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.

You should not use ponesimod if you are allergic to it, or if you have certain serious heart conditions, especially:

• "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.

May harm an unborn baby. Use effective birth control while using ponesimod and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Ponvory Starter Pack (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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.

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.

You may have a higher risk of skin cancer while using ponesimod. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.