Ponesimod

Generic name: Ponesimod
Dosage form: oral tablet (-; 20 mg)
Drug class: Selective immunosuppressants

Usage of 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.

Ponesimod side effects

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

Ponesimod may cause serious side effects. 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 of ponesimod 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.

Before taking Ponesimod

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.

Relate drugs

How to use Ponesimod

Usual Adult Dose for Multiple Sclerosis:

Treatment Initiation:2 mg orally once a day on Day 1 and 23 mg orally once a day on Day 3 and 44 mg orally once a day on Day 5 and 65 mg orally once a day on Day 76 mg orally once a day on Day 87 mg orally once a day on Day 98 mg orally once a day on Day 10 9 mg orally once a day on Day 1110 mg orally once a day on Days 12, 13, and 14Maintenance Dose:20 mg orally once a day starting on Day 15Use: For the treatment of adult patients with relapsing forms of multiple sclerosis (MS), toinclude clinically isolated syndrome, relapsing-remitting disease, and active secondaryprogressive diseaseComments:-Starter pack must be used for patients initiating treatment (14-day titration pack).-Patients undergoing therapy initiation may develop a decrease in heart rate. -Administer the first dose in a setting where resources to properly manage symptomatic bradycardia are available.-First-dose 4-hour monitoring is recommended for patients with sinus bradycardia [HR less than 55 beats per minute (bpm)], first- or second-degree (Mobitz type I) AV block, or a history of myocardial infarction or heart failure occurring more than 6 months prior to treatment initiation and in stable condition.-Interruption during treatment, especially during titration, is not recommended.-Prior to therapy, obtain and review appropriate laboratory tests and medical examinations. -Establish if patients are taking drugs that could slow heart rate or atrioventricular conduction before starting treatment.-Consider possible unintended additive immunosuppressive effects before initiating treatment in patients taking or with prior use of anti-neoplastic, immunosuppressive, or immune-modulating therapies.-Initiating this drug after treatment with alemtuzumab is not recommended.-Assess vaccination status and test for antibodies to varicella zoster virus (VZV).

Warnings

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.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, vomiting, neck stiffness, confusion, increased sensitivity to light. Your risk of infection could last for 2 weeks after you stop taking ponesimod.

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.

Disclaimer

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