Ponesimod (poe-NES-i-mod)

Treats relapsing forms of multiple sclerosis (MS).

Brand Name(s):

Ponvory, Ponvory Starter Pack

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 4 hours when you take the next dose.
• 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 1, 2, or 3 doses in a row during the initial dose titration or the maintenance dose, take it as soon as you remember, then go back to your regular dosing schedule.
  • If you miss a dose for 4 days in a row during the initial dose titration or the maintenance dose, you will need to restart the dose titration.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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 ponesimod works. Tell your doctor if you are using of any of the following:
  • Carbamazepine, digoxin, diltiazem, phenytoin, rifampin, verapamil
  • Beta blockers
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine that may cause heart rhythm problems
  • 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. Do not use this medicine 1 to 2 weeks before and for 1 month after receiving a 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 1 week after the last dose.
• Tell your doctor if you are breastfeeding, or if you have liver disease, diabetes, breathing problems (including 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)
  • Heart rhythm problems
  • Lung or breathing problems
  • Liver problems
  • High blood pressure
  • Increased risk of skin cancer (including basal cell carcinoma, melanoma, squamous cell carcinoma)
  • Eye or vision problems
  • 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 lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• 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

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