ZEPOSIA Hard capsule Ref.[10643] Active ingredients: Ozanimod

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

Posology

The recommended dose is 0.92 mg ozanimod once daily.

The capsules can be taken with or without food.

The initial dose escalation regimen of ozanimod from Day 1 to Day 7 is required and shown below in Table 1. Following the 7-day dose escalation, the maintenance dose is 0.92 mg once daily, starting on Day 8.

Table 1. Dose escalation regimen:

Re-initiation of therapy following treatment interruption

The same dose escalation regimen described in Table 1 is recommended when treatment is interrupted for:

• 1 day or more during the first 14 days of treatment.
• more than 7 consecutive days between Day 15 and Day 28 of treatment.
• more than 14 consecutive days after Day 28 of treatment.

If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned.

Special populations

Adults over 55 years old and elderly population

There are limited data available on RRMS patients >55 years of age. Patients enrolled in the ongoing clinical trials continue to be dosed with 0.92 mg ozanimod daily after they become 55 and older (see sections 5.1 and 5.2). No dose adjustment is needed in patients over 55 years of age. Caution should be used in patients >55 years of age, given the potential for an increased risk of adverse reactions in this population, especially with long-term treatment.

Renal impairment

No dose adjustment is necessary for patients with renal impairment.

Hepatic impairment

No dose adjustment is necessary for patients with mild or moderate hepatic impairment (Child-Pugh class A and B).

Ozanimod was not evaluated in patients with severe hepatic impairment. Therefore, patients with severe hepatic impairment (Child-Pugh class C) must not be treated with ozanimod (see sections 4.3 and 5.2).

Paediatric population

The safety and efficacy of Zeposia in children and adolescents aged below 18 years have not yet been established. No data are available.

Method of administration

Oral use.

In patients with overdosage of ozanimod, monitor for signs and symptoms of bradycardia, which may include overnight monitoring. Regular measurements of HR and blood pressure are required, and ECGs should be performed (see sections 4.4 and 5.1). The decrease in HR induced by ozanimod can be reversed by parenteral atropine or isoprenaline.

3 years.

Do not store above 25°C.

Polyvinyl chloride (pVC)/polychlorotrifluoroethylene (PCTFE)/aluminium foil blisters.

Treatment initiation pack: Zeposia 0.23 mg and 0.46mg: Pack size of 7 hard capsules (4 × 0.23 mg, 3 × 0.46 mg).

Maintenance pack: Zeposia 0.92 mg. Pack size of 28 or 98 hard capsules.

Not all pack sizes may be marketed.

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