PONVORY Film-coated tablet Ref.[27995] Active ingredients: Ponesimod

Treatment should be initiated under the supervision of a physician experienced in the management of multiple sclerosis.

Posology

Treatment initiation

Treatment must be started with the 14-day treatment initiation pack (see section 6.5). Treatment starts with one 2 mg tablet orally once daily on day 1 and dose-escalation progresses with the titration schedule outlined in Table 1.

Table 1. Dose titration regimen:

If dose titration is interrupted, missed dose instructions must be followed (see also section 4.2, “Re-initiation of therapy following treatment interruption during dose titration or maintenance period”).

Maintenance dose

After dose titration is complete (see also section 4.2, Treatment initiation), the recommended maintenance dose of Ponvory is one 20 mg tablet taken orally once daily.

Re-initiation of therapy following treatment interruption during dose titration or maintenance period:

• 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 (2 mg) of the titration regimen (new treatment initiation pack).

The same first dose monitoring as for treatment initiation is recommended when 4 or more consecutive doses of ponesimod are missed during the titration or maintenance periods.

Special populations

Elderly population

Clinical studies of ponesimod did not include patients aged 65 years and older. Ponesimod should be prescribed with caution in patients aged 65 years and over due to the lack of data on safety and efficacy.

Renal impairment

Based on clinical pharmacology studies, no dose adjustment is needed in patients with mild to severe renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A) (see section 5.2).

Ponvory is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh class B and C, respectively) (see sections 4.3, 5.2).

Paediatric population

The safety and efficacy of Ponvory in children and adolescents aged less than 18 years have not been established. No data are available.

Method of administration

Ponesimod should be administered orally once daily. Ponesimod can be taken with or without food (see section 5.2).

Symptoms and signs

In patients with overdose of ponesimod, especially upon initiation/re-initiation of treatment, it is important to observe for signs and symptoms of bradycardia as well as AV conduction blocks, which may include overnight monitoring. Regular measurements of pulse rate and blood pressure are required, and ECGs should be performed (see sections 4.4, 4.8 and 5.1).

Treatment

There is no specific antidote to ponesimod. Neither dialysis nor plasma exchange would result in meaningful removal of ponesimod from the body. The decrease in heart rate induced by ponesimod can be reversed by atropine.

In the event of overdose, ponesimod should be discontinued, and general supportive treatment given until clinical toxicity has been diminished or resolved. It is advisable to contact a poison control centre to obtain the latest recommendations for the management of an overdose.

4 years.

This medicinal product does not require any special storage conditions.

The Alu/alu blister with desiccant consists of a laminated Alu cold form film with integrated desiccant and a laminated Alu push-through lidding film.

Treatment initiation pack:

Each blister pack of 14 film-coated tablets for a 2-week treatment schedule contains:

2 film-coated tablets of 2 mg
2 film-coated tablets of 3 mg
2 film-coated tablets of 4 mg
1 film-coated tablet of 5 mg
1 film-coated tablet of 6 mg
1 film-coated tablet of 7 mg
1 film-coated tablet of 8 mg
1 film-coated tablet of 9 mg
3 film-coated tablets of 10 mg

Ponvory 20 mg film-coated tablets (maintenance pack):

Pack of 28 film-coated tablets or multipack containing 84 (3 packs of 28) film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.