Brand Name(s):

Mayzent^®

WHY is this medicine prescribed?

Siponimod is used to prevent episodes of symptoms and slow the worsening of disability in adults with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Siponimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.

HOW should this medicine be used?

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.

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. If you do not take siponimod for 1 day or longer during the first 4 or 5 days of treatment or for 4 days or longer after the first week of treatment, talk to your doctor before you start taking it again. You may experience slowed heartbeat when you start taking siponimod again, so you will need to restart the medication at a lower dose in your doctor's office and gradually increase the dose over 4 or 5 days.

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.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking siponimod,

tell your doctor and pharmacist if you are allergic to siponimod any other medications, or any of the ingredients in siponimod tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alemtuzumab (Campath, Lemtrada); amiodarone (Nexterone, Pacerone); beta-blockers such as atenolol (Tenormin, in Tenoretic), carteolol, labetalol (Trandate), metoprolol (Lopressor, Toprol-XL, in Dutoprol, in Lopressor HCT), nadolol (Corgard, in Corzide), nebivolol (Bystolic, in Byvalson), propranolol (Inderal LA, Innopran XL), and timolol; carbamazepine (Carbatrol, Equetro, Tegretol, others); digoxin (Lanoxin); diltiazem (Cardizem, Cartia, Tiazac, others); efavirenz (Sustiva, in Atripla, in Symfi); fluconazole (Diflucan); ivabradine (Corlanor); modafinil (Provigil); procainamide; quinidine (in Nuedexta); rifampin (Rifadin, Rimactane, in Rifamate, others); sotalol (Betapace, Sorine, Sotylize); and verapamil (Calan, Verelan, in Tarka). Also tell you doctor if you are taking any of the following medications, or if you have taken them in the past: corticosteroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); medications for cancer; and medications to weaken or control the immune system such as glatiramer acetate (Copaxone, Glatopa) and interferon beta (Betaseron, Extavia, Plegridy). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with siponimod, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
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 an irregular heart rhythm. Your doctor may tell you not to take siponimod.
tell your doctor if you have ever fainted, had a heart attack, stroke, or mini stroke; if you currently have a fever or other signs of infection or if you have an infection that comes and goes or that does not go away; and if you have or have ever had 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 slow heartbeat; skin cancer, or heart 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 at least 10 days after your final dose. If you become pregnant while taking siponimod or within 10 days after your final dose, call your doctor.
do not have any vaccinations for 1 week before you begin your treatment with siponimod, during your treatment, or for 1 month after your final dose without talking to your doctor. Talk to your doctor about vaccinations that you may need to receive before beginning your treatment with siponimod.
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 1 month before beginning your treatment with siponimod.

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?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and call your doctor before you take the next dose. You may need to be monitored as you restart your medication at a lower dose and as the dose is gradually increased over 4 or 5 days. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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 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 a certain period of time. Opened blister packs may be stored at room temperature for up to 1 week after the first use. Opened bottles may be stored at room temperature for up to 1 month after the first use.

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.

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 athttps://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:

slowed 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 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.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2019.