Adverse events reporting | Prescribing informationPONVORY® ▼ (ponesimod) ( ▼ This product is under additional monitoring)
• 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
After dose titration is complete, the recommended maintenance dosage is one 20 mg tablet taken once-daily1
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
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
The first dose of PONVORY® in a setting where resources to appropriately manage symptomatic bradycardia are available
Patients for 4 hours after the first dose for signs and symptoms of bradycardia with a minimum of hourly pulse and blood pressure measurements
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.
Obtain an ECG to determine whether pre-exisiting cardiac abnormalities are present. In patients with certain pre-existing conditions, advice from a cardiologist may be required to initiating PONVORY® and first-dose observation is recommended.
Review results of a CBC with differential White Blood Cell count (including lymphocyte count) within 6 months or after discontinuation of prior MS therapy.
Review results of transaminase and bilirubin levels obtained within the last 6 months.
Obtain an evaluation of the fundus, including the macula.
In women of childbearing potential, a negative pregnancy test must be obtained.
Perform a VZV antibody test, a VZV vaccination of antibody-negative patients is recommended prior to treatment initiation.
Treatment initiation should be delayed in patients with severe active infection until resolution.
If patients are taking anti-neoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects.
Determine whether patients are taking medicinal products that could slow down heart rate (HR) or atrioventicular (AV) conduction.
Refer to the SmPC for contraindications and a full list of requirements prior to initiation.
*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®.