Ponesimod Tablets

What is this medication?

PONESIMOD (poe NES i mod) treats multiple sclerosis (MS). It works by slowing down an overactive immune system, which prevents or delays worsening symptoms. It also decreases the number of flare-ups.

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
• Infections, such as chickenpox, cold sores, 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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication 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 medication. 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 care team 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 care team about the use of this medication 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 care team about what to do if you miss a dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Dronedarone
• Live virus vaccines
• Pimozide
• Saquinavir
• Thioridazine

This medication may also interact with the following:

• Alemtuzumab
• Certain antivirals for HIV or hepatitis
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Medications that lower your chance of fighting infection
• Other medications that cause heart rhythm changes

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

You may need blood work while taking this medication.

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

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

This medication may increase your risk of getting an infection. Call your care team 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 medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, urgently seek other source of medical care.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 1 week after stopping therapy. A reliable form of contraception is recommended while you taking this medication and for 1 week after stopping therapy. Talk to your care team about effective forms of contraception.

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

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

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Shortness of breath
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

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

• Cough
• Dizziness
• Drowsiness
• Pain in the hands or feet

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 medication 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 medication dry. Get rid of any unused medication after the expiration date.

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

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication 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.