Uses

This medication is used to treat multiple sclerosis-MS. It is thought to work by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. Ponesimod is not a cure for MS. However, it may decrease the number of episodes of disease worsening (relapses) and prevent or delay disability.

How To Use

Read the Medication Guide provided by your pharmacist before you start taking ponesimod and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before starting ponesimod, your doctor will do medical/lab tests (such as complete blood count, liver function tests, EKG, pulse, eye exam) to monitor for side effects. Take this medication by mouth with or without food as directed by your doctor, usually once a day. Swallow the tablets whole. Do not split, crush, or chew the tablets.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Some people may need to be monitored for at least 4 hours after the first dose to make sure their heartbeat does not go too slow. A very slow heartbeat increases the risk for a serious heart rhythm problem. Tell your doctor if you have a slow/irregular heartbeat or other heart problems (such as heart failure, previous heart attack).

Do not stop taking this medication without consulting your doctor. Your condition may become worse when this drug is stopped. Tell your doctor right away if your MS symptoms are much worse after stopping ponesimod.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition gets worse.

Side Effects

Drowsiness or dizziness may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

This medication may rarely cause serious liver disease. Tell your doctor right away if you have any symptoms of liver damage, such as:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

This medication can weaken your immune system/increase the risk of infection while you are taking it and for 1 to 2 weeks after your last dose. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, herpes). Tell your doctor right away if you develop any signs of an infection such as sore throat/cough that doesn't go away, fever/chills, cold/flu symptoms, sores, or blisters. Do not start ponesimod if you already have an infection.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Symptoms of PML can seem like a worsening MS attack. Get medical help right away if you have any new or worsening symptoms that have lasted for several days, such as clumsiness or problems with strength, balance, speech, eyesight, or thinking.

Ponesimod may rarely increase your risk of skin cancer. Tell your doctor right away if you notice any unusual skin changes (such as change in appearance/size of moles).

Get medical help right away if you have any very serious side effects, including:

• shortness of breath
• slow/irregular/pounding/fast heartbeat
• severe dizziness/fainting
• unusual tiredness/weakness
• eye pain/sensitivity to light
• vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes)
• mental changes (such as confusion)
• seizure
• sudden/severe headache

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking ponesimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD)
• current/recent/returning infection (including herpes, hepatitis, tuberculosis)
• diabetes
• certain eye problems (macular edema, uveitis)
• heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain, QT prolongation in the EKG)
• high blood pressure
• liver problems
• skin cancer
• stroke or "mini-stroke"/transient ischemic attack (TIA)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Ponesimod can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using ponesimod before having any immunizations/vaccinations. Avoid getting a live vaccine for 1 to 2 weeks after the last dose of this medication. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ponesimod. Ponesimod may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 1 week after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood pressure, pulse, EKG, MRI, eye/skin exams, liver function tests, lung/breathing tests) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is very important to follow your treatment regimen exactly. Read the manufacturer's information carefully for missed dose instructions. If you miss 4 or more doses in a row, contact your doctor right away. You may need to restart this medication at a lower dose and slowly increase it. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the original package at room temperature away from light and moisture. Keep the drying agent (desiccant) in the bottle to protect it from moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.