Ponesimod Oral Tablets

What is this medication?

PONESIMOD (poe NES i mod) helps prevent relapses of multiple sclerosis. The medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): PONVORY

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• diabetes mellitus
• eye disease
• heart disease
• high blood pressure
• immune system problems
• infection especially a viral infection such as chickenpox, cold sores, or herpes
• irregular heartbeat or rhythm
• liver disease
• low blood counts (white cells, platelets, or red blood cells)
• lung or breathing disease (asthma, COPD)
• recent or upcoming vaccine
• skin cancer/melanoma
• stroke or transient ischemic attack
• vision problems
• an unusual or allergic reaction to ponesimod, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your health care provider about what to do if you miss a dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• fingolimod
• pimozide
• saquinavir
• siponimod
• thioridazine

This medicine may also interact with the following medications:

• alemtuzumab
• certain antivirals for HIV or hepatitis
• certain medicines for blood pressure, heart disease, irregular heart beat
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• live virus vaccines
• medicines that lower your chance of fighting infection
• other medicines that prolong the QT interval (abnormal heart rhythm)
• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

You may need blood work while you are taking this medicine.

Your vision may be tested before and during use of this medicine. Tell your health care provider right away if you have any change in your eyesight.

Talk to your health care provider if you have not had chickenpox or the vaccine for chickenpox.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your health care provider right away. If you cannot reach your health care provider, urgently seek other source of medical care.

Do not become pregnant while taking this medicine or for 1 week after stopping it. Women must use a form of birth control while taking this medicine. Women will also need to use it for 1 week after stopping the medicine. There is potential for serious harm to an unborn child. Tell your health care provider right away if you think you might be pregnant

If you stop taking this medicine, your MS symptoms may get worse. You may have more weakness, trouble using your arms or legs, or changes in balance. Talk to your health care provider right away if your symptoms get worse.

Talk to your health care provider about your risk of skin cancer. You may be more at risk for skin cancer if you take this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care provider as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• changes in vision
• confusion
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• meningitis (stiff neck; sensitivity to light; headache; drowsiness; fever; nausea, vomiting; rash)
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• seizures
• trouble breathing
• unusually slow heartbeat

Side effects that usually do not require medical attention (report to your doctor or health care provider if they continue or are bothersome):

• dizziness
• dry mouth
• pain in legs or arms

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original package until you are ready to take it. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medicine dry. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.