This medicine is a sphingosine 1-phosphate receptor modulator used to reduce the number of relapses and delay disability in certain patients with multiple sclerosis (MS).
Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. In the United States, the patient leaflet is a MEDICATION GUIDE approved by the U.S. Food and Drug Administration along with detailed instructions for use. Read them carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine may be taken on an empty stomach or with food. YOUR FIRST DOSE OF THIS MEDICINE will be given in a doctor's office, hospital, or clinic. YOU WILL BE OBSERVED FOR AT LEAST 6 HOURS following your first dose. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in the original blister pack, away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. DO NOT miss any doses. DO NOT STOP TAKING THIS MEDICINE without checking with your doctor. If you stop this medicine for more than 7 days during the first month of treatment or for more than 2 weeks after the first month of treatment, contact your doctor before you start to take it again. IF YOU MISS A DOSE OF THIS MEDICINE WITHIN THE FIRST 2 WEEKS OF TREATMENT, contact your doctor. IF YOU MISS A DOSE OF THIS MEDICINE AFTER 2 WEEKS OF CONTINUOUS TREATMENT, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once. Talk with your doctor for more information.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking certain antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, sotalol). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking antiarrhythmics (eg, flecainide), azole antifungals, (eg, ketoconazole), beta-blockers (eg, atenolol, metoprolol), beta-2 receptor agonists (eg, salmeterol), calcium channel blockers (eg, diltiazem, verapamil), chloroquine, chlorpromazine, cholinesterase inhibitors (eg, galantamine), citalopram, corticosteroids (eg, prednisone), digoxin, domperidone, fluoxetine, haloperidol, macrolide antibiotics (eg, erythromycin), methadone, ondansetron, pilocarpine, protease inhibitors (eg, ritonavir), quinine, quinolone antibiotics (eg, ciprofloxacin), tacrolimus, telithromycin, tetracycline antidepressants (eg, maprotiline), tricyclic antidepressants (eg, amitriptyline), tyrosine kinase inhibitors (eg, sunitinib), vorinostat, or other medicines for MS (eg, interferon beta, mitoxantrone, natalizumab). Tell your doctor if you are taking any medicine for cancer, medicine that may weaken your immune system, or medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may weaken your immune system or may increase the risk of prolonged QT interval. Tell your doctor if you have taken another medicine for MS (eg, natalizumab) within the past 2 to 3 months. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a weakened immune system, a fever, an infection, cancer other than a certain type of skin cancer (basal cell carcinoma), allergies, pregnancy or if you are able to become pregnant, or breast-feeding. Tell your doctor if you have a history of an infection that keeps coming back, fainting, eye problems (eg, an inflammation called uveitis, macular edema), lung or breathing problems (eg, sleep apnea), liver or kidney problems, high cholesterol or triglyceride levels, diabetes, heart attack, angina, stroke, transient ischemic attack (TIA, "mini-stroke"), blood vessel problems (eg in the heart or brain), high or low blood pressure, low blood potassium or magnesium levels, or slow heart rate or other heart problems (eg, irregular heartbeat, heart block, heart failure). Tell your doctor if you have not had chickenpox or the chickenpox vaccine, if you have had a vaccine within 1 month before you start this medicine, if you are scheduled to have a vaccine, or if you have recently received or will be receiving chemotherapy or radiation treatments. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have an active infection, including a long-term infection. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a certain type of irregular heartbeat (prolonged QT interval, congenital QT prolongation), or if you have a history of certain types of irregular heartbeat (eg, heart block, sick sinus syndrome) and you do not have a pacemaker. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have had a heart attack, unstable angina, stroke, TIA, or certain types of heart failure in the last 6 months. Contact your doctor or pharmacist if you have any questions about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include back pain; cough; diarrhea; headache; mild hair loss; tiredness; or weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience burning, numbness, or tingling of the skin; chest pain; confusion; depression; dizziness; eye pain; fainting; feeling cold in the hands or feet; new or worsening breathing problems (eg, shortness of breath); one-sided weakness; severe or persistent headache; skin or nail infection (eg, skin discharge, redness, swelling, or warmth); slow or irregular heartbeat; slurred speech; symptoms of infection (eg, fever, chills, severe or persistent cough or sore throat, body aches, nausea or vomiting, increased or painful urination); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; severe or persistent nausea, vomiting, or stomach pain; yellowing of the skin or eyes); unexpected weight loss; unusual tiredness or weakness; or vision changes (eg, blurred vision, shadows, blind spot, sensitivity to light, unusually colored or tinted vision). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include slow or irregular heartbeat.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.