Adverse events reporting | Prescribing informationPONVORY® ▼ (ponesimod) ( ▼ This product is under additional monitoring)
Getting started on PONVORY® is convenient with the 14-day treatment initiation pack
• Designed to simplify titration
• Once-daily oral tablets taken with or without food1
Dose titration is required for initiation of treatment with PONVORY® to mitigate first-dose cardiac effects2
MAINTENANCE DOSING:
After dose titration is complete, the recommended maintenance dosage is one 20 mg tablet taken once-daily1
Recommendations in the event that your patient misses a dose during initiation or maintenance1
resume treatment with the first missed dose1
reinitiate Day 1 of the dose titration (new treatment initiation pack)1†
† The same first-dose observation for treatment initiation is recommended when ≥4 consecutive doses are missed in patients with pre-existing cardiac conditions.1
First-dose observation is only recommended for select patients with pre-existing cardiac conditions1
Because initiation of PONVORY® treatment results in a decrease in heart rate (HR), first-dose 4-hour observation is recommended for patients with:1
• Sinus bradycardia(HR less than 55 beats per minute [bpm])
• First- or second-degree atrioventricular (AV) block Mobitz type 1 (Wenckebach)
• History of myocardial infarction or heart failure occurring more than 6 months prior to treatment initiation and in stable condition
For select patients who require first-dose observation1
ADMINISTER
The first dose of PONVORY® in a setting where resources to appropriately manage symptomatic bradycardia are available
MONITOR
Patients for 4 hours after the first dose for signs and symptoms of bradycardia with a minimum of hourly pulse and blood pressure measurements
OBTAIN
An ECG in these patients at the end of the 4-hour observation period
Extend first-dose monitoring until resolution of findings if at 4 hours post-dose:1
• HR is <45 bpm
• HR is at the lowest value post-dose
• ECG shows new onset second-degree or higher AV block
Please refer to the SmPC for more information on first-dose monitoring.
Before initiating, the following assessments are required1
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Refer to the SmPC for contraindications and a full list of requirements prior to initiation.
DISCOVER the convenience and flexibility of PONVORY®
SEE overall rates of treatment emergent adverse events vs teriflunomide from OPTIMUM
FIND OUT more about how PONVORY® works
ECG=electrocardiogram
*4-hour first-dose observation is recommended for patients with sinus bradycardia, first- or second-degree AV blocks, Mobitz type I (Wenckebach),
or a history of myocardial infarction or heart failure occurring more than 6 months prior to treatment initiation and in a stable condition.1
Refer to the SmPC for further details including when cardiologist advice should be obtained before initiation of PONVORY®.
References
- Ponvory Summary of Product Characteristics Available at: www.medicines.ie
- Kappos L, et al. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021;78(5):558-567. doi:10.1001/jamaneurol.2021.0405.
