Zeposia (ozanimod) is a sphingosine 1-phosphate receptor modulator.
Zeposia is specifically indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Zeposia is supplied as a capsule for oral administration. Before initiation of treatment with Zeposia, assess the following:
The recommended dose of Zeposia is as follows:
Treatment Initiation: Initiate Zeposia with a 7-day titration according to this schedule:
Maintenance Dosage: After initial titration, the recommended maintenance dosage of Zeposia is 0.92 mg taken orally once daily starting on Day 8.
Zeposia capsules should be swallowed whole and can be administered with or without food.
If a dose of Zeposia is missed during the first 2 weeks of treatment, reinitiate treatment using the titration regimen.
If a dose of Zeposia is missed after the first 2 weeks of treatment, continue with the treatment as planned.
The FDA approval of Zeposia was based on the randomized, active-controlled Phase 3 SUNBEAM (safety and efficacy of Zeposia versus interferon beta-1a in relapsing multiple sclerosis) and RADIANCE (safety and efficacy of the selective sphingosine 1-phosphate receptor modulator Zeposia in relapsing multiple sclerosis) Part B clinical trials. Both head-to-head trials compared Zeposia to Avonex (interferon beta-1a).
SUNBEAM was a pivotal, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of oral Zeposia (0.92 mg, equivalent to 1 mg) against weekly intramuscular Avonex (interferon beta-1a) for at least a 12-month treatment period. The study included 1,346 people with RMS across 152 sites in 20 countries. The primary endpoint of the trial was annualized relapse rates (ARR) during the treatment period.
RADIANCE Part B was a pivotal, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of oral Zeposia (0.92 mg, equivalent to 1 mg) against weekly intramuscular Avonex (interferon beta-1a) over a 24-month treatment period. The study included 1,320 people with RMS across 150 sites in 21 countries. The primary endpoint of the trial was ARR over 24 months
There was no statistically significant difference in the three-month and six-month confirmed disability progression between ZEPOSIA- and AVONEX- treated patients over two years.
Adverse effects associated with the use of Zeposia may include, but are not limited to, the following:
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Ozanimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis is unknown but may involve the reduction of lymphocyte migration into the central nervous system.
For additional information regarding Zeposia or relapsing forms of multiple sclerosis, please visit the Zeposia web page.