| Prescribing informationPONVORY® (ponesimod) ( This product is under additional monitoring)

Getting started on PONVORY
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

Titration day

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

<4 consecutive doses are missed

resume treatment with the first missed dose1

>consecutive doses are missed

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

For select patients who require first-dose observation1

administer

ADMINISTER

The first dose of PONVORY® in a setting where resources to appropriately manage symptomatic bradycardia are available

monitor

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

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

TEST
RESULTS
TEST

Cardiac evaluations

RESULTS
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.
TEST

Complete Blood Count (CBC)

RESULTS
Review results of a CBC with differential White Blood Cell count (including lymphocyte count) within 6 months or after discontinuation of prior MS therapy.
TEST

Liver Function Tests (LFTs)

RESULTS
Review results of transaminase and bilirubin levels obtained within the last 6 months.
TEST

Ophthalmic evaluations

RESULTS
Obtain an evaluation of the fundus, including the macula.
TEST

Pregnancy test

RESULTS
In women of childbearing potential, a negative pregnancy test must be obtained.
TEST

Varicella Zoster Virus (VZV)

RESULTS
Perform a VZV antibody test, a VZV vaccination of antibody-negative patients is recommended prior to treatment initiation.
TEST

Severe active infections

RESULTS
Treatment initiation should be delayed in patients with severe active infection until resolution.
TEST

Current or prior medication history (including vaccinations)

RESULTS
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.
TEST

Concomitant medication

RESULTS
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.

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®.

  1. Ponvory Summary of Product Characteristics Available at: www.medicines.ie
  2. 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.