ponesimod

What is the most important information I should know about ponesimod?

Ponesimod can slow your heart rate when you start taking it. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, or feel like your heart is skipping beats.

What is ponesimod?

Ponesimod is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Ponesimod may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ponesimod?

• "AV block" or sick sinus syndrome (unless you have a pacemaker); or
• recent (within the past 6 months) heart failure, heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem.

Some heart rhythm medications can cause unwanted or dangerous effects when used with ponesimod. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol.

Before you take ponesimod, tell your doctor if you have never had chickenpox or received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking ponesimod.

Tell your doctor if you have received any vaccine within the past 30 days, or if you are scheduled to receive a vaccine.

Tell your doctor if you have a fever or infection, or if you have ever had:

• a weak immune system (caused by disease or by using certain medicine);
• a very slow heart rate;
• heart rhythm problems, long QT syndrome;
• a heart attack, stroke, or chest pain;
• high blood pressure;
• sleep apnea or other breathing problems;
• diabetes;
• liver disease;
• an eye condition called uveitis; or
• skin cancer including melanoma, or basal or squamous cell carcinoma.

How should I take ponesimod?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ponesimod comes in a 14-day starter pack containing tablets of different colors and strengths. Taking the tablets in order will increase your dose gradually during the first 2 weeks.

You may take ponesimod with or without food.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests, and your risk of infection could last for 2 weeks after you stop taking this medicine.

If you get an infection, further doses may be delayed until your infection clears up. If you stop taking ponesimod, you may need to use a starter pack again, to gradually increase your dose.

Always ask your doctor before you stop taking ponesimod for any reason. Your MS symptoms may return and become worse than before or during treatment with this medicine. Tell your doctor if you have any signs of worsening MS.

What happens if I miss a dose?

If you miss up to 3 starter pack doses in a row: Take 1 tablet as soon as you can, then take 1 tablet daily in the planned order for the rest of the pack.

If you miss a dose after the first 2 weeks: Skip the missed dose and use your next dose at the regular time.

Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking ponesimod?

Avoid getting a vaccine without first asking your doctor. While you are taking ponesimod, a "live" vaccine may not fully protect you from disease and you could develop an infection.

Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

You should not receive a live vaccine within 1 month before taking ponesimod, while taking it, and for at least 1 to 2 weeks after you stop taking it.

What are the possible side effects of ponesimod?

• slow heartbeats, chest pain, shortness of breath, or feel like your heart is skipping beats;
• a light-headed feeling, like you might pass out;
• sudden confusion, severe headache, vision loss, or a seizure;
• changes in vision --blurred vision, increased sensitivity to light, seeing an unusual color in your vision, or having a blind spot or shadows in the center of your vision;
• liver problems --nausea, vomiting, upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• skin changes --darkening, a new sore that does not heal, a change in the size or color of a mole, a growth or bump that looks shiny, pearly, or pink; or
• symptoms of infection --fever, headache, aches, tiredness, vomiting, neck stiffness, increased sensitivity to light.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• high blood pressure; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ponesimod?

Ponesimod can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• alemtuzumab;
• rifampin;
• heart or blood pressure medication;
• seizure medicine such as carbamazepine or phenytoin; or other drugs that weaken the immune system (cancer medicine, steroids, medicines to prevent organ transplant rejection).
• This list is not complete. Other drugs may affect ponesimod, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ponesimod can have long lasting effects on your body, especially on your immune system. For 1 or 2 weeks after your last dose, tell any doctor who treats you that you have used ponesimod.

Where can I get more information?

Your doctor or pharmacist can provide more information about ponesimod.