Siponimod is used in adults to treat relapsing multiple sclerosis (MS).

Siponimod is used only if you have a specific genotype. Your doctor will test you for this genotype.

Siponimod may also be used for purposes not listed in this medication guide.

You should not use siponimod if you have a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), or if you've recently had heart block, heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke.

Siponimod can slow your heart rate when you start taking it. You may receive your first dose in a setting where your heart rhythm can be monitored. If you miss any doses, you may also need to restart siponimod under medical observation.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, vomiting, confusion, neck stiffness, or problems with coordination, thought, vision, or muscle movement. Your risk of infection could last for 3 to 4 weeks after you stop taking siponimod.

You may have increased sensitivity to light, blurred vision, eye pain, or have a blind spot or shadows in the center of your vision, unusual color to your vision, or other vision problems while you are taking siponimod, which may occur 1 to 4 months after your first dose.

You should not use siponimod if you have a specific genotype. Your doctor will perform tests to make sure siponimod is the right treatment for you.

Siponimod comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take siponimod at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take siponimod exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of siponimod and gradually increase your dose for the first 4 or 5 days,

Siponimod may cause the heartbeat to slow, especially during the first 6 hours after you take your first dose. You will receive an electrocardiogram (ECG; test that records the electrical activity of the heart) before you take your first dose and again 6 hours after you take the dose. You will take your first dose of siponimod in your doctor's office or another medical facility. You will need to stay at the medical facility for at least 6 hours after you take the medication so that you can be monitored. You may need to stay at the medical facility for longer than 6 hours or overnight if you have certain conditions or take certain medications that increase the risk that your heartbeat will slow or if your heartbeat slows more than expected or continues to slow after the first 6 hours. You may also need to stay at a medical facility for at least 6 hours after you take your second dose if your heartbeat slows too much when you take your first dose. Tell your doctor if you experience dizziness, tiredness, chest pain, or slow or irregular heartbeat at any time during your treatment.

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

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with siponimod 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 visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your dose will be increased gradually during the first 5 to 6 days of taking siponimod. Use the medicine exactly as directed.

You may need medical tests before you start taking siponimod including blood tests, ECG, eye evaluation, heart and liver function tests, and skin exam.

Siponimod can slow your heart rate when you start taking it. You may receive your first dose in a medical setting. Your blood pressure and heart rate may be constantly monitored for at least 6 hours after your first dose of siponimod.

Siponimod affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis. Your risk of infection could last 3 to 4 weeks after you stop taking siponimod.

Always ask your doctor before you stop taking siponimod for any reason. When you stop taking siponimod, your MS symptoms may return. In rare cases, some people who stopped taking siponimod had MS symptoms that were worse than before or during treatment with this medicine.

If you stop taking siponimod, do not start taking it again without asking your doctor. You may need to be under medical observation when you restart this medication.

Do not crush, break, or split siponimod. Swallow it whole.

You may take siponimod with or without food.

Store unopened siponimod in the refrigerator, do not freeze.

After opening, store siponimod in the original container at room temperature away from moisture and heat for up to 3 months.

If you stop taking siponimod, watch for signs of worsening MS, and call your doctor right away if any new or worsening symptoms appear.

You should not use Siponimod if you are allergic to it, or if you have:

• a specific genotype;

• "AV block" (2nd or 3rd degree);

• irregular or abnormal heart rhythm (unless you have a pacemaker); or

• recent (within the past 6 months) heart failure, heart attack, stroke, 'mini-stroke' or TIA, chest pain (unstable angina), or other serious heart problem.

Some heart rhythm medications can cause unwanted or dangerous effects when used with siponimod. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, or sotalol.

Before you take siponimod, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine. You may need to receive the vaccine and then wait 1 month before taking siponimod.

Tell your doctor if you have or ever had:

• weak immune system (caused by disease or by using certain medicines);

• fever or an active or chronic infection;

• high blood pressure;

• slow or irregular heart beats;

• heart problems, a heart attack, a stroke, or chest pain;

• asthma, sleep apnea (breathing stops during sleep), or other breathing disorder;

• skin cancer (melanoma);

• an eye condition called uveitis;

• diabetes; or

• liver disease.

Tell your doctor if you have recently received a vaccine, or if you are scheduled to receive a vaccine.

Siponimod may harm an unborn baby. Use effective birth control while using siponimod and for at least 10 days after your last dose. Tell your doctor if you become pregnant .

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of siponimod on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Call your doctor for instructions. If you miss 1 or more of your first doses, or 4 or more of your maintenance doses, you may need to take your next dose under medical observation in a medical setting.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store unopened containers of this medication in the refrigerator. Opened blister packs and bottles may be stored at room temperature and away from excess heat and moisture (not in the bathroom) for 3 months. Do not refrigerate the tablets after opening.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Avoid receiving a vaccine without asking your doctor. The vaccine may not work as well while you are using siponimod. Receiving a "live" vaccine while using siponimod may cause you to develop an infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

If you need to receive a vaccine, you should stop taking siponimod for at least 1 week ahead of time. After receiving the vaccine, you should wait another 4 weeks before you start taking siponimod again. Do not stop taking siponimod without your doctor's advice.

Always ask your doctor before you stop or start taking siponimod for any reason.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Siponimod may cause serious side effects. Call your doctor at once if you have:

• slow or irregular heartbeats;

• vision problems such as increased sensitivity to light, blurred vision, eye pain, having a blind spot or shadows in the center of your vision, or unusual color to your vision (vision problems may occur 1 to 4 months after you start taking siponimod);

• headache, confusion, change in mental status;

• a seizure;

• sores in your mouth and throat, cold sores, sores on your genital or anal area;

• skin changes, unusual moles that change in color or size;

• shortness of breath;

• liver problems--nausea, vomiting, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or

• symptoms of meningitis--fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, increased sensitivity to light.

Common side effects of siponimod may include:

• headache;

• increased blood pressure; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Siponimod can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Siponimod can have long lasting effects on your body, especially on your immune system. For 3 or 4 weeks after your last dose, tell any doctor who treats you that you have used siponimod.

Tell your doctor about all your current medicines. Many drugs can affect siponimod, especially:

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection;

• other medicines to treat MS symptoms; or

• heart medications.

This list is not complete and many other drugs may affect siponimod. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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 siponimod.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking siponimod.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.