Ponesimod

What is Ponesimod?

• Ponesimod (PONVORY) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS).

What are the uses of this medicine?

• This medicine is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

How does this medicine work?

• An orally available sphingosine-1-phosphate receptor 1 (S1PR1, S1P1) agonist that acts as a functional antagonist, with potential immunomodulating activity.
• Upon oral administration, ponesimod selectively binds to S1PR1 on lymphocytes and causes transient receptor activation followed by S1PR1 internalization and degradation.
• This results in the sequestration of lymphocytes in lymph nodes.
• By preventing egress of lymphocytes, ponesimod reduces both the number of circulating peripheral lymphocytes and the infiltration of lymphocytes into target tissues.
• This prevents a lymphocyte-mediated immune response.
• S1PR1, a G-protein coupled receptor, plays a key role in lymphocyte migration from lymphoid tissues.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• have had a heart attack, chest pain called unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months.
• have certain types of heart block or irregular or abnormal heartbeat (arrhythmia), unless you have a pacemaker.

What drug interactions can this medicine cause?

• PONVORY has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies.
• Coadministration of PONVORY with strong CYP3A4 and UGT1A1 inducers (e.g., rifampin, phenytoin, carbamazepine) is not recommended.
• The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during PONVORY treatment and for 1 to 2 weeks after discontinuation of treatment with PONVORY.
• Caution should be applied when PONVORY is initiated in patients receiving treatment with a beta-blocker.
• PONVORY has not been studied in patients taking QT prolonging drugs.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• Assessments are required prior to initiating PONVORY.
• Titration is required for treatment initiation.

Recommended dosage After dose titration is complete , the recommended maintenance dosage of PONVORY is 20 mg taken orally once daily starting on Day 15.

Treatment Initiation Initiate PONVORY treatment with a 14-day titration; start with one 2 mg tablet orally once daily and progress with the titration schedule as shown below:

• Days 1 and 2:2 mg
• Days 3 and 4:3 mg
• Days 5 and 6:4 mg

* Day 7:5 mg

• Day 8:6 mg
• Day 9:7 mg
• Day 10:8 mg
• Day 11:9 mg
• Days 12, 13, and 14:10 mg

Maintenance

• Day 15 and thereafter:20 mg

Administration

• Take PONVORY exactly as your healthcare provider tells you to take it.
• Take PONVORY 1 time each day.
• Swallow PONVORY tablets whole.
• Take PONVORY with or without food.
• Do not stop taking PONVORY without talking with your healthcare provider first.
• Do not skip a dose.
• Start taking PONVORY with a 14-day starter pack.
• If you miss taking 1, 2, or 3 tablets in a row of PONVORY in the 14-day starter pack, continue treatment by taking the first dose you missed. Take 1 tablet as soon as you remember. Then, take 1 tablet a day to continue with the starter pack dose as planned.
• If you miss taking 1, 2, or 3 tablets in a row of PONVORY while taking the 20 mg maintenance dose, continue treatment with the 20 mg maintenance dose.
• If you miss taking 4 or more tablets in a row of PONVORY, while taking the 14-day starter pack or the 20 mg maintenance dose, you need to restart treatment with a new 14-day starter pack. Call your healthcare provider if you miss 4 or more doses of PONVORY. Do not restart PONVORY after stopping it for 4 or more days in a row without talking to your healthcare provider. If you have certain heart conditions, you may need to be monitored by your healthcare provider for at least 4 hours when you take your next dose.
• Write down the date you start taking PONVORY so you will know if you miss 4 or more doses in a row.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20 mg

This medicine is available in fallowing brand namesː

• PONVORY

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory tract infections
• elevated liver enzymes (abnormal liver tests)
• high blood pressure

PONVORY may cause serious side effects, including:

• breathing problems
• liver problems
• increased blood pressure
• types of skin cancer called basal cell carcinoma (BCC), melanoma, and squamous cell carcinoma
• a problem with your vision called macular edema
• swelling and narrowing of the blood vessels in your brain
• severe worsening of multiple sclerosis (MS) after stopping PONVORY

What special precautions should I follow?

• PONVORY may increase the risk of infections. Obtain a complete blood count (CBC) before initiating treatment. Monitor for infection during treatment and for 1–2 weeks after discontinuation. Do not start PONVORY in patients with active infection.
• PONVORY may result in a transient decrease in heart rate; titration is required for treatment initiation. Check an electrocardiogram (ECG) to assess for preexisting cardiac conduction abnormalities before starting PONVORY. Consider cardiology consultation for conduction abnormalities or concomitant use with other drugs that decrease heart rate.
• This medicine may cause a decline in pulmonary function. Assess pulmonary function (e.g., spirometry) if clinically indicated.
• Discontinue if significant liver injury is confirmed. Obtain liver function tests before initiating PONVORY.
• Monitor BP during treatment.
• Periodic skin examination is recommended, as cutaneous malignancies can occur.
• Women of childbearing potential should use effective contraception during and for 1 week after stopping PONVORY.
• An ophthalmic evaluation is recommended before starting treatment and if there is any change in vision while taking PONVORY. Diabetes mellitus and uveitis increase the risk.

What to do in case of emergency/overdose?

• In patients with overdosage of PONVORY, especially upon initiation/reinitiation of treatment, it is important to observe for signs and symptoms of bradycardia as well as AV conduction blocks, which may include overnight monitoring.
• Regular measurements of pulse rate and blood pressure are required, and ECGs should be performed.

Management of Overdose

• There is no specific antidote to ponesimod.
• Neither dialysis nor plasma exchange would result in meaningful removal of ponesimod from the body.
• The decrease in heart rate induced by PONVORY can be reversed by atropine.
• In the event of overdose, PONVORY should be discontinued, and general supportive treatment given until clinical toxicity has been diminished or resolved.
• It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of PONVORY in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient: ponesimod

Inactive ingredients:

• Tablet core: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, silica colloidal anhydrous, and sodium lauryl sulfate.
• Tablet coating: ferrosoferric oxide (included in 4 mg, 5 mg, 8 mg and 9 mg film-coated tablets), hydroxypropyl methylcellulose 2910, iron oxide red (included in 3 mg, 4 mg, 7 mg, 8 mg, 9 mg and 10 mg film-coated tablets), iron oxide yellow (included in 3 mg, 5 mg, 7 mg, 9 mg, 10 mg and 20 mg film-coated tablets), lactose monohydrate, polyethylene glycol 3350, titanium dioxide, and triacetin.

Who manufactures and distributes this medicine?

• Manufactured by: Janssen Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store PONVORY at room temperature between 68°F to 77°F (20°C to 25°C).
• Store PONVORY in the original package.
• The bottle of PONVORY contains a desiccant sachet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant.

• Dailymed label info on Ponesimod
• FDA Ponesimod

Ponesimod Resources
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