Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
Treatment should be initiated under the supervision of a physician experienced in the management of multiple sclerosis (MS) or ulcerative colitis (UC).
The recommended dose is 0.92 mg ozanimod once daily.
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 once daily dose is 0.92 mg, starting on Day 8.
Table 1. Dose escalation regimen:
| Days 1–4 | 0.23 mg once daily |
| Days 5–7 | 0.46 mg once daily |
| Days 8 and thereafter | 0.92 mg once daily |
The same dose escalation regimen described in Table 1 is recommended when treatment is interrupted for:
If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned.
There are limited data available on RRMS patients >55 years of age and on UC patients ≥65 years of age. No dose adjustment is needed in patients over 55 years of age. Caution should be used in MS patients over 55 years and in UC patients over 65 years of age, given the limited data available and potential for an increased risk of adverse reactions in this population, especially with long-term treatment (see section 5.1 and 5.2).
No dose adjustment is necessary for patients with renal impairment.
Patients with mild or moderate chronic hepatic impairment (Child-Pugh class A or B) are recommended to complete the 7-day dose escalation regimen, and then take 0.92 mg once every other day (see section 5.2).
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).
The safety and efficacy of Zeposia in children and adolescents aged below 18 years have not yet been established. No data are available.
Oral use.
The capsules can be taken with or without food.
In patients with overdose 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 0.46 mg
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.
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