain vaccines, you may get the infection the vaccine should have prevented. Vaccines may not work as well when given during GILENYA treatment. How should I take GILENYA? • You will be observed by a healthcare professional for at least 6 hours after your first dose of GILENYA. See “What is the most important information I should know about GILENYA?” • Take GILENYA exactly as your doctor tells you to take it. • Take GILENYA 1 time each day. • If you take too much GILENYA, call your doctor or go to the nearest hospital emergency room right away. • Take GILENYA with or without food. • Do not stop taking GILENYA without talking with your doctor first. • Call your doctor right away if you miss a dose of GILENYA. 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 profes- sional when you take your next dose of GILENYA 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 • 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 by a healthcare professional in a medical facility after you take your dose of GILENYA. • If you have serious side effects after taking a dose of GILENYA, espe- cially those that require treatment with other medicines, you will stay in the medical facility to be observed overnight. If you were observed overnight, you will also be observed for any serious side effects for at least 6 hours after you take your second dose of GILENYA. See “What is the most important information I should know about GILENYA?” What are possible side effects of GILENYA? GILENYA can cause serious side effects. See “What is the most important information I should know about GILENYA?” Serious side effects include: • swelling and narrowing of the blood vessels in your brain. A condition called PRES (Posterior reversible encephalopathy syndrome) has occurred rarely in patients taking GILENYA. Symptoms of PRES usually get better when you stop taking GILENYA. However, if left untreated it may lead to a stroke. Call your doctor right away if you have any of the following symptoms: • sudden headache • confusion • seizures • loss of vision • weakness • breathing problems. Some people who take GILENYA have shortness of breath. Call your doctor right away if you have trouble breathing. • liver problems. GILENYA may cause liver problems. Your doctor should do blood tests to check your liver before you start taking GILENYA. Call your doctor right away if you have any of the following symptoms of liver problems: • nausea • vomiting • stomach pain • loss of appetite • tiredness • your skin or the whites of your eyes turn yellow • dark urine • a type of skin cancer called basal cell carcinoma (BCC). Talk to your doctor if you notice any skin nodules (e.g., shiny pearly nodules), patches or open sores that do not heal within weeks (these may be signs of BCC). The most common side effects of GILENYA include: • headache • abnormal liver tests • diarrhea • cough • flu • sinusitis • back pain • abdominal pain • pain in arms or legs Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of GILENYA. For more informa- tion, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about GILENYA Medicines are sometimes prescribed for purposes other than those listed in a Brief Summary. Do not use GILENYA for a condition for which it was not pre- scribed. Do not give GILENYA to other people, even if they have the same symptoms you have. It may harm them. This Brief Summary contains the most important information about GILENYA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about GILENYA that is written for health- care professionals. For more information, go to www.pharma.US.Novartis.com or call 1-888-669-6682. What are the ingredients in GILENYA? Active ingredient: fingolimod Inactive ingredients: gelatin, magnesium stearate, mannitol, titanium dioxide, yellow iron oxide. GILENYA is a registered trademark of Novartis AG. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis Revised: February 2016