Medically reviewed by Drugs.com. Last updated on Jul 14, 2021.
Applies to the following strengths: 20 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Multiple Sclerosis
2 mg orally once a day on Day 1 and 2
3 mg orally once a day on Day 3 and 4
4 mg orally once a day on Day 5 and 6
5 mg orally once a day on Day 7
6 mg orally once a day on Day 8
7 mg orally once a day on Day 9
8 mg orally once a day on Day 10
9 mg orally once a day on Day 11
10 mg orally once a day on Days 12, 13, and 14
20 mg orally once a day starting on Day 15
Use: For the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
- Starter pack must be used for patients initiating treatment.
- Initiate treatment with a 14-day titration.
- Treatment initiation results in decrease 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.
- Before treatment initiation, establish if patients are taking drugs that could slow heart rate or atrioventricular conduction.
- Consider possible unintended additive immunosuppressive effects before initiating treatment in patients taking anti-neoplastic, immunosuppressive, or immune-modulating therapies, or a history of prior use of these drugs.
- Initiating treatment with this drug after treatment with alemtuzumab is not recommended.
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
- Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
- Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended.
Reinitiation After Treatment Interruption:
If fewer than 4 consecutive doses are missed:
- During titration: Resume treatment with the first missed titration dose and resume the titration schedule at that dose and titration day.
- During maintenance: Resume treatment with the maintenance dosage.
If 4 or more consecutive doses are missed during titration or maintenance:
- Treatment should be reinitiated with Day 1 of the titration regimen with a new starter pack and complete first-dose 4-hour monitoring as appropriate.
- Patients who in the last 6 months, have experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure.
- Patient who have presence of Mobitz type II second-degree, third-degree atrioventricular (AV) block, or sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
This drug has a high plasma protein binding (greater than 99%); therefore, dialysis is not expected to alter the total and unbound drug concentration, and no dose adjustments are anticipated based on these considerations.
- Take with or without food.
- Swallow the tablets whole.
- Start taking this drug with a 14-day starter pack.
- If you miss taking 1, 2, or 3 tablets in a row 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 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 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 and do not restart this drug 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 this drug so you will know if you miss 4 or more doses in a row.
- Store in the original package at 20C to 25C (68F to 77F); excursions permitted from 15C to 30C (59F to 86F)
- Keep desiccant in the maintenance dose bottle to protect from moisture
- Monitor patients for 4 hours after the first dose for signs and symptoms of bradycardia with at least hourly pulse and blood pressure measurements.
- Continue monitoring after the initial 4 hours if heart rate is less than 45 bpm, is at the lowest value postdose, or a new onset second-degree or higher AV block shows in the ECG or monitoring until these abnormalities are resolved.
- Monitor for infection during treatment and for 1 to 2 weeks after the last dose.
- Monitor for Blood pressure during treatment as appropriate.
- Monitor for suspicious skin lesions as appropriate, particularly for patients at risk for skin cancer.
- Read the patient-approved Medication Guide.
- Advise patients not to discontinue this drug without the prescriber's approval.
- Advise patients to contact their healthcare provider if they accidentally take more drug than prescribed.
- Inform patients that this drug may increase the risks of infections.
- Advise patients to avoid vaccines containing live virus (live attenuated vaccines) during treatment and to pause this drug 1 week prior and until 4 weeks after a planned vaccination.
- Advise patients to postpone treatment with this drug for at least 1 month after varicella-zoster virus vaccination.
- Advise patients to contact their healthcare provider if symptoms of infection develop during or after stopping treatment.
- Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection.
- Advise patients to contact their healthcare provider if they experience new-onset or worsening of dyspnea.
- Advise patients that initiation of this drug results in a temporary decrease in heart rate and that to reduce this effect, dose titration is required.
- Advise patients that dose titration is also required if 4 or more consecutive daily doses are missed during treatment.
- Advise patients that they may be monitored for at least 4 hours after the first dose and after reinitiation if treatment is interrupted or discontinued for certain periods.
- Inform patients that this drug may increase liver enzymes.
- Advise patients that they should contact their healthcare provider if they experience any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine during treatment.
- Advise patients that any suspicious skin lesions should be promptly evaluated.
- Advise patients to limit exposure to sunlight and ultraviolet light by wearing protective clothing and using sunscreen with a high protection factor.
- Inform that this drug may cause fetal harm.
- Advise females of reproductive potential that they should use effective contraception during therapy and for at least one week after the final dose.
- Advise females patients to inform if they are pregnant or planning to become pregnant.
- Advise patients that this drug may cause macular edema, and to contact their healthcare provider if they experience any changes in their vision during treatment.
- Inform that the risk of macular edema is increased in patients with diabetes mellitus or a history of uveitis.
- Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure, and that delayed treatment could lead to permanent neurological damage.
- Inform patients that a severe increase in disability may occur after discontinuation and to contact their healthcare provider if they develop worsening symptoms of MS after discontinuation.
- Advise patients that they may experience side effects to this drug for 1 to 2 weeks after the last dose.
More about ponesimod
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- During pregnancy or Breastfeeding
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- Drug class: selective immunosuppressants
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