- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations containing ponesimod.
Treatment of relapsing-remitting multiple sclerosis
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
20mg once daily
Additional Dosage Information
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
Within 4 weeks of live viral or bacterial vaccination
Decompensated cardiac failure
History of cardiac arrest
History of cardiac failure
Ischaemic heart disease
Long QT syndrome
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
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
First degree atrioventricular block
Glucose-galactose malabsorption syndrome
History of severe hepatic disorder
History of torsade de pointes
QTc interval greater than or equal to 500 msec
Severe obstructive pulmonary disease
Severe respiratory disease
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
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.
Alanine aminotransferase increased
Aspartate aminotransferase increased
Increase in plasma cholesterol
Increase of liver transaminases
Increases in hepatic enzymes
Raised C-reactive protein
Reduced lymphocyte count
Respiratory tract infection
Upper respiratory tract infection
Urinary tract infections
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2021
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
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.