Siponimod (si-PON-i-mod)

Treats relapsing forms of multiple sclerosis (MS).

Brand Name(s):

Mayzent

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• If you are using this medicine and have certain heart conditions, your doctor may want you to stay in the medical facility for at least 6 hours after the first dose of this medicine and after starting it again if you miss 1 or more doses.
• Swallow the tablet whole. Do not split, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • If you miss a dose after the initial dose titration, take it as soon as you remember, then go back to your regular dosing schedule.
  • If you miss 1 or more doses during the initial dose titration, you will need to restart the medicine.
  • If you miss a dose for 4 days in a row, you will need to restart the dose titration.
• Store the unopened medicine in the refrigerator. Do not freeze. You may store the opened medicine in its original container at room temperature for up to 3 months after opening. Do not refrigerate after opening.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine after treatment with alemtuzumab.
• Some medicines can affect how siponimod works. Tell your doctor if you are using of any of the following:
  • Carbamazepine, digoxin, diltiazem, efavirenz, fluconazole, ivabradine, modafinil, rifampin, verapamil
  • Beta blocker
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine the weakens the immune system (including beta interferon, glatiramer acetate, cancer medicine, steroid medicine)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive a live vaccine during treatment with this medicine and for 4 weeks after the last dose. Do not use this medicine 1 week before and for 4 weeks after receiving a live vaccine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment with this medicine and for at least 10 days after the last dose.
• Tell your doctor if you are breastfeeding, or if you have liver disease, diabetes, asthma, COPD, high blood pressure, any type of infection (including chickenpox), a weak immune system, or a history of uveitis (eye swelling) or skin cancer.
• This medicine may cause the following problems:
  • Increased risk of infections, which may be life-threatening (including meningitis, herpes, progressive multifocal leukoencephalopathy)
  • Eye or vision problems
  • Heart rhythm problems
  • Lung or breathing problems
  • Liver problems
  • Increased risk of skin cancer (including basal cell carcinoma, melanoma, squamous cell carcinoma)
  • High blood pressure
  • Brain problems, including posterior reversible encephalopathy syndrome (PRES)
• Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor will also check your skin for any changes before and during treatment with this medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other changes in vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches, neck stiffness, sensitivity to light
• Skin growths, patches, or sores on the skin that do not heal quickly
• Sudden or severe headache, confusion, seizures
• Trouble breathing, chest tightness
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Arm or leg pain
• Diarrhea
• Mild headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088