Brand Gilenya

This medication is used to treat a certain type of multiple sclerosis (relapsing-remitting multiple sclerosis-MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

Read the Medication Guide provided by your pharmacist before you start taking fingolimod and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Do not start taking fingolimod if you have a current infection. Before starting this drug, your doctor may do medical/lab tests (such as complete blood count, eye exam, EKG, liver function test) to prevent serious side effects. Take fingolimod by mouth with or without food as directed by your doctor, usually once a day. You will be monitored for 6 hours after the first dose to make sure your heartbeat does not go too slow. If you stop taking fingolimod for 2 weeks or more, you will need to be monitored again for 6 hours after you take your dose. Dosage is based on your medical condition and response to treatment. Take this medication regularly to get the most benefit from it. Take it at the same time each day to help you remember. Tell your doctor if your condition does not improve or if it worsens.

Before taking fingolimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, bronchitis, emphysema), current/recent/returning infection (including hepatitis and tuberculosis), diabetes, fainting, certain eye problems (macular edema, uveitis), heart problems (such as slow/irregular heartbeat, heart failure, chest pain), liver disease. Do not have immunizations/vaccinations while you are taking fingolimod and for 2 months after your last dose without the consent of your doctor. Also, avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose and people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Fingolimod is not recommended for use during pregnancy. It may harm an unborn baby. Discuss with your doctor the use of reliable forms of birth control while taking this medication and for 2 months after your last dose. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this drug passes into breast milk. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some of the products that may interact with this drug include: ketoconazole, natalizumab, drugs that slow down your heartbeat (such as antiarrhythmics including amiodarone/quinidine, beta-blockers including atenolol).

Cough, headache, back pain, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication can affect your immune system's ability to fight an infection while you are taking the medication and for 2 months after your last dose. You may be more likely to get a serious infection (such as bronchitis, pneumonia). Tell your doctor right away if you develop any signs of an infection such as persistent cough/sore throat, difficulty breathing, fever/chills, or cold/flu symptoms. Do not start fingolimod if you have a current infection. Tell your doctor right away if any of these very serious side effects occur: shortness of breath, chest pain, severe dizziness/fainting, slow/irregular heartbeat, unusual tiredness/weakness, eye pain/sensitivity to light, vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes). This medication may rarely cause serious liver problems. Tell your doctor right away if you experience: yellowing eyes/skin, dark urine, stomach/abdominal pain, persistent nausea. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your medication.