Zeposia

Indication and use

Zeposia is indicated for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS).

It is not known if Zeposia is safe and effective in children under age 18 or adults over 65.

Administration and dose

Zeposia is a 0.92 mg capsule taken orally once a day, with or without food.

Individuals must start Zeposia by slowly increasing doses over the first week using a 7-day starter pack following the dose schedule below. This may reduce the risk of slowing of the heart rate.

• Avoid certain foods that are high (over 150 mg) in tyramine such as aged, fermented, cured, smoked and pickled foods. Eating these foods while taking ZEPOSIA may increase your blood pressure.
• Do not stop taking Zeposia without talking with your healthcare provider first.
• Do not skip a dose.
• Start taking Zeposia with a 7-day starter pack.
• If you miss 1 or more days of your Zeposia dose during the first 14 days of treatment, talk to your healthcare provider. You will need to begin with another Zeposia 7-day starter pack.

Mechanism of action (MOA)

Although the exact mechanism of action for Zeposia in multiple sclerosis is not fully understood, it may involve the reduction of lymphocyte migration into the central nervous system. Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator that binds to S1P receptors 1 and 5. By binding to the S1P receptors, Zeposia prevents harmful immune cells – specifically B cells and T cells – from being activated and released from the lymph nodes and thymus gland into the blood circulation and, hence, the brain and spinal cord.

Side effects

Most common side effects - Upper respiratory infection, elevated liver enzymes, urinary tract infection, back pain, and changes to blood pressure (increase or decrease).

More serious side effects may include:

Infection: Zeposia may increase the risk of infections. Obtain a complete blood count (CBC) before starting treatment. Monitor for infection during treatment and for 3 months after discontinuation. Do not start treatment with Zeposia if you have an active infection.

Cardiac effects: Zeposia may result in a temporary decrease in heart rate; drug titration is required for treatment initiation. Complete an electrocardiogram (ECG) to assess for pre-existing cardiac conduction abnormalities before starting Zeposia. Consult a cardiologist for conduction abnormalities or concurrent use with other medications that decrease heart rate.

Liver damage: Obtain liver function tests before starting Zeposia. Discontinue treatment if significant liver injury is confirmed.

Fetal risk: Women of childbearing potential should use effective contraception during treatment and for 3 months after stopping Zeposia due to risk of the medication on the fetus.

Increased Blood Pressure (BP): monitor blood pressure during treatment

Respiratory function: May cause a decline in respiratory function. Have your respiratory function assessed if indicated by your physician. Macular Edema: A prompt ophthalmic evaluation is recommended if there is any change in vision while taking ZEPOSIA. Diabetes mellitus and uveitis increase the risk of macular edema; patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to starting treatment.

This is not a comprehensive list of all possible side effects of Zeposia. Please see the Zeposia product monograph for a list of other potentially serious side effects. It is important that individuals discuss side effects of any medication they are considering with their physician. (*Health Canada, product monograph for Zeposia.)

Clinical trials

RADIANCE was a combined phase II/III randomized, double-blind placebo-controlled clinical trial to assess the safety and efficacy of ozanimod in 258 individuals with RRMS. Participants were given oral ozanimod (0.5 mg or 1mg) daily, or a placebo for 24-weeks. RADIANCE met its primary endpoint of reduced number of lesions between weeks 12 and 24 of ozanimod treatment at both dosages. Secondary imaging outcomes including the number of lesions and new or enlarging lesions at 24 weeks were also reduced with ozanimod treatment compared to placebo. The RADIANCE clinical trial was extended to a phase III trial that recruited 1,313 individuals at 147 sites in 21 countries. Participants received either ozanimod (0.5 mg or 1mg) daily, a weekly injection of interferon beta-1a (Avonex), or placebo for two years. Both doses of ozanimod met the primary endpoint which was a reduction in the annualized relapse rate compared to interferon beta-1a.

SUNBEAM, a phase III randomized, double-blind clinical trial, assessed the efficacy, and safety of ozanimod (0.5 mg or 1mg) compared to interferon beta-1a over the course of 12-months.Researchers recruited 1,346 individuals with RRMS across 152 sites and 20 countries. The clinical trial met its primary endpoint of reducing annualized relapse rates compared with interferon beta-1a. Treatment with ozanimod also resulted in less new and enlarging lesions compared to interferon beta-1a.

In a pre-specified pooled analysis of the time to confirmed disability progression in both the RADIANCE and SUNBEAM trials, a very low rate of disability progression was observed across the treatment groups, though ozanimod did not reach statistical significance compared to Avonex®.

Cost reimbursement

The price of Zeposia is approximately $25,000 per year. Much of the cost can be reimbursed through private and group health plans for people who meet the prescribing criteria. For more information, speak to your healthcare provider.

Drug support program

be. Your Patient Support Program for Zeposia
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