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Ponesimod oral

Updated 2 Feb 2023 | Ponesimod


Oral formulations containing ponesimod.

Drugs List

  • ponesimod 20mg tablets
  • ponesimod treatment initiation pack 2mg+3mg+4mg+5mg+6mg+7mg+8mg+9mg+10mg tablets
  • PONVORY 20mg tablets
  • PONVORY TREATMENT INITIATION PACK 2mg+3mg+4mg+5mg+6mg+7mg+8mg+9mg+10mg tablets
  • Therapeutic Indications


    Treatment of relapsing-remitting multiple sclerosis



    Initial dose
    Dose titration regimen
    Day 1 and 2: 2mg once daily
    Day 3 and 4: 3mg once daily
    Day 5 and 6: 4mg once daily
    Day 7: 5mg once daily
    Day 8: 6mg once daily
    Day 9: 7mg once daily
    Day 10: 8mg once daily
    Day 11: 9mg once daily
    Day 12, 13 and 14: 10mg once daily

    Maintenance dose
    20mg once daily

    Additional Dosage Information

    Missed doses
    If less than 4 consecutive doses are missed, resume treatment with the first missed dose.
    If 4 or more consecutive doses are missed, reinitiate treatment with day 1 (2mg once daily) of the titration regimen.


    Children under 18 years
    Chronic infection
    Within 4 weeks of live viral or bacterial vaccination
    Cerebrovascular disorder
    Decompensated cardiac failure
    History of cardiac arrest
    History of cardiac failure
    Immunodeficiency syndromes
    Ischaemic heart disease
    Long QT syndrome
    Malignant neoplasm
    Moderate hepatic impairment
    New York Heart Association class III failure
    New York Heart Association class IV failure
    Non-paced sinus node dysfunction
    Second degree atrioventricular block
    Third degree atrioventricular block
    Torsade de pointes
    Uncontrolled hypertension
    Unstable angina
    Within 6 months of a myocardial infarction
    Within 6 months of a transient ischaemic attack

    Precautions and Warnings

    Family history of long QT syndrome
    Females of childbearing potential
    Atrial fibrillation
    Atrial flutter
    Diabetes mellitus
    Electrolyte imbalance
    First degree atrioventricular block
    Glucose-galactose malabsorption syndrome
    History of severe hepatic disorder
    History of torsade de pointes
    Lactose intolerance
    Pulmonary fibrosis
    QTc interval greater than or equal to 500 msec
    Recurrent syncope
    Severe obstructive pulmonary disease
    Severe respiratory disease
    Sinus bradycardia

    Correct electrolyte disorders before treatment
    Obtain ECG 4 hours after first dose in patients with cardiac conditions
    Postpone treatment if there is active or suspected infection
    First dose may cause bradycardia and heart block
    Treatment to be initiated and supervised by a specialist
    Varicella vaccination recommended for antibody-negative patients
    Contains lactose
    Ensure negative pregnancy test in week preceding initiation of treatment
    Monitor serum transaminases before treatment
    Perform ECG before treatment
    Perform full blood count before treatment
    Discontinue treatment immediately if pregnancy is suspected
    If visual disturbances occur, perform ophthalmic evaluation
    Monitor bilirubin levels before treatment
    Monitor blood pressure regularly
    Monitor ECG in patients at risk of QT prolongation
    Monitor serum electrolytes
    May reduce effectiveness of vaccinations during treatment
    Risk of developing opportunistic infections
    Discontinue if AST or ALT level > 3x ULN and bilirubin > 2x ULN
    Discontinue if macular oedema occurs
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Interrupt therapy if lymphocyte count less than 0.2 x10 to the power of 9/L
    Interrupt treatment if severe infection develops
    Female: Contraception required during and for 1 week after treatment
    Advise patient to avoid exposure to direct sunlight

    Ponesimod treatment may result in a transient decrease in heart rate (HR) and atrioventricular (AV) conduction delays, an up-titration scheme must therefore be used to reach the maintenance dose of 20mg once daily.

    Temporary interruption of beta-blocker treatment may be needed prior to the initiation of ponesimod.

    Four hour monitoring following the first dose of ponesimod is recommended in patients with sinus bradycardia, first or second degree AV block, or history of myocardial infarction or heart failure occurring more than 6 months prior to treatment initiation and in a stable condition. Four hour monitoring for signs and symptoms of bradycardia should include a minimum of hourly pulse and blood pressure measurements. At the end of the 4 hour observation, obtain an ECG. Additional monitoring after the 4 hour period is required if:
    HR 4 hours post dose is less than 45 beats per minute,
    HR 4 hours post dose is at lowest value post dose, suggesting that the maximum pharmacodynamic effect on the heart may not have occurred or,
    The ECG 4 hours post dose shown new onset of second degree or higher AV block, continue to monitor until abnormalities are resolved. If pharmacological treatment is required, continue monitoring overnight and repeat 4 hour monitoring after the second dose.

    Treatment of ponesimod should be delayed for 4 weeks after vaccination to allow for full effect.

    Use immunosuppressants with caution up to a week after the last dose of ponesimod due to additive effect on the immune system.

    Perform regular examinations of the fundus, including the macula, prior to treatment initiation of ponesimod and follow up evaluations during therapy in patients with history of uveitis and patients with diabetes mellitus. This is due to an increase risk of macular oedema during therapy with S1P receptor modulators.

    Perform spirometry evaluation of respiratory function during therapy with ponesimod when clinically indicated.

    Monitor for hepatotoxicity if patient develops symptoms suggestive of hepatic dysfunction.

    Patients receiving ponesimod should not receive concomitant phototherapy with UV-B-radiation or PUVA-photochemotherapy.

    If unexpected neurological or psychiatric symptoms occur, complete physical and neurological examination and consider a MRI.

    Pregnancy and Lactation


    Ponesimod is contraindicated during pregnancy.

    Use of ponesimod during pregnancy is contraindicated by the manufacturer. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.


    Ponesimod is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking ponesimod. Animal data reports levels of ponesimod in the breast milk, however presence in human breast milk and the effects on exposed infants are unknown.

    Side Effects

    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Back pain
    Dry mouth
    Herpes zoster
    Increase in plasma cholesterol
    Increase of liver transaminases
    Increases in hepatic enzymes
    Joint swelling
    Ligament injury
    Macular oedema
    Painful extremities
    Raised C-reactive protein
    Reduced lymphocyte count
    Respiratory tract infection
    Upper respiratory tract infection
    Urinary tract infections
    Viral infection


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2021

    Reference Sources

    Summary of Product Characteristics: Ponvory 20mg film coated tablets. Janssen-Cilag Ltd. Revised July 2021.
    Summary of Product Characteristics: Ponvory 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg, 10mg film coated tablets (treatment initiation pack). Janssen-Cilag Ltd. Revised July 2021.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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